Stroke is prevalent and associated with increased morbidity and mortality. Stroke is the leading cause of long-term disability in the US. Within the VA, approximately 60,000 patients had a primary outpatient encounter for stroke during fiscal year 2010 (FY10). Data from the Office of Quality and Performance (OQP) Stroke Special Study demonstrate that more than 5,000 Veterans were admitted to a VA facility for acute ischemic stroke in FY07 and another 5000 Veterans with a transient ischemic attack (TIA) or mini-stroke, were admitted in a VA facility or received care at an urgent clinic or emergency department in VA. The total VA cost of stroke treatment was almost $315 million in FY05, with a cost per patient of over $18,000. Stroke/TIA survivors are at elevated risk for future vascular events and yet, there are no systematic post stroke programs offered widely in VA designed to reduce this risk and increase stroke specific quality of life in Veterans. We recently developed and pilot tested a stroke self-management program that adapted the Stanford Chronic Disease program for stroke.
The objectives of this project were to: 1. Conduct a randomized trial comparing stroke survivors randomly assigned to receive a stroke self-management program on patient functioning, stroke self-management, and stroke specific quality of life compared to stroke survivors assigned to usual care; and 2. Conduct a summative evaluation among VA clinical providers, patients with stroke and their caregivers to understand the barriers and facilitators of implementing the stroke self-management program.
To accomplish these aims, we employed mixed methods. For the first aim, we conducted a randomized controlled trial comparing subjects randomly assigned to the stroke self-management intervention to subjects randomly assigned to usual care. Subjects from both groups were assessed at baseline, 3, 6, and 12 months. The stroke self-management program was delivered over 6 months (12 weeks biweekly sessions followed by 12 weeks of bimonthly telephone and stroke support group sessions). Usual care participants were offered written stroke risk factor materials and invited to attend the stroke support group after the completion of the 12 month assessment and participation in the study. Our primary outcomes were stroke specific quality of life and our secondary outcomes were stroke self-management, self-efficacy, functioning, and post stroke depression. For the second aim, we held focus groups with participants and their caregivers to best understand their barriers to participation and suggestions for future implementation.
Subjects from both groups were assessed at baseline, 3, 6, and 12 months. The stroke self-management program was delivered over 6 months (12 weeks biweekly (6) sessions followed by 12 weeks of bimonthly (6) telephone and stroke support group sessions). Usual care participants were offered written stroke risk factor materials and invited to attend the stroke support group after the completion of the 12 month assessment and participation in the study.
We enrolled 258 participants with an acute stroke, n=218, and TIA, n=40 from two VAMCs and a Joint Commission Stroke Center in the Midwest. The stroke self-management program was delivered with high fidelity: 16/19 program elements were delivered to >90%.
We enrolled our sample within 81.5 days after hospital discharge. Our sample included 19% women with an average age of 61.7 years. Our average NIHSS=3 indicating mild stroke severity.
At baseline, in the adjusted multivariate model, patient perceptions of their self-efficacy to manage health after stroke (p<.001) and depression symptoms (p<.01) remained as independent strong predictors on all Stroke Specific, Quality of Life Outcomes. For one unit increase in self-efficacy score, SSQoL improves with a magnitude of 0.18 - 0.23 which is clinically significant. For one unit increase in depressive symptoms, SSQoL worsens by a magnitude of 0.04 - 0.08.
The intervention and control groups did not differ significantly at 3 months. However at 6 months, there was an intervention effect, m=0.30, 0.07) on mean change in total, stroke specific, quality of life, SSQoL compared to usual care (m=0.16, 0.07) adjusted for baseline value, site, diagnosis, sex, and race (p<0.05). There was also a significant interaction effect (p<0.01) on the total SSQoL changes across the categories of the NIHSS stroke severity where the minor stroke impairment group experienced the most significant changes in SSQOL.
There was a significant intervention by NIHSS interaction P<0.05 for the Active Functioning subdomain. The difference in SSQoL active subdomain changes were not constant across NIHSS categories. We then evaluated within intervention group 6 month changes on SSQoL active comparing NIHSS=0 to >1+. Those with any NIHSS impairment at baseline had significantly higher improvement on the SSQoL active domains at 6 months.
There was a significant intervention by NIHSS category interaction on 6 month changes in SSQoL Psychosocial functioning (Social, Family functioning, Cognitive Functioning, Mood). Changes in SSQoL passive differed across NIHSS categories. The intervention group with an NIHSS between 1-3 experienced greater improvement compared to usual care.
We also conducted baseline self-efficacy and depression analyses. Self-efficacy to manage health and symptoms was associated with overall better SSQoL, 0.16, p<0.0001, social role functioning, 0.12, p<.01, family role functioning, 0.16, p<0.0003, and better work role functioning, 0.31, p<.0001.
Depressive symptoms at baseline were significantly related to poorer SSQoL across all subdomains and having a sense of optimism was related to better SSQoL at baseline.
Among our cohort, 201, 78%, reported baseline antidepressant usage which were verified by medical records review. Among those using antidepressants at time of clinical event, a significantly less proportion, 25.4%, reported moderate to severe depressive symptoms compared to those who reported no usage, 53.7%, p<0.0001.
We also analyzed perceptions of stroke risk among our cohort. Overall, there were no significant differences between the intervention and control groups' knowledge or responses from baseline to 3 months; however, we found significant improvements within the intervention group on knowledge of stroke warning signs at 3 months, p<0.01, and sustained this knowledge at 6, p<.01, and 12 months, p<0.01; and response to warning signs, p<0.03.
This planned evaluation of our stroke self-management program may improve the patient's healthcare by establishing an evidence-based program for which VA case managers may implement to improve patient self-management and the health-related quality of life of stroke survivors. This program will produce standardized manuals for case managers and stroke survivors that may be used in the field, in the patient medical care home and via telehealth.
A post stroke self-management program is effective for improving health-related quality of life among stroke patients with some impairment. A period of 6 months post a clinical event is needed to affect SSQoL improvements. This stroke self-management program will be available to be disseminated and implemented among health providers for stroke survivors to enhance their recovery.
The project has implications for dissemination and implementation through telehealth services within VHA.
External Links for this Project
Grant Number: I01HX000587-01A2
- Chen CX, Kroenke K, Stump T, Kean J, Krebs EE, Bair MJ, Damush T, Monahan PO. Comparative Responsiveness of the PROMIS Pain Interference Short Forms With Legacy Pain Measures: Results From Three Randomized Clinical Trials. The journal of pain : official journal of the American Pain Society. 2019 Jun 1; 20(6):664-675. [view]
- Chen CX, Kroenke K, Stump TE, Kean J, Carpenter JS, Krebs EE, Bair MJ, Damush TM, Monahan PO. Estimating minimally important differences for the PROMIS pain interference scales: results from 3 randomized clinical trials. Pain. 2018 Apr 1; 159(4):775-782. [view]
- Kroenke K, Stump TE, Chen CX, Kean J, Bair MJ, Damush TM, Krebs EE, Monahan PO. Minimally important differences and severity thresholds are estimated for the PROMIS depression scales from three randomized clinical trials. Journal of affective disorders. 2020 Apr 1; 266:100-108. [view]
- Kroenke K, Stump TE, Chen CX, Kean J, Damush TM, Bair MJ, Krebs EE, Monahan PO. Responsiveness of PROMIS and Patient Health Questionnaire (PHQ) Depression Scales in three clinical trials. Health and Quality of Life Outcomes. 2021 Feb 4; 19(1):41. [view]