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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
Shepherd Center, Atlanta GA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Spinal Cord Injury

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    February 29, 2016
    Last Updated
    April 18, 2016
    Sponsor
    Shepherd Center, Atlanta GA
    Collaborators
    Patient-Centered Outcomes Research Institute
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    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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