Asthma
Conditions
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
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
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Patient Perception of Shared Decision Making | 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
| Measure | Time frame | Description |
|---|---|---|
| Health Outcomes | 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. |
| Medication Adherence | 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. |
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
| Arm | Count |
|---|---|
| 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 |
| Total | 6,274 |
Baseline characteristics
| Characteristic | Total | Facilitator-Led Participant Owned (FLOW) Dissemination | Traditional Dissemination (Active Diffusion) | Control |
|---|---|---|---|---|
| Age, Customized Age 21 and Older | 653 Participants | 163 Participants | 300 Participants | 190 Participants |
| Age, Customized Under the Age of 21 | 5621 Participants | 1340 Participants | 2223 Participants | 2058 Participants |
| Sex: Female, Male Female | 2741 Participants | 670 Participants | 1121 Participants | 950 Participants |
| Sex: Female, Male Male | 3533 Participants | 833 Participants | 1402 Participants | 1298 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Facilitator-Led | Patient Perception of Shared Decision Making | The provider mostly made the decision, and I playe | 86 Participants |
| Facilitator-Led | Patient Perception of Shared Decision Making | I mostly made the decision, and the provider play | 30 Participants |
| Facilitator-Led | Patient Perception of Shared Decision Making | The provider and I participated equally in making | 528 Participants |
| Facilitator-Led | Patient Perception of Shared Decision Making | I alone made the decision | 27 Participants |
| Facilitator-Led | Patient Perception of Shared Decision Making | The provider alone made the decision | 34 Participants |
| Traditional | Patient Perception of Shared Decision Making | I alone made the decision | 31 Participants |
| Traditional | Patient Perception of Shared Decision Making | The provider alone made the decision | 40 Participants |
| Traditional | Patient Perception of Shared Decision Making | The provider mostly made the decision, and I playe | 79 Participants |
| Traditional | Patient Perception of Shared Decision Making | The provider and I participated equally in making | 347 Participants |
| Traditional | Patient Perception of Shared Decision Making | I mostly made the decision, and the provider play | 26 Participants |
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Facilitator-Led | Health Outcomes | Patients with Emergency Department Visits | 144 Participants |
| Facilitator-Led | Health Outcomes | Patients with Exacerbations | 599 Participants |
| Facilitator-Led | Health Outcomes | Patients with Oral Steroid Prescriptions | 550 Participants |
| Facilitator-Led | Health Outcomes | Patients with Hospitalizations | 23 Participants |
| Traditional | Health Outcomes | Patients with Oral Steroid Prescriptions | 977 Participants |
| Traditional | Health Outcomes | Patients with Hospitalizations | 29 Participants |
| Traditional | Health Outcomes | Patients with Exacerbations | 1031 Participants |
| Traditional | Health Outcomes | Patients with Emergency Department Visits | 355 Participants |
| Control | Health Outcomes | Patients with Exacerbations | 810 Participants |
| Control | Health Outcomes | Patients with Emergency Department Visits | 288 Participants |
| Control | Health Outcomes | Patients with Hospitalizations | 38 Participants |
| Control | Health Outcomes | Patients with Oral Steroid Prescriptions | 764 Participants |
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