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Title: Comparative Effectiveness of Asthma Interventions Within an AHRQ PBRN

Primary Purpose

Asthma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
electronic medical record
Integrated Approach to Care
usual care
Shared Decision Making
school based care
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Asthma

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

all with asthma diagnosis

Exclusion Criteria:

none

Sites / Locations

  • CMC Elizabeth Family Medicine
  • Department of Family Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Group A - Usual Care Controls

Group B - EMR Control Practices

C Integrated Approach to Care

Group D - Shared Decision Making (SDM)

School Based Care (SBC)

Arm Description

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.

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Improve Quality of Life
Measured via Survey
Reduced School Absenteeism
measured with school absenteeism data
Improved Self-Efficacy
survey
Improved School Performance
measured by yearly end of grade results

Full Information

First Posted
January 19, 2011
Last Updated
April 19, 2022
Sponsor
Wake Forest University Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01280500
Brief Title
Title: Comparative Effectiveness of Asthma Interventions Within an AHRQ PBRN
Official Title
Accelerating Implementation of Comparative Effectiveness Findings on Clinical and Delivery Systems by Leveraging AHRQ Networks
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
August 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1040 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A - Usual Care Controls
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Group B - EMR Control Practices
Arm Type
Active Comparator
Arm Description
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.
Arm Title
C Integrated Approach to Care
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group D - Shared Decision Making (SDM)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
School Based Care (SBC)
Arm Type
Active Comparator
Arm Description
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 Type
Behavioral
Intervention Name(s)
electronic medical record
Intervention Description
Decision Support, Asthma Action Plans, and Population Management Reporting (EAP)
Intervention Type
Other
Intervention Name(s)
Integrated Approach to Care
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
usual care
Intervention Description
No EMR
Intervention Type
Other
Intervention Name(s)
Shared Decision Making
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
school based care
Intervention Description
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 Measure Information:
Title
Reducing Hospitalizations and Emergency Department Visits
Description
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 Outcome Measure Information:
Title
Improving Adherence to Medication
Description
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
Title
Improve Quality of Life
Description
Measured via Survey
Time Frame
2011-2013
Title
Reduced School Absenteeism
Description
measured with school absenteeism data
Time Frame
2011-2013
Title
Improved Self-Efficacy
Description
survey
Time Frame
2011-2013
Title
Improved School Performance
Description
measured by yearly end of grade results
Time Frame
2011-2013

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: all with asthma diagnosis Exclusion Criteria: none
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael F Dulin, MD, PhD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
CMC Elizabeth Family Medicine
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Department of Family Medicine
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States

12. IPD Sharing Statement

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Title: Comparative Effectiveness of Asthma Interventions Within an AHRQ PBRN

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