Publications by authors named "Pamela Duncan"

180 Publications

Economic Outcomes of Rehabilitation Therapy in Older Patients With Acute Heart Failure in the REHAB-HF Trial: A Secondary Analysis of a Randomized Clinical Trial.

JAMA Cardiol 2021 Nov 24. Epub 2021 Nov 24.

Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.

Importance: In the Rehabilitation Therapy in Older Acute Heart Failure Patients (REHAB-HF) trial, a novel 12-week rehabilitation intervention demonstrated significant improvements in validated measures of physical function, quality of life, and depression, but no significant reductions in rehospitalizations or mortality compared with a control condition during the 6-month follow up. The economic implications of these results are important given the increasing pressures for cost containment in health care.

Objective: To report the economic outcomes of the REHAB-HF trial and estimate the potential cost-effectiveness of the intervention.

Design, Setting, Participants: The multicenter REHAB-HF trial randomized 349 patients 60 years or older who were hospitalized for acute decompensated heart failure to rehabilitation intervention or a control group; patients were enrolled from September 17, 2014, through September 19, 2019. For this preplanned secondary analysis of the economic outcomes, data on medical resource use and quality of life (via the 5-level EuroQol 5-Dimension scores converted to health utilities) were collected. Medical resource use and medication costs were estimated using 2019 US Medicare payments and the Federal Supply Schedule, respectively. Cost-effectiveness was estimated using the validated Tools for Economic Analysis of Patient Management Interventions in Heart Failure Cost-Effectiveness Model, which uses an individual-patient simulation model informed by the prospectively collected trial data. Data were analyzed from March 24, 2019, to December 1, 2020.

Interventions: Rehabilitation intervention or control.

Main Outcomes And Measures: Costs, quality-adjusted life-years (QALYs), and the lifetime estimated cost per QALY gained (incremental cost-effectiveness ratio).

Results: Among the 349 patients included in the analysis (183 women [52.4%]; mean [SD] age, 72.7 [8.1] years; 176 non-White [50.4%] and 173 White [49.6%]), mean (SD) cumulative costs per patient were $26 421 ($38 955) in the intervention group (excluding intervention costs) and $27 650 ($30 712) in the control group (difference, -$1229; 95% CI, -$8159 to $6394; P = .80). The mean (SD) cost of the intervention was $4204 ($2059). Quality of life gains were significantly greater in the intervention vs control group during 6 months (mean utility difference, 0.074; P = .001) and sustained beyond the 12-week intervention. Incremental cost-effectiveness ratios were estimated at $58 409 and $35 600 per QALY gained for the full cohort and in patients with preserved ejection fraction, respectively.

Conclusions And Relevance: These analyses suggest that longer-term benefits of this novel rehabilitation intervention, particularly in the subgroup of patients with preserved ejection fraction, may yield good value to the health care system. However, long-term cost-effectiveness is currently uncertain and dependent on the assumption that benefits are sustained beyond study follow-up, which needs to be corroborated in future trials in this patient population.
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http://dx.doi.org/10.1001/jamacardio.2021.4836DOI Listing
November 2021

Skilled Nursing and Inpatient Rehabilitation Facility Use by Medicare Fee-for-Service Beneficiaries s Discharged Home following a Stroke: Findings from the COMPASS Trial.

Arch Phys Med Rehabil 2021 Nov 2. Epub 2021 Nov 2.

Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, 135 Dauer Dr, Chapel Hill, NC, 27599.

Objectives: To examine the effect of a comprehensive transitional care model on the utilization of skilled nursing facility (SNF) and inpatient rehabilitation facility (IRF) care in the 12 months after acute care discharge home following stroke; and to identify predictors of experiencing a SNF or IRF admission following discharge home after stroke.

Design: Cluster randomized pragmatic trial Setting: 41 acute care hospitals in North Carolina.

Participants: 2,262 Medicare fee-for-service beneficiaries with transient ischemic attack or stroke discharged home. The sample was 80.3% White and 52.1% female, with a mean (standard deviation [SD]) age of 74.9 (10.2) years and a mean (SD) NIH stroke scale score of 2.3 (3.7).

Intervention: Comprehensive transitional care model (COMPASS-TC) which consisted of a 2-day follow-up phone call from the post-acute care coordinator (PAC) and 14-day in-person visit with the PAC and advanced practice provider.

Main Outcome Measures: Time to first SNF or IRF and SNF or IRF admission (yes/no) in the 12 months following discharge home. All analyses utilized multivariable mixed models including a hospital-specific random effect to account for the non-independence of measures within hospital. Intent to treat analyses using Cox proportional hazards regression assessed the effect of COMPASS-TC on time to SNF/IRF admission. Logistic regression was used to identify clinical and non-clinical predictors of SNF/IRF admission.

Results: Only 34% of patients in the intervention arm received COMPASS-TC per protocol. COMPASS-TC was not associated with a reduced hazard of a SNF/ IRF admission in the 12 months post-discharge (HR=1.20 [0.95 - 1.52]) compared to usual care. This estimate was robust to additional covariate adjustment (HR=1.23 [0.93-1.64]). Both clinical and non-clinical factors (i.e., insurance, geography) were predictors of SNF/IRF use.

Conclusions: COMPASS-TC was not consistently incorporated into real-world clinical practice. The use of a comprehensive transitional care model for patients discharged home after stroke was not associated with SNF or IRF admissions in a 12-month follow-up period. Non-clinical factors predictive of SNF/IRF use suggest potential issues with access to this type of care.
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http://dx.doi.org/10.1016/j.apmr.2021.10.015DOI Listing
November 2021

Hospital Readmissions and Mortality Among Fee-for-Service Medicare Patients With Minor Stroke or Transient Ischemic Attack: Findings From the COMPASS Cluster-Randomized Pragmatic Trial.

J Am Heart Assoc 2021 Nov 3:e023394. Epub 2021 Nov 3.

Department of Neurology Wake Forest Baptist Health Winston-Salem NC.

Background Mortality and hospital readmission rates may reflect the quality of acute and postacute stroke care. Our aim was to investigate if, compared with usual care (UC), the COMPASS-TC (Comprehensive Post-Acute Stroke Services Transitional Care) intervention (INV) resulted in lower all-cause and stroke-specific readmissions and mortality among patients with minor stroke and transient ischemic attack discharged from 40 diverse North Carolina hospitals from 2016 to 2018. Methods and Results Using Medicare fee-for-service claims linked with COMPASS cluster-randomized trial data, we performed intention-to-treat analyses for 30-day, 90-day, and 1-year unplanned all-cause and stroke-specific readmissions and all-cause mortality between INV and UC groups, with 90-day unplanned all-cause readmissions as the primary outcome. Effect estimates were determined via mixed logistic or Cox proportional hazards regression models adjusted for age, sex, race, stroke severity, stroke diagnosis, and documented history of stroke. The final analysis cohort included 1069 INV and 1193 UC patients (median age 74 years, 80% White, 52% women, 40% with transient ischemic attack) with median length of hospital stay of 2 days. The risk of unplanned all-cause readmission was similar between INV versus UC at 30 (9.9% versus 8.7%) and 90 days (19.9% versus 18.9%), respectively. No significant differences between randomization groups were seen in 1-year all-cause readmissions, stroke-specific readmissions, or mortality. Conclusions In this pragmatic trial of patients with complex minor stroke/transient ischemic attack, there was no difference in the risk of readmission or mortality with COMPASS-TC relative to UC. Our study could not conclusively determine the reason for the lack of effectiveness of the INV. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT02588664.
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http://dx.doi.org/10.1161/JAHA.121.023394DOI Listing
November 2021

Physical Rehabilitation in Older Patients Hospitalized with Acute Heart Failure and Diabetes: Insights from REHAB-HF.

