Medication Management and Culture of Safety

NCT01247454 | Completed DMC

• 2 other identifiers: 09-0481R18HS017886
• Study Type: interventional
• Target: 7,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiovascular Disease

Keywords

CVD; primary prevention; ASA; physician behavioral change; Patient behavioral change

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

academic detailing

OTHER

All arms will receive this intervention

Behavioral: academic detailing

Electronic Health Record (EHR) prompt

EXPERIMENTAL

One intervention arm will receive the EHR prompt along with the academic detailing

Behavioral: Electronic Health Record (EHR) prompt

EHR prompt and patient prompt

EXPERIMENTAL

The final arm will receive this combined intervention plus the academic detailing

Behavioral: EHR prompt and patient prompt

Interventions

academic detailing BEHAVIORAL

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.

academic detailing

Electronic Health Record (EHR) prompt BEHAVIORAL

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.

Electronic Health Record (EHR) prompt

EHR prompt and patient prompt BEHAVIORAL

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.

EHR prompt and patient prompt

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (1)

University Hospital Clinics

Denver, Colorado, 80045, United States

Location

Related Publications (1)

• Folks B, Leblanc WG, Staton EW, Pace WD. Reconsidering low-dose aspirin therapy for cardiovascular disease: a study protocol for physician and patient behavioral change. Implement Sci. 2011 Jun 26;6:65. doi: 10.1186/1748-5908-6-65.

  PMID: 21703023 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Electronic Health Records

Intervention Hierarchy (Ancestors)

Medical Records Systems, Computerized; Medical Records; Records; Data Collection; Epidemiologic Methods; Investigative Techniques; Organization and Administration; Health Services Administration; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Wilson Pace, MD

  University of Colorado Department of Family Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2010
• First Posted: November 24, 2010
• Study Start: July 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: September 1, 2010
• Last Updated: April 17, 2019

Record last verified: 2019-04

Locations

US (1)