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

Primary Purpose

Pressure Ulcers, Spinal Cord Injuries

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Self Management (SM)
Motivational Interviewing (MI)
Education (ED)
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pressure Ulcers focused on measuring Spinal cord injuries, Pressure ulcers, Health behavior, self management, Rehabilitation, Outcome assessment, QUERI, Veterans

Eligibility Criteria

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

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.

Sites / Locations

  • VA Long Beach Healthcare System, Long Beach, CA
  • Charlie Norwood VA Medical Center, Augusta, GA
  • Edward Hines Jr. VA Hospital, Hines, IL
  • Michael E. DeBakey VA Medical Center, Houston, TX
  • Clement J. Zablocki VA Medical Center, Milwaukee, WI

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SM+MI

ED

Arm 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 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.

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-monitoring, or SM techniques, with the exception of encouraging them to become informed consumers of SCI care.

Outcomes

Primary Outcome Measures

Percent of Possible Self-Reported Skin Care Behaviors
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 Checklist, a self-reported measure of adherence to 8 guideline recommended skin care behaviors. The average percentage of the 8 behaviors adhered to for each participant was measured by intervention arms at admission (baseline), 3 and 6 months post-discharge.
Skin Behavior Change
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 adherence to 8 skin care behaviors for each participant.The difference in the average percentage of the 8 behaviors adhered to by each participant was measured for the different intervention arms from admission (baseline) to 3 and 6 months post-discharge.
Any Skin Worsening
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 participant with a closed wound at discharge is found to have a new or reopened wound at 3 or 6 months post-discharge.
Skin Status
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 participant with a closed wound at discharge is found to have a new or reopened wound at 3 or 6 months post-discharge.

Secondary Outcome Measures

Mean Number of Skin-related Admissions
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 reporting of skin breakdown.

Full Information

First Posted
September 26, 2008
Last Updated
April 6, 2015
Sponsor
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT00763282
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pressure Ulcers, Spinal Cord Injuries
Keywords
Spinal cord injuries, Pressure ulcers, Health behavior, self management, Rehabilitation, Outcome assessment, QUERI, Veterans

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
144 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SM+MI
Arm Type
Experimental
Arm 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 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 Title
ED
Arm Type
Active Comparator
Arm 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-monitoring, or SM techniques, with the exception of encouraging them to become informed consumers of SCI care.
Intervention Type
Behavioral
Intervention Name(s)
Self Management (SM)
Intervention 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.
Intervention Type
Behavioral
Intervention Name(s)
Motivational Interviewing (MI)
Intervention 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.
Intervention Type
Behavioral
Intervention Name(s)
Education (ED)
Intervention 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.
Primary Outcome Measure Information:
Title
Percent of Possible Self-Reported Skin Care Behaviors
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 Checklist, a self-reported measure of adherence to 8 guideline recommended skin care behaviors. The average percentage of the 8 behaviors adhered to for each participant was measured by intervention arms at admission (baseline), 3 and 6 months post-discharge.
Time Frame
Admission (Baseline), 3 months, 6 months
Title
Skin Behavior Change
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 adherence to 8 skin care behaviors for each participant.The difference in the average percentage of the 8 behaviors adhered to by each participant was measured for the different intervention arms from admission (baseline) to 3 and 6 months post-discharge.
Time Frame
Admission (Baseline), 3 months, 6 months
Title
Any Skin Worsening
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 participant with a closed wound at discharge is found to have a new or reopened wound at 3 or 6 months post-discharge.
Time Frame
6 months
Title
Skin Status
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 participant with a closed wound at discharge is found to have a new or reopened wound at 3 or 6 months post-discharge.
Time Frame
Admission (Baseline), 3 months, 6 months
Secondary Outcome Measure Information:
Title
Mean Number of Skin-related Admissions
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 reporting of skin breakdown.
Time Frame
Discharge to end of study (6 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marylou Guihan, PhD MA BA
Organizational Affiliation
Edward Hines Jr. VA Hospital, Hines, IL
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Long Beach Healthcare System, Long Beach, CA
City
Long Beach
State/Province
California
ZIP/Postal Code
90822
Country
United States
Facility Name
Charlie Norwood VA Medical Center, Augusta, GA
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30904
Country
United States
Facility Name
Edward Hines Jr. VA Hospital, Hines, IL
City
Hines
State/Province
Illinois
ZIP/Postal Code
60141-5000
Country
United States
Facility Name
Michael E. DeBakey VA Medical Center, Houston, TX
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Clement J. Zablocki VA Medical Center, Milwaukee, WI
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53295-1000
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24486242
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.
Results Reference
result

Learn more about this trial

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

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