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Comparing Types of Implementation of a Shared Decision Making Intervention

Comparing Traditional and Participatory Dissemination of a Shared Decision Making Intervention

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02047929
Acronym
ADAPT-NC
Enrollment
30
Registered
2014-01-28
Start date
2013-08-31
Completion date
2017-01-31
Last updated
2022-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

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

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.

Interventions

OTHERAsthma 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.

Sponsors

Patient-Centered Outcomes Research Institute
CollaboratorOTHER
Wake Forest University Health Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Years to No maximum
Healthy volunteers
Yes

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. \-

Design outcomes

Primary

MeasureTime frameDescription
Patient Perception of Shared Decision Making18 monthsSuccess 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

MeasureTime frameDescription
Health Outcomes18 monthsHealth 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 Adherence18 monthsAdditional 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.

Countries

United States

Participant flow

Recruitment details

All practices were recruited and randomized by May 2014.

Pre-assignment details

All practices were randomized in the study. Since the intervention was practice wide, individual patients were not required to be enrolled or consented.

Participants by arm

ArmCount
Facilitator-Led Participant Owned (FLOW) Dissemination
This approach to dissemination allows clinics some freedom to tailor the 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. 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), identified by both the Institute of Medicine and the Patient-Centered Outcomes Research Institute as an important new means of improving patient outcomes. In the SDM process, patients and their health care providers are engaged jointly in making decisions about medical tests and treatments. This study will continue to evaluate the Toolkit in a wide array of practices across NC while testing a new method of dissemination.
1,503
Traditional Dissemination (Active Diffusion)
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 SDM Toolkit, access to the internet link with additional information, and a copy of all printed materials associated with the Toolkit.
2,523
Control
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.
2,248
Total6,274

Baseline characteristics

CharacteristicTotalFacilitator-Led Participant Owned (FLOW) DisseminationTraditional Dissemination (Active Diffusion)Control
Age, Customized
Age 21 and Older
653 Participants163 Participants300 Participants190 Participants
Age, Customized
Under the Age of 21
5621 Participants1340 Participants2223 Participants2058 Participants
Sex: Female, Male
Female
2741 Participants670 Participants1121 Participants950 Participants
Sex: Female, Male
Male
3533 Participants833 Participants1402 Participants1298 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 00 / 00 / 0
other
Total, other adverse events
0 / 00 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 00 / 0

Outcome results

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.

Time frame: 18 months

Population: Number of surveys collected. Per the protocol, surveys were not collected for the Usual Care cohort.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Facilitator-LedPatient Perception of Shared Decision MakingThe provider mostly made the decision, and I playe86 Participants
Facilitator-LedPatient Perception of Shared Decision MakingI mostly made the decision, and the provider play30 Participants
Facilitator-LedPatient Perception of Shared Decision MakingThe provider and I participated equally in making528 Participants
Facilitator-LedPatient Perception of Shared Decision MakingI alone made the decision27 Participants
Facilitator-LedPatient Perception of Shared Decision MakingThe provider alone made the decision34 Participants
TraditionalPatient Perception of Shared Decision MakingI alone made the decision31 Participants
TraditionalPatient Perception of Shared Decision MakingThe provider alone made the decision40 Participants
TraditionalPatient Perception of Shared Decision MakingThe provider mostly made the decision, and I playe79 Participants
TraditionalPatient Perception of Shared Decision MakingThe provider and I participated equally in making347 Participants
TraditionalPatient Perception of Shared Decision MakingI mostly made the decision, and the provider play26 Participants
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.

Time frame: 18 months

Population: Medicaid Patients diagnosed with Asthma

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Facilitator-LedHealth OutcomesPatients with Emergency Department Visits144 Participants
Facilitator-LedHealth OutcomesPatients with Exacerbations599 Participants
Facilitator-LedHealth OutcomesPatients with Oral Steroid Prescriptions550 Participants
Facilitator-LedHealth OutcomesPatients with Hospitalizations23 Participants
TraditionalHealth OutcomesPatients with Oral Steroid Prescriptions977 Participants
TraditionalHealth OutcomesPatients with Hospitalizations29 Participants
TraditionalHealth OutcomesPatients with Exacerbations1031 Participants
TraditionalHealth OutcomesPatients with Emergency Department Visits355 Participants
ControlHealth OutcomesPatients with Exacerbations810 Participants
ControlHealth OutcomesPatients with Emergency Department Visits288 Participants
ControlHealth OutcomesPatients with Hospitalizations38 Participants
ControlHealth OutcomesPatients with Oral Steroid Prescriptions764 Participants
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.

Time frame: 18 months

Population: Data was not collected

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026