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Completed

NCT Number: NCT03620071

GoalKeeper: Intelligent Information Sharing for Children With Medical Complexity

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.

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Key information

Conditions

Childhood Cancer Brain Damage, Chronic Brain Diseases Cardiovascular Abnormalities Cardiovascular Diseases Central Nervous System Diseases Cerebral Palsy Chronic Lung Disease Congenital Abnormalities Congenital Heart Disease Congenital Metabolic Disorder Congenital, Hereditary, and Neonatal Diseases and Abnormalities Gastrostomy Genetic Diseases, Inborn Heart Defects, Congenital Heart Diseases Metabolic Diseases Metabolism, Inborn Errors Neoplasms Nervous System Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford Children's Health

Palo Alto, California, 94304, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GoalKeeper

Other

Mobile-health communication tool for parents of children with medical complexity

Standard care

Other

Standard Clinical Care

Primary outcomes

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

    Time frame: 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 outcomes

  1. Count of parent participants with change in perception of goal-centered care from baseline to 3-Month Follow-up based on Investigator assessment.

    Time frame: 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.

Other outcomes

  1. Change in parent perception of quality of shared decision making from baseline to 1 month

    Time frame: Baseline and 1-Month Follow-up

    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.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • Harvard University
  • National Cancer Institute (NCI)

Registry information

Official study title

Intelligent Information Sharing: Advancing Teamwork in Complex Care

Acronym: GoalKeeper

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Aug 8, 2018
Registry last updated
Sep 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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