Comparing Types of Implementation of a Shared Decision Making Intervention

Asthma Clinical Trial

— ADAPT-NC  

Official title:

Comparing Traditional and Participatory Dissemination of a Shared Decision Making Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02047929
• Other study ID #: CD-12-11-4276
• Status: Completed
• Phase: N/A
• Start date: August 2013
• Est. completion date: January 31, 2017

Study information

• Verified date: April 2019
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Asthma is a common disease that affects people of all ages and has significant morbidity and mortality. Poor outcomes and health disparities related to asthma result in part from the difficulty of disseminating new evidence and paradigms of care delivery such as shared decision making (SDM) into clinical practice. This study will evaluate a novel mechanism for dissemination of an evidence-based SDM Toolkit for asthma care in primary care practices. The study is ideally suited to study dissemination methods because it will leverage a partnership between an established consortium of practice based research networks (PBRNs) and an advanced Medicaid Network.

This study will evaluate a novel dissemination process (FLOW) to spread an Asthma Shared Decision Making Toolkit to practices within a Medicaid network using a consortium of practice-based research networks (NCNC). The knowledge gained from this proposal and the partnerships formed between practice-based research networks and NC Medicaid will facilitate widespread dissemination to almost 300 practices.

Description:

Changing the behavior of health providers can be challenging, and significant gaps exist in our knowledge of how to best disseminate new medical evidence into everyday practice. This is true when the evidence involves a new paradigm of patient-centered care delivery such as shared decision making (SDM). The most common dissemination used is passive diffusion, which includes journal publications, didactic presentations, and educational material and often fails to produce timely or sustainable practice level changes. A unique partnership between a Medicaid network and a well established consortium of practice-based research networks provides an ideal venue to examine the effectiveness of new effective methods of dissemination. We previously developed an asthma toolkit that was funded by the Agency for Healthcare Research and Quality (AHRQ) and tested across a regional network of Pediatric, Family Medicine, and Internal Medicine ambulatory practices in Mecklenburg County North Carolina. During this study, key principles of community based participatory research were used engaging providers and patients to develop a Facilitator-Led participant OWned (FLOW) Approach to dissemination. The FLOW approach uses Practice Facilitators to guide practices through the process of adapting the Toolkit into the existing culture and workflow. This approach led to rapid dissemination and sustainability of the Toolkit across six practices. The initial results have showed marked improvement in patient outcomes (improved medication adherence and decreased asthma exacerbations) with increased patient involvement in the creation of the care plans. The objective is to determine what dissemination strategy most effectively increases practice level adoption of shared decision making, improves patient outcomes, and increases patient involvement in care decisions. We will leverage a partnership between the statewide Medicaid network and NCNC, a state-wide consortium of research networks, to identify best practices for dissemination of the shared decision making toolkit. We will test the FLOW method for dissemination on a larger scale by randomizing 30 primary care practices from 4 practice based research networks to one of three dissemination arms: (1) Facilitator-Led participant OWned (FLOW) Approach to Dissemination; (2) Traditional dissemination (Active Diffusion) with facilitator exposure; and (3) Passive dissemination.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 31, 2017
• Est. primary completion date: August 31, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year and older

Eligibility

Inclusion Criteria: North Carolina practices will be eligible for participation in the study if they have over 75 active Medicaid patients in their panel with the diagnosis of asthma.

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Exclusion Criteria: Prior participation in the Asthma Comparative Effectiveness Study.

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Related Conditions & MeSH terms

• Asthma

Intervention

Other:
• Asthma Shared Decision Making (SDM) Toolkit
A potential solution to improving asthma outcomes is the use of patient-centered approaches like Shared Decision Making (SDM), In the SDM process, patients and their health care providers are engaged jointly in making decisions about medical tests and treatments. The research team for this proposal was funded by the Agency for Health Care Research and Quality to build, disseminate and evaluate a novel Asthma SDM Toolkit - The Asthma Comparative Effectiveness Study. The Toolkit development was completed in 2010 and has been in evaluation for 2 years. This study will continue to evaluate the Toolkit in a wide array of practices across NC while testing a new method of dissemination.

Locations

Country	Name	City	State
United States	Department of Family Medicine	Charlotte	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Perception of Shared Decision Making	Success of the dissemination process will be determined by looking at process and outcome measures collected at the patient and clinic level. The primary outcome will be the patient's perceptions of shared decision making using a patient survey.	18 months
Secondary	Health Outcomes	Health outcomes data collected from Continuing Care of North Carolina that indicate poor asthma control and/or marker for exacerbations. These include patients with: Emergency Department Visits, Hospitalizations, Oral Steroid prescriptions, or patients with one or more of the markers for exacerbation: Emergency Department Visits, Hospitalizations, Oral Steroid prescriptions.	18 months
Secondary	Medication Adherence	Additional measures that will be evaluated to determine the success of dissemination will be based on indicators of poor asthma control including: medication adherence (controller medication refills). Data was not collected.	18 months