Rehabilitation in Safety-net Environments (RISE) to Improve Outcomes in Vulnerable Patients With COPD

Study Overview
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Brief Summary
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Chronic obstructive pulmonary disease (COPD), one of the leading causes of death in the US, disproportionately affects low socioeconomic communities. While few interventions effectively modify the course of COPD and improve outcomes, pulmonary rehabilitation is the one notable exception. However, implementation of this resource-intensive program in real-life settings, and in particular, for underserved communities, has proven to be challenging. Safety-net centers that serve primarily under-insured populations lack financial resources to provide pulmonary rehabilitation. The 10-week COPD Wellness and Plus+ Program directly addresses this gap, and yet, programs like these do not automatically lead to improved outcomes, which leads to the implementation of a Health Advocates program to address participant's social needs and barriers to healthcare.

Detailed Description
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The proposed study will directly test the benefit of the 10-week COPD Wellness and Plus+ Program relative to usual care and estimate the added benefit of the HA in COPD Wellness Plus+ to COPD Wellness alone in a three-arm, randomized waitlist-controlled trial conducted in three geographically isolated urban primary care sites that provide care for some of the most socially vulnerable patient populations with COPD. In this Type 1 effectiveness-implementation hybrid design, the investigators aim to 1) determine the effectiveness of COPD Wellness and Plus+ to improve functional and symptom outcomes; and, using a mixed-methods approach 2) to evaluate the implementation of COPD Wellness and Plus+ across study sites applying the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) and Consolidated Framework for Implementation Research (CFIR) frameworks to identify additional barriers and enablers of intervention implementation and patient acceptance and adherence.

Official Title
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Community-based Pulmonary Rehabilitation (COPD Wellness) and Social Navigation (Health Advocates) to Improve Outcomes in Vulnerable Patients With COPD

Conditions
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COPD (Chronic Obstructive Pulmonary Disease)

Intervention / Treatment
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* Behavioral: COPD Wellness
* Behavioral: COPD Wellness Plus+
* Behavioral: Usual Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of signed and dated informed consent form Willingness to participate in the COPD Wellness program 40 to 90 years old English or Spanish speaking Physician-diagnosed COPD Spirometry-confirmed FEV1/FVC ratio <= 0.7 and FEV1% predicted <80% based on GLI-O prediction equation COPD Assessment Test ≥ 10 or history of 1+ exacerbation requiring hospitalization or 2+ outpatient exacerbations requiring steroid therapy Currently prescribed COPD medication(s) Ability to exercise with lower extremities No COPD exacerbations for ≥ 6 weeks Currently receiving care within SFHN Note: Forced expiratory volume in the first second (FEV1); Forced vital capacity (FVC) Exclusion Criteria: Pregnancy Dementia, cognitive impairment, or symptomatic psychiatric illness that would impair them from participating Unstable cardiovascular disease (includes recent [<6 months] myocardial infarction or pulmonary embolism, uncontrolled arrhythmia, poorly controlled heart failure) Other severe co-morbidity which means exercise is contraindicated (screened by Registered Nurse in consultation with Pulmonologist) Transmittable pulmonary infection (tuberculosis, COVID19) Participated in pulmonary rehabilitation in the past 12-months COPD exacerbation in the past 6 weeks Activities restrictions that limit one's ability to engage in moderate physical activity Other diagnosis or condition that carry a prognosis of death within the next year

