Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Providence Healthcare | OTHER |
| Vancouver Coastal Health | OTHER_GOV |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention: Use of the SHARE-HF decision aid during clinic visits | Experimental |
| |
| Usual care | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| Measure | Description | 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 |
| 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 |
|
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ricky D Turgeon, BSc(Pharm), ACPR, PharmD | Contact | 236-777-6961 | ricky.turgeon@ubc.ca |
| Name | Affiliation | Role |
|---|---|---|
| Ricky D Turgeon, BSc(Pharm), ACPR, PharmD | University of British Columbia | Principal Investigator |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Stepped-wedge cluster randomized trial
Not provided
Not provided
Not provided
Not provided
|
| 1 year |
| Utilization of individual HFrEF medication classes at any dose | Months 3, 6, and 12 |
| 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) |
| 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
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 |