Am J Med 2021 Sep 10. Epub 2021 Sep 10.

Department of Medicine, Division of Cardiology, Duke University School of Medicine, Durham, NC. Electronic address:

Background: Prior studies showed an attenuated response to exercise training among patients with heart failure and type 2 diabetes mellitus. We explored the interaction between diabetes status and a novel, transitional, tailored, progressive rehabilitation intervention that improved physical function compared with usual care in the Rehabilitation Therapy in Older Acute Heart Failure Patients (REHAB-HF) trial.

Methods: The effect of the intervention on 3-month Short Physical Performance Battery (SPPB) (primary endpoint), 6-minute walk distance (6MWD), modified Fried frailty criteria, and quality-of-life scores (Kansas City Cardiomyopathy Questionnaire [KCCQ] and EuroQoL Visual Analogue Scale [VAS]) was compared between participants with and without diabetes. Differences in 6-month clinical outcomes were also explored.

Results: Of the 349 participants enrolled in REHAB-HF, 186 (53%) had diabetes. The prevalence of diabetes was higher in the intervention group (59% vs 48%). Participants with diabetes had worse baseline physical function by the SPPB and 6MWD, but similar frailty and quality-of-life scores. There was a consistent improvement with the intervention for 3-month SPPB, 6MWD, and VAS regardless of diabetes status (all interaction P value > .6), but participants with diabetes had significantly less improvement for frailty (P = .021) and a trend toward lower improvement in KCCQ (P = .11). There was no significant interaction by diabetes status for 6-month clinical event outcomes (all interaction P value > .3).

Conclusions: Participants with diabetes had worse baseline physical function but showed similar clinically meaningful improvements from the intervention. There was less benefit for frailty with the intervention in participants with diabetes.
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http://dx.doi.org/10.1016/j.amjmed.2021.08.001DOI Listing
September 2021

Rapid Implementation of Outpatient Teleneurology in Rural Appalachia: Barriers and Disparities.

Neurol Clin Pract 2021 Jun;11(3):232-241

Wake Forest School of Medicine (RES, LS, KD, AS, ST, AA, AMT, CO, LDS, MSC, HMC, JM, ME, CT); and Wake Forest Baptist Medical Center (RG, AG, RW, PD), Winston-Salem, NC.

Objective: To describe rapid implementation of telehealth during the COVID-19 pandemic and assess for disparities in video visit implementation in the Appalachian region of the United States.

Methods: A retrospective cohort of consecutive patients seen in the first 4 weeks of telehealth implementation was identified from the Neurology Ambulatory Practice at a large academic medical center. Telehealth visits defaulted to video, and when unable, phone-only visits were scheduled. Patients were divided into 2 groups based on the telehealth visit type: video or phone only. Clinical variables were collected from the electronic medical record including age, sex, race, insurance status, indication for visit, and rural-urban status. Barriers to scheduling video visits were collected at the time of scheduling. Patient satisfaction was obtained by structured postvisit telephone call.

Results: Of 1,011 telehealth patient visits, 44% were video and 56% phone only. Patients who completed a video visit were younger (39.7 vs 48.4 years, < 0.001), more likely to be female (63% vs 55%, < 0.007), be White or Caucasian ( = 0.024), and not have Medicare or Medicaid insurance ( < 0.001). The most common barrier to scheduling video visits was technology limitations (46%). Although patients from rural and urban communities were equally likely to be scheduled for video visits, patients from rural communities were more likely to consider future telehealth visits (55% vs 42%, = 0.05).

Conclusion: Rapid implementation of ambulatory telemedicine defaulting to video visits successfully expanded video telehealth. Emerging disparities were revealed, as older, male, Black patients with Medicare or Medicaid insurance were less likely to complete video visits.
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http://dx.doi.org/10.1212/CPJ.0000000000000906DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8382377PMC
June 2021

Rehabilitation Intervention in Older Patients With Acute Heart Failure With Preserved Versus Reduced Ejection Fraction.

JACC Heart Fail 2021 10 7;9(10):747-757. Epub 2021 Jul 7.

Section on Cardiovascular Medicine, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA; Sections on Geriatrics, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA. Electronic address:

Objectives: This study assessed for treatment interactions by ejection fraction (EF) subgroup (≥45% [heart failure with preserved ejection fraction (HFpEF); vs <45% [heart failure with reduced ejection fraction (HFrEF)]).

Background: The REHAB-HF trial showed that an early multidomain rehabilitation intervention improved physical function, frailty, quality-of-life, and depression in older patients hospitalized with acute decompensated heart failure (ADHF).

Methods: Three-month outcomes were: Short Physical Performance Battery (SPPB), 6-min walk distance (6MWD), and Kansas City Cardiomyopathy Questionnaire (KCCQ). Six-month end points included all-cause rehospitalization and death and a global rank of death, all-cause rehospitalization, and SPPB. Prespecified significance level for interaction was P ≤ 0.1.

Results: Among 349 total participants, 185 (53%) had HFpEF and 164 (47%) had HFrEF. Compared with HFrEF, HFpEF participants were more often women (61% vs 43%) and had significantly worse baseline physical function, frailty, quality of life, and depression. Although interaction P values for 3-month outcomes were not significant, effect sizes were larger for HFpEF vs HFrEF: SPPB +1.9 (95% CI: 1.1-2.6) vs +1.1 (95% CI: 0.3-1.9); 6MWD +40 meters (95% CI: 9 meters-72 meters) vs +27 (95% CI: -6 meters to 59 meters); KCCQ +9 (2-16) vs +6 (-2 to 14). All-cause rehospitalization rate was nominally lower with intervention in HFpEF but not HFrEF [effect size 0.83 (95% CI: 0.64-1.09) vs 0.99 (95% CI: 0.74-1.33); interaction P = 0.40]. There were significantly greater treatment benefits in HFpEF vs HFrEF for all-cause death [interaction P = 0.08; intervention rate ratio 0.63 (95% CI: 0.25-1.61) vs 2.21 (95% CI: 0.78-6.25)], and the global rank end point (interaction P = 0.098) with benefit seen in HFpEF [probability index 0.59 (95% CI: 0.50-0.68)] but not HFrEF.

Conclusions: Among older patients hospitalized with ADHF, compared with HFrEF those with HFpEF had significantly worse impairments at baseline and may derive greater benefit from the intervention. (A Trial of Rehabilitation Therapy in Older Acute Heart Failure Patients [REHAB-HF]; NCT02196038).
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http://dx.doi.org/10.1016/j.jchf.2021.05.007DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8487922PMC
October 2021

Telerehabilitation: Has Its Time Come?

Stroke 2021 Aug 1;52(8):2694-2696. Epub 2021 Jul 1.

Florey Institute of Neuroscience and Mental Health, Melbourne, Australia (J.B.).

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http://dx.doi.org/10.1161/STROKEAHA.121.033289DOI Listing
August 2021

Physical Rehabilitation for Older Patients Hospitalized for Heart Failure.

N Engl J Med 2021 07 16;385(3):203-216. Epub 2021 May 16.

