Condition category
Circulatory System
Date applied
04/06/2005
Date assigned
14/06/2005
Last edited
21/09/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Sumit R. Majumdar

ORCID ID

Contact details

2E3.07 WMC
University of Alberta Hospital
8440-112th Street
Edmonton
Alberta
T6G 2B7
Canada
me2.majumdar@ualberta.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00175279

Protocol/serial number

N/A

Study information

Scientific title

Acronym

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/01/2002

Overall trial end date

30/06/2005

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

160

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

Trial participating centre

2E3.07 WMC
Edmonton, Alberta
T6G 2B7
Canada

Sponsor information

Organisation

Alberta Heritage Foundation for Medical Research (Canada)

Sponsor details

Suite 1500
10104-103 Avenue
Edmonton
Alberta
T5J 4A7
Canada
+1 780 423 5727
ahfmrinfo@ahfmr.ab.ca

Sponsor type

Government

Website

http://www.ahfmr.ab.ca

Funders

Funder type

Research organisation

Funder name

Alberta Heritage Foundation for Medical Research (Canada)

Alternative name(s)

AHFMR

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

Canada

Funder name

Institute of Health Economics (Canada)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Protocol in http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15982421

Results in http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=17174632

Publication citations

  1. Protocol

    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, 5, 1, 17, doi: 10.1186/1471-2261-5-17.

  2. Results

    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, 153, 1, 22.e1-8, doi: 10.1016/j.ahj.2006.07.030.

Additional files

Editorial Notes