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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT02746978
Other study ID # IH-12-11-5106
Secondary ID
Status Enrolling by invitation
Phase N/A
First received February 29, 2016
Last updated April 18, 2016
Start date August 2013
Est. completion date December 2016

Study information

Verified date April 2016
Source Shepherd Center, Atlanta GA
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.

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.


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 800
Est. completion date December 2016
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Other:
Peer directed education
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 Portal
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.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Shepherd Center, Atlanta GA Patient-Centered Outcomes Research Institute

Outcome

Type Measure Description Time frame Safety issue
Other Depression as measured by the Patient Health Questionnaire (PHQ) Data aggregated per scoring rules of validated measure. patient report on telephone interview 180 days post rehabilitation discharge
Other Societal participation as measured by CHART (Craig Handicap Assessment and Reporting Technique)- questionnaire Data aggregated per scoring rules of validated measure. patient report on telephone interview 180 days post rehabilitation discharge
Other Satisfaction with Life Scale patient report on telephone interview 180 days post rehabilitation discharge
Other Healthcare utilization - rehospitalization, emergency room visits, urgent care visits per patient report on telephone interview 180 day post rehabilitation discharge
Other Press Gainey patient satisfaction with care - interview Data aggregated per scoring rules of validated measure 30 days post rehabilitation discharge
Primary Rehospitalization patient report on telephone interview 30 days post rehabilitation discharge
Secondary Rehospitalization patient report on telephone interview 90 days post rehabilitation discharge
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