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A Cluster Randomized Trial to Assess the Impact of Opinion Leader Endorsed Evidence Summaries on Improving Quality of Prescribing for Patients With Chronic Cardiovascular Disease

A Cluster Randomized Trial to Assess the Impact of Opinion Leader Endorsed Evidence Summaries on Improving Quality of Prescribing for Patients With Chronic Cardiovascular Disease

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00175279
Enrollment
160
Registered
2005-09-15
Start date
2002-01-31
Completion date
2005-04-30
Last updated
2011-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Disease, Heart Failure, Ischemic Heart Disease

Keywords

coronary disease, heart failure, quality improvement, knowledge translation, opinion leaders

Brief summary

BACKGROUND: Although much has been written about the influence of local opinion leaders on clinical practice, there have been few controlled studies of their effect, and almost none have attempted to change prescribing in the community for chronic conditions such as congestive heart failure (CHF) or ischemic heart disease (IHD). These two conditions are common and there is very good evidence about how to best prevent morbidity and mortality - and very good evidence that quality of care is, in general, suboptimal. Practice audits have demonstrated that about half of eligible CHF patients are prescribed ACE inhibitors (and fewer still reaching appropriate target doses) and less than one-third of patients with established IHD are prescribed statins (with many fewer reaching recommended cholesterol targets). It is apparent that interventions to improve quality of prescribing are urgently needed. HYPOTHESIS: An intervention that consists of patient-specific one-page evidence summaries, generated and then endorsed by local opinion leaders, will be able to change prescribing practices of community-based primary care physicians. DESIGN: A single centre randomized controlled trial comparing an opinion leader intervention to usual care. Based on random allocation of all physicians in one large Canadian health region, patients with CHF or IHD (not receiving ACE inhibitors or statins, respectively) recruited from community pharmacies will be allocated to intervention or usual care. The primary outcome is improvement in prescription of proven efficacious therapies for CHF (ACE inhibitors) or IHD (statins) within 6 months of the intervention.

Detailed description

BACKGROUND: Although much has been written about the influence of local opinion leaders on clinical practice, there have been few controlled studies of their effect, and almost none have attempted to change prescribing in the community for chronic conditions such as congestive heart failure (CHF) or ischemic heart disease (IHD). These two conditions are common and there is very good evidence about how to best prevent morbidity and mortality - and very good evidence that quality of care is, in general, suboptimal. Practice audits have demonstrated that about half of eligible CHF patients are prescribed ACE inhibitors (and fewer still reaching appropriate target doses) and less than one-third of patients with established IHD are prescribed statins (with many fewer reaching recommended cholesterol targets). It is apparent that interventions to improve quality of prescribing are urgently needed. HYPOTHESIS: An intervention that consists of patient-specific one-page evidence summaries, generated and then endorsed by local opinion leaders, will be able to change prescribing practices of community-based primary care physicians. DESIGN: A single centre randomized controlled trial comparing an opinion leader intervention to usual care. Based on random allocation of all physicians in one large Canadian health region, patients with CHF or IHD (not receiving ACE inhibitors or statins, respectively) recruited from community pharmacies will be allocated to intervention or usual care. The primary outcome is improvement in prescription of proven efficacious therapies for CHF (ACE inhibitors) or IHD (statins) within 6 months of the intervention.

Interventions

BEHAVIORALOpinion leader generated and endorsed evidence summaries

Sponsors

Alberta Heritage Foundation for Medical Research
CollaboratorOTHER
Institute of Health Economics, Canada
CollaboratorOTHER
University of Alberta
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients with HF or IHD who are not currently taking the study medications of interest (ACE inhibitors/angiotensin receptor blockers for HF or statins for IHD) and whose primary care physicians are part of the study population

Exclusion criteria

* Patients who are unable or unwilling to give informed consent, * previously taken the study medications according to dispensing records * allergy or intolerance to study medications * residents of long-term care facilities * unable to confirm a diagnosis of either HF or IHD * primary care physician has already contributed 5 patients to the study

Design outcomes

Primary

MeasureTime frame
The primary outcome measure will be the improvement of prescribing for efficacious therapies in patients with a chronic cardiovascular disease within six months of the intervention.

Secondary

MeasureTime frame
1. Condition-specific improvement in prescribing after 6 months.
2. Optimization of dosage for each of the medications prescribed (i.e., ACE inhibitors or angiotensin receptor blockers and statins).
3. Patient adherence
4. Subgroup analyses based on condition, age, and sex.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026