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

University of California, San Francisco387 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

DOUBLE

Enrollment

Interventions

COPD WellnessBEHAVIORAL

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.

COPD Wellness Plus+BEHAVIORAL

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.

Usual CareBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 40 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (3)

Zuckerberg San Francisco General (ZSFG) Hospital

San Francisco, California, United States

RECRUITING

Maxine Hall Health Center (MHHC)

San Francisco, California, United States

RECRUITING

Southeast Health Center (SEHC)

San Francisco, California, United States

RECRUITING

Outcomes

Primary Outcomes

Change from Baseline 6 Minute Walk Test to end-of-intervention (3-month) visit

Standardized validated test to measure distance walked in 6 minutes

Time frame: 3-month (End of intervention) visit

Secondary Outcomes

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)

Time frame: 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

Time frame: 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.

Time frame: 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

Time frame: 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

Time frame: 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)

Time frame: 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

Time frame: 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+

Time frame: Baseline, Year 3 of study period (end of study activities)

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

Overview

Conditions

Interventions

Eligibility

Locations (3)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts