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NCT Number: NCT07670845

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

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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Key information

Conditions

Heart Failure With Reduced Ejection Fraction (HFrEF)

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Efficacy-weighted HFrEF guideline-directed medical therapy (GDMT) score

    Time frame: 6 months

    Scores range from 0 to 8, with a higher score indicating greater (better) GDMT utilization.

Secondary outcomes

  1. Worsening heart failure events

    Time frame: 1 year; 3 years

  2. Adherence to HFrEF GDMT

    Time frame: 1 year; 3 years

  3. Average percent concordance between prescribed and dispensed prescriptions for GDMT

    Time frame: 1 year

  4. Utilization of individual HFrEF medication classes at any dose

    Time frame: Months 3, 6, and 12

Other outcomes

  1. Provider workload and burnout

    Time frame: Months 2, 4, 6, 8, 10, 12

    Brief clinician survey, including a validated single-item measure of self-reported burnout.

  2. Healthcare utilization

    Time frame: 12 months

    • Annualized HF clinic follow-up visits per patient
    • Total physician encounters per patient

  3. Reach (RE-AIM framework)

    Time frame: Months 4, 6, 8, 10, 12

    Number of patients at each participating clinic with documented use of SHARE-HF during the intervention period.

  4. Adoption (RE-AIM framework)

    Time frame: 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

  5. Implementation (fidelity & adaptations) (RE-AIM framework)

    Time frame: 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.

  6. Maintenance (RE-AIM framework)

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Ricky D Turgeon, BSc(Pharm), ACPR, PharmD

CONTACT

[email protected]

236-777-6961

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Collaborators

  • Providence Healthcare
  • Vancouver Coastal Health

Registry information

Acronym: SHARE-HF

Important dates

Study start
2026
Primary completion
2028
Study completion
2030
First posted
Jun 26, 2026
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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