GoalKeeper: Intelligent Information Sharing for Children With Medical Complexity

Not Applicable

Completed

• Conditions: Cerebral Palsy; Congenital Metabolic Disorder; Gastrostomy; Childhood Cancer; Chronic Lung Disease; Congenital Heart Disease
• Interventions: Other: Standard Care; Other: GoalKeeper

• Registration Number: NCT03620071
• Lead Sponsor: Stanford University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2018-07-19
• Study First Submitted QC: 2018-08-02
• Study First Posted: 2018-08-08
• Study Start: 2019-04-19
• Primary Completion: 2021-01-19
• Study Completion: 2021-03-17
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-22
• Last Update Posted: 2023-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

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

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Exclusion Criteria

• Parent with known mental illness or neurocognitive impairment.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Standard Care	Standard Care
Intervention	Standard Care	Receipt of a novel mobile-health tool, GoalKeeper Plus Standard Care
Intervention	GoalKeeper	Receipt of a novel mobile-health tool, GoalKeeper Plus Standard Care

Primary Outcome Measures

Name	Time	Method
Change in Parent Perception of Goal-Centered Care questionnaire from Baseline to 1-Month Follow-up	Baseline and 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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Stanford Children's Health; 🇺🇸 Palo Alto, California, United States