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

Spinal Cord Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00105859
• Other study ID #: IIR 01-151
• Status: Terminated
• Phase: N/A
• First received: March 17, 2005
• Last updated: May 6, 2010

Study information

• Verified date: June 2005
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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).

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 278
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pressure Ulcer
• Pressure Ulcers
• Spinal Cord Injuries
• Spinal Cord Injury
• Ulcer

Intervention

Behavioral:
• Education and Counseling

Locations

Country	Name	City	State
United States	VA Medical Center, Augusta	Augusta	Georgia
United States	Houston VA Medical Center	Houston	Texas
United States	Memphis, TN	Memphis	Tennessee
United States	Clement J. Zablocki VAMC	Milwaukee	Wisconsin
United States	Hunter Holmes McGuire VA Medical Center	Richmond	Virginia
United States	VA Puget Sound Health Care System, Seattle	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation