A cluster randomised trial to assess the impact of opinion leader endorsed evidence summaries on improving quality of prescribing for patients with chronic cardiovascular disease

ISRCTN	ISRCTN26365328
DOI	https://doi.org/10.1186/ISRCTN26365328
ClinicalTrials.gov number	NCT00175279
Secondary identifying numbers	N/A

Submission date: 04/06/2005
Registration date: 14/06/2005
Last edited: 21/09/2007

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Not provided at time of registration

Contact information

Dr Sumit R. Majumdar
Scientific

2E3.07 WMC
University of Alberta Hospital
8440-112th Street
Edmonton, Alberta
T6G 2B7
Canada

Email	me2.majumdar@ualberta.ca

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title
Study hypothesis	We propose having locally-nominated opinion leaders generate and endorse one-page evidence summaries for two common and chronic cardiovascular conditions. These evidence summaries, linked with specific patient-level medication profiles (generated at the community pharmacy), will be distributed to practicing physicians and attached to their patients chart. Our hypothesis is that this will act as both a source of credible and convincing information and a specific reminder for action at the next patient encounter. Our study is designed to test this hypothesis, by assessing the impact of this intervention on the quality of prescribing for patients with Heart Failure (HF) or Ischaemic Heart Disease (IHD).
Ethics approval(s)	Not provided at time of registration
Condition	Heart failure, ischaemic heart disease
Intervention	The intervention consists of a disease-specific and patient-specific one-page evidence summary. It will be a patient-specific letter addressed to the patients primary care physician, along with a description of the potential risks of undertreatment and current evidence-based treatment recommendations. The letter will be signed and endorsed by all five of the study opinion leaders. Accompanying the letter will be the most recent pharmacy record of medications dispensed to the study patient. It is intended that the evidence summary and the pharmacy medication profile will become part of the patients medical record and act as a reminder or prompt at the next patient visit. These materials will be faxed to the primary care physician directly from the patients community pharmacy. Control: usual care
Intervention type	Other
Primary outcome measure	The primary outcome measure will be the 'improvement' of prescribing for efficacious therapies in patients with a chronic cardiovascular disease within 6 months of the intervention. By study design, none of the study patients will be taking the medications of interest. For HF, starting any ACE inhibitor or angiotensin receptor blocker will be considered a positive outcome. For IHD, starting any statin will be considered a positive outcome. For the primary outcome all positive study-related medication changes will be pooled for an overall estimate of effect, compared with usual care controls.
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 (using prescription refill rates based on dispensing records) 4. Potential influence of age and sex on outcomes
Overall study start date	01/01/2002
Overall study end date	30/06/2005

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	160
Participant inclusion criteria	Patients with HF or IHD who are not currently taking the study medications of interest (Angiotensin-Converting Enzyme [ACE] inhibitors/angiotensin receptor blockers for HF or statins for IHD), and whose primary care physician of record is part of the study. For patients who happen to be eligible for both HF and for IHD, only one condition will be selected at random.
Participant exclusion criteria	1. Decline enrolment 2. Unable or unwilling to give informed consent 3. Have previously taken the study medications according to dispensing records 4. Have a documented allergy or intolerance to study medications according to pharmacist records 5. Are in long-term care facilities or institutions 6. Do not confirm on the basis of self-report that they have a diagnosis of either HF or IHD 7. Primary care physician has already contributed 5 patients to the study
Recruitment start date	01/01/2002
Recruitment end date	30/06/2005

Locations

Countries of recruitment

Canada

Study participating centre

2E3.07 WMC

Edmonton, Alberta
T6G 2B7
Canada

Sponsor information

Alberta Heritage Foundation for Medical Research (Canada)
Government

Suite 1500, 10104-103 Avenue
Edmonton, Alberta
T5J 4A7
Canada

Phone	+1 780 423 5727
Email	ahfmrinfo@ahfmr.ab.ca
Website	http://www.ahfmr.ab.ca
"ROR"	https://ror.org/006b2g567

Funders

Funder type

Research organisation

Alberta Heritage Foundation for Medical Research (Canada)
Government organisation / Local government

Alternative name(s): AHFMR
Location: Canada

Institute of Health Economics (Canada)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	Protocol	27/06/2005		Yes	No
Results article	Results	01/01/2007		Yes	No