From the Department of Internal Medicine, Sections of Cardiovascular Medicine (D.W.K., M.B.N., B.U.) and Gerontology and Geriatric Medicine (D.W.K., M.A.E.), and the Departments of Neurology (P.D.) and Biostatistics and Data Science (H.C., M.A.E.), Wake Forest School of Medicine, Winston-Salem, the Department of Orthopedic Surgery, Doctor of Physical Therapy Division (A.M.P.), the Department of Medicine, Division of Cardiology (R.J.M.), and the Department of Population Health Sciences (S.D.R.), Duke University School of Medicine, Durham, and Novant Health Heart and Vascular Institute, Charlotte (G.R.R.) - all in North Carolina; the Department of Medicine, Sidney Kimmel Medical College at Thomas Jefferson University (D.J.W.), and the Department of Physical Therapy, Jefferson College of Rehabilitation Sciences at Thomas Jefferson University (L.A.H.) - both in Philadelphia; and Inova Heart and Vascular Institute, Fairfax, VA (C.M.O.).

Background: Older patients who are hospitalized for acute decompensated heart failure have high rates of physical frailty, poor quality of life, delayed recovery, and frequent rehospitalizations. Interventions to address physical frailty in this population are not well established.

Methods: We conducted a multicenter, randomized, controlled trial to evaluate a transitional, tailored, progressive rehabilitation intervention that included four physical-function domains (strength, balance, mobility, and endurance). The intervention was initiated during, or early after, hospitalization for heart failure and was continued after discharge for 36 outpatient sessions. The primary outcome was the score on the Short Physical Performance Battery (total scores range from 0 to 12, with lower scores indicating more severe physical dysfunction) at 3 months. The secondary outcome was the 6-month rate of rehospitalization for any cause.

Results: A total of 349 patients underwent randomization; 175 were assigned to the rehabilitation intervention and 174 to usual care (control). At baseline, patients in each group had markedly impaired physical function, and 97% were frail or prefrail; the mean number of coexisting conditions was five in each group. Patient retention in the intervention group was 82%, and adherence to the intervention sessions was 67%. After adjustment for baseline Short Physical Performance Battery score and other baseline characteristics, the least-squares mean (±SE) score on the Short Physical Performance Battery at 3 months was 8.3±0.2 in the intervention group and 6.9±0.2 in the control group (mean between-group difference, 1.5; 95% confidence interval [CI], 0.9 to 2.0; P<0.001). At 6 months, the rates of rehospitalization for any cause were 1.18 in the intervention group and 1.28 in the control group (rate ratio, 0.93; 95% CI, 0.66 to 1.19). There were 21 deaths (15 from cardiovascular causes) in the intervention group and 16 deaths (8 from cardiovascular causes) in the control group. The rates of death from any cause were 0.13 and 0.10, respectively (rate ratio, 1.17; 95% CI, 0.61 to 2.27).

Conclusions: In a diverse population of older patients who were hospitalized for acute decompensated heart failure, an early, transitional, tailored, progressive rehabilitation intervention that included multiple physical-function domains resulted in greater improvement in physical function than usual care. (Funded by the National Institutes of Health and others; REHAB-HF ClinicalTrials.gov number, NCT02196038.).
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http://dx.doi.org/10.1056/NEJMoa2026141DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8353658PMC
July 2021

How engagement of a diverse set of stakeholders shaped the design, implementation, and dissemination of a multicenter pragmatic trial of stroke transitional care: The COMPASS study.

J Clin Transl Sci 2020 Nov 5;5(1):e60. Epub 2020 Nov 5.

Wake Forest School of Medicine, Department of Neurology, Winston-Salem, NC, USA.

Evidence is limited on how to synthesize and incorporate the views of stakeholders into a multisite pragmatic trial and how much academic teams change study design and protocol in response to stakeholder input. This qualitative study describes how stakeholders contributed to the design, conduct, and dissemination of findings of a multisite pragmatic clinical trial, the COMprehensive Post-Acute Stroke Services (COMPASS) Study. We engaged stakeholders as integral research partners by embedding them in study committees and community resource networks that supported local sites. Data stemmed from formal focus groups and continuous participation in working groups. Guided by Grounded Theory, we extracted themes from focus group and meeting notes. These were discussed as a team and with other stakeholder groups for feasibility. A consensus approach was used. Stakeholder input changed many aspects of the study including: the care model that treated stroke as a chronic condition after hospital discharge, training for hospital-based providers who often lacked awareness of the barriers to recovery that patients face, support for caregivers who were essential for stroke patients' recovery, and for community-based health and social service providers whose services can support recovery yet often go underutilized. Stakeholders brought value to both pragmatic research and health service delivery. Future studies should test the impact of elements of study implementation informed by stakeholders vs those that are not.
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http://dx.doi.org/10.1017/cts.2020.552DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8057438PMC
November 2020

Examining brief and ultra-brief anxiety and depression screening methods in a real-world epilepsy clinic sample.

Epilepsy Behav 2021 05 8;118:107943. Epub 2021 Apr 8.

Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, NC, USA. Electronic address:

Objective: Recent epilepsy quality measure recommendations for depression and anxiety screening endorse ultra-brief screeners, the Patient Health Questionnaire-2 (PHQ-2) and Generalized Anxiety Disorder-2 (GAD-2). Thus, it is important to assess how symptom detection may be affected using ultra-brief screeners compared with slightly longer, well-validated instruments: Neurological Disorders Depression Inventory-Epilepsy (NDDI-E) and Generalized Anxiety Disorder-7 (GAD-7). The objective was to compare symptom detection by brief versus ultra-brief depression and anxiety screeners in a large real-world epilepsy clinic sample.

Methods: This was a prospective, cross-sectional assessment of consecutive patients in an adult tertiary epilepsy practice who completed the GAD-7 and NDDI-E with embedded ultra-brief scales (GAD-2; GAD-Single Item: GAD-SI; NDDI-E 2 item: NDDIE-2) on a tablet and had clinic staff administered ultra-brief PHQ-2 (yes/no version) documented in the medical record at the same visit. Prevalences of positive anxiety and depression screens were calculated for each instrument overall, and by epilepsy status. Concordance correlation coefficients (CCC) were calculated comparing the ultra-brief with brief anxiety and depression instruments, and receiver operating curves (ROC) were calculated using the longer instruments as alternative standards.

Results: Among N = 422 individuals the prevalence of positive anxiety screen by GAD-7 was 24% and positive depression screen by NDDI-E was 20%. Positive anxiety and depression screens were significantly less prevalent among seizure-free individuals than those with continued seizures. The verbally administered yes/no PHQ-2 had only 1 positive screen (0.2%). Other than poor concordance between the PHQ-2 and NDDI-E, the screener pairs had acceptable concordance (CCC 0.79 to 0.92). Areas under the ROC curves were acceptable for the NDDIE-2, GAD-2 and GAD-SI (0.96, 0.98, and 0.89, respectively).

Significance: In this sample, clinic staff interview-administered yes/no PHQ-2 had exceedingly low sensitivity compared with the NDDI-E self-reported on a tablet. Further investigation is warranted to assess if poor detection is due to characteristics of this PHQ-2 in epilepsy samples, or method of administration in this clinic. The other ultra-brief anxiety and depression instruments demonstrated good concordance with the longer, well-validated instruments and may be useful in clinical practice.
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http://dx.doi.org/10.1016/j.yebeh.2021.107943DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8477167PMC
May 2021

Relationship of physical function with quality of life in older patients with acute heart failure.

J Am Geriatr Soc 2021 07 10;69(7):1836-1845. Epub 2021 Apr 10.

Section of Cardiovascular Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina, United States.

Background: Older patients with acute decompensated heart failure (ADHF) have severely impaired physical function (PF) and quality of life (QOL). However, relationships between impairments in PF and QOL are unknown but are relevant to clinical practice and trial design.

