GoalKeeper: Intelligent Information Sharing for Children With Medical Complexity

Sponsor

Lee Sanders (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03620071

Collaborator

National Cancer Institute (NCI) (NIH), Harvard University (Other)

Enrollment

Location

Arms

32.4

Anticipated Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Childhood Cancer Cerebral Palsy Chronic Lung Disease Congenital Heart Disease Congenital Metabolic Disorder Gastrostomy	Other: GoalKeeper Other: Standard Care	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

67 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Intelligent Information Sharing: Advancing Teamwork in Complex Care

Actual Study Start Date :

Apr 19, 2019

Anticipated Primary Completion Date :

Jun 30, 2021

Anticipated Study Completion Date :

Dec 31, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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.

Other Outcome Measures

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