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Medication Management and Culture of Safety (MM)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01247454
First Posted: November 24, 2010
Last Update Posted: December 6, 2016
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.
Collaborator:
Agency for Healthcare Research and Quality (AHRQ)
Information provided by (Responsible Party):
University of Colorado, Denver
  Purpose

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.


Condition Intervention
Cardiovascular Disease Behavioral: academic detailing Behavioral: Electronic Health Record (EHR) prompt Behavioral: EHR prompt and patient prompt

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Risk Informed Intervention Development and Implementation of Safe Ambulatory Care

Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • 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 ]

Enrollment: 7000
Study Start Date: July 2009
Study Completion Date: September 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01247454


Locations
United States, Colorado
University Hospital Clinics
Denver, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Agency for Healthcare Research and Quality (AHRQ)
Investigators
Study Director: Wilson Pace, MD University of Colorado Department of Family Medicine
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01247454     History of Changes
Other Study ID Numbers: 09-0481
R18HS017886 ( U.S. AHRQ Grant/Contract )
First Submitted: November 19, 2010
First Posted: November 24, 2010
Last Update Posted: December 6, 2016
Last Verified: December 2016

Keywords provided by University of Colorado, Denver:
CVD
primary prevention
ASA
physician behavioral change
Patient behavioral change

Additional relevant MeSH terms:
Cardiovascular Diseases