- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01750892
Primary Care Transition Study
October 11, 2023 updated by: Children's Hospital of Philadelphia
Transition From Pediatric to Adult Services: A Primary Care Based Model for Patients With Chronic Conditions
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
43
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- Children's Hospital of Philadelphia
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Young Adult 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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Group 1: Control
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.
|
The Study Materials include a Care Binder, a Resource list, an Adult Doctor List and a Wallet Card.
The Care Binder is an organizational tool to help patients with special healthcare needs manage and track important information related to their health and medical care.
The Resource list has information about important community resources.
The Adult Doctor List provides information about finding an adult primary care provider.
The Wallet Card is a sheet for tracking important medical and personal information.
|
Experimental: Group 3: Group Intervention
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.
|
The Study Materials include a Care Binder, a Resource list, an Adult Doctor List and a Wallet Card.
The Care Binder is an organizational tool to help patients with special healthcare needs manage and track important information related to their health and medical care.
The Resource list has information about important community resources.
The Adult Doctor List provides information about finding an adult primary care provider.
The Wallet Card is a sheet for tracking important medical and personal information.
REACH for Independence is a transition and self-care skill-building peer support group led by a social worker.
It is comprised of two 2.5-hour group sessions where participants participate in activities designed to teach self-care, self-advocacy and improve transition to adulthood skills.
|
Experimental: Group 4: Full Intervention
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.
|
The Study Materials include a Care Binder, a Resource list, an Adult Doctor List and a Wallet Card.
The Care Binder is an organizational tool to help patients with special healthcare needs manage and track important information related to their health and medical care.
The Resource list has information about important community resources.
The Adult Doctor List provides information about finding an adult primary care provider.
The Wallet Card is a sheet for tracking important medical and personal information.
REACH for Independence is a transition and self-care skill-building peer support group led by a social worker.
It is comprised of two 2.5-hour group sessions where participants participate in activities designed to teach self-care, self-advocacy and improve transition to adulthood skills.
The transition consult is a 1-on-1 visit with an MD and social worker.
At the consults, participants will receive individualized information related to their unique medical and psychosocial needs and support related to issues relevant to their gaining healthcare independence and finding an adult doctor, such as accommodations, transportation, insurance and finances.
After the consult, this group will have access to a transition coordinator who can help with any transition-related problems that may occur.
|
Experimental: Group 2: Basic Intervention
Group 2 (Basic Intervention) will receive the Study Materials at the beginning of the study but will otherwise continue with their usual PCP care.
|
The Study Materials include a Care Binder, a Resource list, an Adult Doctor List and a Wallet Card.
The Care Binder is an organizational tool to help patients with special healthcare needs manage and track important information related to their health and medical care.
The Resource list has information about important community resources.
The Adult Doctor List provides information about finding an adult primary care provider.
The Wallet Card is a sheet for tracking important medical and personal information.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Successful transition to an adult provider
Time Frame: 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.
|
10 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Increased self-care and transition related skills
Time Frame: 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.
|
6 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Participant satisfaction with the intervention
Time Frame: 6 months
|
Self-reported satisfaction with the intervention will be assessed at 6-months post-baseline via a phone interview or online survey.
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Nadja Peter, MD, Children's Hospital of Philadelphia
- Principal Investigator: Oana Tomescu, MD, PhD, Children's Hospital of Philadelphia
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2012
Primary Completion (Actual)
July 1, 2014
Study Completion (Actual)
July 1, 2014
Study Registration Dates
First Submitted
December 13, 2012
First Submitted That Met QC Criteria
December 13, 2012
First Posted (Estimated)
December 17, 2012
Study Record Updates
Last Update Posted (Actual)
October 13, 2023
Last Update Submitted That Met QC Criteria
October 11, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Peter_12-009117
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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