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Completed

NCT Number: NCT02047929

Comparing Types of Implementation of a Shared Decision Making Intervention

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.

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Key information

Age range

1 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Family Medicine

Charlotte, North Carolina, 28207, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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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Treatment and study plan

Asthma Shared Decision Making (SDM) Toolkit

Other

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 outcomes

  1. Patient Perception of Shared Decision Making

    Time frame: 18 months

    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 outcomes

  1. Health Outcomes

    Time frame: 18 months

    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.

  2. Medication Adherence

    Time frame: 18 months

    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.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • Patient-Centered Outcomes Research Institute

Registry information

Official study title

Comparing Traditional and Participatory Dissemination of a Shared Decision Making Intervention

Acronym: ADAPT-NC

Important dates

Study start
2013
Primary completion
2016
Study completion
2017
First posted
Jan 28, 2014
Registry last updated
Apr 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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