Primary Care Transition Study

Not Applicable

Completed

• Conditions: Cognitive Disability; Chronic Health Condition
• Interventions: Behavioral: REACH for Independence; Other: Study Materials; Behavioral: Transition Consult

• Registration Number: NCT01750892
• Lead Sponsor: Children's Hospital of Philadelphia

Brief Summary

This study is looking at ways to help young people with chronic health conditions take better care of their health and find an adult doctor.

Detailed Description

The purpose of this study is to determine whether providing targeted transition-related skills through interventions with varying degrees of intensity (from the low intensity Basic intervention group, to the mild intensity Group Intervention group, to the high intensity Full Intervention group) results in improved transition readiness and self-care skills and improved successful transition to adult-based services for young adults with chronic health conditions. Secondary objectives include determining if the transition interventions enhance transition-related satisfaction among participants, their caregivers and the involved pediatric and adult providers.

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-12-13
• Study First Submitted QC: 2012-12-13
• Study First Posted: 2012-12-17
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-11
• Last Update Posted: 2023-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

• Males or females age 19 years of age or older
• Presence of at least 1 Chronic Condition and/or Cognitive Disability
• Last visit with pediatric primary care provider occurring on or after January 1, 2011
• Currently active in one of four identified pediatric practices (Cobbs Creek, Chestnut Hill, Market Street, West Chester)
• Current primary care provider approval for participation
• English speaking

Young Adult

Exclusion Criteria

• Male or female age < 19 years
• No presence of a chronic condition or cognitive disability
• Last visit with pediatric PCP occurring prior to January 1, 2011
• Not currently active in one of four identified pediatric practices (Cobbs Creek, Chestnut Hill, Market Street, West Chester)
• Current PCP disapproves participation
• Non-English speaking

Caregiver Inclusion Criteria:

• Has a child enrolled in the study
• Child has consented/assented to allow them to participate
• English speaking

Caregiver Exclusion Criteria:

• Child did not consent/assent to allow them to participate
• Non-English speaking

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 3: Group Intervention	Study Materials	Group 3 (Group Intervention) will receive the Study Materials at the beginning of the study and will also be invited to attend two REACH for Independence group sessions.
Group 4: Full Intervention	Transition Consult	Group 4 (Full Intervention) will receive the Study Materials at the beginning of the study, will be invited to attend the REACH for Independence group sessions, and will be invited to a Transition Consult with an MD and social worker.
Group 1: Control	Study Materials	Group 1 will be the control group. They will complete questionnaires but will otherwise receive usual care from their Primary Care Provider (PCP). At the end of the study period they will be given the Study Materials for participating.
Group 4: Full Intervention	REACH for Independence	Group 4 (Full Intervention) will receive the Study Materials at the beginning of the study, will be invited to attend the REACH for Independence group sessions, and will be invited to a Transition Consult with an MD and social worker.
Group 4: Full Intervention	Study Materials	Group 4 (Full Intervention) will receive the Study Materials at the beginning of the study, will be invited to attend the REACH for Independence group sessions, and will be invited to a Transition Consult with an MD and social worker.
Group 2: Basic Intervention	Study Materials	Group 2 (Basic Intervention) will receive the Study Materials at the beginning of the study but will otherwise continue with their usual PCP care.
Group 3: Group Intervention	REACH for Independence	Group 3 (Group Intervention) will receive the Study Materials at the beginning of the study and will also be invited to attend two REACH for Independence group sessions.

Primary Outcome Measures

Name	Time	Method
Successful transition to an adult provider	10 months	The primary outcome is successful transition to an adult provider, as evidenced by at least 1 visit with an adult provider within 10 months of the baseline visit.

Secondary Outcome Measures

Name	Time	Method
Increased self-care and transition related skills	6 months	Self-care and transition related skills will be measured pre- and post- intervention with the Transition Readiness Assessment Questionnaire (TRAQ). The TRAQ is a validated 33-item self-administered tool that measures skills needed to progress towards independence in key areas of life like education and work as well as skills needed to successfully transition from pediatric to adult healthcare. The TRAQ will be completed over the phone or via an online survey with young adult participants and their caregivers at baseline and at the 6-month follow-up visit.

Trial Locations

Locations (1)

Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States