An Intervention to Improve Management of Dyslipidemia in Primary Care

May 5, 2015 updated by: The University of The West Indies

A Cluster Randomized Controlled Trial of an Intervention to Improve the Management of Dyslipidemia in Primary Care

To assess the effectiveness of a clinical audit and physician based intervention in improving the management of dyslipidemia at Health centres in the Southeast Health Region of Jamaica

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Attended the clinic for at least 18 months
  • Is diagnosed with any of hypertension, diabetes, dyslipidemia, stroke, coronary heart disease (including angina, myocardial infarction), congestive cardiac failure or peripheral arterial disease, were eligible to be included in the audit

Exclusion Criteria:

  • acutely ill or was diagnosed with established kidney disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Audit and Physician intervention
The intervention will comprise the feedback of the results of the baseline audit, training in motivational interviewing for clinic staff, use of a physician reminder stamp in the patients' charts and distribution of patient education cards
Other: Audit
An assessment of medical records using a pre-specified audit instrument to assess the level of care given for clinic attendees with cardiovascular disease including dyslipidemia
Other: Physician Intervention
Feedback Training sessions for physicians inclusive Motivational Interviewing training and the use of physician reminders on medical records before each clinic session
Sham Comparator: Audit only
The intervention will comprise the feedback of the results of the baseline audit only
Other: Audit
An assessment of medical records using a pre-specified audit instrument to assess the level of care given for clinic attendees with cardiovascular disease including dyslipidemia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of persons attending health centers in the Southeast Health region with normal lipid values
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of persons attending health centers in the Southeast Health region with normal glucose values
Time Frame: 1 year
1 year
Proportion of persons attending health centers in the Southeast Health region with normal blood pressure values
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of The West Indies

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

May 5, 2015

First Submitted That Met QC Criteria

May 5, 2015

First Posted (Estimate)

May 8, 2015

Study Record Updates

Last Update Posted (Estimate)

May 8, 2015

Last Update Submitted That Met QC Criteria

May 5, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ECP218,11/12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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