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
|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|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||67 participants|
|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|
Receipt of a novel mobile-health tool, GoalKeeper Plus Standard Care
Mobile-health communication tool for parents of children with medical complexity
Other: Standard Care
Standard Clinical Care
Other: Standard Care
Standard Clinical Care
- 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.
- 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.
- 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.
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
|United States, California|
|Stanford Children's Health|
|Palo Alto, California, United States, 94304|
|Principal Investigator:||Lee M Sanders, MD, MPH||Associate Professor, Pediatrics|