Results Summary
What was the research about?
Shared decision making, or SDM, is a process in which patients work with their doctors to select treatments based on what’s most important to them. Doctors and patients discuss information about the health problem, treatment options, and what patients prefer.
The research team created two different training programs to help doctors and their staff use SDM with patients who have asthma:
- Twelve-week training session. A trainer visited doctors’ offices one hour each week for 12 weeks to teach SDM. Trainers worked with the doctors’ offices to customize the process for each office. After a year, the trainer did a refresher class.
- One-hour training session. A trainer visited doctors’ offices once for one hour to teach SDM. The trainer didn’t customize the SDM process for these offices.
The research team looked to see if patients felt more involved in decisions about their care after their doctors’ offices took part in training. The team also compared the two groups of doctors’ offices that got training with each other and with a group of offices that didn’t get training.
What were the results?
Patients whose doctors’ offices had the 12-week training program felt more involved in making treatment decisions than patients whose doctors’ offices had the one-hour training.
The three groups didn’t differ in how often patients with asthma went to the emergency room, were admitted to the hospital, or got a steroid prescription.
Who was in the study?
The study included 30 doctors’ offices across North Carolina.
What did the research team do?
The research team assigned each of the doctors’ offices by chance to receive one of the two kinds of training or no training. Then, the team surveyed 1,228 patients with asthma who got care at doctors’ offices that had trainings. Surveys asked patients how involved they felt in decisions about their asthma treatment.
The team also looked at health records for 6,274 patients with Medicaid across all the doctors’ offices. They checked how many times the patients’ asthma led to emergency room visits, hospital stays, or steroid prescriptions.
Patients, caregivers, Medicaid health insurers, and staff from asthma advocacy organizations helped the research team design, plan, and conduct the study.
What were the limits of the study?
A Medicaid asthma program may have helped to improve how often patients had asthma problems in all three groups during this study.
The research team didn’t collect patient surveys at doctors’ offices that didn’t have the trainings. The team doesn’t know how SDM for these patients compared with patients at the offices that had trainings. The team doesn’t know if patients who filled out the surveys had SDM during their doctors’ visits or if patients filled out the surveys more than once.
Future research could look more closely at patients who have SDM during their doctors’ visits to compare the effect of the training programs on these patients’ involvement in decisions.
How can people use the results?
Doctors’ offices can use the results as they consider how to help doctors and their patients with asthma use SDM.
Professional Abstract
Objective
To examine the effectiveness of two training programs for clinical staff to promote the uptake of asthma shared decision making (SDM) at primary care practices compared with no training
Study Design
| Design Elements | Description |
|---|---|
| Design | Cluster-randomized controlled trial |
| Population | Survey data for 1,228 patients receiving care at 20 practices that had facilitator-led or lunch-and-learn training programs; EMR data for 6,274 patients receiving care across 30 primary care practices in North Carolina |
| Interventions/ Comparators |
|
| Outcomes |
Primary: level of patient involvement in the decision-making process Secondary: asthma exacerbations, including ED visits, hospitalizations, and oral steroid prescriptions |
| Timeframe | 1-year follow-up for primary outcome |
This cluster-randomized controlled trial compared the effectiveness of two asthma SDM training programs for clinical staff to determine effects on patient involvement in treatment decisions and asthma exacerbations.
Researchers cluster-randomized 30 practices in North Carolina to one of three groups:
- Facilitator-led training. In weekly hour-long meetings throughout 12 weeks, facilitators trained clinical staff about the asthma SDM program. A core team consisting of a provider, practice manager, health coach, nurse, and registration staff adapted the program to each practice’s needs with the facilitator. After one year, the facilitator provided refresher training.
- Lunch-and-learn style training. A facilitator visited doctors’ offices once for one hour to teach SDM. The facilitator did not customize the SDM process for these offices.
- No training. Practices received no interaction with facilitators, training on the SDM program, or training materials.
