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Clinical Trial to Evaluate One-to-one Peer Mentoring

Primary Purpose

Injuries, Spinal Cord

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
one-to-one peer mentoring
general peer support
Sponsored by
Shepherd Center, Atlanta GA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Injuries, Spinal Cord

Eligibility Criteria

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

Inclusion Criteria:

  • • All patients admitted to Shepherd Center for rehabilitation following spinal cord injury and discharged to a community setting

Exclusion Criteria:

  • • Not discharged from Shepherd Center
  • • Discharged from Shepherd Center to non-community setting

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Intervention

    Control

    Arm Description

    Intervention group receiving one-to-one peer mentoring

    Control group receiving general peer support

    Outcomes

    Primary Outcome Measures

    Self-efficacy Scale. It Includes an Adapted Self-efficacy Scale From Chronic Disease Literature Focused on Confidence in Managing Self-care Needs Plus Project-specific Items for Assessment of Confidence Regarding Integration Into Community Life.
    The General Self-Efficacy scale (6 items) developed at Stanford University for persons with chronic health conditions was adapted for persons with spinal cord injury. Added to this scale were 5 similarly constructed project-specific self-efficacy items focused on community navigation and accessibility (major focus of peer support program). Respondents (via telephone interview) provided a response to each of 11 items using a 10-point Likert scale ranging from 1 (not confident) to 10 (very confident). Item response scores were averaged for the total self-efficacy score. Total scores ranged from 11 to 110 (11 items with 10 response options). Higher scores indicate greater self-efficacy to manage injury conditions. Growth Curve Analysis was used to determined significant changes over time in self-efficacy. Initial status coefficients depict where participants begin at the first time point (3 days post discharge) and growth rate coefficients show how participants change over time.
    Rehospitalization - Number of Days
    Rehospitalization days (number) within 30 days post inpatient rehabilitation discharge
    Rehospitalization - Percent of Patients Rehospitalized
    Percent of patients rehospitalized at 30 days post discharge from inpatient rehabilitation

    Secondary Outcome Measures

    Rehospitalization - Number of Days (Cumulative)
    Rehospitalization days (cumulative) within 90 days post inpatient rehabilitation discharge
    Rehospitalization - Percent of Patients Rehospitalized (90 Days)
    Percent of patients (cumulative) rehospitalized within 90 days post discharge from inpatient rehabilitation
    Rehospitalization - Number of Days (Cumulative)
    Rehospitalization days (cumulative) within 180 days post inpatient rehabilitation discharge
    Rehospitalization - Percent of Patients (180 Days)
    Percent of patients (cumulative) rehospitalized within 180 days post discharge from inpatient rehabilitation

    Full Information

    First Posted
    October 22, 2014
    Last Updated
    January 31, 2019
    Sponsor
    Shepherd Center, Atlanta GA
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02274649
    Brief Title
    Clinical Trial to Evaluate One-to-one Peer Mentoring
    Official Title
    A Patient Centered Approach to Successful Community Transition After Catastrophic Injury: Clinical Trial to Evaluate One-to-one Peer Mentoring
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2014 (undefined)
    Primary Completion Date
    April 2016 (Actual)
    Study Completion Date
    April 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Shepherd Center, Atlanta GA

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The research will examine the effects of enhanced peer mentor interactions on facilitating a successful transition to community living following traumatic spinal cord injury (SCI). Participants in the research will be assigned to either (1) the control group that will receive traditional peer mentor types of interactions or (2) to the intervention group that will receive an enhanced peer mentor program called the One-on-One Initiative. Assignment to one of these two groups will occur randomly on admission to Shepherd Center; the only stratifying criteria is injury level - C6 and above vs. C7 and below.
    Detailed Description
    The Peer Support Program was enhanced by the addition of Shepherd staff mentors and volunteer mentors from the community. The Peer Support Supervisor recruited volunteer peer mentors who are at least 10 months post injury, live within a 50 mile radius of Shepherd Center, and have developed a successful reintegration into community living (employed, manage a family, student, etc.). Volunteers completed Shepherd Center volunteer training and were paid a stipend of $20 per patient interaction. Each recruited volunteer mentor, along with Shepherd Center peer mentor employees, participated in the Christopher and Dana Reeve Foundation peer support mentor training program to help ensure quality interactions with Shepherd Center patients and understand/practice patient confidentiality awareness. This Foundation provides training on a national level by breaking up the country into eight regions - each with a regional coordinator and training program schedule. The faculty and staff of the University of New Mexico developed and maintain the training and certification program, including the mentor management system. The certification program is a "hybrid" program - a series of on-line modules followed by a one-day on-site session. On-line learning is great for conveying information. It saves time and allows everyone to get that information at their own pace. The one-day training session revisits topics covered in the on-line modules: effective peer mentoring, ethics, communication and resources. It includes breakout groups and group discussions. Benefits of partnering with the Foundation, including providing access to certified peer mentors for patients who live outside the Atlanta area are outlined in the attached document (ReevePeer Partnerships.pdf). A special training session for Shepherd employees/volunteers involved: Part 1: 3-hour on-line course (notification has been sent to potential mentors by CDRF) Part 2: 6-hour face-to-face training meeting at Shepherd Center on March 10, 2014 These training sessions typically are run on a regional basis, so having the program here at Shepherd saved travel expenses and time for the volunteer participants. The PowerPoint used for the March 10 session is attached. Subjects in the control group received traditional peer support provided by Shepherd Center currently: Within 5-10 days of admission, the patient is introduced to the peer support team. Patients are seen by peer mentors on a referral basis from therapists, nurses, counselors, or physicians or on request from the patient or family. Patients are made aware of monthly peer support meetings, women's groups and caregiver support groups; participation in these groups is optional for patient and/or family. Patients have access to the SCI Peer Support FaceBook page maintained by the Shepherd Peer Mentors Subjects in the intervention group (and his/her family) received the enhanced One-on-One initiative: Patient was assigned one primary certified peer mentor and 2-3 supplemental mentors to meet individual patient/family needs (if needed). The Peer Support Supervisor matched certified peer mentors with each patient based on characteristics such as age, date of injury, level of injury, cause of injury, marital status, work status before and after injury, interests, leisure activities, and adaptive equipment utilization. Secondary mentors were used to supplement individual patient/family needs. For example, if guidance is needed regarding airline travel, a peer mentor who has mastered airline travel was consulted if the primary peer mentor did not have this experience. Each patient/family evaluated the interaction with his/her peer mentors. PCORI interviewers facilitated completion of this evaluation. Evaluations were reviewed within one week post completion to modify support provided if indicated and ensure that patient/family needs were met. Patients participated in male and female discussion groups, community dinner, and caregiver dinner sponsored by the peer team. Each meeting includes opportunities for discussion in group settings.These meetings are included in the patients' schedules. Peer mentors provide and organize social networking opportunities on FaceBook (Shepherd SCI peers page), CDRF, SCILife, SPINALpedia, facingdisabilities.com,etc. On the Shepherd SCI Peers Facebook page, the peer mentor supervisor posts questions posed by patients or community members anonymously and feedback volunteered from any of the >2000 Facebook friends.This is especially helpful for sensitive topics that people may not want to be associated with initiating the question. Evaluation All study patients were interviewed during the 10th-15th day of their stay at Shepherd Center and completed the Self Efficacy scale. Patients were contacted post via telephone at 3, 30, 90 and 180 days post discharge. At each of these times, they were asked healthcare utilization and Self Efficacy questions. R