Methods: We assessed 202 consecutive patients hospitalized with ADHF in the multicenter Rehabilitation Therapy in Older Acute HF Patients (REHAB-HF) Trial. PF measures included Short Physical Performance Battery (SPPB) and 6-min walk distance (6MWD). Disease-specific QOL was assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ). General QOL was assessed by the Short Form-12 (SF-12) and EuroQol-5D-5L. PF was evaluated as a predictor of QOL using stepwise regression adjusted for age, sex, race, and New York Heart Association class.

Results: Participants were 72 ± 8 years, 54% women, 55% minority race, 52% with reduced ejection fraction, and body mass index 33 ± 9 kg/m . Participants had severe impairments in PF (6MWD 185 ± 99 m, SPPB 6.0 ± 2.5 units) and disease-specific QOL (KCCQ Overall Score 41 ± 21 and Physical Score 47 ± 24) and general QOL (SF-12 Physical Score 28 ± 9 and EuroQol Visual Analog Scale 57 ± 23). There were modest, statistically significant correlations between 6MWD and KCCQ Overall, KCCQ Physical Limitation, and SF-12 Physical Scores (r = 0.23, p < 0.001; r = 0.30, p < 0.001; and r = 0.24, p = 0.001, respectively); and between SPPB and KCCQ Physical and SF-12 Physical Scores (r = 0.20, p = 0.004, and r = 0.19, p = 0.007, respectively). Both 6MWD and SPPB were correlated with multiple components of the EuroQol-5D-5L. 6MWD was a significant, weak predictor of KCCQ Overall Score and SF-12 Physical Score (estimate = 0.05 ± 0.01, p < 0.001 and estimate = 0.05 ± 0.02, p = 0.012, respectively). SPPB was a significant, weak predictor of KCCQ Physical Score and SF-12 Physical Score (estimate = 1.37 ± 0.66, p = 0.040 and estimate = 0.54 ± 0.25, p = 0.030, respectively).

Conclusion: In older, hospitalized ADHF patients, PF and QOL are both severely impaired but are only modestly related, suggesting that PF and QOL provide complementary information and assessment of both should be considered to fully assess clinically meaningful patient-oriented outcomes.
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http://dx.doi.org/10.1111/jgs.17156DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8273137PMC
July 2021

Hospital to Home Transition for Patients With Stroke Under Bundled Payments.

Arch Phys Med Rehabil 2021 08 1;102(8):1658-1664. Epub 2021 Apr 1.

Department of Health Policy and Management, Gillings School of Global Public Health, the University of North Carolina at Chapel Hill, Chapel Hill, NC.

Bundled payments are a promising alternative payment model for reducing costs and improving the coordination of postacute stroke care, yet there is limited evidence supporting the effectiveness of bundled payments for stroke. This may be due to the lack of effective strategies to address the complex needs of stroke survivors. In this article, we describe COMprehensive Post-Acute Stroke Services (COMPASS), a comprehensive transitional care intervention focused on discharge from the acute care setting to home. COMPASS may serve as a potential care redesign strategy under bundled payments for stroke, such as the Centers for Medicare & Medicaid Innovation Bundled Payment for Care Improvement Initiative. The COMPASS care model is aligned with the incentive structures and essential components of bundled payments in terms of care coordination, patient assessment, patient and family involvement, and continuity of care. Ongoing evaluation will inform the design of incorporating COMPASS-like transitional care interventions into a stroke bundle.
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http://dx.doi.org/10.1016/j.apmr.2021.03.010DOI Listing
August 2021

Comprehensive Stroke Care and Outcomes: Time for a Paradigm Shift.

Stroke 2021 01 22;52(1):385-393. Epub 2020 Dec 22.

Department of Rehabilitation Medicine, Cornell University, Weill Cornell Medical College, New York, NY (J.S.).

Worldwide, stroke is prevalent, costly, and disabling in >80 million survivors. The burden of stroke is increasing despite incredible progress and advancements in evidence-based acute care therapies and despite the substantial changes being made in acute care stroke systems, processes, and quality metrics. Although there has been increased global emphasis on the importance of postacute stroke care, stroke system changes have not expanded to include postacute care and outcome follow-up. Our objectives are to describe the gaps and challenges in postacute stroke care and suboptimal stroke outcomes; to report on stroke survivors' and caregivers' perceptions of current postacute stroke care and their call for improvements in follow-up services for recovery and secondary prevention; and, ultimately, to make the case that a paradigm shift is needed in the definition of comprehensive stroke care and the designation of Comprehensive Stroke Center. Three recommendations are made for a paradigm shift in comprehensive stroke care: (1) criteria should be established for designation of rehabilitation readiness for Comprehensive Stroke Centers, (2) The American Heart Association/American Stroke Association implement an expanded Get With The Guidelines-Stroke program and criteria for comprehensive stroke centers to be inclusive of rehabilitation readiness and measure outcomes at 90 days, and (3) a public health campaign should be launched to offer hopeful and actionable messaging for secondary prevention and recovery of function and health. Now is the time to honor the patients' and caregivers' strongest ask: better access and improved secondary prevention, stroke rehabilitation, and personalized care.
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http://dx.doi.org/10.1161/STROKEAHA.120.029678DOI Listing
January 2021

The Cost of Implementing and Sustaining the COMprehensive Post-Acute Stroke Services Model.

Med Care 2021 02;59(2):163-168

Department of Health Policy and Management, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill.

Background: The COMprehensive Post-Acute Stroke Services (COMPASS) model, a transitional care intervention for stroke patients discharged home, was tested against status quo postacute stroke care in a cluster-randomized trial in 40 hospitals in North Carolina. This study examined the hospital-level costs associated with implementing and sustaining COMPASS.

Methods: Using an activity-based costing survey, we estimated hospital-level resource costs spent on COMPASS-related activities during approximately 1 year. We identified hospitals that were actively engaged in COMPASS during the year before the survey and collected resource cost estimates from 22 hospitals. We used median wage data from the Bureau of Labor Statistics and COMPASS enrollment data to estimate the hospital-level costs per COMPASS enrollee.

Results: Between November 2017 and March 2019, 1582 patients received the COMPASS intervention across the 22 hospitals included in this analysis. Average annual hospital-level COMPASS costs were $2861 per patient (25th percentile: $735; 75th percentile: $3,475). Having 10% higher stroke patient volume was associated with 5.1% lower COMPASS costs per patient (P=0.016). About half (N=10) of hospitals reported postacute clinic visits as their highest-cost activity, while a third (N=7) reported case ascertainment (ie, identifying eligible patients) as their highest-cost activity.

Conclusions: We found that the costs of implementing COMPASS varied across hospitals. On average, hospitals with higher stroke volume and higher enrollment reported lower costs per patient. Based on average costs of COMPASS and readmissions for stroke patients, COMPASS could lower net costs if the model is able to prevent about 6 readmissions per year.
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http://dx.doi.org/10.1097/MLR.0000000000001462DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8594619PMC
February 2021

Movement Matters, and So Does Context: Lessons Learned From Multisite Implementation of the Movement Matters Activity Program for Stroke in the Comprehensive Postacute Stroke Services Study.

Arch Phys Med Rehabil 2021 03 22;102(3):532-542. Epub 2020 Oct 22.

University of Pittsburgh School of Health and Rehabilitation Science, Pittsburgh, Pennsylvania.

