Heart Failure With Reduced Ejection Fraction (HFrEF)
Conditions
Keywords
shared decision-making, decision aid, encounter-based decision aid, guideline-directed medical therapy, GDMT
Brief summary
The goal of this clinical trial is to learn if a shared decision-making tool called SHARE-HF can help more people with heart failure receive guideline-recommended medications. The study includes adults with a type of heart failure called heart failure with reduced ejection fraction (HFrEF), who attend heart function clinics in British Columbia, Canada. The main question it aims to answer is: \- Does use of SHARE-HF during clinic visits lead to more participants receiving their recommended heart failure medications after 6 months? Researchers will compare clinics using the SHARE-HF tool to clinics providing usual care to see if the tool helps more participants get their recommended medications. Participants will use the SHARE-HF web-based tool with their clinician during regular clinic visits. The tool shows participants how their heart failure may affect their health over time, explains their medication options, and helps them and their clinician make treatment decisions together.
Interventions
OTHERSHARE-HF decision aid
Web-based, interactive decision aid that: (1) provides individualized prognosis based on a validated clinical prediction model; (2) presents evidence-based medication options aligned with guidelines; and (3) quantifies benefits and downsides across six patient-prioritized features.
Sponsors
University of British Columbia
Providence Healthcare
Vancouver Coastal Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Stepped-wedge cluster randomized trial
Eligibility
Sex/Gender
ALL
Age
40 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Patient in a participating HF clinic; 2. In-person initial HF clinic visit; 3. Age 40-85 years; 4. Heart failure with reduced ejection fraction (HFrEF), as indicated by latest cardiac imaging demonstrating ejection fraction ≤40%.
Exclusion criteria
1. Previous request to the clinic not to be contacted for research; 2. Consent opt-out; 3. Non-BC residents; 4. Residents of long-term care facilities or hospice; 5. Receiving palliative care; 6. End-stage kidney disease on dialysis or latest estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m2.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy-weighted HFrEF guideline-directed medical therapy (GDMT) score | 6 months | Scores range from 0 to 8, with a higher score indicating greater (better) GDMT utilization. |
Secondary
| Measure | Time frame |
|---|---|
| Worsening heart failure events | 1 year; 3 years |
| Adherence to HFrEF GDMT | 1 year; 3 years |
| Average percent concordance between prescribed and dispensed prescriptions for GDMT | 1 year |
| Utilization of individual HFrEF medication classes at any dose | Months 3, 6, and 12 |
Contacts
CONTACTRicky D Turgeon, BSc(Pharm), ACPR, PharmD
PRINCIPAL_INVESTIGATORRicky D Turgeon, BSc(Pharm), ACPR, PharmD
University of British Columbia
Outcome results
None listed