Trial Outcomes & Findings for Comparing Types of Implementation of a Shared Decision Making Intervention (NCT NCT02047929)
NCT ID: NCT02047929
Last Updated: 2022-04-22
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
18 months
Results posted on
2022-04-22
Participant Flow
All practices were recruited and randomized by May 2014.
All practices were randomized in the study. Since the intervention was practice wide, individual patients were not required to be enrolled or consented.
Unit of analysis: Primary Care Practices
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
1503 10
|
2523 10
|
2248 10
|
|
Overall Study
Practice Rollout
|
1503 10
|
2523 10
|
0 0
|
|
Overall Study
Practice Refresher
|
1503 10
|
2523 10
|
0 0
|
|
Overall Study
Surveys Collected
|
1503 10
|
2523 10
|
0 0
|
|
Overall Study
COMPLETED
|
1503 10
|
2523 10
|
2248 10
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparing Types of Implementation of a Shared Decision Making Intervention
Baseline characteristics by cohort
| Measure |
Facilitator-Led Participant Owned (FLOW) Dissemination
n=1503 Participants
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.
|
Traditional Dissemination (Active Diffusion)
n=2523 Participants
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.
|
Control
n=2248 Participants
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.
|
Total
n=6274 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
Under the Age of 21
|
1340 Participants
n=5 Participants
|
2223 Participants
n=7 Participants
|
2058 Participants
n=5 Participants
|
5621 Participants
n=4 Participants
|
|
Age, Customized
Age 21 and Older
|
163 Participants
n=5 Participants
|
300 Participants
n=7 Participants
|
190 Participants
n=5 Participants
|
653 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
670 Participants
n=5 Participants
|
1121 Participants
n=7 Participants
|
950 Participants
n=5 Participants
|
2741 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
833 Participants
n=5 Participants
|
1402 Participants
n=7 Participants
|
1298 Participants
n=5 Participants
|
3533 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 18 monthsPopulation: Number of surveys collected. Per the protocol, surveys were not collected for the Usual Care cohort.
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.
Outcome measures
| Measure |
Facilitator-Led
n=705 Participants
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.
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
|
Traditional
n=523 Participants
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.
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 te
|
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.
|
|---|---|---|---|
|
Patient Perception of Shared Decision Making
The provider alone made the decision
|
34 Participants
|
40 Participants
|
—
|
|
Patient Perception of Shared Decision Making
The provider mostly made the decision, and I playe
|
86 Participants
|
79 Participants
|
—
|
|
Patient Perception of Shared Decision Making
The provider and I participated equally in making
|
528 Participants
|
347 Participants
|
—
|
|
Patient Perception of Shared Decision Making
I mostly made the decision, and the provider play
|
30 Participants
|
26 Participants
|
—
|
|
Patient Perception of Shared Decision Making
I alone made the decision
|
27 Participants
|
31 Participants
|
—
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: Medicaid Patients diagnosed with Asthma
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.
Outcome measures
| Measure |
Facilitator-Led
n=1503 Participants
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.
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
|
Traditional
n=2523 Participants
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.
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 te
|
Control
n=2248 Participants
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.
|
|---|---|---|---|
|
Health Outcomes
Patients with Emergency Department Visits
|
144 Participants
|
355 Participants
|
288 Participants
|
|
Health Outcomes
Patients with Hospitalizations
|
23 Participants
|
29 Participants
|
38 Participants
|
|
Health Outcomes
Patients with Oral Steroid Prescriptions
|
550 Participants
|
977 Participants
|
764 Participants
|
|
Health Outcomes
Patients with Exacerbations
|
599 Participants
|
1031 Participants
|
810 Participants
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: Data was not collected
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.
Outcome measures
Outcome data not reported
Adverse Events
Facilitator-Led Participant Owned (FLOW) Dissemination
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Traditional Dissemination (Active Diffusion)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place