Medication Management and Culture of Safety

Cardiovascular Disease Clinical Trial

— MM  

Official title:

Risk Informed Intervention Development and Implementation of Safe Ambulatory Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01247454
• Other study ID #: 09-0481
• Secondary ID: R18HS017886
• Status: Completed
• Phase: N/A
• Start date: July 2009
• Est. completion date: September 2010

Study information

• Verified date: April 2019
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7000
• Est. completion date: September 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	University Hospital Clinics	Denver	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		12 months later