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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

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : April 19, 2019
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : December 31, 2021

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




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03620071


Locations
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United States, California
Stanford Children's Health
Palo Alto, California, United States, 94304
Sponsors and Collaborators
Lee Sanders
National Cancer Institute (NCI)
Harvard University
Investigators
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Principal Investigator: Lee M Sanders, MD, MPH Associate Professor, Pediatrics
Publications of Results:
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Responsible Party: Lee Sanders, Associate Professor, Pediatrics, Stanford University
ClinicalTrials.gov Identifier: NCT03620071    
Other Study ID Numbers: 1R01CA204585-01 ( U.S. NIH Grant/Contract )
1R01CA204585-01 ( U.S. NIH Grant/Contract )
First Posted: August 8, 2018    Key Record Dates
Last Update Posted: June 7, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lee Sanders, Stanford University:
complex chronic condition
care coordination
shared decision making
health literacy
Additional relevant MeSH terms:
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Lung Diseases
Cerebral Palsy
Heart Diseases
Heart Defects, Congenital
Metabolism, Inborn Errors
Metabolic Diseases
Cardiovascular Diseases
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Respiratory Tract Diseases
Cardiovascular Abnormalities
Congenital Abnormalities
Genetic Diseases, Inborn