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Engaging end-users in intervention research study design
Molly A Martin1, Valerie G Press2, Kim Erwin3
1a Department of Pediatrics , University of Illinois at Chicago , Chicago , IL , USA.
Insights
Engaging end-users in asthma research design improved trial feasibility. Modifying discharge education timing and delivery enhanced asthma intervention plans for children in emergency departments.
Area of Science:
- Implementation Science
- Pediatric Asthma Research
- Health Services Research
Background:
- Childhood asthma is a significant public health concern, particularly for high-risk populations in urban settings.
- The Coordinated Healthcare Interventions for Childhood Asthma Gaps in Outcomes (CHICAGO) Plan trial aims to evaluate asthma interventions for children presenting to emergency departments (EDs).
- A formative evaluation was conducted to gather end-user input for optimizing trial design and outcome measures.
Purpose of the Study:
- To incorporate end-user feedback into the design of a pragmatic trial for childhood asthma interventions.
- To enhance the feasibility and relevance of the CHICAGO Plan trial through formative evaluation.
- To identify and address potential challenges in study implementation and recruitment.
Main Methods:
- Employed a multi-level data gathering framework combining design principles and qualitative methods.
- Conducted focus groups with Community Health Workers and caregivers, in-home interviews with caregivers, and key informant interviews at clinical sites.
- Included direct observation through ED tours and site visits.
Main Results:
- Identified that ED discharge protocols often deliver patient education at inopportune times, reducing family receptiveness.
- Recommended and implemented modifications to the trial design, including repositioning discharge asthma plan education to earlier "teachable moments."
- Reassigned the delivery of asthma discharge plans to study-employed ED coordinators to improve effectiveness.
Conclusions:
- End-user engagement in the design phase of implementation research is crucial for enhancing research feasibility and relevance.
- Tailoring intervention delivery to optimal "teachable moments" can improve patient education and engagement.
- Addressing practical implementation challenges proactively through formative evaluation leads to more effective research designs.
Objective:
Coordinated Healthcare Interventions for Childhood Asthma Gaps in Outcomes (CHICAGO) Plan is a 3-arm multicenter pragmatic trial to evaluate asthma interventions in high-risk Chicago children presenting to emergency departments (ED) with asthma. A formative evaluation with end-users to provide input into the trial design and outcome instruments was conducted prior to trial initiation.
Methods:
A multi-level data gathering framework from the field of design and standard qualitative methods was employed. This included one focus group with asthma Community Health Workers (N = 8), two focus groups with caregivers of children with asthma (N = 9), in-home interviews with caregivers (N = 9), key informant interviews at six EDs and outpatient clinical sites (N = 19), and ED tours and observations (N = 6). Data were presented, discussed, and organized into themes.
Results:
Data indicated that changes to the study design and discharge tool were warranted. A key insight was that ED discharge protocols typically place patient education at a single inopportune time, as families are preparing to leave the ED. At this point in time, families are less receptive to education due to fatigue and a desire to expedite the discharge process. The trial design was modified to reposition the discharge asthma plan to occur at earlier "teachable moments." Delivery of the asthma discharge plan was assigned to study-employed ED coordinators instead of ED providers and staff. Other potential challenges to study recruitment and implementation were raised and addressed.
Conclusions:
Engagement of end-users in the design phase of implementation research is critical to improve research feasibility and relevance.
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