The purpose of this Special Communication is to discuss the rationale and design of the Movement Matters Activity Program for Stroke (MMAP) and explore implementation successes and challenges in home health and outpatient therapy practices across the stroke belt state of North Carolina. MMAP is an interventional component of the Comprehensive Postacute Stroke Services Study, a randomized multicenter pragmatic trial of stroke transitional care. MMAP was designed to maximize survivor health, recovery, and functional independence in the community and to promote evidence-based rehabilitative care. MMAP provided training, tools, and resources to enable rehabilitation providers to (1) prescribe physical activity and exercise according to evidence-based guidelines and programs, (2) match service setting and parameters with survivor function and benefit coverage, and (3) align treatment with quality metric reporting to demonstrate value-based care. MMAP implementation strategies were aligned with the Expert Recommendations for Implementing Change project, and MMAP site champion and facilitator survey feedback were thematically organized into the Consolidated Framework for Implementation Research domains. MMAP implementation was challenging, required modification and was affected by provider- and system-level factors. Program and study participation were limited and affected by practice priorities, productivity standards, and stroke patient volume. Sites with successful implementation appeared to have empowered MMAP champions in vertically integrated systems that embraced innovation. Findings from this broad evaluation can serve as a road map for the design and implementation of other comprehensive, complex interventions that aim to bridge the currently disconnected realms of acute care, postacute care, and community resources.
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http://dx.doi.org/10.1016/j.apmr.2020.09.386DOI Listing
March 2021

Neurologist prescribing versus psychiatry referral: Examining patient preferences for anxiety and depression management in a symptomatic epilepsy clinic sample.

Epilepsy Behav 2021 01 24;114(Pt A):107543. Epub 2020 Nov 24.

Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC, USA. Electronic address:

Objective: Anxiety and depression symptoms in epilepsy are common, impactful and under-recognized and undertreated. While prior survey data suggests equipoise among epileptologists for managing anxiety and/or depression via prescribing in the epilepsy clinic versus psychiatry referral, patient preferences are unknown and should potentially influence practice habits among epileptologists. Thus, the primary objective of this study was to determine patient preference for anxiety and/or depression prescribing by neurologists versus psychiatry referral among an adult epilepsy clinic sample of symptomatic patients.

Methods: Management preferences for anxiety and/or depression were surveyed in an adult tertiary care epilepsy clinic. Individuals who screened positive for anxiety and/or depression symptoms on validated instruments during a routine care-embedded learning health system study were recruited. Demographics, social variables, psychiatric treatment history, and treatment priorities and preferences were surveyed. Preference was defined as a slightly greater than 2:1 ratio in favor neurology prescribing or psychiatry referral. The study was powered to assess this primary objective using a two-sample binomial test. Multinomial logistic regression examined an a priori multivariable model of treatment preference (secondary objective).

Results: The study sample included N = 63 symptomatic adults, with 64% women and mean age 42.2 years. Most reported past or current treatment for anxiety and/or depression, and treatment for these symptoms was a high or moderate priority among 65.1% of the sample. Neurologist prescribing was preferred in 83.0% (nearly 5:1) over psychiatry referral among those who chose neurology or psychiatry (as opposed to neither of the two; p < 0.001, 95% CI 0.702-0.919). Overall, 69.8% of the total study sample preferred neurology prescribing. Multivariable modeling indicated preference for neither management option (compared with neurologist prescribing) was associated with low overall treatment prioritization and having never received neurologist medication management. None of the factors examined in the a priori multivariable model were associated with selecting psychiatry referral (compared to neurologist prescribing).

Conclusion: In this sample, most patients indicated a preference for neurologists to prescribe for anxiety or depression symptoms in the epilepsy clinic. Care models involving neurologist prescribing for anxiety and depression symptoms merit further investigation and potential adoption in clinical practice.
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http://dx.doi.org/10.1016/j.yebeh.2020.107543DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7855561PMC
January 2021

Interventions Targeting Racial/Ethnic Disparities in Stroke Prevention and Treatment.

Stroke 2020 11 26;51(11):3425-3432. Epub 2020 Oct 26.

Department of Population Health and Department of Medicine, New York University Grossman School of Medicine, NY (O.G.O.).

Systemic racism is a public health crisis. Systemic racism and racial/ethnic injustice produce racial/ethnic disparities in health care and health. Substantial racial/ethnic disparities in stroke care and health exist and result predominantly from unequal treatment. This special report aims to summarize selected interventions to reduce racial/ethnic disparities in stroke prevention and treatment. It reviews the social determinants of health and the determinants of racial/ethnic disparities in care. It provides a focused summary of selected interventions aimed at reducing stroke risk factors, increasing awareness of stroke symptoms, and improving access to care for stroke because these interventions hold the promise of reducing racial/ethnic disparities in stroke death rates. It also discusses knowledge gaps and future directions.
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http://dx.doi.org/10.1161/STROKEAHA.120.030427DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7594115PMC
November 2020

Effect of a Multifactorial Fall Injury Prevention Intervention on Patient Well-Being: The STRIDE Study.

J Am Geriatr Soc 2021 01 9;69(1):173-179. Epub 2020 Oct 9.

Brigham and Women's Hospital, Boston, Massachusetts, USA.

Background/objectives: In the Strategies to Reduce Injuries and Develop Confidence in Elders (STRIDE) study, a multifactorial intervention was associated with a nonsignificant 8% reduction in time to first serious fall injury but a significant 10% reduction in time to first self-reported fall injury relative to enhanced usual care. The effect of the intervention on other outcomes important to patients has not yet been reported. We aimed to evaluate the effect of the intervention on patient well-being including concern about falling, anxiety, depression, physical function, and disability.

Design: Pragmatic cluster-randomized trial of 5,451 community-living persons at high risk for serious fall injuries.

Setting: A total of 86 primary care practices within 10 U.S. healthcare systems.

Participants: A random subsample of 743 persons aged 75 and older.

Measurements: The well-being measures, assessed at baseline, 12 months, and 24 months, included a modified version of the Fall Efficacy Scale, Patient-Reported Outcomes Measurement Information System (PROMIS) anxiety and depression scales, and Late-Life Function and Disability Instrument.

Results: Participants in the intervention (n = 384) and control groups (n = 359) were comparable in age: mean (standard deviation) of 81.9 (4.7) versus 81.8 (5.0) years. Mean scores were similar between groups at 12 and 24 months for concern about falling, physical function, and disability, whereas the intervention group's mean scores on anxiety and depression were .7 points lower (i.e., better) at 12 months and .6 to .8 points lower at 24 months. For each of these outcomes, differences between the groups' adjusted least square mean changes from baseline to 12 and 24 months, respectively, were quantitatively small. The overall difference in means between groups over 2 years was statistically significant only for depression, favoring the intervention: -1.19 (99% confidence interval, -2.36 to -.02), with 3.5 points representing a minimally important difference.

Conclusions: STRIDE's multifactorial intervention to reduce fall injuries was not associated with clinically meaningful improvements in patient well-being.
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http://dx.doi.org/10.1111/jgs.16854DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8178516PMC
January 2021

Cognition, Physical Function, and Quality of Life in Older Patients With Acute Decompensated Heart Failure.

J Card Fail 2021 03 18;27(3):286-294. Epub 2020 Sep 18.

Department of Neurology and Sticht Center on Aging Gerontology and Geriatric Medicine, Wake Forest School of Medicine, Winston-Salem, NC.

Background: Older adults with acute decompensated heart failure have persistently poor clinical outcomes. Cognitive impairment (CI) may be a contributing factor. However, the prevalence of CI and the relationship of cognition with other patient-centered factors such a physical function and quality of life (QOL) that also may contribute to poor outcomes are incompletely understood.

