Social Prescribing to Improve Adherence and Outcomes in Women With Heart Failure
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 200
- Locations
- 2
- Primary Endpoint
- Proportion of days
Study Overview
Brief Summary
Background: Heart Failure (HF) is the second most common cause of hospitalizations for women in North America. Non-adherence to guideline-directed medical therapy (GDMT) is associated with 50% of all treatment failures and high rates of hospitalizations and death. A recent Canadian study showed that adherence to three or more GDMT medications occurred in only 20% of Canadian HF patients. Despite clear guidelines on the pharmacologic management of HF and the introduction of new and effective drugs, adherence to GDMT in women with HF is low. Furthermore, the rates of hospitalizations have not improved in Canada over the last decade, and mortality in Canadian women with HF remains high. One explanation may be that social determinants of health (SDOH), which are known to be strong predictors of both adherence and adverse outcomes in HF, have not specifically been targeted to improve either adherence or outcomes in HF. Social prescribing (SP) is an innovative, non-medical intervention that aims to improve health by addressing SDOH. However, whether using SP to LINK clinical and social services for the benefit of socially vulnerable HF women can improve outcome is unknown. By targeting SDOH, which are strong predictors of adherence and outcomes in HF, and which have been shown to disproportionately disfavor women, SP has the potential to significantly improve medication adherence, quality of life and outcomes in women with HF.
Objectives: The overall aim of this study is to assess whether SP, through individualized, SDOH-targeted interventions, can improve adherence and quality of life in Canadian women with HF and at high risk for no adherence. Primary objective: To determine whether SP can improve adherence to GDMT. Secondary objective: To determine whether SP can improve quality of life.
Methods: This is an intention to treat, multicenter (five centers), and open-labeled, randomized clinical trial. Women with HF with two or more points on a weighted SDOH questionnaire (SPARK tool) will be randomly assigned to either SP or control group. Women in the SP group will meet with a link worker (LW) who will perform SP. SP will consist of personalized referrals to non-medical supports or services based on women's specific SDOH-related vulnerabilities and social needs. SP will address social needs such as issues with income, unemployment, transportation, mobility, dependents, housing, loneliness, mental health, health literacy, medication management and medical appointment schedules. Social prescriptions will be based on the interview conducted by the LW and will prioritize SDOH-related vulnerabilities identified on the SPARK questionnaire. Participants in the control group will receive standard care as is typically offered in the current specialized HF clinic in the participating centers. Controls will not meet with a LW, but, as usual, their physician or treating team may refer them to any specialists or services deemed necessary.
Outcome measures: The primary outcome will be adherence to GDMT measured with PDC obtained from provincial administrative databases and the secondary outcome will be quality of life measures including physical limitations, social limitations, as measured with the Kansas City Cardiomyopathy Questionnaire (KCCQ-12).
Sample size Calculations: The sample size was calculated using the primary outcome of adherence to GDMT measured with PDC as a continuous variable. In one observational study on adherence to HF medications which compared women and males adherence using PDCs, adherence in women was 63% with a SD of 23%. The impact of an absolute increase of 10% in PDC on clinical end points was considered significant. Using an alpha of 0.05 and a power of 0.80, a minimum of 166 participants would be needed to detect a statistically significant difference. Based on pilot data, the proportion of women followed in heart failure clinics is 28% and the proportion of eligible women (i.e. 1 point or more on the SPARK questionnaire) is about 30%. Considering a 30% refusal rate and a 5% dropout rate (intention to treat with registry based outcome), the five chosen centers should totalize 188 participants. The secondary outcome, the KCCQ, is a continuous variable for which a change of five points or more (5%) is considered clinically significant. Using an alpha of 0.05 and a power of 0.80, 126 patients would be required to detect such a difference.
Significance: SP holds immense potential for women with HF by addressing critical gaps in care. SP may help bridge the gap between healthcare providers and community resources, providing tailored support addressing SDOH that disproportionately affect women with HF. SP has the potential to significantly enhance adherence to GDMT, which has been shown to greatly, reduce hospitalizations and mortality in this vulnerable population.
