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Clinical Trials/NCT01280500
NCT01280500CompletedNot Applicable

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

Wake Forest University Health Sciences2 sites in 1 country1,040 target enrollmentStarted: March 1, 2011Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
1,040
Locations
2
Primary Endpoint
Reducing Hospitalizations and Emergency Department Visits

Study Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Crossover
Primary Purpose
Health Services Research
Masking
None

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • all with asthma diagnosis

Exclusion Criteria

  • Not provided

Arms & Interventions

Group B - EMR Control Practices

Active Comparator

There are currently 65 primary care practices within the Carolinas Healthcare System network that have electronic medical record with decision support (EAP)access at baseline. These practices will serve as a second level of control for comparison with the intervention groups. Each of these practices is currently using Cerner PowerChart and at the start of the study and will have access to the asthma decision support tools; an electronically generated Asthma Action Plan (AAP); and a built-in system of population management reports which will be pushed to the practices on an on-going basis to help in patient recall and management. The EAP approach to care has been developed with input from clinicians, hospital administrators, hospital information services personnel, and Cerner consultants.

Intervention: electronic medical record (Behavioral)

C Integrated Approach to Care

Active Comparator

There are 10 practices within the Carolinas Healthcare System (CHS) network that have already received additional training for improving outcomes for patients with chronic diseases termed the Integrated Approach to Care (IAC). This IAC approach developed by CHS is based on the Chronic Care Model (CCM). The IAC approach includes a heavy emphasis on the use of health information technology that practices receive during the initial EAP rollout.

Intervention: Integrated Approach to Care (Other)

Group D - Shared Decision Making (SDM)

Active Comparator

This approach has great potential for improved patient outcomes and provides an additional step in the successful implementation of patient self-management. The research team will develop the SDM intervention during the first 6 months of the study. In particular, the Shared decision making (SDM) intervention will be designed to be deployed within the 4 large clinics that care for the majority of the community's underserved and disadvantaged patients. The SDM intervention development will be overseen by the study advisory board and actively recruit providers from within the clinics for feedback about the intervention.

Intervention: Shared Decision Making (Other)

School Based Care (SBC)

Active Comparator

Activities included: spending individual time with students to assess, treat, and monitor and to educate students in proper asthma management; facilitate access to health care and medicine; and communicate with parents.

Intervention: school based care (Other)

Group A - Usual Care Controls

Placebo Comparator

Group A will consist of 20 primary care clinics who are part of the Carolinas Healthcare System network but have not yet adopted the Electronic Medical Record System. These practices do use the same billing databases as the remaining clinics, allowing easy identification of asthma patients and their health services utilization patterns. Data from the billing systems will be used to retrospectively populate a database for these clinics from January 2009 forward.

Intervention: usual care (Other)

Outcomes

Primary Outcomes

Reducing Hospitalizations and Emergency Department Visits

Time Frame: 2011-2013

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.

Secondary Outcomes

  • Improving Adherence to Medication(2011-2013)
  • Improve Quality of Life(2011-2013)
  • Reduced School Absenteeism(2011-2013)
  • Improved Self-Efficacy(2011-2013)
  • Improved School Performance(2011-2013)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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