Heart Failure
Conditions
Keywords
Adrenergic beta-Antagonists, Guideline Adherence, Drug Prescriptions, target dose
Brief summary
The overall objective of the proposed pilot study is to begin evaluation of two methods for promoting adherence to guidelines for beta-blocker therapy in heart failure. The design includes site level baseline measurement, feedback, remeasurement after six months, and randomized (by site) comparison samples. The setting is VA sites, with intervention directed at the pharmacy.
Detailed description
Current evidence-based guidelines in VA recommend one of three beta-blockers (carvedilol, metoprolol succinate, or bisoprolol) that have been shown to reduce mortality in heart failure patients with systolic dysfunction, with recommended target doses. However, Pharmacy Benefits Management (PBM) data indicate that prescribing for beta-blockers in heart failure patients that is not in accordance with guidelines is substantial, both in terms of the agent selected and the dose. Sites will be recruited and randomized to two different intensities of intervention to promote adherence to guidelines.
Interventions
OTHERLevel 1: (provide site-specifi information)
provide site-specific information on non-adherence to guideline
OTHERLevel 2 (Provide site- and patient-specific information)
provide site-specific information on non-adherence to guideline as well as list of patients with non-adherent prescriptions
Sponsors
US Department of Veterans Affairs
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* VA sites * Males and females
Exclusion criteria
none
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Adherence to Guideline Prescription | 6 months | full adherence to guideline medication and dose |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progress Toward Adherence to Guideline Prescription | 6 months | either change to a guideline agent or dose increase of a guideline agent |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Level 1 site-specific information provided | 98 |
| Level 2 site- and patient-specific information provided | 122 |
| Total | 220 |
Baseline characteristics
| Characteristic | Level 1 | Level 2 | Total |
|---|---|---|---|
| Age, Continuous | 70 years STANDARD_DEVIATION 11.5 | 71 years STANDARD_DEVIATION 11 | 71 years STANDARD_DEVIATION 11.3 |
| Region of Enrollment United States | 98 patients | 122 patients | 220 patients |
| Sex: Female, Male Female | 3 Participants | 2 Participants | 5 Participants |
| Sex: Female, Male Male | 95 Participants | 120 Participants | 215 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 98 | 0 / 122 |
| serious Total, serious adverse events | 0 / 98 | 0 / 122 |
Outcome results
Primary
Rate of Adherence to Guideline Prescription
full adherence to guideline medication and dose
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Level 1 | Rate of Adherence to Guideline Prescription | 4 patients |
| Level 2 | Rate of Adherence to Guideline Prescription | 6 patients |
95% CI: [1.1, 3.2]
Secondary
Progress Toward Adherence to Guideline Prescription
either change to a guideline agent or dose increase of a guideline agent
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Level 1 | Progress Toward Adherence to Guideline Prescription | 10 patients |
| Level 2 | Progress Toward Adherence to Guideline Prescription | 22 patients |