COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Title: Comparative Effectiveness of Asthma Interventions Within an AHRQ PBRN

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01280500
Recruitment Status : Completed
First Posted : January 20, 2011
Last Update Posted : February 6, 2018
Information provided by (Responsible Party):
Michael Dulin, Atrium Health

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.

Condition or disease Intervention/treatment Phase
Asthma Behavioral: electronic medical record Other: Integrated Approach to Care Other: usual care Other: Shared Decision Making Other: school based care Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1040 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Accelerating Implementation of Comparative Effectiveness Findings on Clinical and Delivery Systems by Leveraging AHRQ Networks
Study Start Date : March 2011
Actual Primary Completion Date : August 2017
Actual Study Completion Date : August 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
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

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.

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Improving Adherence to Medication [ 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.

  2. Improve Quality of Life [ Time Frame: 2011-2013 ]
    Measured via Survey

  3. Reduced School Absenteeism [ Time Frame: 2011-2013 ]
    measured with school absenteeism data

  4. Improved Self-Efficacy [ Time Frame: 2011-2013 ]

  5. Improved School Performance [ Time Frame: 2011-2013 ]
    measured by yearly end of grade results

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

all with asthma diagnosis

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01280500

Layout table for location information
United States, North Carolina
CMC Elizabeth Family Medicine
Charlotte, North Carolina, United States, 28207
Department of Family Medicine
Charlotte, North Carolina, United States, 28207
Sponsors and Collaborators
Atrium Health
Layout table for additonal information
Responsible Party: Michael Dulin, Chair, Department of Family Medicine, Atrium Health Identifier: NCT01280500    
Other Study ID Numbers: HS10-014
First Posted: January 20, 2011    Key Record Dates
Last Update Posted: February 6, 2018
Last Verified: February 2018
Additional relevant MeSH terms:
Layout table for MeSH terms
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases