Pressure Ulcers, Spinal Cord Injuries
Conditions
Keywords
Spinal cord injuries, Pressure ulcers, Health behavior, self management, Rehabilitation, Outcome assessment, QUERI, Veterans
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.
Interventions
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.
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.
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.
Sponsors
Study design
Eligibility
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Possible Self-Reported Skin Care Behaviors | Admission (Baseline), 3 months, 6 months | 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 | Admission (Baseline), 3 months, 6 months | 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 | 6 months | 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 | Admission (Baseline), 3 months, 6 months | 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
| Measure | Time frame | Description |
|---|---|---|
| Mean Number of Skin-related Admissions | Discharge to end of study (6 months) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Self Management (SM) + Motivational Interviewing (MI) Self Management (SM) + Motivational Interviewing (MI)
Self Management and Motivational Interviewing (SM+MI): 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 motivational interviewing to support ongoing self-management activities, and 5) distance technology. | 71 |
| Education (ED) Education (ED)
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. | 72 |
| Total | 143 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 4 | 3 |
| Overall Study | Lost to Follow-up | 22 | 26 |
| Overall Study | Withdrawal by Subject | 6 | 5 |
Baseline characteristics
| Characteristic | Education (ED) | Total | Self Management (SM) + Motivational Interviewing (MI) |
|---|---|---|---|
| Age, Continuous | 59.0 years | 59.3 years | 59.4 years |
| American Spinal Injury Association (ASIA) Score A = Complete | 48 participants | 101 participants | 53 participants |
| American Spinal Injury Association (ASIA) Score B = Sensory Incomplete | 8 participants | 15 participants | 7 participants |
| American Spinal Injury Association (ASIA) Score C = Motor Incomplete | 10 participants | 17 participants | 7 participants |
| American Spinal Injury Association (ASIA) Score D = Motor Incomplete | 6 participants | 10 participants | 4 participants |
| Comorbid Conditions (baseline) Depression | 29 participants | 58 participants | 29 participants |
| Comorbid Conditions (baseline) Diabetes | 22 participants | 56 participants | 34 participants |
| Comorbid Conditions (baseline) Osteomyelitis | 10 participants | 28 participants | 18 participants |
| Current Employment Employed | 11 participants | 22 participants | 11 participants |
| Current Employment Unemployed | 61 participants | 121 participants | 60 participants |
| Duration of Spinal Cord Injury | 24.0 years | 24.0 years | 23.8 years |
| Educational Level College Graduate | 9 participants | 19 participants | 10 participants |
| Educational Level Graduate School | 3 participants | 6 participants | 3 participants |
| Educational Level High School Graduate or Lower | 22 participants | 45 participants | 23 participants |
| Educational Level Some College | 38 participants | 73 participants | 35 participants |
| Etiology Diving | 4 participants | 9 participants | 5 participants |
| Etiology Driving | 35 participants | 70 participants | 35 participants |
| Etiology Fall | 6 participants | 11 participants | 5 participants |
| Etiology Gunshot Wound | 11 participants | 17 participants | 6 participants |
| Etiology Other | 16 participants | 36 participants | 20 participants |
| History of PrUs | 56 participants | 112 participants | 56 participants |
| Hospital-acquired PrU | 9 Pressure Ulcers | 21 Pressure Ulcers | 12 Pressure Ulcers |
| Level of Injury Cervical | 30 participants | 60 participants | 30 participants |
| Level of Injury Lumbar | 6 participants | 7 participants | 1 participants |
| Level of Injury Thoracic | 36 participants | 76 participants | 40 participants |
| Locations of Current Pressure Ulcers Coccyx | 6 Pressure Ulcers | 15 Pressure Ulcers | 9 Pressure Ulcers |
| Locations of Current Pressure Ulcers Ischium | 38 Pressure Ulcers | 78 Pressure Ulcers | 40 Pressure Ulcers |
| Locations of Current Pressure Ulcers Other locations (e.g., feet) | 16 Pressure Ulcers | 32 Pressure Ulcers | 16 Pressure Ulcers |
| Locations of Current Pressure Ulcers Sacrum | 13 Pressure Ulcers | 28 Pressure Ulcers | 15 Pressure Ulcers |
| Locations of Current Pressure Ulcers Trochanter | 9 Pressure Ulcers | 20 Pressure Ulcers | 11 Pressure Ulcers |
| Marital Status Divorced | 27 participants | 52 participants | 25 participants |
| Marital Status Live with Partner | 1 participants | 1 participants | 0 participants |
| Marital Status Married | 28 participants | 57 participants | 29 participants |
| Marital Status Missing | 0 participants | 1 participants | 1 participants |
| Marital Status Never Married | 10 participants | 21 participants | 11 participants |
| Marital Status Widowed | 6 participants | 11 participants | 5 participants |
| Pressure Ulcer (PrU) Characteristics Number of current PrUs | 1.3 Pressure Ulcers | 1.4 Pressure Ulcers | 1.6 Pressure Ulcers |
| Pressure Ulcer (PrU) Characteristics Number of prior PrUs | 1.93 Pressure Ulcers | 2.41 Pressure Ulcers | 2.89 Pressure Ulcers |
| Prior PrU Surgery No | 26 participants | 46 participants | 20 participants |
