Promoting Blood Pressure Control and Cholesterol Reduction to Prevent Major Complications in Persons With Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00210262
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : September 21, 2005
Information provided by:
Institute for Clinical Evaluative Sciences

Brief Summary:
Diabetes mellitus (DM) imposes a significant burden of early mortality and decreased quality of life on the 6% of Canadians affected by it. There is a growing body of research evidence showing that the use of certain medications (ACE inhibitors, blood pressure medications and cholesterol lowering agents) can reduce the major complications of diabetes such as heart, blood vessel and kidney disease and amputations. Unfortunately this research knowledge does not appear to be routinely translated into clinical practice. The proposed study examines the effect of simple mailed interventions to patients or physicians on improving the use of these therapies. The strategies to be tested are direct patient education with an emphasis on blood pressure and lipid control rather than use of particular drugs and, for physicians, the provision of confidential prescribing feedback together with targeted educational bulletins. With patient and physician consent, health care administrative data will be used to examine the impact of the interventions. If successful, the study will identify low cost reproducible interventions to promote the use of proven preventive therapies in clinical practice.

Condition or disease Intervention/treatment Phase
Diabetes Behavioral: Feedback and Education Not Applicable

Detailed Description:

Preventing major complications is a cornerstone in the outpatient management of diabetes mellitus (DM). While glycaemic control remains important, recent evidence supports the role of blood pressure and lipids and the use of ACE inhibitors in reducing complications. Effective interventions are required to ensure implementation of these findings. Since optimal DM management involves the participation of both patients and providers, strategies to improve care can reasonably be directed toward either group.

The proposed study explores the impact of simple mailed interventions directed toward patients or providers on the rates of use of ACE inhibitors, Blood pressure lowering drugs and Cholesterol lowering therapies – the ABCs - by older patients with DM. We hypothesize that: 1) mailed interventions including prescriber feedback can increase the ABCs relative to controls; 2) that interventions directed toward patients and providers are equally effective in promoting the ABCs among patients selected to receive the intervention and 3) that interventions directed towards clusters of patients within a physician’s practice will also change the care provided by those physicians to their other patients, in the absence of any direct intervention to the physician.

Practices of 300 randomly selected primary care physicians in Ontario and, through their physicians, 10 patients over age 65 with known DM in each practice will be recruited to participate. Practices (physicians and their index patients) will be randomized to one of 3 arms: 1) physician intervention, 2) patient intervention or 3) control. In arm 1, participating physicians will receive confidential prescribing feedback on the ABCs and, as a masking intervention, patients will receive educational materials regarding DM eye care. In arm 2, patients will receive a mailed educational intervention regarding blood pressure and lipid control while physicians will receive education and feedback regarding eye care as a masking intervention. In arm 3, no educational intervention regarding hypertension and lipids will be provided and both patients and physicians will receive the eye care intervention. Data sources will be claims data from the Ontario Drug Benefit Program and the Ontario Health Insurance Plan and the Ontario Diabetes Database (a validated, linkable administrative data diabetes registry).

The primary outcomes will be the proportion of patients receiving ACE inhibitors, the proportion receiving 2 or more antihypertensive drugs and the proportion receiving lipid lowering drugs. All prescriptions received by the patient will be included whether or not written by the study physician. The unit of analysis will be the physician. Data will be analyzed in a multilevel logistic model with covariates measured at the physician level and outcomes measured at the patient level. The primary analysis will include only the data on index patients in each of the three arms. A secondary analysis will include all patients with diabetes over age 65 within the practices of the participating physicians. This project will further elucidate the role of prescribing feedback in guideline implementation and will explore a novel patient-based approach to improving the quality of diabetes care. The relative simplicity and the central administration of the proposed strategy suggest that, if effective, it could readily be widely implemented.

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Educational/Counseling/Training
Official Title: Promoting Blood Pressure Control and Cholesterol Reduction to Prevent Major Complications in Persons With Diabetes
Study Start Date : October 2002
Study Completion Date : January 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. rate of ACE inhibitor use in index patients

Secondary Outcome Measures :
  1. rate of ACE inhibitor use in all patients
  2. Rate of lipid-lowering drug use in index patients
  3. Rate of lipid-lowering drug use in all patients
  4. Rate of use of 2 or more antihypertensives in index patients
  5. Rate of use of 2 or more antihypertensives in all patients
  6. Rate of retinopathy screening in index patients
  7. Rate of retinopathy screening in all patients

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • age >65 years
  • consent
  • within the practices of participating primary care physicians

Exclusion Criteria:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00210262

Canada, Ontario
Toronto, Ontario, Canada
Sponsors and Collaborators
Institute for Clinical Evaluative Sciences
Principal Investigator: Janet E. Hux, MD, SM ICES Identifier: NCT00210262     History of Changes
Other Study ID Numbers: 251.070
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: September 21, 2005
Last Verified: November 2003

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases