NCT03620071

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 19, 2018

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 8, 2018

Completed
8 months until next milestone

Study Start

First participant enrolled

April 19, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 19, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 17, 2021

Completed
Last Updated

September 26, 2023

Status Verified

September 1, 2023

Enrollment Period

1.8 years

First QC Date

July 19, 2018

Last Update Submit

September 22, 2023

Conditions

Childhood CancerCerebral PalsyChronic Lung DiseaseCongenital Heart DiseaseCongenital Metabolic DisorderGastrostomy

Keywords

complex chronic conditioncare coordinationshared decision makinghealth literacy

Outcome Measures

Primary Outcomes (1)

  • Change in Parent Perception of Goal-Centered Care questionnaire from Baseline to 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.

    Baseline and 1-Month Follow-up

Secondary Outcomes (1)

  • 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

Other Outcomes (1)

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

    Baseline and 1-Month Follow-up

Study Arms (2)

Intervention

EXPERIMENTAL

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

Other: GoalKeeperOther: Standard Care

Control

EXPERIMENTAL

Standard Care

Other: Standard Care

Interventions

GoalKeeperOTHER

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

Intervention
Standard CareOTHER

Standard Clinical Care

ControlIntervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Parent with known mental illness or neurocognitive impairment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford Children's Health

Palo Alto, California, 94304, United States

Location

Related Publications (2)

  • 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.

    PMID: 32540424RESULT

  • 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.

    PMID: 35998021DERIVED

MeSH Terms

Conditions

NeoplasmsCerebral PalsyHeart Defects, CongenitalMetabolism, Inborn Errors

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGenetic Diseases, InbornMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Lee M Sanders, MD, MPH

    Associate Professor, Pediatrics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2018

First Posted

August 8, 2018

Study Start

April 19, 2019

Primary Completion

January 19, 2021

Study Completion

March 17, 2021

Last Updated

September 26, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)