Title: Comparative Effectiveness of Asthma Interventions Within an AHRQ PBRN

Asthma Clinical Trial

Official title:

Accelerating Implementation of Comparative Effectiveness Findings on Clinical and Delivery Systems by Leveraging AHRQ Networks

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01280500
• Other study ID #: HS10-014
• Status: Completed
• Phase: N/A
• Start date: March 2011
• Est. completion date: August 2017

Study information

• Verified date: February 2018
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The overall goal is to identify best practices for improving health outcomes for patients with asthma using comparative effectiveness research within an Agency for Healthcare Research and Quality (AHRQ) Practice-Based Research Network (PBRN). This goal will be achieved by completing the following aims: (1) Create a centralized database for comparative effectiveness research on asthma by combining clinical and billing data from one of the largest healthcare systems in the country (Carolinas Healthcare System) with data from the school system, Medicaid, and patient and community-level datasets; (2) Deploy a fully developed integrated approach to asthma management based on the Chronic Care Model; (3) Develop and implement a "shared decision making" approach for asthmatic patients from disadvantaged backgrounds; (4) Implement an electronic data collection system for an existing CDC funded school-based asthma intervention that will allow program evaluation and link school nurses with providers; (5) Evaluate and compare the effectiveness of these three asthma management strategies on: overall healthcare consumption and medical costs; quality of life, school absenteeism and performance; asthma clinical measures; and medication utilization; and (6) Disseminate findings across the state via the statewide PBRN and other network partners. This project has the potential to impact over 30,000 asthma patients across the Carolinas including many patients from disadvantaged backgrounds.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1040
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

all with asthma diagnosis

Exclusion Criteria:

none

Related Conditions & MeSH terms

• Asthma

Intervention

Behavioral:
• electronic medical record
Decision Support, Asthma Action Plans, and Population Management Reporting (EAP)

Other:
• Integrated Approach to Care
Patients within the IAC group will also receive their own copy of an asthma action plan to allow for some degree of self-management support. In addition, IAC practices receive assistance from a practice coach trained in practice redesign and rapid cycle process improvement.
• usual care
No EMR
• Shared Decision Making
The research team will develop the SDM intervention during the first 6 months of the study. The team will model this intervention on the randomized control trial performed by Dr. Sandra Wilson and colleagues within the Kaiser Permanente Clinics in California and Oregon
• school based care
the research team will start an electronic data capture system linking school data and the clinical EMR (Cerner Power Chart) that will be implemented over the first year. Flow of data between schools and the hospital system will allow the children who have a regular source of care as well as those without a medical home to be treated with a unified asthma program by the school nurse and the hospital system.

Locations

Country	Name	City	State
United States	CMC Elizabeth Family Medicine	Charlotte	North Carolina
United States	Department of Family Medicine	Charlotte	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reducing Hospitalizations and Emergency Department Visits	Quality goals will be measured by the percentage of patients who reach the goal out of all patients identified with the disease through healthcare system data.	2011-2013
Secondary	Improving Adherence to Medication	Quality goals will be measured by the percentage of patients who reach the goal out of all patients identified with the disease.	2011-2013
Secondary	Improve Quality of Life	Measured via Survey	2011-2013
Secondary	Reduced School Absenteeism	measured with school absenteeism data	2011-2013
Secondary	Improved Self-Efficacy	survey	2011-2013
Secondary	Improved School Performance	measured by yearly end of grade results	2011-2013