Methods And Results: Older (≥60 years) hospitalized patients with acute decompensated heart failure were assessed for cognition (Montreal Cognitive Assessment [MoCA]), physical function (Short Physical Performance Battery [SPPB], 6-minute walk distance [6MWD]), and QOL (Kansas City Cardiomyopathy Questionnaire, Short Form-12). Among patients (N = 198, 72.1 ± 7.6 years), 78% screened positive for CI (MoCA of <26) despite rare medical record documentation (2%). Participants also had severely diminished physical function (SPPB 6.0 ± 2.5 units, 6MWD 186 ± 100 m) and QOL (scores of <50). MoCA positively related to SPPB (ß = 0.47, P < .001), 6MWD ß = 0.01, P = .006) and inversely related to Kansas City Cardiomyopathy Questionnaire Overall Score (ß = -0.05, P < .002) and Short Form-12 Physical Component Score (ß = -0.09, P = .006). MoCA was a small but significant predictor of the results on the SPPB, 6MWD, and Kansas City Cardiomyopathy Questionnaire.

Conclusions: Among older hospitalized patients with acute decompensated heart failure, CI is highly prevalent, is underrecognized clinically, and is associated with severe physical dysfunction and poor QOL. Formal screening may reduce adverse events by identifying patients who may require more tailored care.
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http://dx.doi.org/10.1016/j.cardfail.2020.09.007DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7914148PMC
March 2021

A Randomized Trial of a Multifactorial Strategy to Prevent Serious Fall Injuries.

N Engl J Med 2020 07;383(2):129-140

From the Boston Claude D. Pepper Older Americans Independence Center, Research Program in Men's Health: Aging and Metabolism (S. Bhasin, N.K.L., S. Basaria, T.W.S., T.G.T., L.G., B.F.B., R.E.), Brigham and Women's Hospital (S. Bhasin, N.K.L., S. Basaria, P.C.D., T.W.S., T.G.T., P.G., M.B.C., L.G., B.F.B., R.E.), Marcus Institute for Aging Research, Hebrew SeniorLife, Harvard Medical School (T.G.T.), and the University of Massachusetts Boston (P.G.), Boston, and Meyers Primary Care Institute (joint endeavor of Reliant Medical Group, Fallon Health, and University of Massachusetts Medical School), Worcester (J.H.G.); the Yale Claude D. Pepper Older Americans Independence Center (T.M.G., P.C., K.A., J.M.M., E.A.S., D.B.), the Yale Center for Analytical Sciences (E.J.G., J.D., D.E., C.L., H.R., C.M., H.A., P.P.), and the Section of Geriatrics, Department of Internal Medicine, Yale School of Medicine (T.M.G., H.A.), Yale University, New Haven, CT; the Multicampus Program in Geriatric Medicine and Gerontology, David Geffen School of Medicine at UCLA (D.B.R., D.A.G.), the Geriatric Research, Education and Clinical Center, Veterans Affairs Greater Los Angeles Healthcare System (D.A.G.), and the UCLA Claude D. Pepper Older Americans Independence Center (D.B.R, D.A.G.), Los Angeles, and HealthCare Partners, El Segundo (J.R.) - all in California; the School of Nursing, University of Minnesota, Minneapolis (S.M.M.), and Essentia Health, Duluth (S.C.W.) - both in Minnesota; Wake Forest University, School of Medicine, Winston-Salem, NC (M.E.M., P.W.D.); the University of Miami Health System, Miami (M.F.); the Pittsburgh Claude D. Pepper Older Americans Independence Center, Division of Geriatrics and Gerontology, University of Pittsburgh, Pittsburgh (S.L.G., N.M.R.); the University of Michigan, Ann Arbor (N.A., J.W.); Icahn School of Medicine at Mount Sinai, New York (F.K., A.L.S.); the UTMB Claude D. Pepper Older Americans Independence Center, Sealy Center on Aging, University of Texas Medical Branch, Galveston (E.V.); Johns Hopkins University (A.W.W., C.B.) and the University of Maryland School of Medicine (J.M.), Baltimore, and the National Institute on Aging, Bethesda (R.C.-A.) - all in Maryland; and the University of Iowa, Iowa City (R.B.W., C.C.).

Background: Injuries from falls are major contributors to complications and death in older adults. Despite evidence from efficacy trials that many falls can be prevented, rates of falls resulting in injury have not declined.

Methods: We conducted a pragmatic, cluster-randomized trial to evaluate the effectiveness of a multifactorial intervention that included risk assessment and individualized plans, administered by specially trained nurses, to prevent fall injuries. A total of 86 primary care practices across 10 health care systems were randomly assigned to the intervention or to enhanced usual care (the control) (43 practices each). The participants were community-dwelling adults, 70 years of age or older, who were at increased risk for fall injuries. The primary outcome, assessed in a time-to-event analysis, was the first serious fall injury, adjudicated with the use of participant report, electronic health records, and claims data. We hypothesized that the event rate would be lower by 20% in the intervention group than in the control group.

Results: The demographic and baseline characteristics of the participants were similar in the intervention group (2802 participants) and the control group (2649 participants); the mean age was 80 years, and 62.0% of the participants were women. The rate of a first adjudicated serious fall injury did not differ significantly between the groups, as assessed in a time-to-first-event analysis (events per 100 person-years of follow-up, 4.9 in the intervention group and 5.3 in the control group; hazard ratio, 0.92; 95% confidence interval [CI], 0.80 to 1.06; P = 0.25). The rate of a first participant-reported fall injury was 25.6 events per 100 person-years of follow-up in the intervention group and 28.6 events per 100 person-years of follow-up in the control group (hazard ratio, 0.90; 95% CI, 0.83 to 0.99; P = 0.004). The rates of hospitalization or death were similar in the two groups.

Conclusions: A multifactorial intervention, administered by nurses, did not result in a significantly lower rate of a first adjudicated serious fall injury than enhanced usual care. (Funded by the Patient-Centered Outcomes Research Institute and others; STRIDE ClinicalTrials.gov number, NCT02475850.).
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http://dx.doi.org/10.1056/NEJMoa2002183DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7421468PMC
July 2020

Sleep problems worsen health-related quality of life and participation during the first 12 months of stroke rehabilitation.

Clin Rehabil 2020 Nov 30;34(11):1400-1408. Epub 2020 Jun 30.

SUNY Upstate Medical University, Syracuse, NY, USA.

Objective: Evaluate the impact of self-reported sleep problems on post-stroke recovery.

Design: Cross-sectional secondary analysis of longitudinal data from the Locomotor Experience Applied Post-Stroke (LEAPS) rehabilitation and recovery study (phase-III single-blind randomized controlled clinical trial). Group medians were compared for three sleep problem groups across three time points.

Setting: Outpatient and in-home physical therapy.

Subjects: Adults during the first year following stroke ( = 408, 380, 360 at 2, 6, 12 months, respectively).

Interventions: The original study compared effects of locomotor training with body weight support in the year post-stroke. This analysis evaluated function in three sleep/functional-impact groups: no sleep problems, sleep problems with no-to-minimal-impact and sleep problems with moderate-to-quite-a-bit of impact.

Main Measures: Participants' responses regarding if they had "a sleep problem, such as insomnia" and, if so, what the impact was on their function. Stroke Impact Scale subscales for strength, hand function, mobility, ADLs, memory, communication, emotion, participation, and percent recovery.

Results: About 25% of people with stroke reported sleep difficulty, 10% perceived sleep problems negatively impact function. Groups self-reporting worse sleep performed worse in all functional subscales (except self-perceived percent recovery) during the first year post-stroke.

Conclusion: Self-reported poor sleep adversely effects post-stroke functional recovery.
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http://dx.doi.org/10.1177/0269215520935940DOI Listing
November 2020

Randomized Pragmatic Trial of Stroke Transitional Care: The COMPASS Study.

