GoalKeeper: Intelligent Information Sharing for Children With Medical Complexity (GoalKeeper)

Intelligent Information Sharing: Advancing Teamwork in Complex Care

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.

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy; Childhood Cancer; Congenital Heart Disease; Chronic Lung Disease; Congenital Metabolic Disorder; Gastrostomy
• Intervention / Treatment: Other: GoalKeeper; Other: Standard Care

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 Type: Interventional
• Enrollment (Actual): 67
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • Stanford Children's Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in parent perception of quality of shared decision making from baseline to 1 month	Parent perception will be measured using the "National Survey of Children with Special Health Care Needs Shared Decision Making Domain," which includes 4 domain items each with a scale of 1 (never), 2 (sometimes), 3 (usually) or 4 (always). Positive SDM is defined as parent report of "usually" or "always" on all 4 items. Shared decision making refers to a communication process where parents and providers participate in decision making to reach treatment plan agreement.	Baseline and 1-Month Follow-up

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: National Cancer Institute (NCI); Harvard University
• Investigators: Principal Investigator: Lee M Sanders, MD, MPH, Associate Professor, Pediatrics

Publications and helpful links

General Publications

• Lin JL, Clark CL, Halpern-Felsher B, Bennett PN, Assis-Hassid S, Amir O, Nunez YC, Cleary NM, Gehrmann S, Grosz BJ, Sanders LM. Parent Perspectives in Shared Decision-Making for Children With Medical Complexity. Acad Pediatr. 2020 Nov-Dec;20(8):1101-1108. doi: 10.1016/j.acap.2020.06.008. Epub 2020 Jun 12.
• Lin JL, Huber B, Amir O, Gehrmann S, Ramirez KS, Ochoa KM, Asch SM, Gajos KZ, Grosz BJ, Sanders LM. Barriers and Facilitators to the Implementation of Family-Centered Technology in Complex Care: Feasibility Study. J Med Internet Res. 2022 Aug 23;24(8):e30902. doi: 10.2196/30902.

Study record dates

Study Major Dates

• Study Start (Actual): April 19, 2019
• Primary Completion (Actual): January 19, 2021
• Study Completion (Actual): March 17, 2021

Study Registration Dates

• First Submitted: July 19, 2018
• First Submitted That Met QC Criteria: August 2, 2018
• First Posted (Actual): August 8, 2018

Study Record Updates

• Last Update Posted (Actual): September 26, 2023
• Last Update Submitted That Met QC Criteria: September 22, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: complex chronic condition; care coordination; shared decision making; health literacy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Respiratory Tract Diseases; Congenital Abnormalities; Brain Damage, Chronic; Genetic Diseases, Inborn; Cardiovascular Abnormalities; Heart Diseases; Cerebral Palsy; Lung Diseases; Heart Defects, Congenital; Metabolism, Inborn Errors; Metabolic Diseases
• Other Study ID Numbers: 1R01CA204585-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No