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Injuries, Spinal Cord

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Masking Description
    Interviewer collecting outcomes data was not aware of group assignment
    Allocation
    Randomized
    Enrollment
    194 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm Description
    Intervention group receiving one-to-one peer mentoring
    Arm Title
    Control
    Arm Type
    Active Comparator
    Arm Description
    Control group receiving general peer support
    Intervention Type
    Behavioral
    Intervention Name(s)
    one-to-one peer mentoring
    Intervention Description
    Each patient received one-to-one peer mentoring each week during rehabilitation and for 90 days post discharge
    Intervention Type
    Behavioral
    Intervention Name(s)
    general peer support
    Intervention Description
    General (traditional) peer support includes introduction and provision of support services upon request
    Primary Outcome Measure Information:
    Title
    Self-efficacy Scale. It Includes an Adapted Self-efficacy Scale From Chronic Disease Literature Focused on Confidence in Managing Self-care Needs Plus Project-specific Items for Assessment of Confidence Regarding Integration Into Community Life.
    Description
    The General Self-Efficacy scale (6 items) developed at Stanford University for persons with chronic health conditions was adapted for persons with spinal cord injury. Added to this scale were 5 similarly constructed project-specific self-efficacy items focused on community navigation and accessibility (major focus of peer support program). Respondents (via telephone interview) provided a response to each of 11 items using a 10-point Likert scale ranging from 1 (not confident) to 10 (very confident). Item response scores were averaged for the total self-efficacy score. Total scores ranged from 11 to 110 (11 items with 10 response options). Higher scores indicate greater self-efficacy to manage injury conditions. Growth Curve Analysis was used to determined significant changes over time in self-efficacy. Initial status coefficients depict where participants begin at the first time point (3 days post discharge) and growth rate coefficients show how participants change over time.
    Time Frame
    3 days post rehabilitation discharge through 180 days post discharge
    Title
    Rehospitalization - Number of Days
    Description
    Rehospitalization days (number) within 30 days post inpatient rehabilitation discharge
    Time Frame
    30 days
    Title
    Rehospitalization - Percent of Patients Rehospitalized
    Description
    Percent of patients rehospitalized at 30 days post discharge from inpatient rehabilitation
    Time Frame
    30 days
    Secondary Outcome Measure Information:
    Title
    Rehospitalization - Number of Days (Cumulative)
    Description
    Rehospitalization days (cumulative) within 90 days post inpatient rehabilitation discharge
    Time Frame
    90 days
    Title
    Rehospitalization - Percent of Patients Rehospitalized (90 Days)
    Description
    Percent of patients (cumulative) rehospitalized within 90 days post discharge from inpatient rehabilitation
    Time Frame
    90 days
    Title
    Rehospitalization - Number of Days (Cumulative)
    Description
    Rehospitalization days (cumulative) within 180 days post inpatient rehabilitation discharge
    Time Frame
    180 days
    Title
    Rehospitalization - Percent of Patients (180 Days)
    Description
    Percent of patients (cumulative) rehospitalized within 180 days post discharge from inpatient rehabilitation
    Time Frame
    180 days

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: • All patients admitted to Shepherd Center for rehabilitation following spinal cord injury and discharged to a community setting Exclusion Criteria: • Not discharged from Shepherd Center • Discharged from Shepherd Center to non-community setting
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Michael Jones, PhD
    Organizational Affiliation
    VP Clinical Research
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    28342829
    Citation
    Gassaway J, Jones ML, Sweatman WM, Hong M, Anziano P, DeVault K. Effects of Peer Mentoring on Self-Efficacy and Hospital Readmission After Inpatient Rehabilitation of Individuals With Spinal Cord Injury: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2017 Aug;98(8):1526-1534.e2. doi: 10.1016/j.apmr.2017.02.018. Epub 2017 Mar 23. Erratum In: Arch Phys Med Rehabil. 2017 Nov;98 (11):2345-2346.
    Results Reference
    derived

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    Clinical Trial to Evaluate One-to-one Peer Mentoring

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