Researchers collected anonymous surveys from 1,228 patients receiving care from practices in facilitator-led or lunch-and-learn training groups, but not from control-group patients, to measure the level of patient involvement in the decision-making process. Survey collection began after the 12-week rollout at facilitator-led practices and three months after the lunch-and-learn presentation. Researchers collected de-identified practice-level Medicaid data for 6,274 patients across all three groups to assess the number of asthma exacerbations, including the number of emergency department visits, hospitalizations, and oral steroid prescriptions.
Patients, caregivers, health insurers, and representatives from advocacy groups helped design, plan, and conduct the study.
Results
More patients who visited the practices with facilitator-led trainings reported participating equally with their providers in making treatment decisions than in the lunch-and-learn training practices (75% versus 66%; p=0.001).
The three groups did not differ in measures of asthma exacerbations, which improved across all groups over time.
Limitations
A statewide Medicaid asthma initiative may have contributed to improvements in asthma exacerbations across the three groups. Patients at the control clinics did not fill out the surveys; therefore, researchers do not know how this group compares with the two intervention groups. Clinic providers and staff at the intervention practices identified and approached patients with asthma to participate in the survey. The recruitment strategy may have introduced selection bias into the sample. Further, selected patients may not have participated in an SDM visit with their providers, or some may have filled out the survey previously. Researchers did not document levels of SDM occurring at practices before or during the study.
Conclusions and Relevance
Compared with patients at practices using lunch-and-learn trainings, more patients at practices with facilitator-led trainings felt they had participated equally with their providers in decision making. However, asthma-related exacerbations did not differ between facilitator-led, lunch-and-learn, and control practices.
Future Research Needs
Future research could focus on testing the effectiveness of facilitator-led trainings on patient involvement in decision making among patients known to have had an SDM visit with their providers.
Final Research Report
View this project's final research report.
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Peer-Review Summary
Peer review of PCORI-funded research helps make sure the report presents complete, balanced, and useful information about the research. It also assesses how the project addressed PCORI’s Methodology Standards. During peer review, experts read a draft report of the research and provide comments about the report. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. These reviewers cannot have conflicts of interest with the study.
The peer reviewers point out where the draft report may need revision. For example, they may suggest ways to improve descriptions of the conduct of the study or to clarify the connection between results and conclusions. Sometimes, awardees revise their draft reports twice or more to address all of the reviewers’ comments.
Peer reviewers commented, and the researchers made changes or provided responses. The comments and responses included the following:
- Reviewers wondered why the study compared three groups of patients rather than two, that is two intervention arms and a third group of patients that had usual care. The researchers said that the usual care arm allowed them to control for outside factors that could have influenced shared decision making (SDM) in asthma care over the time of the study.
- Reviewers asked why the researchers did not assess patients’ baseline SDM levels so that the change in SDM within practices could be measured over time. The researchers responded that they measured SDM only at the end of the study since they did not plan to assess changes in SDM over time but instead in comparison to usual care.
- Reviewers expressed concern about the statistical analyses given the lack of accounting for the possibility of patients completing the anonymous survey more than once, or the possibility of clustering within sites. The researchers acknowledged that they were unable to account for patients completing the survey more than once and that this was a limitation of the study. They did note that they analyzed survey data at the practice level and added some related caveats to the study limitations related to this.
- Reviewers noted that the report did not discuss the costs of intervention. The researchers said cost analysis wasn’t part of this project. They suspected, however, that there would be significant benefits to improved SDM training because it would lead to improved management of asthma for patients, including reduced emergency visits and hospitalizations. However, future research would be needed to assess the costs and benefits of intervention.
- Reviewers expressed concern that the results were subject to bias because of clinic practice and demographic differences not accounted for in analyses. For instance, the set of practices with facilitator-led SDM training, which had the greatest change in observed results, also had younger patients, who were more often Caucasian. The researchers said the numbers involved were too low to give them the power to analyze demographic effects. They noted that stratifying by practice size before randomization could have helped them perform more-detailed statistical analyses.