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

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ClinicalTrials.gov Identifier: NCT03620071
Recruitment Status : Active, not recruiting
First Posted : August 8, 2018
Last Update Posted : June 7, 2021
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Harvard University
Information provided by (Responsible Party):
Lee Sanders, Stanford University

Tracking Information
First Submitted Date  ICMJE July 19, 2018
First Posted Date  ICMJE August 8, 2018
Last Update Posted Date June 7, 2021
Actual Study Start Date  ICMJE April 19, 2019
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 2, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 2, 2018)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: August 2, 2018)
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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE GoalKeeper: Intelligent Information Sharing for Children With Medical Complexity
Official Title  ICMJE Intelligent Information Sharing: Advancing Teamwork in Complex 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Childhood Cancer
  • Cerebral Palsy
  • Chronic Lung Disease
  • Congenital Heart Disease
  • Congenital Metabolic Disorder
  • Gastrostomy
Intervention  ICMJE
  • Other: GoalKeeper
    Mobile-health communication tool for parents of children with medical complexity
  • Other: Standard Care
    Standard Clinical Care
Study Arms  ICMJE
  • Experimental: Intervention
    Receipt of a novel mobile-health tool, GoalKeeper Plus Standard Care
    Interventions:
    • Other: GoalKeeper
    • Other: Standard Care
  • Experimental: Control
    Standard Care
    Intervention: Other: Standard Care
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: June 2, 2021)
67
Original Estimated Enrollment  ICMJE
 (submitted: August 2, 2018)
60
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03620071
Other Study ID Numbers  ICMJE 1R01CA204585-01( U.S. NIH Grant/Contract )
1R01CA204585-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Lee Sanders, Stanford University
Study Sponsor  ICMJE Lee Sanders
Collaborators  ICMJE
  • National Cancer Institute (NCI)
  • Harvard University
Investigators  ICMJE
Principal Investigator: Lee M Sanders, MD, MPH Associate Professor, Pediatrics
PRS Account Stanford University
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP