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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Heart Failure With Reduced Ejection Fraction (HFrEF)
• Intervention / Treatment: Other: SHARE-HF decision aid

• Study Type: Interventional
• Enrollment (Estimated): 1350
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ricky D Turgeon, BSc(Pharm), ACPR, PharmD; Phone Number: 236-777-6961; Email: ricky.turgeon@ubc.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual care
Experimental: Intervention: Use of the SHARE-HF decision aid during clinic visits	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy-weighted HFrEF guideline-directed medical therapy (GDMT) score	Scores range from 0 to 8, with a higher score indicating greater (better) GDMT utilization.	6 months

Secondary Outcome Measures

Outcome 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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Provider workload and burnout	Brief clinician survey, including a validated single-item measure of self-reported burnout.	Months 2, 4, 6, 8, 10, 12
Healthcare utilization	Annualized HF clinic follow-up visits per patient; Total physician encounters per patient	12 months
Reach (RE-AIM framework)	Number of patients at each participating clinic with documented use of SHARE-HF during the intervention period.	Months 4, 6, 8, 10, 12
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	Months 4, 6, 8, 10, 12
Implementation (fidelity & adaptations) (RE-AIM framework)	Self-reported fidelity to core components of SHARE-HF and adaptations made during delivery via reports to the project manager.	Through study completion, up to 1 year
Maintenance (RE-AIM framework)	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).	Up to 3 years

Collaborators and Investigators

• Sponsor: University of British Columbia
• Collaborators: Vancouver Coastal Health; Providence Healthcare
• Investigators: Principal Investigator: Ricky D Turgeon, BSc(Pharm), ACPR, PharmD, University of British Columbia

Study record dates

Study Major Dates

• Study Start (Estimated): November 2, 2026
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): October 31, 2030

Study Registration Dates

• First Submitted: June 17, 2026
• First Submitted That Met QC Criteria: June 22, 2026
• First Posted (Actual): June 26, 2026

Study Record Updates

• Last Update Posted (Actual): June 26, 2026
• Last Update Submitted That Met QC Criteria: June 22, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: decision aid; shared decision-making; guideline-directed medical therapy; GDMT; encounter-based decision aid
• Other Study ID Numbers: H26-01673

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No