Spinal Cord Injury Clinical Trial
Official title:
Preventing Pressure Ulcers in Veterans With Spinal Cord Injury (SCI)
Pressure ulcers are a serious, costly, and life-long complication of spinal cord injury (SCI). Pressure ulcer prevalence has been estimated at between 17 and 33% among persons with SCI residing in the community. Epidemiological studies have found that 36-50% of all persons with SCI who develop pressure ulcers will develop a recurrence within the first year after initial healing (Carlson et al., 1992; Fuhrer et al., 1993; Goldstein, 1998; Niazi et al., 1997; Salzberg et al. 1998). Recurrence rates have ranged from 21% to 79%, regardless of treatment (Schryvers et al., 2000; Goodman et al., 1999; Niazi et al., 1997). Pressure ulcer treatment is expensive. Surgical costs associated with pressure ulcer treatment can exceed $70,000 per case (Braun et al., 1992). VA administrative (National Patient Care Database, NPCD) data indicate that 41% of inpatient days in the SCI population are accounted for by either primary or secondary diagnoses of pressure ulcers or 23% of SCI inpatient days if restricted to primary diagnoses of pressure ulcers. Pressure ulcer recurrence has been associated with many factors including previous pressure ulcer surgery (Niazi et al., 1997). Although little data exist describing the factors associated with recurrence following surgery, some investigators reported recurrence rates of 11%-29% in cases with post-operative complications and 6% to 61% in cases without post-operative complications (Mandrekas & Mastorakos, 1992; Relander & Palmer, 1988; Disa et al., 1992). In a retrospective study of 48 veterans with SCI, investigators reported a 79% recurrence rate following surgery (Goodman et al., 1999).
Background:
Pressure ulcers are a serious, costly, and life-long complication of spinal cord injury
(SCI). Pressure ulcer prevalence has been estimated at between 17 and 33% among persons with
SCI residing in the community. Epidemiological studies have found that 36-50% of all persons
with SCI who develop pressure ulcers will develop a recurrence within the first year after
initial healing (Carlson et al., 1992; Fuhrer et al., 1993; Goldstein, 1998; Niazi et al.,
1997; Salzberg et al. 1998). Recurrence rates have ranged from 21% to 79%, regardless of
treatment (Schryvers et al., 2000; Goodman et al., 1999; Niazi et al., 1997). Pressure ulcer
treatment is expensive. Surgical costs associated with pressure ulcer treatment can exceed
$70,000 per case (Braun et al., 1992). VA administrative (National Patient Care Database,
NPCD) data indicate that 41% of inpatient days in the SCI population are accounted for by
either primary or secondary diagnoses of pressure ulcers or 23% of SCI inpatient days if
restricted to primary diagnoses of pressure ulcers. Pressure ulcer recurrence has been
associated with many factors including previous pressure ulcer surgery (Niazi et al., 1997).
Although little data exist describing the factors associated with recurrence following
surgery, some investigators reported recurrence rates of 11%-29% in cases with
post-operative complications and 6% to 61% in cases without post-operative complications
(Mandrekas & Mastorakos, 1992; Relander & Palmer, 1988; Disa et al., 1992). In a
retrospective study of 48 veterans with SCI, investigators reported a 79% recurrence rate
following surgery (Goodman et al., 1999).
Objectives:
The purpose of this project was to identify effective interventions for reducing recurrent
pressure ulcers, a severe costly complication in veterans with SCI. The effect of an
educational and structured telephone counseling follow-up program on prevention and health
care utilization were being evaluated. Hypotheses included the following: 1) After discharge
from the hospital for treatment of a severe healed pelvic pressure ulcer, patients receiving
the education and structured telephone counseling intervention would be significantly less
likely to develop a new or recurrent severe (e.g., Stage III or IV), pelvic (defined for
this study as occurring in the sacrum, coccyx, trochanter, or ischium) pressure ulcer than
those receiving customary care. 2) Admissions and inpatient days for severe pelvic pressure
ulcers will be significantly lower for veterans receiving the education and structured
telephone counseling intervention when compared to those receiving customary care.
Methods:
Veterans admitted to 6 VA SCI Centers for medical and/or surgical treatment of a Stage III
or IV pelvic pressure ulcer (sacrum, coccyx, trochanter or ischium) were randomly assigned
to (1) an Intervention Group consisting of education plus structured telephone counseling
follow-up or (2) a Customary Care (Control) group. Intervention Group subjects received a
cognitive behavioral intervention based on the Trans-theoretical Stages of Change Model,
which is designed to help individuals identify ways of improving health behaviors. On
admission, interviewers collected information on demographics, health status/well being,
locus of control, pressure ulcer knowledge, readiness-to-change, and health
beliefs/practices. Some of these measures were re-administered prior to randomization and at
9 and 18 months post-discharge. Health care utilization was monitored for all participants
for the length of the study. The primary outcome (dependent) variables were (1) the
occurrence or non-occurrence of another pelvic pressure ulcer within 18 months of discharge
following healing and, (2) for individuals who develop pressure ulcers during the study
period, time to recurrence. Intervention Group participants were expected to have fewer
pressure ulcer-related admissions and, if admitted, a shorter hospital stay. Secondary
outcomes included health care utilization, pressure ulcer prevention knowledge, medical and
psychological health status, health beliefs and practices, and quality of life.
Multi-variate logistic models are being used to examine factors associated with recurrence
and to evaluate the impact of recurrence on health care utilization.
Status:
A total of 64 patients were randomized in this study, 33 to customary care and 31 to the
intervention group. Most were male, white, married and had their SCI at the thoracic level
resulting in paraplegia. Mean time to recurrence was 114.50 days for the total randomized
subjects. All data from all 15 questionnaires are being analyzed and will be put into a
manuscript for publication at a future time.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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