Circ Cardiovasc Qual Outcomes 2020 06 1;13(6):e006285. Epub 2020 Jun 1.

Department of Epidemiology, Gillings School of Global Public Health (S.B.J., A.M.J., A.M.K.-N., L.H.M., W.D.R.), University of North Carolina at Chapel Hill.

Background The objectives of this study were to develop and test in real-world clinical practice the effectiveness of a comprehensive postacute stroke transitional care (TC) management program. Methods and Results The COMPASS study (Comprehensive Post-Acute Stroke Services) was a pragmatic cluster-randomized trial where the hospital was the unit of randomization. The intervention (COMPASS-TC) was initiated at 20 hospitals, and 20 hospitals provided their usual care. Hospital staff enrolled 6024 adult stroke and transient ischemic attack patients discharged home between 2016 and 2018. COMPASS-TC was patient-centered and assessed social and functional determinates of health to inform individualized care plans. Ninety-day outcomes were evaluated by blinded telephone interviewers. The primary outcome was functional status (Stroke Impact Scale-16); secondary outcomes were mortality, disability, medication adherence, depression, cognition, self-rated health, fatigue, care satisfaction, home blood pressure monitoring, and falls. The primary analysis was intention to treat. Of intervention hospitals, 58% had uninterrupted intervention delivery. Thirty-five percent of patients at intervention hospitals attended a COMPASS clinic visit. The primary outcome was measured for 59% of patients and was not significantly influenced by the intervention. Mean Stroke Impact Scale-16 (±SD) was 80.6±21.1 in TC versus 79.9±21.4 in usual care. Home blood pressure monitoring was self-reported by 72% of intervention patients versus 64% of usual care patients (adjusted odds ratio, 1.43 [95% CI, 1.21-1.70]). No other secondary outcomes differed. Conclusions Although designed according to the best available evidence with input from various stakeholders and consistent with Centers for Medicare and Medicaid Services TC policies, the COMPASS model of TC was not consistently incorporated into real-world health care. We found no significant effect of the intervention on functional status at 90 days post-discharge. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT02588664.
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http://dx.doi.org/10.1161/CIRCOUTCOMES.119.006285DOI Listing
June 2020

Using REDCap to track stakeholder engagement: A time-saving tool for PCORI-funded studies.

J Clin Transl Sci 2020 Apr 6;4(2):108-114. Epub 2020 Feb 6.

Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC, USA.

Background: Research Electronic Data Capture (REDCap) is a secure, web-based electronic data capture application for building and managing surveys and databases. It can also be used for study management, data transfer, and data export into a variety of statistical programs. REDcap was developed and supported by the National Center for Advancing Translational Sciences Program and is used in over 3700 institutions worldwide. It can also be used to track and measure stakeholder engagement, an integral element of research funded by the Patient-Centered Outcomes Research Institute (PCORI). Continuously and accurately tracking and reporting on stakeholder engagement activities throughout the life of a PCORI-funded trial can be challenging, particularly in complex trials with multiple types of engagement.

Methods: In this paper, we show our approach for collecting and capturing stakeholder engagement activities using a shareable REDCap tool in one of the PCORI's first large pragmatic clinical trials (the Comprehensive Post-Acute Stroke Services) to inform other investigators planning cluster-randomized pragmatic trials. Benefits and challenges are highlighted for researchers seeking to consistently monitor and measure stakeholder engagement.

Conclusions: We describe how REDCap can provide a time-saving approach to capturing how stakeholders engage in a PCORI-funded study and reporting how stakeholders influenced the study in progress reports back to PCORI.
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http://dx.doi.org/10.1017/cts.2019.444DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7159814PMC
April 2020

Implementation of a Transitional Care Model for Stroke: Perspectives From Frontline Clinicians, Administrators, and COMPASS-TC Implementation Staff.

Gerontologist 2020 08;60(6):1071-1084

Department of Social Sciences and Health Policy, Wake Forest School of Medicine, Winston-Salem, North Carolina.

Background And Objectives: Stroke is a chronic, complex condition that disproportionally affects older adults. Health systems are evaluating innovative transitional care (TC) models to improve outcomes in these patients. The Comprehensive Post-Acute Stroke Services (COMPASS) Study, a large cluster-randomized pragmatic trial, tested a TC model for patients with stroke or transient ischemic attack discharged home from the hospital. The implementation of COMPASS-TC in complex real-world settings was evaluated to identify successes and challenges with integration into the clinical workflow.

Research Design And Methods: We conducted a concurrent process evaluation of COMPASS-TC implementation during the first year of the trial. Qualitative data were collected from 4 sources across 19 intervention hospitals. We analyzed transcripts from 43 conference calls with hospital clinicians, individual and group interviews with leaders and clinicians from 9 hospitals, and 2 interviews with the COMPASS-TC Director of Implementation using iterative thematic analysis. Themes were compared to the domains of the RE-AIM framework.

Results: Organizational, individual, and community factors related to Reach, Adoption, and Implementation were identified. Organizational readiness was an additional key factor to successful implementation, in that hospitals that were not "organizationally ready" had more difficulty addressing implementation challenges.

Discussion And Implications: Multifaceted TC models are challenging to implement. Facilitators of implementation were organizational commitment and capacity, prioritizing implementation of innovative delivery models to provide comprehensive care, being able to address challenges quickly, implementing systems for tracking patients throughout the intervention, providing clinicians with autonomy and support to address challenges, and adequately resourcing the intervention.

Clinical Trial Registration: NCT02588664.
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http://dx.doi.org/10.1093/geront/gnaa029DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7427484PMC
August 2020

Reply to Braillon.

Epilepsy Behav 2020 06 4;107:107049. Epub 2020 Apr 4.

Department of Neurology, Wake Forest University School of Medicine, Winston-Salem, NC, USA.

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http://dx.doi.org/10.1016/j.yebeh.2020.107049DOI Listing
June 2020

Neuroinflammation after Intracerebral Hemorrhage and Potential Therapeutic Targets.

J Stroke 2020 Jan 31;22(1):29-46. Epub 2020 Jan 31.

Department of Neurological Surgery, Wake Forest School of Medicine, Winston-Salem, NC, USA.

Spontaneous intracerebral hemorrhage (ICH) is a catastrophic illness causing significant morbidity and mortality. Despite advances in surgical technique addressing primary brain injury caused by ICH, little progress has been made treating the subsequent inflammatory cascade. Pre-clinical studies have made advancements identifying components of neuroinflammation, including microglia, astrocytes, and T lymphocytes. After cerebral insult, inflammation is initially driven by the M1 microglia, secreting cytokines (e.g., interleukin-1β [IL-1β] and tumor necrosis factor-α) that are involved in the breakdown of the extracellular matrix, cellular integrity, and the blood brain barrier. Additionally, inflammatory factors recruit and induce differentiation of A1 reactive astrocytes and T helper 1 (Th1) cells, which contribute to the secretion of inflammatory cytokines, augmenting M1 polarization and potentiating inflammation. Within 7 days of ICH ictus, the M1 phenotype coverts to a M2 phenotype, key for hematoma removal, tissue healing, and overall resolution of inflammation. The secretion of anti-inflammatory cytokines (e.g., IL-4, IL-10) can drive Th2 cell differentiation. M2 polarization is maintained by the secretion of additional anti-inflammatory cytokines by the Th2 cells, suppressing M1 and Th1 phenotypes. Elucidating the timing and trigger of the anti-inflammatory phenotype may be integral in improving clinical outcomes. A challenge in current translational research is the absence of an equivalent disease animal model mirroring the patient population and comorbid pathophysiologic state. We review existing data and describe potential therapeutic targets around which we are creating a bench to bedside translational research model that better reflects the pathophysiology of ICH patients.
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http://dx.doi.org/10.5853/jos.2019.02236DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7005353PMC
January 2020

Who is willing to participate in research? A screening model for an anxiety and depression trial in the epilepsy clinic.

