Medication Management and Culture of Safety (MM)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01247454
First received: November 19, 2010
Last updated: June 18, 2013
Last verified: June 2013
  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
(CVD)
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: 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01247454

Locations
United States, Colorado
University Hospital Clinics
Denver, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Study Director: Wilson Pace, MD University of Colorado Department of Family Medicine
  More Information

No publications provided by University of Colorado, Denver

Additional 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
Study First Received: November 19, 2010
Last Updated: June 18, 2013
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 18, 2014