Implementation of an Encounter-based Patient Decision Aid for Heart Failure Medications in Heart Function Clinics: the SHARE-HF Pragmatic, Stepped-wedge Trial

NCT07670845 — Not applicable, Not yet recruiting, 1350 participants, University of British Columbia
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RegistryNCT07670845, acronym SHARE-HF
StatusNot yet recruiting
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: none, health services research
Enrollment1350 (Estimated)
SponsorUniversity of British Columbia (Other); collaborators: Providence Healthcare, Vancouver Coastal Health
ConditionsHeart Failure With Reduced Ejection Fraction (HFrEF)
InterventionsSHARE-HF decision aid (Other)
Datesstart 2026-11-02 (estimated), primary completion 2028-04-30 (estimated), completion 2030-10-31 (estimated), first posted 2026-06-26, last updated 2026-06-26

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All trials for Heart Failure With Reduced Ejection Fraction (HFrEF) All trials of SHARE-HF decision aid

-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.

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+Arms and interventions

ArmTypeInterventionsDescription
Intervention: Use of the SHARE-HF decision aid during clinic visitsExperimentalOther: SHARE-HF decision aid
Usual careNo intervention
  • SHARE-HF decision aid (Other): 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.

+Outcome measures

Primary outcomes

  • 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 outcomes

  • 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]

Other outcomes

  • Provider workload and burnout [Months 2, 4, 6, 8, 10, 12]: Brief clinician survey, including a validated single-item measure of self-reported burnout.
  • Healthcare utilization [12 months]: * Annualized HF clinic follow-up visits per patient * Total physician encounters per patient
  • Reach (RE-AIM framework) [Months 4, 6, 8, 10, 12]: Number of patients at each participating clinic with documented use of SHARE-HF during the intervention period.
  • Adoption (RE-AIM framework) [Months 4, 6, 8, 10, 12]: * Proportion of participating clinics with documented use of SHARE-HF during each intervention period; * Proportion of individual clinicians with documented use of SHARE-HF during each intervention period * Number of documented uses of SHARE-HF by each HF clinic in BC during in the trial
  • Implementation (fidelity & adaptations) (RE-AIM framework) [Through study completion, up to 1 year]: Self-reported fidelity to core components of SHARE-HF and adaptations made during delivery via reports to the project manager.
  • Maintenance (RE-AIM framework) [Up to 3 years]: Temporal patterns in * SHARE-HF use over course of each step; * SHARE-HF website access times over course of each step; * Proportion of patients at each participating clinic with documented use of SHARE-HF across intervention periods. Monthly number of documented uses of SHARE-HF by each participating clinic in the post-trial period (up to 3 years).

+Eligibility

Sex: All, ages: 40 Years to 85 Years

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.

+Investigators