Epilepsy Behav 2020 03 27;104(Pt A):106907. Epub 2020 Jan 27.

Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC, USA. Electronic address:

Objective: Anxiety and depression in epilepsy are prevalent, associated with poor outcomes, underrecognized, undertreated, and thus a key area of need for treatment research. The objective of this study was to assess factors associated with research participation among epilepsy clinic patients who screened positive for anxiety or depression. This was accomplished by characterizing clinical and psychiatric factors among patients seen in an epilepsy clinic and evaluating which factors were associated with consent for potential research participation, via a combined clinical and research screening model.

Methods: In a pragmatic trial of anxiety and depression treatment in epilepsy, individuals with a positive screen for anxiety and/or depression at a routine epilepsy clinic visit were invited to opt-in (via brief electronic consent) to further eligibility assessment for a randomized treatment study. Information on psychiatric symptoms and treatment characteristics were collected for dual clinical care and research screening purposes. Cross-sectional association of demographic, clinical, and psychiatric factors with opting-in to research was analyzed by multiple logistic regression.

Results: Among N = 199 unique adults with a first positive screen for anxiety and/or depression among 786 total screening events, 154 (77.4%) opted-in to further potential research assessment. Higher depression scores and current treatment with an antidepressant were independently associated with opting-in to research (depression odds ratio (OR) = 1.13 per 1-point increase in Neurological Disorders Depression Inventory-Epilepsy (NDDI-E) score, p = 0.028, 95% confidence interval (CI): 1.01-1.26; antidepressant OR = 2.37, p = 0.041, CI: 1.04-5.41). Nearly half of the 199 individuals (43.7%) with anxiety and/or depression symptoms were already being treated with an antidepressant, and 46.7% were receiving neither antidepressant therapy nor mental health specialty care. One-quarter (24.1%) reported a past psychiatric hospitalization, yet only half of these individuals were receiving mental health specialty care.

Significance: Our results demonstrate a high willingness to participate in research using a brief electronic consent approach at a routine clinic visit. Adults with persistent anxiety or depression symptoms despite antidepressant therapy and those with higher depression scores were more willing to consider a randomized treatment study. This has implications for future study design, as individuals already on treatment or those with more severe symptoms are often excluded from traditional research designs. We also found a high burden of psychiatric disease and high prevalence of persistent symptoms despite ongoing antidepressant treatment.
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http://dx.doi.org/10.1016/j.yebeh.2020.106907DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7282472PMC
March 2020

Implementation of a billable transitional care model for stroke patients: the COMPASS study.

BMC Health Serv Res 2019 Dec 19;19(1):978. Epub 2019 Dec 19.

Department of Neurology, Wake Forest School of Medicine, Winston-Salem, NC, USA.

Background: The COMprehensive Post-Acute Stroke Services (COMPASS) pragmatic trial compared the effectiveness of comprehensive transitional care (COMPASS-TC) versus usual care among stroke and transient ischemic attack (TIA) patients discharged home from North Carolina hospitals. We evaluated implementation of COMPASS-TC in 20 hospitals randomized to the intervention using the RE-AIM framework.

Methods: We evaluated hospital-level Adoption of COMPASS-TC; patient Reach (meeting transitional care management requirements of timely telephone and face-to-face follow-up); Implementation using hospital quality measures (concurrent enrollment, two-day telephone follow-up, 14-day clinic visit scheduling); and hospital-level sustainability (Maintenance). Effectiveness compared 90-day physical function (Stroke Impact Scale-16), between patients receiving COMPASS-TC versus not. Associations between hospital and patient characteristics with Implementation and Reach measures were estimated with mixed logistic regression models.

Results: Adoption: Of 95 eligible hospitals, 41 (43%) participated in the trial. Of the 20 hospitals randomized to the intervention, 19 (95%) initiated COMPASS-TC. Reach: A total of 24% (656/2751) of patients enrolled received a billable TC intervention, ranging from 6 to 66% across hospitals.

Implementation: Of eligible patients enrolled, 75.9% received two-day calls (or two attempts) and 77.5% were scheduled/offered clinic visits. Most completed visits (78% of 975) occurred within 14 days. Effectiveness: Physical function was better among patients who attended a 14-day visit versus those who did not (adjusted mean difference: 3.84, 95% CI 1.42-6.27, p = 0.002). Maintenance: Of the 19 adopting hospitals, 14 (74%) sustained COMPASS-TC.

Conclusions: COMPASS-TC implementation varied widely. The greatest challenge was reaching patients because of system difficulties maintaining consistent delivery of follow-up visits and patient preferences to pursue alternate post-acute care. Receiving COMPASS-TC was associated with better functional status.

Trial Registration: ClinicalTrials.gov number: NCT02588664. Registered 28 October 2015.
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http://dx.doi.org/10.1186/s12913-019-4771-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6923985PMC
December 2019

Frailty Among Older Decompensated Heart Failure Patients: Prevalence, Association With Patient-Centered Outcomes, and Efficient Detection Methods.

JACC Heart Fail 2019 12;7(12):1079-1088

Heart and Vascular Institute, Novant Health, Charlotte, North Carolina. Electronic address:

Objectives: This study sought to assess the prevalence of frailty, its associations with physical function, quality of life (QoL), cognition, and depression and to investigate more efficient methods of detection in older patients hospitalized with acute decompensated heart failure (ADHF).

Background: In contrast to the outpatient population with chronic HF, much less is known regarding frailty in older, hospitalized patients with ADHF.

Methods: Older hospitalized patients (N = 202) with ADHF underwent assessment of frailty (using Fried criteria), short physical performance battery (SPPB), 6-min walk test (6-MWT) distance, quality of life (QoL using the Kansas City Cardiomyopathy Questionnaire), cognition (using the Montreal Cognition Assessment), and depression (using the Geriatric Depression Screen [GDS]). The associations of frailty with these patient-centered outcomes were assessed by using adjusted linear regression models. Novel strategies to identify frailty were examined.

Results: A total of 50% of older, hospitalized patients with ADHF were frail, 48% were pre-frail, and 2% were non-frail. Female sex, burden of comorbidity, and prior HF hospitalization were significantly associated with higher likelihood of frailty. Frailty (vs. pre-frail status) was associated with a significantly worse SPPB score (5 ± 2.2 vs. 7 ± 2.4, respectively), 6-MWT distance (143 ± 79 m vs. 221 ± 99 m, respectively), QoL (35 ± 19 vs. 46 ± 21, respectively), and more depression (GDS score: 5.5 ± 3.5 vs. 4.2 ± 3.3, respectively) but similar cognition. These associations were unchanged after adjustment for age, sex, race, total comorbidities, and body mass index. Slow gait speed plus low physical activity signaled frailty status as well (C-statistic = 0.85).

Conclusions: Ninety-eight percent of older, hospitalized patients with ADHF are frail or pre-frail. Frailty (vs. pre-frail status) is associated with worse physical function, QoL, comorbidity, and depression. The simple 4-m walk test combined with self-reported physical activity may quickly and efficiently identify frailty in older patients with ADHF.
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http://dx.doi.org/10.1016/j.jchf.2019.10.003DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8067953PMC
December 2019
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