Heart FailureNCT01002456
Beta-Blockers in Heart Failure: Pharmacy-level Intervention Comparison
A study testing Level 1: (provide site-specifi information) and Level 2 (Provide site- and patient-specific information) in people with Heart Failure, run by US Department of Veterans Affairs at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Failure
- What is being tested?
- Level 1: (provide site-specifi information) and Level 2 (Provide site- and patient-specific information)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Oct 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- VA sites
- Males and females
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
United States1 site
Edward Hines Jr. VA Hospital, Hines, IL
Hines, Illinois, 60141-5000
About this study
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.
Read the 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.
- Conditions
- Heart Failure
- Being tested
- Level 1: (provide site-specifi information), Level 2 (Provide site- and patient-specific information)
- Keywords
- Adrenergic beta-Antagonists, Guideline Adherence, Drug Prescriptions, target dose
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Level 1: (provide site-specifi information)Other
provide site-specific information on non-adherence to guideline
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
| Study group | Role | What they receive |
|---|---|---|
| Level 1: site-specific information | Other | provide site-specific information on nonadherence Receives: Other: Level 1: (provide site-specifi information) |
| Level 2: site-, patient-specific info | Other | provide site- and patient-specific information on nonadherence Receives: Other: Level 2 (Provide site- and patient-specific information) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Adherence to Guideline Prescription
full adherence to guideline medication and dose
Measured: 6 months
Secondary outcomes (1)
Progress Toward Adherence to Guideline Prescription
either change to a guideline agent or dose increase of a guideline agent
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionJun 2011
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Madeline McCarren, PhD MPH, Principal investigator, Edward Hines Jr. VA Hospital, Hines, IL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01002456
- Sponsor's protocol ID
- RRP 09-136
- Other IDs
- VMS #120
- Status last verified
- Sep 2014
- First submitted
- 23 Oct 2009
- Last updated
- 28 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beta-Blockers in Heart Failure: Pharmacy-level Intervention Comparison
- ClinicalTrials.gov ID
- NCT01002456
- Acronym / sponsor ID
- RRP 09-136
- Conditions
- Heart Failure
- Keywords
- Adrenergic beta-Antagonists, Guideline Adherence, Drug Prescriptions, target dose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Oct 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 27 Oct 2009 (estimated)
- Results
- Posted 15 Oct 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Level 1: site-specific information | Other | Other: Level 1: (provide site-specifi information)provide site-specific information on nonadherence |
| Level 2: site-, patient-specific info | Other | Other: Level 2 (Provide site- and patient-specific information)provide site- and patient-specific information on nonadherence |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- VA sites
- Males and females
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Level 1: (provide site-specifi information)provide site-specific information on non-adherence to guideline | Other | Level 1: site-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 | Other | Level 2: site-, patient-specific info |
Primary outcome
Rate of Adherence to Guideline Prescription
Time frame: 6 months
full adherence to guideline medication and dose
1 secondary outcome
Progress Toward Adherence to Guideline Prescription
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Madeline McCarren, PhD MPH principal investigator
Edward Hines Jr. VA Hospital, Hines, IL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Level 1: (provide site-specifi information) and Level 2 (Provide site- and patient-specific information) in people with Heart Failure, run by US Department of Veterans Affairs at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Adherence to Guideline Prescription (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2015.