Lessons Learned While Conducting Research on Prevention of Pressure Ulcers in Veterans With Spinal Cord Injury

Article Outline

• Abstract
• Methods
  • Study Design
  • Sample Size
  • Setting and Participants
  • Data Collection Procedures
  • Intervention
  • Customary Care Group
  • Dependent Variable
• Results
• Discussion
  • Recruitment
  • Variability in Ulcer Management
  • Recurrence
  • Power
  • Stratification
  • Strengthening the Intervention
    • Enhance skin inspection and surveillance techniques
    • Enhance participation of caregivers and social supports
    • Opportunities to optimize and standardize ulcer management
    • Need for additional data on patient characteristics
• Conclusions
• Acknowledgments
• References
• Copyright

Abstract 

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.

Objective

To describe the challenges of conducting a large randomized controlled trial (RCT) to assess the effectiveness of an intervention to prevent recurrent pressure ulcers among a high-risk population of subjects with spinal cord injury (SCI).

Design

Prospective multisite, randomized design comparing outcomes of patients who received individualized education and structured telephone counseling follow-up with those of patients receiving customary care. This study was stopped early because of unanticipated recruitment problems.

Setting

Six Veterans Affairs SCI specialty centers.

Participants

Veterans (N=150) treated for stage III or IV pelvic pressure ulcers.

Interventions

Not applicable.

Main Outcome Measure

Recurrence (defined as new skin breakdown in the pelvic area) and time to recurrence. The study was stopped early because of slow recruitment, so the focus of this study is lessons learned, not the main planned outcome measures.

Results

Subject recruitment did not meet original expectations because almost 50% of those enrolled left the hospital with the study ulcer unhealed (having a healed ulcer was a requirement for participation). No significant differences were observed between groups on rate of or time to recurrence at the time the study was stopped. Among the 6 sites, variability in ulcer management (eg, length of stay, receipt of medical vs surgical treatment, sitting tolerance before discharge) and time to recurrence (median, 4mo) were observed.

Conclusions

RCTs in real-world settings are the most robust method of assessing the effectiveness of prevention strategies. However, in complex, rapidly changing health care organizations, blinding is infeasible, it may be impractical to control for every variable that influences a study’s outcome, and any assumptions that usual care is static are probably mistaken. Investigators must be prepared to use innovative approaches to maintain the integrity of the study design, including flexibility in inclusion and exclusion criteria to support accrual, obtaining a better understanding of the important aspects of usual care that may need to be standardized, continuous improvement within the intervention arm, and anticipation and minimization of risks from organizational changes. With attention to these delivery system issues and the usual design features of randomized trials, we believe real-world care settings can serve as important laboratories to test pressure ulcer prevention strategies in this population.

Key Words: Pressure ulcers, Rehabilitation, Spinal cord injuries, Veterans

PREVENTION OF PRESSURE ulcers in the spinal cord injury (SCI) population is important for several reasons. First, anyone with SCI is at risk of developing pressure ulcers. Second, once a person with SCI has had a pressure ulcer, he/she is at very high risk of developing recurrent ulcers. Third, the overall costs of treating pressure ulcers are very high. Finally, there is little evidence to guide clinical management of pressure ulcers in this population.

Factors such as lack of sensation and immobility increase the risk of pressure ulcer development in people with SCI, making pressure ulcers a serious, costly, and life-long complication of SCI. The pressure ulcer literature is often contradictory with regard to risk factors for pressure ulcer development because existing research is limited by heterogeneity in the populations studied (eg, nursing home residents, acute vs chronic SCI), inadequate sample sizes, different ways of defining the outcome variables, and/or poor or uncontrolled study designs.¹, ²

Although pressure ulcers in SCI often have been conceptualized as a mechanical problem, there is ample evidence that supports the presence of a behavioral component to pressure ulcer development. The literature suggests that appropriate treatment should be complemented by psychosocial interventions aimed at improving skin care behaviors.³, ⁴, ⁵, ⁶ Holmes et al⁷ believed that skin care behaviors might be improved by enhanced education and frequent reminders. Toward this end, they conducted a small randomized controlled trial (RCT) (n=41) that showed the effectiveness of a program of individualized, enhanced education about pressure ulcer prevention and management for patients who received surgical treatment for pressure ulcers.

Participants who received the enhanced education and telephone follow-up intervention gained significantly more knowledge than those who received standard education (20 vs 10 percentage points gained, P<.03) and had a significantly lower recurrence rate. The overall recurrence rate for the 38 participants with follow-up data was 54%, with a significantly lower recurrence rate in the intervention group (33%) compared with controls (75%) within 24 months after discharge (P<.014).

