Comparing Types of Implementation of a Shared Decision Making Intervention

NCT02047929 | Completed Results DMC

• 1 other identifier: CD-12-11-4276
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Keywords

Asthma; Shared decision making; Participatory methods; Practice facilitator; Health coach

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Health Outcomes

  18 months

• Medication Adherence

  18 months

Study Arms (3)

Facilitator-Led

ACTIVE COMPARATOR

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.

Other: Asthma Shared Decision Making (SDM) Toolkit

Traditional

ACTIVE COMPARATOR

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.

Other: Asthma Shared Decision Making (SDM) Toolkit

Control

NO INTERVENTION

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.

Interventions

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.

Facilitator-Led; Traditional

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

Department of Family Medicine

Charlotte, North Carolina, 28207, United States

Location

Related Publications (4)

• 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.

  PMID: 32477003 DERIVED

• 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.

  PMID: 32152153 DERIVED

• 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.

  PMID: 31868043 DERIVED

• 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.

  PMID: 25359128 DERIVED

MeSH Terms

Conditions

Asthma

Interventions

SDM

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Limitations and Caveats

Due to system data changes with our secondary outcomes data source, medication adherence was not collected for the study. Age data was only collected based under the age of 21 and 21 and older.

Results Point of Contact

• Title: Dr. Thomas Ludden
• Organization: Carolinas HealthCare System

tom.ludden@carolinashealthcare.org

704-608-2390

Study Officials

• Hazel Tapp

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2014
• First Posted: January 28, 2014
• Study Start: August 1, 2013
• Primary Completion: August 31, 2016
• Study Completion: January 31, 2017
• Last Updated: April 22, 2022
• Results First Posted: June 28, 2019

Record last verified: 2019-04

Locations

US (1)