Title: Comparative Effectiveness of Asthma Interventions Within an AHRQ PBRN

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Michael Dulin, Carolinas Healthcare System
ClinicalTrials.gov Identifier:
NCT01280500
First received: January 19, 2011
Last updated: March 18, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention
Asthma
Behavioral: electronic medical record
Other: Integrated Approach to Care
Other: usual care
Other: Shared Decision Making
Other: school based care

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Accelerating Implementation of Comparative Effectiveness Findings on Clinical and Delivery Systems by Leveraging AHRQ Networks

Resource links provided by NLM:


Further study details as provided by Carolinas Healthcare System:

Primary Outcome Measures:
  • Reducing Hospitalizations and Emergency Department Visits [ Time Frame: 2011-2013 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Improving Adherence to Medication [ Time Frame: 2011-2013 ] [ Designated as safety issue: No ]
    Quality goals will be measured by the percentage of patients who reach the goal out of all patients identified with the disease.

  • Improve Quality of Life [ Time Frame: 2011-2013 ] [ Designated as safety issue: No ]
    Measured via Survey

  • Reduced School Absenteeism [ Time Frame: 2011-2013 ] [ Designated as safety issue: No ]
    measured with school absenteeism data

  • Improved Self-Efficacy [ Time Frame: 2011-2013 ] [ Designated as safety issue: No ]
    survey

  • Improved School Performance [ Time Frame: 2011-2013 ] [ Designated as safety issue: No ]
    measured by yearly end of grade results


Estimated Enrollment: 1040
Study Start Date: March 2011
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Group A - Usual Care Controls
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.
Other: usual care
No EMR
Active Comparator: Group B - EMR Control Practices
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.
Behavioral: electronic medical record
Decision Support, Asthma Action Plans, and Population Management Reporting (EAP)
Active Comparator: C Integrated Approach to Care
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.
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.
Active Comparator: Group D - Shared Decision Making (SDM)
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.
Other: 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
Active Comparator: School Based Care (SBC)
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.
Other: 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

all with asthma diagnosis

Exclusion Criteria:

none

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01280500

Locations
United States, North Carolina
Department of Family Medicine
Charlotte, North Carolina, United States, 28207
CMC Elizabeth Family Medicine
Charlotte, North Carolina, United States, 28207
Sponsors and Collaborators
Carolinas Healthcare System
  More Information

No publications provided

Responsible Party: Michael Dulin, Chair, Department of Family Medicine, Carolinas Healthcare System
ClinicalTrials.gov Identifier: NCT01280500     History of Changes
Other Study ID Numbers: HS10-014
Study First Received: January 19, 2011
Last Updated: March 18, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on April 17, 2014