AsthmaNCT01280500
Title: Comparative Effectiveness of Asthma Interventions Within an AHRQ PBRN
A study testing electronic medical record, Integrated Approach to Care and Shared Decision Making in people with Asthma, run by Wake Forest University Health Sciences at 2 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- electronic medical record, Integrated Approach to Care and Shared Decision Making
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,040 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2011to Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- all with asthma diagnosis
Who cannot join
- none
Trial locations and contacts
2 sites in 1 country.
United States2 sites
CMC Elizabeth Family Medicine
Charlotte, North Carolina, 28207
Department of Family Medicine
Charlotte, North Carolina, 28207
About this study
Official title: Accelerating Implementation of Comparative Effectiveness Findings on Clinical and Delivery Systems by Leveraging AHRQ Networks
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.
- Conditions
- Asthma
- Being tested
- electronic medical record, Integrated Approach to Care, usual care, Shared Decision Making, school based care
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electronic medical recordBehavioural
Decision Support, Asthma Action Plans, and Population Management Reporting (EAP)
Integrated Approach to CareOther
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.
usual careOther
No EMR
Shared Decision MakingOther
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
school based careOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A - Usual Care Controls | Placebo comparator | 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. Receives: Other: usual care |
| Group B - EMR Control Practices | Active comparator | 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. Receives: Behavioral: electronic medical record |
| C Integrated Approach to Care | Active comparator | 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. Receives: Other: Integrated Approach to Care |
| Group D - Shared Decision Making (SDM) | Active comparator | 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. Receives: Other: Shared Decision Making |
| School Based Care (SBC) | Active comparator | 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. Receives: Other: school based care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2011-2013
Secondary outcomes (5)
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.
Measured: 2011-2013
Improve Quality of Life
Measured via Survey
Measured: 2011-2013
Reduced School Absenteeism
measured with school absenteeism data
Measured: 2011-2013
Improved Self-Efficacy
survey
Measured: 2011-2013
Improved School Performance
measured by yearly end of grade results
Measured: 2011-2013
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2011 (estimated)
- Study startMar 2011
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 1,040 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael F Dulin, MD, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01280500
- Sponsor's protocol ID
- HS10-014
- Status last verified
- Feb 2018
- First submitted
- 19 Jan 2011
- Last updated
- 25 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accelerating Implementation of Comparative Effectiveness Findings on Clinical and Delivery Systems by Leveraging AHRQ Networks
- ClinicalTrials.gov ID
- NCT01280500
- Acronym / sponsor ID
- HS10-014
- Conditions
- Asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,040 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 20 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group A - Usual Care Controls | Placebo comparator | Other: usual careGroup 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. |
| Group B - EMR Control Practices | Active comparator | Behavioral: electronic medical recordThere 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. |
| C Integrated Approach to Care | Active comparator | Other: Integrated Approach to CareThere 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. |
| Group D - Shared Decision Making (SDM) | Active comparator | Other: Shared Decision MakingThis 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. |
| School Based Care (SBC) | Active comparator | Other: school based careActivities 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- all with asthma diagnosis
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| electronic medical recordDecision Support, Asthma Action Plans, and Population Management Reporting (EAP) | Behavioural | Group B - EMR Control Practices |
| Integrated Approach to CarePatients 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. | Other | C Integrated Approach to Care |
| usual careNo EMR | Other | Group A - Usual Care Controls |
| Shared Decision MakingThe 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 | Other | Group D - Shared Decision Making (SDM) |
| school based carethe 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. | Other | School Based Care (SBC) |
Primary outcome
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.
5 secondary outcomes
Improving Adherence to Medication
Time frame: 2011-2013
Improve Quality of Life
Time frame: 2011-2013
Reduced School Absenteeism
Time frame: 2011-2013
Improved Self-Efficacy
Time frame: 2011-2013
Improved School Performance
Time frame: 2011-2013
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael F Dulin, MD, PhD principal investigator
Wake Forest University Health Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electronic medical record, Integrated Approach to Care and Shared Decision Making in people with Asthma, run by Wake Forest University Health Sciences at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reducing Hospitalizations and Emergency Department Visits (time frame: 2011-2013). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2022.