Long Beach, California 90822

  • Spinal Cord Injuries

Purpose:

Pressure ulcers (PrUs) are the most frequent significant medical complication after spinal cord injury (SCI). PrU prevalence, morbidity, mortality, and recurrence rates are high, and most persons with SCI will have at least one serious PrU during their lifetime. VA costs of treating the almost 3,500 unique Veterans with SCI and a severe ulcer at an SCI Center in FY10 was just under $400 million.


Study summary:

Background: Pressure ulcers (PrUs) are the most frequent significant medical complication after spinal cord injury (SCI). PrU prevalence, morbidity, mortality, and recurrence rates are high, and most persons with SCI will have at least one serious PrU during their lifetime. VA costs of treating the almost 3,500 unique Veterans with SCI and a severe ulcer at an SCI Center in 2010 was just under $400 million. Objectives: The primary objective of this randomized clinical trial (RCT) was to determine whether a multi-component self-management (SM) intervention increases the use of skin-protective behaviors and reduces skin worsening in Veterans with SCI, compared to an education control (ED) intervention. Secondary outcomes included PrU knowledge, self-management skills, communication with providers, self-efficacy, community integration and days on bedrest. Another objective was to conduct focus group interviews with patients and providers and to analyze transcripts of SM group sessions to determine barriers and facilitators with regard to spinal cord injury and pressure ulcer prevention. Methods: This was a multi-site efficacy intervention study with a single blind prospective randomized design. Descriptive statistics were used to summarize demographic and key variables. Supplemental focus group interviews were conducted with patients with SCI (n=35) and SCI providers (n=39). Focus group interviews and SM group calls were transcribed verbatim and analyzed using constant comparative techniques. Study participants included Veterans hospitalized for Stage III/IV PrUs at or below the level of injury, from six VA SCI Centers around the country (Long Beach, Houston, Milwaukee, Augusta, Hines and St. Louis). Prior to discharge, PrU risk factors were identified and 1:1 PrU education was provided. Randomization and the behavioral interventions began at discharge. The number of randomized subjects were 72 in the ED group and 72 in the SM group (n=144). The analytic sample included subjects with complete data (n=92). The intervention included 8 site coordinator-initiated calls using didactic (ED) or Motivational Interviewing (MI) strategies to address PrU risk factors. The second component included telephone group calls that included either didactic information about SCI or SM skills including: 1) knowledge about the medical condition; 2) self-monitoring; 3) problem-solving skills; 4) skill for managing the effects of the condition; 5) adherence to necessary health behaviors; and 6) self-advocacy with health care providers. ED subjects received general health information and were not instructed in any specific problem solving, self-monitoring or SM techniques. The ED intervention was comparable to the SM with respect to natural history/ time, dosing, measurement processes, attention, therapeutic alliance, social support, and in receiving a manualized treatment with specific therapist procedures. Self-reported outcome data were obtained by phone at 3 and 6 months, and from mailed photos of study ulcers. Status: Study is complete. Additional analyses are ongoing and future manuscripts are planned.


Criteria:

Inclusion Criteria: - over 18 years of age, - SCI of at least six month's duration, - hospitalized for a Stage III or IV PrU, - cognitively intact, - available for telephone follow-up, and - discharged to a community setting or able to direct own care. Exclusion Criteria: We excluded patients with a terminal diagnosis, severe psychiatric comorbidities (eg, current psychosis), cognitive impairments that limited their ability to consent or participate, severe hearing loss, and wounds not expected to heal. People discharged to nursing homes unable to direct their own care were also excluded.


Study is Available At:


Original ID:

IIR 06-203


NCT ID:

NCT00763282


Secondary ID:


Study Acronym:


Brief Title:

Self-Management to Prevent Ulcers in Veterans With SCI (Spinal Cord Injury)


Official Title:

Self-Management to Prevent Ulcers in Veterans With Spinal Cord Injury


Overall Status:

Completed


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: E


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

144


Enrollment Type:

Actual


Overall Contact Information

Official Name:Marylou Guihan, PhD MA BA
Principal Investigator
Edward Hines Jr. VA Hospital

Study Dates

Start Date:November 2008
Completion Date:December 2011
Completion Type:Actual
Primary Completion Date:June 2011
Primary Completion Type:Actual
Verification Date:January 2015
Last Changed Date:January 7, 2015
First Received Date:September 26, 2008
First Results Date:November 24, 2014

