Results Summary and Professional Abstract
|This project's final research report is expected to be available by March 2021.|
Related PCORI Dissemination and Implementation Project
Improving Outcomes for Asthma Patients
Principal Investigator James Stout, MD, MPH, speaks about his project and how its involvement of people with poorly controlled asthma has impacted other clinics, which have adopted its electronic health records system.
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. Those comments and responses included the following:
- The reviewers asked the researchers to acknowledge in the report that they had sufficient power to test the success of the community health worker (CHW) intervention but not the enhanced clinical care intervention. The researchers acknowledged that their study was originally conceptualized as a Two-by-Two factorial design where they could determine the interaction between the enhanced clinical care and CHW interventions. However, because patients were not randomized for enhanced clinical care the project could not really be considered a factorial design. In addition, the enhanced clinical care implementation was not successful in most of the targeted clinics. The researchers, therefore, reconceptualized their study as a randomized controlled trial of the CHW intervention compared to no intervention, overlaid onto a feasibility study of the clinic-level intervention.
- The reviewers asked for clarification about the timeframe of the clinic-level intervention in relation to the CHW intervention. The researchers explained that the clinic-level intervention began before they enrolled the first study participant in the CHW intervention.
- The reviewers noted that most people likely think that community health workers (CHWs) focus on education and support rather than physical changes to homes and asked what is known about the benefit of ongoing engagement by CHWs for medical education as compared with single home visits to reduce environmental triggers of asthma. The researchers explained that in 20 years of research studies on the impact of CHWs, trials initially focused on workers helping with living spaces. However, their roles expanded later to add medication management and chronic disease self-management. The researchers said that at this point the standard of care is for CHWs to provide both advice on the physical environment and medical management.
- The reviewers commented on the small number of patients or patients’ parents, six in all, who participated in shaping the study in a focus group meeting. The reviewers noted that this low number of patients and patients’ parents may not have been a representative sample or likely to address the range of issues that could have been raised. The researchers acknowledged this was a limitation of the study and said they found it challenging to induce more low-income people to attend a stakeholder meeting. They agreed that ideally, they would have been able to speak with a larger number of patients and parents. Also, they said they would be grateful to learn from others who have had better success.
- The reviewers asked whether the study tracked whether the study participants used the dust mite bed covers, vacuum cleaners, and air filters supplied to them. The researchers said they did not systematically assess if participants used these resources. They said that previous trials suggest that providing a full package of such tools is most helpful, allowing participants to use the tools most suited to their needs, but this study did not try to address which of the tools were most effective.
Conflict of Interest Disclosures
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Other Clinical Interventions
Other Health Services Interventions
Training and Education Interventions
^James W. Krieger, MD, MPH, was the original principal investigator for this project.