The present study was designed to replicate and extend the study by Holmes et al.⁷ In addition to implementing the education and telephone follow-up intervention, we conceptualized people with severe pressure ulcers as having a chronic medical problem (recurrent pressure ulcers). The intervention consisted of an evidence-based form of behavior change counseling⁸, ⁹ designed to provide sustained, proactive support via scheduled telephone calls to assist patients in making improvements in their skin care behaviors. The present study provided up to 3 hours of pressure ulcer education before discharge with monthly motivationally oriented telephone counseling for intervention group subjects discharged from 6 Veterans Affairs (VA) SCI units with healed pressure ulcers. The primary outcomes for the current study were rate of and time to recurrence.

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Methods 

Study Design 

This study used a prospective, multisite, randomized research design to test whether participation in an intervention consisting of individualized education and structured telephone counseling either prevented, delayed, or led to fewer and/or less severe pressure ulcers compared with customary care.

Sample Size 

The power analysis indicated that a sample size of 278 patients over a 4-year period, with 21 months of recruitment followed by up to 18 months of follow-up, would enable us to distinguish differences in recurrence rates between the 2 groups.

Setting and Participants 

Veterans with SCI and stage III or IV pressure ulcers admitted to 6 VA SCI centers participated in the study. To be eligible for participation in the study, subjects had to have a traumatic SCI of longer than 1 year in duration and be hospitalized for the treatment of a stage III or IV pelvic ulcer (defined as occurring over the sacrum, coccyx, trochanter, or ischium). Only those whose ulcers had healed by discharge and were discharged to a community setting (ie, not nursing home) were eligible for randomization. Additional exclusion criteria included a terminal diagnosis and/or significant psychiatric comorbidities (eg, schizophrenia and other active psychoses) or cognitive impairments that limited a patient’s ability to participate in the telephone counseling intervention.

The study received approval from all the participating institutional review boards (IRBs) at each VA medical center and/or its affiliated university committees.

Data Collection Procedures 

Enrollment in the study began in November 2003 and ended in June 2005. All eligible patients were approached by the local study site coordinator about their willingness to participate in the study. After following locally approved IRB consent procedures, site coordinators interviewed patients to obtain demographic, clinical, SCI, and ulcer history. Information on comorbid conditions and ulcer characteristics was obtained from the patients’ electronic medical records and verified by the primary care provider.

All subjects received usual care (ie, medical and/or surgical treatment) for existing pressure ulcers. Just before discharge, veterans with healed ulcers were randomly assigned to receive customary care (n=33) or the education plus structured telephone counseling intervention (n=31).

Intervention 

Participants randomized to the intervention group received individualized education just before discharge from the hospital and proactive telephone-based motivational interviewing at home. The educational intervention consisted of 3 hours of individualized, interactive pressure ulcer prevention education, presented by the site coordinator just before discharge. Topics included pressure ulcer etiology, preventive behaviors believed to reduce pressure ulcer risk, skin care, nutrition, support surfaces for the bed and wheelchair, early intervention strategies should a pressure ulcer develop, and how to recognize and describe the 4 stages of a pressure ulcer.

In addition, specific behaviors thought to promote skin integrity and reduce the risk of developing new pressure ulcers were explored (pressure relief while sitting and turning at night; cessation of smoking, alcohol, and drug use; cushion maintenance; hygiene; skin checks and seeking medical attention as soon as skin breakdown was observed). Printed educational materials included the consumer guide developed by the clinical practice guideline development panel of the Consortium for Spinal Cord Medicine (CSCM) on pressure ulcers.¹⁰

Patients in the intervention group also received monthly scheduled telephone counseling beginning 2 weeks after discharge (and up to 18mo postdischarge). The telephone counseling approach was based on the principles of motivational interviewing developed by Miller and Rollnick¹¹, ¹² and aimed at helping subjects identify and implement more effective pressure ulcer prevention strategies in their daily activities. Calls typically lasted 15 to 30 minutes. The content of the calls covered the same topics as the pressure ulcer educational intervention but was tailored specifically to each subject. Each phone call began with a discussion of the prevention behaviors the subjects performed routinely, any problems they encountered, and their confidence about practicing preventive behaviors. The tailored aspect of the calls refers to the site coordinators consistently bringing up behaviors or problems that patients had already indicated they were willing to change.

Consistent with motivational interviewing, site coordinators used open-ended questions to elicit reasons and the desire to improve skin care behaviors, affirmed changes that the subjects had already made, and used reflective listening and summaries to promote understanding and empathy and to resolve ambivalence to change and avoid resistance. Site coordinators were trained in motivational interviewing in a 2-day workshop and supervised via monthly telephone calls by the study’s primary consultant (CHB), a psychologist who is an experienced motivational interviewing trainer.

