CClinicalTrials.gg
CompletedNCT01280500Updated Apr 25, 2022

Title: Comparative Effectiveness of Asthma Interventions Within an AHRQ PBRN

An interventional study of electronic medical record and Integrated Approach to Care in Asthma, sponsored by Wake Forest University Health Sciences. Completed at 2 sites in United States. Per ClinicalTrials.gov, last updated 2022-04-25.

Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
1,040
Allocation
Non-randomized
Sex
All
01

Study 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.

02

Conditions studied

  • Asthma

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03

In context

Asthma

3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.

This study's enrollment of 1,040 is above the median of 83 across 2,752 interventional studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

Wake Forest University Health Sciences is the lead sponsor of 1,320 studies on the registry; 199 are open to participants now.

Of its 323 completed or terminated interventional studies of FDA-regulated products, 243 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

all with asthma diagnosis

Exclusion criteria

Exclusion Criteria:

none

05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
1,040 participants (actual)

Study arms

  • 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

  • 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

  • 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

  • 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

Interventions

  • Behavioralelectronic medical record

    Decision Support, Asthma Action Plans, and Population Management Reporting (EAP)

  • OtherIntegrated 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.

  • Otherusual care

    No EMR

  • OtherShared 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

  • Otherschool 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 2011-2013

Secondary outcomes

  1. 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.

    Time frame: 2011-2013

  2. Improve Quality of Life

    Measured via Survey

    Time frame: 2011-2013

  3. Reduced School Absenteeism

    measured with school absenteeism data

    Time frame: 2011-2013

  4. Improved Self-Efficacy

    survey

    Time frame: 2011-2013

  5. Improved School Performance

    measured by yearly end of grade results

    Time frame: 2011-2013

07

Study locations

2 sites
  • CMC Elizabeth Family Medicine
    Charlotte, North Carolina 28207, United States
  • Department of Family Medicine
    Charlotte, North Carolina 28207, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 25, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01280500
Lead sponsor
Wake Forest University Health Sciences
Responsible party
Sponsor
First posted
Jan 20, 2011
Start date
Mar 2011
Primary completion
Aug 2017
Completion
Aug 2017
Last update
Apr 25, 2022

Study contacts

Michael F Dulin, MD, PhD
principal investigator · Wake Forest University Health Sciences

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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