GoalKeeper: Intelligent Information Sharing for Children With Medical Complexity

Study Overview
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Brief Summary
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This proposal addresses the major challenge of improving health outcomes for children with cancer and other complex conditions, for whom the effectiveness of outpatient care depends on care coordination across a diverse group of caregivers that includes parents, community support organizations and pediatric care providers. The investigators have developed GoalKeeper, a prototype system for supporting care coordination across multiple care providers. The primary aim of the clinical trial is to assess the potential for this new system, GoalKeeper, to improve meaningful use of goal-centered care plans in the care of children with cancer and other complex chronic conditions.

Detailed Description
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The overarching aim of the research is to improve care coordination and goal setting for children with medical complexity (CMC). Specific aims of the pilot clinical trail are as follows: (1) To assess the efficacy of GoalKeeper on goal-setting in the health care encounter. (2) To examine the roles of parent health literacy and parent activation in moderating the effect of the intervention. Study Population: Stanford's Primary and Subspecialty Care Clinics at Stanford Children's Health will serve as the setting for study recruitment. The pilot randomized controlled trial will enroll 60 parents of children with medical complexity and their health-care providers. Eligibility criteria for participants will be age 18 years or older, English-speaking, and (for parents) child<12 years old. Exclusion criteria are parent with known mental illness or neurocognitive impairment. A stepped wedge approach by provider will introduce families to GoalKeeper at different time points in the study. A pre-intervention period will occur at least 1 month before the trial start where clinical observations and baseline survey information will be obtained of each providers' practice. Each family will be given training and 4-month access to the GoalKeeper application and participate in an exit interview at the end of study.

Official Title
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Intelligent Information Sharing: Advancing Teamwork in Complex Care

Conditions
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Childhood Cancer, Cerebral Palsy, Chronic Lung Disease, Congenital Heart Disease, Congenital Metabolic Disorder, Gastrostomy

Intervention / Treatment
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* Other: GoalKeeper
* Other: Standard Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Parent-child dyads and their medical provider Parent and provider age 18 years or older Parent English- or Spanish-speaking Child > age 12 months and <12 years old Exclusion Criteria: Parent with known mental illness or neurocognitive impairment.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Receipt of a novel mobile-health tool, GoalKeeper Plus Standard Care | Other: GoalKeeper<br>* Mobile-health communication tool for parents of children with medical complexity<br>Other: Standard Care<br>* Standard Clinical Care<br>|
| Experimental: Control<br>Standard Care | Other: Standard Care<br>* Standard Clinical Care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Parent Perception of Goal-Centered Care questionnaire from Baseline to 1-Month Follow-up | Parent perception of goal-centered care will be measured using a modified version of the Patient Assessment of Chronic Illness Care, Goal-Setting Domain questionnaire, using a scale of 1(Almost Never) to 5 (Almost Always) with higher values representing better goal-centered care. | Baseline and 1-Month Follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Count of parent participants with change in perception of goal-centered care from baseline to 3-Month Follow-up based on Investigator assessment. | Change in perception in quality of goal-centered care will be assessed by Investigators based on parent baseline interviews and parent exit interviews. | Baseline and 3 month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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complex chronic condition, care coordination, shared decision making, health literacy