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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-85
SponsorUniversity of British Columbia

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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%.

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • SHARE-HF decision aid

    Other intervention

    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.

Treatment groups

1,350 Participants
are divided into 2 treatment groups
Group A: Intervention: Use of the SHARE-HF decision aid during clinic visitsExperimental treatment 1 intervention
Group B: Usual careNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

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

Time frame
6 months

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

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

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

Healthcare utilization

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

Time frame
12 months
3

Reach (RE-AIM framework)

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

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

Adoption (RE-AIM framework)

* 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

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

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of British Columbia

Lead sponsor

Providence Healthcare

Collaborator

Vancouver Coastal Health

Collaborator

This trial is not recruiting at the moment. You can still explore other options: