NCT07670845

Brief 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.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,350

participants targeted

Target at P75+ for not_applicable

Timeline
49mo left

Started Nov 2026

Longer than P75 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 17, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 26, 2026

Completed
4 months until next milestone

Study Start

First participant enrolled

November 2, 2026

Expected
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2028

2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2030

Last Updated

June 26, 2026

Status Verified

June 1, 2026

Enrollment Period

1.5 years

First QC Date

June 17, 2026

Last Update Submit

June 22, 2026

Conditions

Keywords

shared decision-makingdecision aidencounter-based decision aidguideline-directed medical therapyGDMT

Outcome Measures

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.

    6 months

Secondary Outcomes (4)

  • 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 (6)

  • Provider workload and burnout

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

  • Healthcare utilization

    12 months

  • Reach (RE-AIM framework)

    Months 4, 6, 8, 10, 12

  • +3 more other outcomes

Study Arms (2)

Intervention: Use of the SHARE-HF decision aid during clinic visits

EXPERIMENTAL
Other: SHARE-HF decision aid

Usual care

NO INTERVENTION

Interventions

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.

Intervention: Use of the SHARE-HF decision aid during clinic visits

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

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

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Stepped-wedge cluster randomized trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 17, 2026

First Posted

June 26, 2026

Study Start (Estimated)

November 2, 2026

Primary Completion (Estimated)

April 30, 2028

Study Completion (Estimated)

October 31, 2030

Last Updated

June 26, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share