Clinical trial NCT06186752: Feasibility Test of Action Planning in Pediatric IBD
Official title: Feasibility of a Care Team-Focused Action Plan to Improve Quality of Care for Children and Adolescents With Inflammatory Bowel Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Inflammatory Bowel Diseases
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2024-01-02
Enrollment: 60
Sex: ALL
Minimum age (years): 13
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects will be randomized 1:1 overall to intervention and control using permuted blocks (four) designed according to each alphabetic cluster's assigned nurse coordinator.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of this interventional study is to test the feasibility of a new communication tool, call MyIBD, in youth ages 13 to 19 years with inflammatory bowel disease. The main question\[s\] it aims to answer are:

* Is the MyIBD communication tool feasible to use in everyday clinical practice?
* Does the MyIBD tool have potential to improve patients' self-management skills and the quality of care they receive?

Participants who receive the MyIBD intervention will complete surveys about their care at three times points - at study enrollment, at 6 months, and at 12 months. The surveys will help the research team learn about the feasibility of using MyIBD in practice and about any effects on patients' self-management skills and quality of care.

Researchers will compare those receiving a MyIBD document to a randomly selected control group (patients receiving usual care for pediatric inflammatory bowel disease) to see if self-management skills and quality of care differ between the groups.

Detailed description: Quality of care for youth with chronic disease suffers because of gaps in care coordination and communication among patients/families and multiple health care providers. As youth with inflammatory bowel disease (IBD) have preventive and acute care needs beyond those of peers, IBD provides an excellent use case to evaluate interventions to enhance coordination and improve quality. Electronic health records (EHRs) have unfulfilled potential to facilitate coordination and effective action among teams of providers and families. This project leverages web-based and mobile phone application access points to share patient-specific information from an IBD center's EHR. The intervention, MyIBD, has been developed with systematic input from patients, families, and providers. Our objective is to assess the feasibility of delivering tailored guidance on IBD-related health needs to families and care team members using a low-cost, low-risk health communication innovation using existing health information technology. The rationale is that brief, actionable, individually tailored guidance from IBD specialists to families and other providers will support decisions about seeking and providing timely preventive and acute care. Though the intervention builds on prior work and evidence and has been pilot tested, it requires feasibility testing in practice prior to large-scale evaluation. We will assess feasibility of MyIBD through a pilot randomized, controlled trial at one site (n=60). The study has three research aims: (1) assess the feasibility of a rollout effectiveness trial design; (2) assess the feasibility and acceptability of implementing MyIBD in a pediatric IBD clinic; (3) explore the feasibility of MyIBD to improve (a) care quality measures collected from participants and the EHR and (b) patient self-management. In Aim 1 we will assess subject recruitment, randomization, retention, intervention completion, and contamination of control subjects using a study log. For Aim 2 we will use interviews (will take place after completion of the feasibility trial) and surveys to learn about barriers and facilitators of adoption by IBD clinics and acceptability and appropriateness from the perspectives of patients/families and care providers. For Aim 3 we will use surveys and medical record data to explore change over time in family-reported care quality, patient self-management, and completion of guideline-supported quality indicators for pediatric IBD for intervention and control groups. This project is innovative in seeking to change the default ways that care team members share information and address shared responsibilities. MyIBD targets well-described barriers to coordination and incorporates behavioral strategies of individual tailoring, family participation, expert modeling, and facilitation to streamline information delivery and enhance its relevance, accessibility, and actionability. The proposed study is significant because of its potential to improve health through a low-cost intervention to enhance use of existing health information technology. The study's findings could provide a framework for EHR-supported quality improvements through learning health system research across a range of childhood-onset chronic diseases.

Eligibility criteria: Inclusion Criteria:

* age 13-19 years old at time of recruitment; AND
* diagnosis at least 3 months earlier of Crohn's disease, ulcerative colitis, or indeterminate colitis (to exclude families who have not had sufficient time to become familiar with condition and/or clinic personnel); AND
* receiving ongoing care at UNC (at least one visit in the past year)

Exclusion Criteria:

* speaker of a language other than English or Spanish

Primary outcomes:
measure: Number of overall participants recruited and randomized
timeFrame: Measured and reported at the end of study year 1
measure: Number of intervention group participants who receive a MyIBD document
timeFrame: Measured and reported at the end of study year 1
measure: Number of overall participants retained through baseline survey
timeFrame: Measured and reported at the end of study year 1
measure: Number of overall participants retained through 6-month survey
timeFrame: Measured and reported at the mid-point of study year 2
measure: Number of overall participants retained through 12-month survey
timeFrame: Measured and reported at end of study year 2
measure: Number of control group participants who receive a MyIBD document
timeFrame: Measured and reported at the end of study year 1
measure: Number of intervention group participants who agree or completely agree that MyIBD is an acceptable intervention using the Acceptability of Intervention Measure
timeFrame: Reported at the end of study year 2
measure: Number of intervention group participants who agree or completely agree that MyIBD is an appropriate intervention using the Intervention Appropriateness Measure
timeFrame: Reported at the end of study year 2
Secondary outcomes:
measure: Mean self-management score on the Partners in Health scale at baseline
timeFrame: Measured in each participant's baseline survey; reported at end of study year 1
measure: Mean self-management score on the Partners in Health scale at 6 months
timeFrame: Measured in each participant's 6-month survey; reported at end of study year 2
measure: Mean self-management score on the Partners in Health scale at 12 months
timeFrame: Measured in each participant's 12-month survey; reported at end of study year 2
measure: Mean perceived Quality of Care score at baseline using the Patient Assessment of Chronic Illness Care survey
timeFrame: Measured in each participant's baseline survey; reported at end of study year 1
measure: Mean perceived Quality of Care score at 12 months using the Patient Assessment of Chronic Illness Care survey
timeFrame: Measured in each participant's 12-month survey; reported at end of study year 2
Other outcomes:
measure: Number of overall participants who completed a primary care health supervision visit in the past year, baseline
timeFrame: Measured by self-report in baseline survey; reported at end of study year 1
measure: Number of overall participants who completed a primary care health supervision visit in the past year, 12 months
timeFrame: Measured by self-report in 12-month survey; reported at end of study year 2
measure: Number of overall participants who completed special vaccine recommendations, baseline
timeFrame: Measured by self-report in baseline survey; reported at end of study year 1
measure: Number of overall participants who completed special vaccine recommendations, 12 months
timeFrame: Measured by self-report in 12-month survey; reported at end of study year 2
measure: Number of overall participants who participated in mood disorder screening in the past year, baseline
timeFrame: Measured by self-report in baseline survey; reported at end of study year 1
measure: Number of overall participants who participated in mood disorder screening in the past year, 12 months
timeFrame: Measured by self-report in 12-month survey; reported at end of study year 2
measure: Average number of non-injury-related visits to an emergency department (ED) in the past year, baseline
timeFrame: Measured by self-report in baseline survey; reported at end of study year 1
measure: Average number of non-injury-related visits to an emergency department (ED) in the past year, 12 months
timeFrame: Measured by self-report in 12-month survey; reported at end of study year 2
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina-Chapel Hill School of Medicine
state: North Carolina
Study officials:
affiliation: UNC-Chapel Hill School of Medicine
name: Neal deJong, MD
role: PRINCIPAL_INVESTIGATOR
References: