Medication Management and Culture of Safety (MM)

April 15, 2019 updated by: University of Colorado, Denver

Risk Informed Intervention Development and Implementation of Safe Ambulatory Care

There will be no significant decrease in the use of low dose acetylsalicylic acid (ASA) therapy for primary prevention across the three intervention arms from baseline to completion of the project.

There will be no significant differences in the percentage of patients with diabetes mellitus greater than 44 years of age on low dose ASA therapy for primary prevention across the three arms of the study using repeated measures from baseline to completion of the project.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

We will assess the current use of aspirin therapy for primary and secondary cardiovascular disease prevention in six general internal medicine and family medicine clinics within the University of Colorado Hospital system using electronic health record data.

We will develop messages concerning the appropriate use of aspirin for cardiovascular disease prevention for academic detailing to clinicians, a point of care (EHR) decision support aid for clinicians, and a short information sheet (generated by a CDS) for patients.

We will test the effectiveness of interventions to improve the evidence-based use of aspirin for primary and secondary prevention of cardiovascular disease using a randomized trial in the six University of Colorado Hospital primary care practices studied. The three intervention arms will include:

1.academic detailing and cessation of the primary prevention reminder within the point of care clinical decision support system (EHR/CDS) only 2. academic detailing with an EHR/CDS message asking clinicians to consider stopping aspirin therapy for primary prevention embedded in the point of care clinical decision support system 3. academic detailing with the EHR/CDS point of care message for clinicians in the second paragraph above, and a short information sheet to be given to patients prior to a visit to ask them to check with their provider concerning their use of aspirin for primary prevention

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Study Type

Interventional

Enrollment (Actual)

7000

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

  • United States
    • Colorado
      • Denver, Colorado, United States, 80045
        • University Hospital Clinics

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All patient on low-dose aspirin without an appropriate diagnosis of coronary artery disease or thrombotic stroke/transient ischemic attack (TIA) within the six practices.

Exclusion Criteria:

  • Persons not on aspirin therapy or persons on aspirin therapy for reasons other than prevention of cardiovascular disease (i.e., pain relief) will not be included in the study.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: academic detailing
All arms will receive this intervention
Behavioral: academic detailing
EHR message that encourages providers to consider ASA therapy for patients at high-risk for developing cardiovascular disease is turned off. Providers receive academic detailing.
Experimental: Electronic Health Record (EHR) prompt
One intervention arm will receive the EHR prompt along with the academic detailing
Behavioral: Electronic Health Record (EHR) prompt
EHR message that encourages providers to consider ASA therapy for patients at high-risk for developing cardiovascular disease is replaced with a message asking providers to consider terminating aspirin in patients who do not have appropriate cardiovascular disease.
Experimental: EHR prompt and patient prompt
The final arm will receive this combined intervention plus the academic detailing
Behavioral: EHR prompt and patient prompt
EHR message that encourages providers to consider ASA therapy for patients at high-risk for developing cardiovascular disease is replaced with a message asking providers to consider terminating aspirin in patients who do not have appropriate cardiovascular disease. And a brief information sheet is distributed to patients prior to their visit asking them to discuss ASA therapy for primary prevention with their provider.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Using a baseline cohort design is there any difference in the number of patients on ASA based on EHR medication lists for apparent primary prevention among the three groups after 24 months.
Time Frame: 12 months later
12 months later

Collaborators and Investigators

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

Sponsor

University of Colorado, Denver

Collaborators

Agency for Healthcare Research and Quality (AHRQ)

Investigators

  • Study Director: Wilson Pace, MD, University of Colorado Department of Family Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

July 1, 2009

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

November 19, 2010

First Submitted That Met QC Criteria

November 23, 2010

First Posted (Estimate)

November 24, 2010

Study Record Updates

Last Update Posted (Actual)

April 17, 2019

Last Update Submitted That Met QC Criteria

April 15, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09-0481
  • R18HS017886 (U.S. AHRQ Grant/Contract)

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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