Self-Management to Prevent Ulcers in Veterans With SCI (Spinal Cord Injury)



Status:Archived
Conditions:Skin and Soft Tissue Infections, Hospital, Orthopedic, Gastrointestinal
Therapuetic Areas:Dermatology / Plastic Surgery, Gastroenterology, Orthopedics / Podiatry, Other
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:November 2008
End Date:December 2011

Use our guide to learn which trials are right for you!

Self-Management to Prevent Ulcers in Veterans With Spinal Cord Injury


The major objective of this randomized control trial is to determine whether a
multi-component self-management intervention can increase the use of skin-protective
behaviors in veterans with SCI. We will also determine whether improvements in skin care
behaviors prevent or delay PrU recurrence.


Expected Contribution to the VA and Others: Lack of sensation and immobility increase risk
of pressure ulcers (PrUs) in SCI, making them a serious, costly, and life-long complication
for veterans with SCI. Prevention and/or early detection and reporting of PrUs in the
community-dwelling SCI population is important because: SCI is the most costly medical
condition in VA; PrUs cause morbidity and mortality in the SCI population; everyone with SCI
is at risk of developing ulcers; and little empirical evidence exists to guide
prevention/treatment of PrUs in this population. Reducing the prevalence of PrUs in SCI will
have a significant impact on the VA's financial and resources. The study's long-term
objective is to implement effective, consistent, and cost-effective PrU prevention protocols
into routine clinical practice within VHA, enhancing veterans' general health and quality of
life by reducing the need for costly hospitalizations and PrU surgery.

Objectives: The primary objective of this study is to determine whether a multi-component
self-management (SM) intervention increases the use of skin-protective behaviors and reduce
skin worsening in veterans with SCI. The SM intervention consists of: 1) on-site decisional
support to promote provider adherence to ulcer management guidelines, 2) enhanced,
interactive PrU education, 3) chronic disease self-management skill-building via telephone
based groups, 4) proactive care management using motivational interviewing to support
ongoing self-management activities, and 5) distance technology. An education control
intervention (ED) designed to be a credible intervention that is comparable to the SM will
control for potential effects of natural history/time, treatment dosing, measurement
processes, attention, the non-specific effects of therapeutic alliance, social support, and
of receiving a manualized treatment with specific therapist procedures. The ED intervention
will differ only in that subjects will not be instructed in any specific problem solving,
self-monitoring, or SM techniques, with the exception of encouraging them to become informed
consumers of SCI care. This project focuses on improving patient behavior and making health
system changes.

Methods:

Research Design: A randomized prospective multi-site, pre-test/post-test design.

Population: Veterans hospitalized for Stage III/IV pelvic PrUs from 6 VA SCI Centers.
Participants must be >18 years, >6 months post-SCI, cognitively intact, reside in the
community and oversee their own skin care.

Sources of Data: Patient demographic information measures of pressure ulcer knowledge, skin
management needs assessment, readiness-to-change SM behaviors (symptom management,
communication with providers, cognitive symptom management, etc.), and self-efficacy will be
collect at 0, 3 and 6 months, Medical diagnosis, treatment and utilization information will
be obtained from VA administrative data. Digital photos will be used to verify patient
self-reported skin status.

Analysis: The primary outcomes of this study are: 1) increased use of skin-protective
behaviors and 2) skin worsening outcomes (e.g., recurrence/new skin breakdown, median time
to skin worsening,). Secondary objectives include: days in bed due to skin problems,
severity of the recurrence/new skin breakdown, and hospital days due to skin problems; PrU
knowledge, skin care self-efficacy, community integration/ participation and perceived
quality of life. Multivariate and Cox proportional hazards regression models will be used
to examine study outcomes.


We found this trial at
6
sites
East Orange, New Jersey 07018
?
mi
from
East Orange, NJ
Click here to add this to my saved trials
5000 West National Avenue
Milwaukee, Wisconsin 53295
?
mi
from
Milwaukee, WI
Click here to add this to my saved trials
Augusta, Georgia 30904
?
mi
from
Augusta, GA
Click here to add this to my saved trials
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Hines, Illinois 60141
?
mi
from
Hines, IL
Click here to add this to my saved trials
?
mi
from
St Louis, MO
Click here to add this to my saved trials