Detailed Description
2. The Proposed Trial 2.1 Proposed Trial Design This study is an intention to treat, multicenter, open-labeled, randomized clinical trial. Patients will be matched within centers (i.e. compared to patients from the same center) to account for the different demographics of each center as well as regional and provincial particularities (see section 2.4). It will be conducted in five HF clinics, in five different Canadian hospitals from two provinces: Alberta and Quebec with whom collaborations have already been confirmed.
2.2 Trial Intervention The intervention has multiple phases: 1) preparation phase and LW selection, 2) LW training, 3) listing of community supports and services, 4) SP, 5) follow-up.
2.2.1 Preparation phase: The preparation phase of the trial will last six months and will, in part, be used to identify and train LW as well as to develop lists of available resources in the community for each center. Choosing appropriate LW will be an important part of the trial preparation. Link workers need to be highly motivated individuals who already have some knowledge of the communities served by the hospital. For instance, LW are often individuals who have already been working or volunteering in the community or the hospital. LW are typically not social workers since a LW should be "linking" and not doing social interventions per se.
2.2.2 LW training: The first goal of the training will be to teach LW how to assess and provide SP to vulnerable individuals. The training of LW will happen in three stages. The first step will be a series of online modules developed by the Alberta Healthy Aging group to train LW. The second will be a zoom-based bootcamp. The investigator will leverage the expertise and resources of Dr. Alayne M. Adams, who serves as Co-Principal Investigator (Co-PI) and is an active member of the Canadian Social Prescribing Communities of Practice. Dr. Adams' extensive knowledge and access to numerous resources in the field of SP will be invaluable in structuring and organizing the boot camp. By tapping into Dr. Adams' expertise, the investigator can ensure that the boot camp is well-designed and incorporates best practices in SP. This collaboration will enhance the effectiveness and impact of SP, ultimately benefiting the patients and communities involved. LWs will also be trained to find resources in communities they are not familiar with and to enter these resources in the project's databases. The third stage of the training will be longitudinal and consist of weekly virtual meetings between LW, PIs and the study coordinator. These meetings will provide continuous support for LW, updates and discussion about their patients. They will also be used to offer as needed training sessions based on needs that will arise. After the six months of preparation, these weekly meetings will continue throughout the intervention and data collection phases.
2.2.3 Listing of community supports and services: During the preparation phase, each LW will develop a unique list of community supports and services available in the areas they most serve. Resources identified will be indexed according to the population, needs and SDOH they are intended to address and entered into a database that will be regularly updated and accessible to the LW to search as needed.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •18 years of age or older
- •Documented HF of any etiology
- •Valid personal health identifier
- •Two or more points on the weighted SPARK questionnaire
Exclusion Criteria
- •Patients not meeting inclusion criteria
- •Do not take HF medications
- •Not residents of the province where they are being followed or who have opted out from their provincial health registry
- •Patients with severe cognitive impairment or other conditions that significantly impact the ability to participate in SP will also be excluded.
Arms & Interventions
Social prescription
The intervention consists of SP, wherein patients identified as having significant SDOH-related vulnerabilities on the SPARK questionnaire or during an interview will have a consultation with a LW who will provide them with social prescriptions.
Intervention: Social prescribing (Behavioral)
Control
Usual Care
Outcomes
Primary Outcomes
Proportion of days
Time Frame: 6- 12 months
The primary outcome will be the adherence to GDMT measured with the proportion of days covered (PDC). PDC(59), calculated as the sum of the number of unique days during which the patient had medication available, divided by a fixed time interval of 6-, or 12-months as applicable. The resulting ratio provides an estimate of the proportion of time the patient had access to their medication
Secondary Outcomes
- KCCQ overall score(12 months)
Investigators
Louise Pilote
Professor of Medicine, James McGill Chair
McGill University Health Centre/Research Institute of the McGill University Health Centre