Clinical trial NCT03620071: GoalKeeper: Intelligent Information Sharing for Children With Medical Complexity
Official title: Intelligent Information Sharing: Advancing Teamwork in Complex Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Cancer
Cerebral Palsy
Chronic Lung Disease
Congenital Heart Disease
Congenital Metabolic Disorder
Gastrostomy
Keywords: complex chronic condition
care coordination
shared decision making
health literacy
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Harvard University
First posted: 2018-08-08
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Parent Perception of Goal-Centered Care questionnaire from Baseline to 1-Month Follow-up
timeFrame: Baseline and 1-Month Follow-up
Secondary outcomes:
measure: Count of parent participants with change in perception of goal-centered care from baseline to 3-Month Follow-up based on Investigator assessment.
timeFrame: Baseline and 3 month follow-up
Other outcomes:
measure: Change in parent perception of quality of shared decision making from baseline to 1 month
timeFrame: Baseline and 1-Month Follow-up
Locations:
city: Palo Alto
country: United States
facility: Stanford Children's Health
state: California
Study officials:
affiliation: Associate Professor, Pediatrics
name: Lee M Sanders, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.