Spinal Cord InjuryNCT02746978
A Patient-centered Approach to Successful Community Transition After Catastrophic Injury
A study testing Peer directed education and Patient Engagement Portal in people with Spinal Cord Injury and Peer Group, run by Shepherd Center, Atlanta GA.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injury, Peer Group
- What is being tested?
- Peer directed education and Patient Engagement Portal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- No sites listed yet
- Study dates
- Aug 2013to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient receiving inpatient rehabilitation at Shepherd Center following spinal cord injury
- discharge to community setting
Who cannot join
- discharge to non-community setting
- patient without spinal cord injury at Shepherd Center
About this study
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.
Read the 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:
- 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.
- Peer mentoring and peer-led self-management training The peer mentor randomized clinical trial is reported separately on clinicaltrials.gov and not repeated here.
- 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.
- Conditions
- Spinal Cord Injury, Peer Group
- Being tested
- Peer directed education, Patient Engagement Portal
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer directed educationOther
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
Patient Engagement PortalOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Peer directed education | Active comparator | 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 Receives: Other: Peer directed education |
| Patient Engagement Portal | Other | 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. Receives: Other: Patient Engagement Portal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rehospitalization
patient report on telephone interview
Measured: 30 days post rehabilitation discharge
Secondary outcomes (1)
Rehospitalization
patient report on telephone interview
Measured: 90 days post rehabilitation discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2016 (estimated)
- Study startAug 2013
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shepherd Center, Atlanta GA
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, Michael Jones, Shepherd Center, Atlanta GA
- Investigators
- Julie Gassaway, Study director, Dir Health and Wellness
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02746978
- Sponsor's protocol ID
- IH-12-11-5106
- Status last verified
- Apr 2016
- First submitted
- 29 Feb 2016
- Last updated
- 21 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Patient-centered Approach to Successful Community Transition After Catastrophic Injury
- ClinicalTrials.gov ID
- NCT02746978
- Acronym / sponsor ID
- IH-12-11-5106
- Conditions
- Spinal Cord Injury, Peer Group
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Shepherd Center, Atlanta GAUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- Aug 2013
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 21 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- Peer mentoring and peer-led self-management training The peer mentor randomized clinical trial is reported separately on clinicaltrials.gov and not repeated here.
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peer directed education | Active comparator | Other: Peer directed educationA 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 |
| Patient Engagement Portal | Other | Other: Patient Engagement PortalA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patient receiving inpatient rehabilitation at Shepherd Center following spinal cord injury
- discharge to community setting
Key exclusion criteria (2 listed)
- discharge to non-community setting
- patient without spinal cord injury at Shepherd Center
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peer directed educationNo 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 | Other | Peer directed education |
| Patient Engagement PortalNo 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. | Other | Patient Engagement Portal |
Primary outcome
Rehospitalization
Time frame: 30 days post rehabilitation discharge
patient report on telephone interview
1 secondary outcome
Rehospitalization
Time frame: 90 days post rehabilitation discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie Gassaway study director
Dir Health and Wellness
Questions about this trial
What is this clinical trial studying?
A study testing Peer directed education and Patient Engagement Portal in people with Spinal Cord Injury and Peer Group, run by Shepherd Center, Atlanta GA.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rehospitalization (time frame: 30 days post rehabilitation discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2016; AzTrials last refreshed its copy on 7 Nov 2026.