| Prior PrU Surgery Yes | 46 participants | 97 participants | 51 participants |
| PrU Duration for Largest PrU | 407 days STANDARD_DEVIATION 631 | 307 days STANDARD_DEVIATION 482 | 213 days STANDARD_DEVIATION 244 |
| PrU Size of Largest Ulcer | 4.5 cm^2 | 6.3 cm^2 | 8.2 cm^2 |
| Race/Ethnicity, Customized Black | 18 participants | 38 participants | 20 participants |
| Race/Ethnicity, Customized Hispanic | 2 participants | 6 participants | 4 participants |
| Race/Ethnicity, Customized Other | 0 participants | 1 participants | 1 participants |
| Race/Ethnicity, Customized White | 52 participants | 98 participants | 46 participants |
| Residence Type Apartment | 12 participants | 27 participants | 15 participants |
| Residence Type House | 56 participants | 106 participants | 50 participants |
| Residence Type Nursing Home | 0 participants | 1 participants | 1 participants |
| Residence Type Other | 4 participants | 9 participants | 5 participants |
| Salzburg PrU Risk Score | 9.3 Scores on a scale | 9.5 Scores on a scale | 9.8 Scores on a scale |
| Sex: Female, Male Female | 2 Participants | 4 Participants | 2 Participants |
| Sex: Female, Male Male | 70 Participants | 139 Participants | 69 Participants |
| Source of Assistance No Regular Assistance | 11 participants | 23 participants | 12 participants |
| Source of Assistance Other Regular Assistance | 8 participants | 13 participants | 5 participants |
| Source of Assistance Paid Attendant | 18 participants | 48 participants | 30 participants |
| Source of Assistance Spouse; partner/significant other; Relative | 45 participants | 95 participants | 50 participants |
| Stage of PrUs at randomization Stage III = Full thickness | 31 Pressure Ulcers | 53 Pressure Ulcers | 22 Pressure Ulcers |
| Stage of PrUs at randomization Stage IV = Full thickness | 43 Pressure Ulcers | 97 Pressure Ulcers | 54 Pressure Ulcers |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 72 | 0 / 72 |
| serious Total, serious adverse events | 4 / 72 | 3 / 72 |
Outcome results
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.
Time frame: 6 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Self Management (SM) + Motivational Interviewing (MI) | Any Skin Worsening | No | 36 participants |
| Self Management (SM) + Motivational Interviewing (MI) | Any Skin Worsening | Yes | 35 participants |
| Education (ED) | Any Skin Worsening | No | 33 participants |
| Education (ED) | Any Skin Worsening | Yes | 39 participants |
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.
Time frame: Admission (Baseline), 3 months, 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Self Management (SM) + Motivational Interviewing (MI) | Percent of Possible Self-Reported Skin Care Behaviors | Admission | 73.8 % of Possible Self-Reported Behaviors | Standard Deviation 23.3 |
| Self Management (SM) + Motivational Interviewing (MI) | Percent of Possible Self-Reported Skin Care Behaviors | 3 Months | 83.5 % of Possible Self-Reported Behaviors | Standard Deviation 17.5 |
| Self Management (SM) + Motivational Interviewing (MI) | Percent of Possible Self-Reported Skin Care Behaviors | 6 Months | 85.0 % of Possible Self-Reported Behaviors | Standard Deviation 15.2 |
| Education (ED) | Percent of Possible Self-Reported Skin Care Behaviors | Admission | 74.1 % of Possible Self-Reported Behaviors | Standard Deviation 18.6 |
| Education (ED) | Percent of Possible Self-Reported Skin Care Behaviors | 3 Months | 79.5 % of Possible Self-Reported Behaviors | Standard Deviation 19.6 |
| Education (ED) | Percent of Possible Self-Reported Skin Care Behaviors | 6 Months | 83.0 % of Possible Self-Reported Behaviors | Standard Deviation 14.6 |
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.
Time frame: Admission (Baseline), 3 months, 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Self Management (SM) + Motivational Interviewing (MI) | Skin Behavior Change | Baseline to 3 months | 9.7 % Change | Standard Deviation 19.3 |
| Self Management (SM) + Motivational Interviewing (MI) | Skin Behavior Change | Baseline to 6 months | 11.3 % Change | Standard Deviation 20 |
| Education (ED) | Skin Behavior Change | Baseline to 6 months | 8.9 % Change | Standard Deviation 18.1 |
| Education (ED) | Skin Behavior Change | Baseline to 3 months | 5.4 % Change | Standard Deviation 22.9 |
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.
Time frame: Admission (Baseline), 3 months, 6 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Self Management (SM) + Motivational Interviewing (MI) | Skin Status | Worse 4-6 Months | 9 participants |
| Self Management (SM) + Motivational Interviewing (MI) | Skin Status | No Skin Worsening | 36 participants |
| Self Management (SM) + Motivational Interviewing (MI) | Skin Status | Worse 0-3 Months | 26 participants |
| Education (ED) | Skin Status | Worse 0-3 Months | 28 participants |
| Education (ED) | Skin Status | Worse 4-6 Months | 11 participants |
| Education (ED) | Skin Status | No Skin Worsening | 33 participants |
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.
Time frame: Discharge to end of study (6 months)
Population: Mean number of skin-related post-discharge admissions (ICD9 code =707.xx)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Self Management (SM) + Motivational Interviewing (MI) | Mean Number of Skin-related Admissions | 1.5 admissions/participant | Standard Deviation 0.8 |
| Education (ED) | Mean Number of Skin-related Admissions | 1.6 admissions/participant | Standard Deviation 0.7 |