Customary Care Group 

Customary care group participants received site-specific customary care and a copy of the pressure ulcer consumer guide developed by the CSCM’s pressure ulcer clinical practice guideline development panel.¹⁰ After discharge from the hospital, customary care subjects continued to receive usual care (eg, routine inpatient and outpatient care) within the VA SCI system. In no case did the standard follow-up care include routine telephone contact with patients whose ulcers had been healed.

Dependent Variable 

The primary outcome variable was recurrence, defined as a new or recurrent skin breakdown in the pelvic area.

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Results 

Subject recruitment did not meet original expectations because almost 50% of those enrolled left the hospital with the study ulcer unhealed. No significant differences were observed between groups on rate of or time to recurrence during the limited duration of the study.

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Discussion 

We encountered a number of issues that will be addressed in future studies, including (1) problems in recruitment, (2) variability in ulcer management, (3) recurrence rates, (4) power, (5) stratification, and (6) strengthening the intervention. These issues, as well as some proposed solutions, are discussed below.

Recruitment 

In the original pilot study conducted by Holmes et al,⁷ only those patients with surgically healed ulcers were eligible to participate. Despite the large number of veterans with SCI and severe pressure ulcers (between one third and one half of all the inpatients at the 6 participating sites at any given time), an assessment of VA national data indicated that even if all SCI patients whose ulcers were surgically treated could be recruited into the study, power would have been inadequate. Therefore, the decision to enroll all SCI patients with severe pelvic pressure ulcers, regardless of method of healing (surgery vs medical management) was a practical one. In addition, the advantage of including patients whose ulcers were medically healed was that their inclusion would enhance the generalizability of any study findings to all VA SCI pressure ulcer patients.

In retrospect, this decision served as a source of heterogeneity that was not present in the original study. Unlike the pilot study site, which kept pressure ulcer patients in the hospital until their ulcers were healed, the most common reason for exclusion from randomization for our study was being discharged from the hospital with the study ulcer unhealed (50%). One proposed strategy for enhancing recruitment was to follow up patients who were discharged with unhealed ulcers for up to 3 months postdischarge to see if their ulcers healed at home. Hence, accrual could have been improved by systematically monitoring patients discharged with unhealed study ulcers. Monitoring would provide information on ulcer healing status, and those patients whose ulcers healed then could participate in the intervention phase of the study.

Variability in Ulcer Management 

Variability in ulcer management was observed in a number of important areas, including inpatient length of stay (LOS), type and duration of treatments received, availability of surgery, whether all patients participated in a progressive mobilization program before discharge, the amount of sitting time attained before discharge, and most important, in the percentage of patients discharged with unhealed ulcers, which directly affected our ability to accrue enough patients. The median time to recurrence was 9 months in the pilot study and was 4 months in the current study. The observed difference in LOS before healing between this study and the pilot study (which ended >5y ago) may reflect changes in ulcer management across the VA. Future studies should strive to standardize these aspects of usual care.

Recurrence 

The endpoint of the pilot study was recurrence, and no data were collected on the severity of the recurrence. In the current study, intervention group subjects were encouraged to be proactive in conducting daily skin inspections and in reporting any changes to a health care provider. However, by virtue of being contacted every month as part of the intervention, intervention group subjects also had more opportunities to report skin problems. We found a shorter time to recurrence in our intervention group; however, it is unclear whether intervention group subjects had earlier recurrences or if they simply reported recurrences sooner than the usual care group.

The short time to recurrence in this study suggests that prevention efforts must begin earlier and may need to be implemented early in the hospitalization. Early recurrence (eg, almost immediately after discharge from the hospital) may also reflect a greater overall burden of illness, incomplete healing of the ulcer or other undetected or untreated medical conditions. In these cases, it may not be possible to prevent recurrences by changing patient skin care behaviors alone.

Power 

When the power analysis for this study was originally conducted, we used the absolute rate of recurrence for the 2 groups from the pilot study (81% for the customary care group vs 29% for the intervention group). In retrospect, we believe that the assumptions underlying our original power analysis were overly conservative. Using our own recurrence data provided a more precise estimate on which to base a new power analysis. Although we were not permitted to recalculate the power analysis midway through our study using the new information, it was determined that using our study data in a future study, we can achieve adequate power using a smaller sample size (from 278 to 136).

Stratification 

Based on previous literature, a number of variables were considered for stratification purposes. As much as VA administrative data have improved over the past few years, the detailed clinical information that would have enabled us to assess these factors (duration, number of ulcers, stage, history of ulcers) to include these variables in stratification still is not available. The decision was made to stratify on the number of previous ulcers (0 vs 1+). However, only 14% of potential subjects had no previous ulcers. The mean duration of the study ulcers in our study was 1 year before enrollment, which was unanticipated. In addition, almost 40% of our study patients had multiple ulcers. In discussions with site private investigators, we were unable to reach a consensus about including patients with any unhealed ulcers at discharge. In the absence of such a consensus among clinicians, it seems prudent to exclude these patients from participation in future studies. Further analyses will be conducted to assess whether there are more appropriate variables for stratification purposes in any future studies.

