Primary Care Transition Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT01750892
First received: December 13, 2012
Last updated: January 28, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Chronic Health Condition
Cognitive Disability
Behavioral: REACH for Independence
Behavioral: Transition Consult
Other: Study Materials

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Transition From Pediatric to Adult Services: A Primary Care Based Model for Patients With Chronic Conditions

Further study details as provided by Children's Hospital of Philadelphia:

Primary Outcome Measures:
  • Successful transition to an adult provider [ Time Frame: 10 months ] [ Designated as safety issue: No ]
    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:
  • Increased self-care and transition related skills [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • Satisfaction [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Self-reported satisfaction with the intervention will be assessed at 6-months post-baseline via a phone interview or online survey.


Estimated Enrollment: 102
Study Start Date: October 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other: Study Materials
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.
Behavioral: REACH for Independence
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.
Other: Study Materials
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 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.
Behavioral: REACH for Independence
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.
Behavioral: Transition Consult
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.
Other: Study Materials
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 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.
Other: Study Materials
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.

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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01750892

Locations
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Children's Hospital of Philadelphia
Investigators
Principal Investigator: Nadja Peter, MD Children's Hospital of Philadelphia
Principal Investigator: Oana Tomescu, MD, PhD Children's Hospital of Philadelphia
  More Information

No publications provided

Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT01750892     History of Changes
Other Study ID Numbers: Peter_12-009117
Study First Received: December 13, 2012
Last Updated: January 28, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on August 28, 2014