Clinical trial NCT00175279: 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
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Disease
Ischemic Heart Disease
Heart Failure
Keywords: coronary disease
heart failure
quality improvement
knowledge translation
opinion leaders
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: Alberta Heritage Foundation for Medical Research
name: Institute of Health Economics, Canada
First posted: 2005-09-15
Enrollment: 160
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: 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:
measure: 1. Condition-specific "improvement" in prescribing after 6 months.
measure: 2. "Optimization" of dosage for each of the medications prescribed (i.e., ACE inhibitors or angiotensin receptor blockers and statins).
measure: 3. Patient adherence
measure: 4. Subgroup analyses based on condition, age, and sex.
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
Study officials:
affiliation: University of Alberta
name: Sumit R Majumdar, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.