A Patient-centered Approach to Successful Community Transition After Catastrophic Injury
Primary Purpose
Spinal Cord Injury, Peer Group
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Peer directed education
Patient Engagement Portal
Sponsored by
About this trial
This is an interventional prevention trial for Spinal Cord Injury
Eligibility Criteria
Inclusion Criteria:
- patient receiving inpatient rehabilitation at Shepherd Center following spinal cord injury
- discharge to community setting
Exclusion Criteria:
- discharge to non-community setting
- patient without spinal cord injury at Shepherd Center
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Other
Arm Label
Peer directed education
Patient Engagement Portal
Arm Description
A revised education approach that focuses on problem solving discussions delivered by peers and grounded clinical information is compared to traditional approach of didactic clinician-driven education lectures
A patient-owned portal to manage injury information is maintained in real-time by patients and families and shared with other care providers after inpatient rehabilitation discharge.
Outcomes
Primary Outcome Measures
Rehospitalization
patient report on telephone interview
Secondary Outcome Measures
Rehospitalization
patient report on telephone interview
Full Information
NCT ID
NCT02746978
First Posted
February 29, 2016
Last Updated
April 18, 2016
Sponsor
Shepherd Center, Atlanta GA
Collaborators
Patient-Centered Outcomes Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT02746978
Brief Title
A Patient-centered Approach to Successful Community Transition After Catastrophic Injury
Official Title
A Patient-centered Approach to Successful Community Transition After Catastrophic Injury
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Unknown status
Study Start Date
August 2013 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shepherd Center, Atlanta GA
Collaborators
Patient-Centered Outcomes Research Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Shepherd Center is bringing a more patient-centered focus to educational, peer-support, and technology resources offered to patients with spinal cord injury and their families and is evaluating these changes.
Approximately 740 patients have provided information about healthcare utilization following inpatient rehabilitation. This information will help Shepherd Center staff follow utilization trends and plan programs targeted at the high-use areas.
Detailed Description
Research efforts are transforming the educational, peer-support and technology resources offered to patients and their caregivers, and evaluating how these changes help improve outcomes, including building patients' sense of self-efficacy - the belief that they can effectively manage their own care. Goals of the three focus areas include:
A. Patient and Family Education Revamp patient education modules for bladder management, skin management, and medical complications management to follow the chronic disease self management approach that replaces didactic lectures with participant-focused problem solving discussions led by peers (persons with SCI). Multiple baseline implementation approaches will be evaluated in interrupted time series analyses.
B. Peer mentoring and peer-led self-management training The peer mentor randomized clinical trial is reported separately on clinicaltrials.gov and not repeated here.
C. Patient and family web portal Shepherd Center, along with our collaborators at Craig Hospital in Denver, Colorado, are developing an engagement portal to provide a mechanism for patients to manage all aspects of injury following rehabilitation discharge and share information with other providers and caregivers.The portal will become a standard part of rehabilitation care and discharge planning for all Shepherd Center patients - starting first with patients with spinal cord injuries and later expanding to others. Stakeholders will be actively involved in providing feedback about portal usability and content so that the product continues to meet their needs.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury, Peer Group
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
800 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Peer directed education
Arm Type
Active Comparator
Arm Description
A revised education approach that focuses on problem solving discussions delivered by peers and grounded clinical information is compared to traditional approach of didactic clinician-driven education lectures
Arm Title
Patient Engagement Portal
Arm Type
Other
Arm Description
A patient-owned portal to manage injury information is maintained in real-time by patients and families and shared with other care providers after inpatient rehabilitation discharge.
Intervention Type
Other
Intervention Name(s)
Peer directed education
Intervention Description
No drug or device is included. The intervention of interest is the redesigned approach to inpatient education that follows the Stanford chronic disease self management approach which includes peer-led problem solving discussions compared to traditional didactic education lectures provided by nurse educators
Intervention Type
Other
Intervention Name(s)
Patient Engagement Portal
Intervention Description
No drug or device interventions. The Engagement Portal is populated by electronic medication record information (demographics, medications, supplies) then owned/maintained by patient after discharge. This approach to managing information and conditions associated with injury will be compared to the traditional approach of providing patients with a large instruction manual to carry home with them.
Primary Outcome Measure Information:
Title
Rehospitalization
Description
patient report on telephone interview
Time Frame
30 days post rehabilitation discharge
Secondary Outcome Measure Information:
Title
Rehospitalization
Description
patient report on telephone interview
Time Frame
90 days post rehabilitation discharge
Other Pre-specified Outcome Measures:
Title
Depression as measured by the Patient Health Questionnaire (PHQ)
Description
Data aggregated per scoring rules of validated measure. patient report on telephone interview
Time Frame
180 days post rehabilitation discharge
Title
Societal participation as measured by CHART (Craig Handicap Assessment and Reporting Technique)- questionnaire
Description
Data aggregated per scoring rules of validated measure. patient report on telephone interview
Time Frame
180 days post rehabilitation discharge
Title
Satisfaction with Life Scale
Description
patient report on telephone interview
Time Frame
180 days post rehabilitation discharge
Title
Healthcare utilization - rehospitalization, emergency room visits, urgent care visits
Description
per patient report on telephone interview
Time Frame
180 day post rehabilitation discharge
Title
Press Gainey patient satisfaction with care - interview
Description
Data aggregated per scoring rules of validated measure
Time Frame
30 days post rehabilitation discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patient receiving inpatient rehabilitation at Shepherd Center following spinal cord injury
discharge to community setting
Exclusion Criteria:
discharge to non-community setting
patient without spinal cord injury at Shepherd Center
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julie Gassaway
Organizational Affiliation
Dir Health and Wellness
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Patient-centered Approach to Successful Community Transition After Catastrophic Injury
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