Nervous System Diseases

All Conditions

Symptoms and General Pathology

Heart and Blood Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Nutritional and Metabolic Diseases

Diseases and Abnormalities at or Before Birth

Wounds and Injuries

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Heart Defects, Congenital

Metabolism, Inborn Errors

Brain Injuries

Brain Damage, Chronic

Brain Diseases

Central Nervous System Diseases

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Congenital Abnormalities

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Receipt of a novel mobile-health tool, GoalKeeper Plus Standard Care

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

GoalKeeper

Standard Care

Lee M Sanders, MD, MPH

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.

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.

GoalKeeper: Intelligent Information Sharing for Children With Medical Complexity

Intelligent Information Sharing: Advancing Teamwork in Complex Care

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.

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.

Change in perception in quality of goal-centered care will be assessed by Investigators based on parent baseline interviews and parent exit interviews.

National Cancer Institute (NCI)

Harvard University

Stanford University

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
GoalKeeper: Intelligent Information Sharing for Children With Medical Complexity	NCT03620071	Childhood Cance... Cerebral Palsy Chronic Lung Di... Congenital Hear... Congenital Meta... Gastrostomy	GoalKeeper Standard Care	18 Years -	Stanford University
GoalKeeper: Intelligent Information Sharing for Children With Medical Complexity	NCT03620071	Childhood Cance... Cerebral Palsy Chronic Lung Di... Congenital Hear... Congenital Meta... Gastrostomy	GoalKeeper Standard Care	18 Years -	Stanford University

Spots Global Cancer Trial Database for congenital metabolic disorder