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

Primary Purpose

Spinal Cord Injury, Pressure Ulcers

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Education and Counseling
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Spinal Cord Injury

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

Sites / Locations

  • VA Medical Center, Augusta
  • Memphis, TN
  • Houston VA Medical Center
  • Hunter Holmes McGuire VA Medical Center
  • VA Puget Sound Health Care System, Seattle
  • Clement J. Zablocki VAMC

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
March 17, 2005
Last Updated
May 6, 2010
Sponsor
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT00105859
Brief Title
Preventing Pressure Ulcers in Veterans With Spinal Cord Injury (SCI)
Official Title
Preventing Pressure Ulcers in Veterans With Spinal Cord Injury (SCI)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2005
Overall Recruitment Status
Terminated
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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).
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury, Pressure Ulcers

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
278 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Other
Intervention Type
Behavioral
Intervention Name(s)
Education and Counseling

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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:
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan Garber, MA BS
Organizational Affiliation
Michael E. DeBakey VA Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Medical Center, Augusta
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30904-6285
Country
United States
Facility Name
Memphis, TN
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Facility Name
Houston VA Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Hunter Holmes McGuire VA Medical Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
Facility Name
VA Puget Sound Health Care System, Seattle
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108
Country
United States
Facility Name
Clement J. Zablocki VAMC
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53295-1000
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17601465
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. doi: 10.1016/j.apmr.2007.03.014.
Results Reference
result
PubMed Identifier
19086713
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. doi: 10.1080/10790268.2008.11754570.
Results Reference
result
PubMed Identifier
22925750
Citation
Guihan M, Bombardier CH. Potentially modifiable risk factors among veterans with spinal cord injury hospitalized for severe pressure ulcers: a descriptive study. J Spinal Cord Med. 2012 Jul;35(4):240-50. doi: 10.1179/2045772312Y.0000000016. Erratum In: J Spinal Cord Med. 2012 Nov;35(6):635.
Results Reference
derived

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

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