- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02274649
Clinical Trial to Evaluate One-to-one Peer Mentoring
A Patient Centered Approach to Successful Community Transition After Catastrophic Injury: Clinical Trial to Evaluate One-to-one Peer Mentoring
Study Overview
Status
Conditions
Intervention / Treatment
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
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
Intervention group receiving one-to-one peer mentoring
|
Each patient received one-to-one peer mentoring each week during rehabilitation and for 90 days post discharge
|
Active Comparator: Control
Control group receiving general peer support
|
General (traditional) peer support includes introduction and provision of support services upon request
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
Time Frame: 3 days post rehabilitation discharge through 180 days post discharge
|
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. |
3 days post rehabilitation discharge through 180 days post discharge
|
Rehospitalization - Number of Days
Time Frame: 30 days
|
Rehospitalization days (number) within 30 days post inpatient rehabilitation discharge
|
30 days
|
Rehospitalization - Percent of Patients Rehospitalized
Time Frame: 30 days
|
Percent of patients rehospitalized at 30 days post discharge from inpatient rehabilitation
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rehospitalization - Number of Days (Cumulative)
Time Frame: 90 days
|
Rehospitalization days (cumulative) within 90 days post inpatient rehabilitation discharge
|
90 days
|
Rehospitalization - Percent of Patients Rehospitalized (90 Days)
Time Frame: 90 days
|
Percent of patients (cumulative) rehospitalized within 90 days post discharge from inpatient rehabilitation
|
90 days
|
Rehospitalization - Number of Days (Cumulative)
Time Frame: 180 days
|
Rehospitalization days (cumulative) within 180 days post inpatient rehabilitation discharge
|
180 days
|
Rehospitalization - Percent of Patients (180 Days)
Time Frame: 180 days
|
Percent of patients (cumulative) rehospitalized within 180 days post discharge from inpatient rehabilitation
|
180 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Michael Jones, PhD, VP Clinical Research
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 581327-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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