Implementation of an Encounter-based Patient Decision Aid for Heart Failure Medications in Heart Function Clinics: the SHARE-HF Pragmatic, Stepped-wedge Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SHARE-HF decision aid.
- Who it may be relevant to
- Registry conditions: Heart Failure With Reduced Ejection Fraction (HFrEF). Basic parameters: 40 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Other SHARE-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.
Primary outcome measures
- Efficacy-weighted HFrEF guideline-directed medical therapy (GDMT) score [Time frame: 6 months]
Secondary outcome measures (4)
- Worsening heart failure events [Time frame: 1 year; 3 years]
- Adherence to HFrEF GDMT [Time frame: 1 year; 3 years]
- Average percent concordance between prescribed and dispensed prescriptions for GDMT [Time frame: 1 year]
- Utilization of individual HFrEF medication classes at any dose [Time frame: Months 3, 6, and 12]
Eligibility criteria
Inclusion criteria
- Patient in a participating HF clinic;
- In-person initial HF clinic visit;
- Age 40-85 years;
- Heart failure with reduced ejection fraction (HFrEF), as indicated by latest cardiac imaging demonstrating ejection fraction ≤40%.
Exclusion criteria
- Previous request to the clinic not to be contacted for research;
- Consent opt-out;
- Non-BC residents;
- Residents of long-term care facilities or hospice;
- Receiving palliative care;
- End-stage kidney disease on dialysis or latest estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07670845 · H26-01673