NCT00175279

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2002

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2002

Completed
3.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 10, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
Last Updated

May 10, 2011

Status Verified

May 1, 2011

First QC Date

September 10, 2005

Last Update Submit

May 9, 2011

Conditions

Coronary DiseaseIschemic Heart DiseaseHeart Failure

Keywords

coronary diseaseheart failurequality improvementknowledge translationopinion leaders

Outcome Measures

Primary Outcomes (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 Outcomes (4)

  • 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.

Interventions

Opinion leader generated and endorsed evidence summariesBEHAVIORAL

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G 2B7, Canada

Location

Related Publications (2)

  • Majumdar SR, McAlister FA, Tsuyuki RT. 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: rationale and design [ISRCTN26365328]. BMC Cardiovasc Disord. 2005 Jun 27;5(1):17. doi: 10.1186/1471-2261-5-17.

    PMID: 15982421BACKGROUND

  • Majumdar SR, Tsuyuki RT, McAlister FA. Impact of opinion leader-endorsed evidence summaries on the quality of prescribing for patients with cardiovascular disease: a randomized controlled trial. Am Heart J. 2007 Jan;153(1):22.e1-8. doi: 10.1016/j.ahj.2006.07.030.

    PMID: 17174632RESULT

MeSH Terms

Conditions

Coronary DiseaseMyocardial IschemiaHeart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Sumit R Majumdar, MD, MPH

    University of Alberta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 10, 2005

First Posted

September 15, 2005

Study Start

January 1, 2002

Study Completion

April 1, 2005

Last Updated

May 10, 2011

Record last verified: 2011-05

Locations

CA(1)