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Richmond, Virginia 23249

  • Pressure Ulcers

Purpose:

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).


Study summary:

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.


Criteria:

Inclusion Criteria: SCI more than 1 year duration, admitted to VA for treatment of a stage III or IV pressure ulcer, access to telephone for follow-up, understands english, cognitively intact Exclusion Criteria:


Study is Available At:


Original ID:

IIR 01-151


NCT ID:

NCT00105859


Secondary ID:


Study Acronym:


Brief Title:

Preventing Pressure Ulcers in Veterans With Spinal Cord Injury (SCI)


Official Title:

Preventing Pressure Ulcers in Veterans With Spinal Cord Injury (SCI)


Overall Status:

Terminated


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Department of Veterans Affairs


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

278


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Susan Garber, MA BS
Principal Investigator
Houston VA Medical Center

Study Dates

Verification Date:June 2005
Last Changed Date:May 6, 2010
First Received Date:March 17, 2005

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Behavioral
Name:Education and Counseling
Arm Name:1

Study Arms

Study Arm Type:Other
Arm Name:1

Study Agencies

Agency Class:U.S. Fed
Agency Type:Lead Sponsor
Agency Name:Department of Veterans Affairs

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
Citation:Guihan M, Garber SL, Bombardier CH, Durazo-Arizu R, Goldstein B, Holmes SA. Lessons learned while conducting research on prevention of pressure ulcers in veterans with spinal cord injury. Arch Phys Med Rehabil. 2007 Jul;88(7):858-61.
PMID:17601465
Reference Type:Results Reference
Citation:Guihan M, Garber SL, Bombardier CH, Goldstein B, Holmes SA, Cao L. Predictors of pressure ulcer recurrence in veterans with spinal cord injury. J Spinal Cord Med. 2008;31(5):551-9.
PMID:19086713

Data Source: ClinicalTrials.gov

Date Processed: April 03, 2020

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