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Comparing Types of Implementation of a Shared Decision Making Intervention (ADAPT-NC)

Primary Purpose

Asthma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Asthma Shared Decision Making (SDM) Toolkit
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 focused on measuring Asthma, Shared decision making, Participatory methods, Practice facilitator, Health coach

Eligibility Criteria

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

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.

-

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

-

Sites / Locations

  • Department of Family Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

Facilitator-Led

Traditional

Control

Arm Description

This approach to dissemination allows clinics some freedom to tailor the Asthma Shared Decision Making (SDM) Toolkit and training process for their specific environment and patient population while maintaining fidelity of certain key elements that are felt to be essential for success. The expertise of the trained Practice Facilitator will help guide the process of implementation at the practice level.

The most commonly used dissemination technique is active diffusion, which includes didactic presentations, academic detailing, exposure to journal publications and subject matter experts, and educational material distribution. We have defined this type of dissemination, "traditional dissemination". For the purpose of this study, practices randomized to traditional dissemination will receive a lunchtime presentation by a physician champion / subject matter expert on shared decision making. The presentation will give an overview of the Asthma Shared Decision Making (SDM) Toolkit, access to the internet link with additional information, and a copy of all printed materials associated with the Toolkit.

A third group will be randomized into an arm with no formal dissemination. This arm will receive information only through passive exposure to the concepts of shared decision making. This would include introduction to the SDM concepts through the media, conferences, or social networks. Having this control in place will allow the research team to isolate the effect of both the FLOW approach and the traditional approach to dissemination.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
January 27, 2014
Last Updated
April 20, 2022
Sponsor
Wake Forest University Health Sciences
Collaborators
Patient-Centered Outcomes Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02047929
Brief Title
Comparing Types of Implementation of a Shared Decision Making Intervention
Acronym
ADAPT-NC
Official Title
Comparing Traditional and Participatory Dissemination of a Shared Decision Making Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
August 31, 2016 (Actual)
Study Completion Date
January 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
Patient-Centered Outcomes Research Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma, Shared decision making, Participatory methods, Practice facilitator, Health coach

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Facilitator-Led
Arm Type
Active Comparator
Arm Description
This approach to dissemination allows clinics some freedom to tailor the Asthma Shared Decision Making (SDM) Toolkit and training process for their specific environment and patient population while maintaining fidelity of certain key elements that are felt to be essential for success. The expertise of the trained Practice Facilitator will help guide the process of implementation at the practice level.
Arm Title
Traditional
Arm Type
Active Comparator
Arm Description
The most commonly used dissemination technique is active diffusion, which includes didactic presentations, academic detailing, exposure to journal publications and subject matter experts, and educational material distribution. We have defined this type of dissemination, "traditional dissemination". For the purpose of this study, practices randomized to traditional dissemination will receive a lunchtime presentation by a physician champion / subject matter expert on shared decision making. The presentation will give an overview of the Asthma Shared Decision Making (SDM) Toolkit, access to the internet link with additional information, and a copy of all printed materials associated with the Toolkit.
Arm Title
Control
Arm Type
No Intervention
Arm Description
A third group will be randomized into an arm with no formal dissemination. This arm will receive information only through passive exposure to the concepts of shared decision making. This would include introduction to the SDM concepts through the media, conferences, or social networks. Having this control in place will allow the research team to isolate the effect of both the FLOW approach and the traditional approach to dissemination.
Intervention Type
Other
Intervention Name(s)
Asthma Shared Decision Making (SDM) Toolkit
Intervention Description
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.
Primary Outcome Measure Information:
Title
Patient Perception of Shared Decision Making
Description
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.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Health Outcomes
Description
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.
Time Frame
18 months
Title
Medication Adherence
Description
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.
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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. - Exclusion Criteria: Prior participation in the Asthma Comparative Effectiveness Study. -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hazel Tapp
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Family Medicine
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
32477003
Citation
Shade L, Reeves K, Rees J, Hendrickson L, Halladay J, Dolor RJ, Bray P, Tapp H. Research nurses as practice facilitators to disseminate an asthma shared decision making intervention. BMC Nurs. 2020 May 18;19:40. doi: 10.1186/s12912-020-00414-0. eCollection 2020.
Results Reference
derived
PubMed Identifier
32152153
Citation
Ludden T, Shade L, Welch M, Halladay J, Donahue KE, Coyne-Beasley T, Bray P, Tapp H. What types of dissemination of information occurred between researchers, providers and clinical staff while implementing an asthma shared decision-making intervention: a directed content analysis. BMJ Open. 2020 Mar 8;10(3):e030883. doi: 10.1136/bmjopen-2019-030883.
Results Reference
derived
PubMed Identifier
31868043
Citation
Shade L, Ludden T, Dolor RJ, Halladay J, Reeves K, Rees J, Hendrickson L, Bray P, Tapp H. Using the Consolidated Framework for Implementation Research (CFIR) to evaluate implementation effectiveness of a facilitated approach to an asthma shared decision making intervention. J Asthma. 2021 Apr;58(4):554-563. doi: 10.1080/02770903.2019.1702200. Epub 2019 Dec 23.
Results Reference
derived
PubMed Identifier
25359128
Citation
Tapp H, McWilliams A, Ludden T, Kuhn L, Taylor Y, Alkhazraji T, Halladay J, Derkowski D, Mohanan S, Dulin M. Comparing traditional and participatory dissemination of a shared decision making intervention (ADAPT-NC): a cluster randomized trial. Implement Sci. 2014 Oct 29;9:158. doi: 10.1186/s13012-014-0158-0.
Results Reference
derived

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Comparing Types of Implementation of a Shared Decision Making Intervention

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