Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00105859
Status:
TERMINATED
Last Update Posted:
2010-05-10
First Post:
2005-03-17
Brief Title:
Preventing Pressure Ulcers in Veterans With Spinal Cord Injury SCI
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Preventing Pressure Ulcers in Veterans With Spinal Cord Injury SCI
Status:
TERMINATED
Status Verified Date:
2005-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 70000 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 70000 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 eg 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 andor 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 statuswell being locus of control pressure ulcer knowledge readiness-to-change and health beliefspractices 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 11450 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
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 70000 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 eg 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 andor 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 statuswell being locus of control pressure ulcer knowledge readiness-to-change and health beliefspractices 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 11450 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None