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

This study has been completed.
Sponsor:
Collaborators:
Alberta Heritage Foundation for Medical Research
Institute of Health Economics, Canada
Information provided by:
University of Alberta
ClinicalTrials.gov Identifier:
NCT00175279
First received: September 10, 2005
Last updated: May 9, 2011
Last verified: May 2011
  Purpose

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 Intervention
Coronary Disease
Ischemic Heart Disease
Heart Failure
Behavioral: Opinion leader generated and endorsed evidence summaries

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
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

Resource links provided by NLM:


Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • 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. 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.

Estimated Enrollment: 160
Study Start Date: January 2002
Estimated Study Completion Date: April 2005
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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00175279

Locations
Canada, Alberta
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
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00175279     History of Changes
Other Study ID Numbers: ISRCTN26365328, IHE#102
Study First Received: September 10, 2005
Last Updated: May 9, 2011
Health Authority: Canada: Health Canada

Keywords provided by University of Alberta:
coronary disease
heart failure
quality improvement
knowledge translation
opinion leaders

Additional relevant MeSH terms:
Cardiovascular Diseases
Coronary Artery Disease
Coronary Disease
Heart Diseases
Heart Failure
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014