Social Prescribing for Heart Failure
Trial Summary
Do I need to stop my current medications to join the trial?
The trial does not specify whether you need to stop taking your current medications. It focuses on improving adherence to existing heart failure medications through social support.
What data supports the effectiveness of the treatment Social Prescribing for heart failure?
While there is no direct evidence for Social Prescribing in heart failure, multidisciplinary interventions, which often include social support components, have been shown to reduce hospital admissions and mortality in heart failure patients. This suggests that incorporating social elements into care, like those in Social Prescribing, could potentially benefit heart failure patients.12345
How is the treatment Social Prescribing for heart failure different from other treatments?
Social Prescribing is unique because it focuses on connecting patients with community resources and support networks to improve their overall well-being, rather than relying solely on medication. This approach is different from traditional heart failure treatments that primarily involve drugs to manage symptoms and improve heart function.45678
What is the purpose of this trial?
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 they deem 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.
Eligibility Criteria
This trial is for Canadian women with heart failure who are at high risk of not following their medical treatment plans. They must score two or more points on a social health questionnaire and be willing to potentially receive non-medical support based on their needs.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Preparation
Preparation phase includes LW selection, training, and listing of community supports and services
Intervention
Social prescribing intervention where participants receive personalized social prescriptions based on SDOH vulnerabilities
Follow-up
Participants are monitored for adherence to GDMT and quality of life improvements
Treatment Details
Interventions
- Social Prescribing
Find a Clinic Near You
Who Is Running the Clinical Trial?
McGill University Health Centre/Research Institute of the McGill University Health Centre
Lead Sponsor
Canadian Institutes of Health Research (CIHR)
Collaborator