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| ID | Type | Description | Link |
|---|---|---|---|
| VMS #120 | Other Identifier | PBM VAMedSAFE |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Level 1: site-specific information | Other | provide site-specific information on nonadherence |
|
| Level 2: site-, patient-specific info | Other | provide site- and patient-specific information on nonadherence |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Level 1: (provide site-specifi information) | Other | provide site-specific information on non-adherence to guideline |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Adherence to Guideline Prescription | full adherence to guideline medication and dose | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progress Toward Adherence to Guideline Prescription | either change to a guideline agent or dose increase of a guideline agent | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
none
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| Name | Affiliation | Role |
|---|---|---|
| Madeline McCarren, PhD MPH | Edward Hines Jr. VA Hospital, Hines, IL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Edward Hines Jr. VA Hospital, Hines, IL | Hines | Illinois | 60141-5000 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1 | provide site-specific information Level 1 (Provide site-specific information): provide site-specific information on non-adherence to guideline |
| FG001 | Arm 2 | provide site- and patient-specific information Level 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Level 1 | site-specific information provided |
| BG001 | Level 2 | site- and patient-specific information provided |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Rate of Adherence to Guideline Prescription | full adherence to guideline medication and dose | Posted | Number | patients | 6 months |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Level 1: Provide Site-specific Information | Level 1: provide site-specific information on non-adherence |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Madeline McCarren | Dept. of Veterans Affairs | 708 786 7987 | madeline.mccarren@va.gov |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Level 2 (Provide site- and patient-specific information) | Other | provide site-specific information on non-adherence to guideline as well as list of patients with non-adherent prescriptions |
|
| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | patients |
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|
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| Secondary | Progress Toward Adherence to Guideline Prescription | either change to a guideline agent or dose increase of a guideline agent | Posted | Number | patients | 6 months |
|
|
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| 0 |
| 98 |
| 0 |
| 98 |
| EG001 | Level 2: Provide Site- and Patient-specific Information | Level 2: provide site-specific information on non-adherence to guideline as well as list of patients with non-adherent prescriptions | 0 | 122 | 0 | 122 |
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