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Mean Number of Skin-related Admissions
Time Frame:Discharge to end of study (6 months)
Safety Issues:True
Description:Post-discharge skin-related hospitalizations were for both groups (SM+MI vs. ED) but not as study-related or as an adverse event. This study examined an outpatient intervention during which rehospitalization could be triggered by the participants' early r
Outcome Type:Primary Outcome
Measure:Skin Status
Time Frame:Admission (Baseline), 3 months, 6 months
Safety Issues:False
Description:Skin worsening was defined as when a participant with an open wound at the time of discharge is found to have >20% wound area at 3 or 6 months post-discharge (including new wounds and reopened wounds). Worsening was also defined as a when a participan
Outcome Type:Primary Outcome
Measure:Any Skin Worsening
Time Frame:6 months
Safety Issues:False
Description:Skin worsening was defined as when a participant with an open wound at the time of discharge is found to have >20% wound area at 3 or 6 months post-discharge (including new wounds and reopened wounds). Worsening was also defined as a when a participan
Outcome Type:Primary Outcome
Measure:Skin Behavior Change
Time Frame:Admission (Baseline), 3 months, 6 months
Safety Issues:False
Description:Self-reported improvement in skin care behaviors in the SM+MI versus ED control intervention arms. The study reported the number of guideline-recommended skin care behaviors, assessed by the Skin Care Behavior Checklist, a self-report measure of adherenc
Outcome Type:Primary Outcome
Measure:Percent of Possible Self-Reported Skin Care Behaviors
Time Frame:Admission (Baseline), 3 months, 6 months
Safety Issues:False
Description:Skin Behavior Change was calculated as the percentage of Self-Reported Behavior at 3 and 6 months (minus the percentage at baseline). The study reported the number of guideline-recommended skin care behaviors, assessed by the Skin Care Behavior Checklis

Study Interventions

Intervention Type:Behavioral
Name:Self Management (SM)
Description:Self Management (SM) consists of: 1) on-site decisional support to promote provider adherence to ulcer management guidelines, 2) enhanced, interactive PrU education, 3) chronic disease self-management skill building via telephone based groups, 4) proactive care management using MI to support ongoing self-management activities, and 5) distance technology.
Arm Name:SM+MI
Intervention Type:Behavioral
Name:Motivational Interviewing (MI)
Description:Self Management and Motivational Interviewing (SM+MI) participants were assigned to both a self-management and motivational interview group. An education control intervention (ED) designed to be a credible intervention that is comparable to the SM will control for potential effects of natural history/time, treatment dosing, measurement processes, attention, the non-specific effects of therapeutic alliance, social support, and of receiving a manualized treatment with specific therapist procedures
Arm Name:SM+MI
Intervention Type:Behavioral
Name:Education (ED)
Description:The ED intervention differs only in that subjects will not be instructed in any specific problem solving, self-monitoring, or SM techniques, with the exception of encouraging them to become informed consumers of SCI care.
Arm Name:ED

Study Arms

Study Arm Type:Active Comparator
Arm Name:ED
Description:Education (ED). An education control intervention (ED) designed to be a credible intervention that is comparable to the SM will control for potential effects of natural history/time, treatment dosing, measurement processes, attention, the non-specific effects of therapeutic alliance, social support, and of receiving a manualized treatment with specific therapist procedures. The ED intervention will differ only in that subjects will not be instructed in any specific problem solving, self-monitori
Study Arm Type:Experimental
Arm Name:SM+MI
Description:Self Management (SM) + Motivational Interviewing (MI). Self Management and Motivational Interviewing (SM+MI) participants were assigned to both a self-management and motivational interview group. Motivational Interviewing (MI) is an evidence-based form of counseling to help individuals to engage in behavior change. Self Management (SM) consists of: 1) on-site decisional support to promote provider adherence to ulcer management guidelines, 2) enhanced, interactive PrU education, 3) chronic diseas

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, Bombardier CH, Ehde DM, Rapacki LM, Rogers TJ, Bates-Jensen B, Thomas FP, Parachuri R, Holmes SA. Comparing multicomponent interventions to improve skin care behaviors and prevent recurrence in veterans hospitalized for severe pressure ulcers. Arch Phys Med Rehabil. 2014 Jul;95(7):1246-1253.e3. doi: 10.1016/j.apmr.2014.01.012. Epub 2014 Jan 30.
PMID:24486242

Data Source: ClinicalTrials.gov

Date Processed: March 30, 2020

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