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

Sponsor
University of Alberta (Other)
Overall Status
Completed
CT.gov ID
NCT00175279
Collaborator
Alberta Heritage Foundation for Medical Research (Other), Institute of Health Economics, Canada (Other)
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Opinion leader generated and endorsed evidence summaries
N/A

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.

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single
Primary Purpose:
Treatment
Official Title:
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
Study Start Date :
Jan 1, 2002
Study Completion Date :
Apr 1, 2005

Outcome Measures

Primary Outcome Measures

  1. 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 Outcome Measures

  1. 1. Condition-specific "improvement" in prescribing after 6 months. []

  2. 2. "Optimization" of dosage for each of the medications prescribed (i.e., ACE inhibitors or angiotensin receptor blockers and statins). []

  3. 3. Patient adherence []

  4. 4. Subgroup analyses based on condition, age, and sex. []

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Alberta Edmonton Alberta Canada T6G 2B7

Sponsors and Collaborators

  • University of Alberta
  • Alberta Heritage Foundation for Medical Research
  • Institute of Health Economics, Canada

Investigators

  • Principal Investigator: Sumit R Majumdar, MD, MPH, University of Alberta

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00175279
Other Study ID Numbers:
  • ISRCTN26365328
  • IHE#102
First Posted:
Sep 15, 2005
Last Update Posted:
May 10, 2011
Last Verified:
May 1, 2011

Study Results

No Results Posted as of May 10, 2011