DiabetesNCT00210262
Promoting Blood Pressure Control and Cholesterol Reduction to Prevent Major Complications in Persons With Diabetes
A study testing Feedback and Education in people with Diabetes, run by Institute for Clinical Evaluative Sciences at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Diabetes
- What is being tested?
- Feedback and Education
- Type of treatment
- Lifestyle or therapy programme
- How many people
- Not given
- Where
- 1 siteCanada
- Study dates
- Oct 2002to Jan 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- age >65 years
- consent
- within the practices of participating primary care physicians
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Diabetes
- Being tested
- Feedback and Education
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Feedback and EducationBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of ACE inhibitor use in index patients
Secondary outcomes (7)
rate of ACE inhibitor use in all patients
Rate of lipid-lowering drug use in index patients
Rate of lipid-lowering drug use in all patients
Rate of use of 2 or more antihypertensives in index patients
Rate of use of 2 or more antihypertensives in all patients
Rate of retinopathy screening in index patients
Rate of retinopathy screening in all patients
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startOct 2002
- Study completionJan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Sponsor and investigators
- Lead sponsor
- Institute for Clinical Evaluative Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Janet E. Hux, MD, SM, Principal investigator, ICES
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00210262
- Sponsor's protocol ID
- 251.070
- Other IDs
- MCT-58342
- Status last verified
- Nov 2003
- First submitted
- 15 Sep 2005
- Last updated
- 21 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Blood Pressure Control and Cholesterol Reduction to Prevent Major Complications in Persons With Diabetes
- ClinicalTrials.gov ID
- NCT00210262
- Acronym / sponsor ID
- 251.070
- Conditions
- Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Institute for Clinical Evaluative SciencesUniversity, hospital or other
- Study start
- Oct 2002
- Study completion
- Jan 2005
- First posted
- 21 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- age >65 years
- consent
- within the practices of participating primary care physicians
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Feedback and Education | Behavioural | – |
Primary outcome
rate of ACE inhibitor use in index patients
7 secondary outcomes
rate of ACE inhibitor use in all patients
Rate of lipid-lowering drug use in index patients
Rate of lipid-lowering drug use in all patients
Rate of use of 2 or more antihypertensives in index patients
Rate of use of 2 or more antihypertensives in all patients
Rate of retinopathy screening in index patients
Rate of retinopathy screening in all patients
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janet E. Hux, MD, SM principal investigator
ICES
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Feedback and Education in people with Diabetes, run by Institute for Clinical Evaluative Sciences at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of ACE inhibitor use in index patients. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2005.