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.|
|ClinicalTrials.gov Identifier: NCT01280500|
Recruitment Status : Completed
First Posted : January 20, 2011
Last Update Posted : February 6, 2018
|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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1040 participants|
|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|
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.
- 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.
- 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.
- Improve Quality of Life [ Time Frame: 2011-2013 ]Measured via Survey
- Reduced School Absenteeism [ Time Frame: 2011-2013 ]measured with school absenteeism data
- Improved Self-Efficacy [ Time Frame: 2011-2013 ]survey
- Improved School Performance [ Time Frame: 2011-2013 ]measured by yearly end of grade results
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 ClinicalTrials.gov identifier (NCT number): NCT01280500
|United States, North Carolina|
|CMC Elizabeth Family Medicine|
|Charlotte, North Carolina, United States, 28207|
|Department of Family Medicine|
|Charlotte, North Carolina, United States, 28207|