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Wait-list randomized controlled trial.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: COPD Wellness<br>This arm, COPD Wellness gives low-intensity exercise component with pulmonary rehabilitation for individuals with moderate-to-severe COPD. COPD Wellness is a program that was built from the Better Breathing Program, that is a part of San Francisco Health Network (SFHN) standard care for COPD. | Behavioral: COPD Wellness<br>* COPD Wellness consists of 10 weekly sessions led by the COPD Wellness Coach. The intervention was designed to be portable, rely on little equipment, and require limited space ( 300sqft). The curriculum was iteratively developed with patient input and builds behavioral capability and self-efficacy through 30 minutes blocks of disease education and self-management skill building, exercise training, and social support.<br>|
| Active Comparator: Usual Care<br>This includes access to comprehensive primary care services. Participants randomized to the usual care arm will be offered referral to the Better Breathing Program that is part of SFHN standard care for COPD. This program consists of an evidence-based curriculum that improves disease knowledge and management skills but has no effect on symptoms or functional status. At end of study enrollment, usual care participants will be offered the COPD Wellness intervention. | Behavioral: Usual Care<br>* Includes access to comprehensive primary care services that is standardized across the SFHN. Participants randomized to the usual care arm will be offered referral to the Better Breathing Program that is part of SFHN standard care for COPD. At end of study enrollment, usual care participants will be offered the COPD Wellness intervention.<br>|
| Experimental: COPD Wellness Plus+<br>This arm includes COPD Wellness Plus+. This arm is built from COPD Wellness with the addition of Health Advocates (i.e. Plus+). This intervention seeks to understand the effects of addressing social needs on overall health and wellness through Zuckerberg San Francisco General Hospital's (ZSFG) Health Advocate (HA) program; participation and engagement with the HA's will serve as an adherence strategy. | Behavioral: COPD Wellness Plus+<br>* Couples COPD Wellness with the ZSFG Health Advocates Program. The HA will help the participant prioritize identified needs and, using an algorithm informed approach to connect the individual to the needed resource, this includes providing referrals to outside social or legal service agencies, help with applications for social benefits, or other services. The HA will use a checklist to track activities including review and prioritization of needs, referrals or resources provided, and contacts/contact attempts.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline 6 Minute Walk Test to end-of-intervention (3-month) visit | Standardized validated test to measure distance walked in 6 minutes | 3-month (End of intervention) visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline 6 Minute Walk Test at 6-month and 9-month visit following end-of-intervention | Standardized validated test to examine functional status and measure distance walked in 6 minutes (reported in meters) | Baseline, 6-month, and 9-month visit following end-of-intervention | 
| Change from Baseline COPD Assessment Test (CAT) at 3-month (End of Intervention) visit, 6-month, and 9-month visit | Standardized validated comprehensive measure COPD Assessment Test (CAT) of symptom burden for individuals with COPD, minimum score: 0 - maximum score: 40, higher score indicates a more symptomatic COPD | Baseline, 3-month (End of intervention) visit, 6-month, and 9-month visit | 
| Change from Baseline Quality of Life (SF-CRQ) assessment at 3-month (End of Intervention) visit, 6-month, and 9-month visit | Health related quality of life is assessed using the validated Short-Form Chronic Respiratory Disease Questionnaire (SF-CRQ). This includes questions about four domains: dyspnea, fatigue, emotional function, and mastery. Items are answered using a 7-point scale Likert scale and summed within each domain. Higher results indicate a higher health-related quality of life. | Baseline, 3-month (End of intervention) visit, 6-month, and 9-month visit | 
| Intervention Adherence at End-of-intervention (3 month) | Adherence as defined by the proportion of sessions attended out of ten | Assessed during 10-week COPD Wellness Intervention | 
| Change from Baseline COPD exacerbation history at 3-month (End of Intervention) visit, 6-month, and 9-month follow up | Self-report non-standardized questionnaire on COPD exacerbation episodes; Exacerbation defined as a visit to an urgent care or emergency department for COPD, a hospitalization for COPD, or a prescription of an oral steroid for worsening COPD symptoms; not scored, higher exacerbations indicate more symptomatic COPD | Baseline, 3-month (End of intervention) visit, 6-month, and 9-month visit | 
| Health System Proportion of patients referred to the intervention | Proportion of patients referred who enroll and participate in the study, which refers to the percent of patients referred that accept (attend 1+ session) COPD Wellness and Plus+ (intervention reach) | Baseline, 24-months after study implementation | 
| Health System Adoption of intervention for patients referred | Proportion of de novo referrals from primary care/post-hospitalization versus prompted referrals from research coordinator | Baseline, 24-months after study implementation | 
| Healthy System Maintenance of intervention from start of study to end of study activities | Referral pattern at start vs. at end of study period; staff and leadership intension to continue COPD Wellness and Plus+ | Baseline, Year 3 of study period (end of study activities) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Social Needs, Lung Diseases, Chronic Disease, Health Disparities, Community Resources