Strengthening the Intervention 

We have studied a number of other proposed strategies that would strengthen the intervention and make it easier to conduct research on this population. Our results support introducing the intervention while patients are still being treated for the study ulcer, so that the intervention is fully potent at the time of discharge, rather than trying to develop the relationship with the patients over time after discharge (as was done in the pilot and the current study).

In addition, we have determined that our educational intervention was not strong enough. Study investigators strongly believed that patients already had considerable knowledge about pressure ulcer development and prevention. However, our results indicate a serious lack of information in this population. Because of the concern study reviewers raised about contamination, we had little time to provide education between the end of the mobilization program and discharge. Future studies should integrate education with treatment throughout the entire admission.

In addition, we have been conducting analyses of baseline and outcome data to determine whether there are other aspects of the intervention that could be strengthened. There are several potential strategies we have considered: (1) enhance skin inspection and surveillance techniques, (2) enhance involvement of caregivers and social support, and (3) standardize certain aspects of ulcer management. We also identified the need for additional data on patient and treatment characteristics. These are discussed below.

As innovations such as cellular phones with digital camera technology have become considerably smaller and less expensive, there is a better opportunity to use this technology in this population to promote self-management activities. Technology could be used to support patient self-monitoring of skin in the patient’s home with provider feedback for early detection of potential problems. This is an excellent use of distance technology, especially because traveling long distances to receive care in a medical setting is in itself a potential risk factor for aggravating or causing skin problems.

Our data indicate that only a small proportion of this population (36%) has strong social supports. To restrict study enrollment only to those patients with caregivers would unnecessarily limit participation in and accrual for future studies. However, in those cases where even some minimal amount of social support is available to veterans in the community, we plan to encourage these caregivers to participate more actively in the intervention by encouraging veterans to develop, practice, and incorporate desired preventive behaviors into daily activities.

As part of a future study, we will work with local site principal investigators to begin developing a consensus about possible opportunities to optimize or standardize selected aspects of customary care (eg, LOS, type of treatments received, availability of surgery, progressive sitting and mobilization, amount of sitting time before discharge) that are believed to affect recurrence.

Because a high percentage of patients with pressure ulcers have chronic comorbid illnesses (eg, diabetes, hypertension) that directly affect skin integrity and wound healing, we also plan to include items addressing these problems to the readiness to change scale and to have the site coordinators assess the study patients’ adherence to treatment recommendations associated with those comorbidities.

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Conclusions 

This study describes the challenges of conducting a large-scale RCT to prevent recurrent pressure ulcers among a high-risk population with SCI. We have identified important areas that warrant additional study, including (1) the role of patient characteristics (eg, comorbid illness) and (2) variability in ulcer management (eg, LOS, sitting time, type of treatment, amount of sitting time).

The high incidence and short time to new breakdown that we found in this population emphasizes the necessity of developing stronger, more effective interventions to prevent pressure ulcers. Significant variation in patient characteristics and ulcer management (based on lack of strong evidence) prevents systematic clinical observation and research to improve the prevention and treatment of pressure ulcers. Our experience in identifying modifiable risk factors and more effective treatment delivery models will help us and others address these complex issues in future prevention trials.

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Acknowledgments 

We thank the Spinal Cord Initiative Quality Enhancement Research Initiative directors, Frances M. Weaver, PhD, and Margaret C. Hammond, MD, and CMC³ director, Kevin Weiss, MD. We also acknowledge the invaluable assistance of the principal investigators at the participating sites, including Amy Aftandilian, MD (Memphis VAMC), Stephen P. Burns, MD (Seattle VAMC), Meena Midha, MD (Richmond VAMC), Paul Sanford, MD (Milwaukee VAMC), and Rose Trincher, MD (Augusta VAMC). We also thank the site coordinators for this project, including Barbara Padgett, RN (Augusta VAMC), Mary Green, RN (Houston VAMC), Carol Distretti, RN (Memphis VAMC), Joseph Berman, PT, and Laurie Gatewood, RN (Milwaukee VAMC), Camilo Castillo, MD (Richmond VAMC), and Irene Reep, MSW (Seattle VAMC). We acknowledge the technical assistance in data management provided by Lindsay Edwards (Houston VAMC), Mary Biondic (Hines VAMC), and Tom Sindowski (Hines VAMC) and statistical analysis provided by Lishan Cao, MS (Hines VAMC). The findings and conclusions of this study are those of the authors; they do not necessarily represent the Department of Veterans Affairs or the Health Services Research and Development Service.

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References 

1. Rintala DH. Quality-of-life considerations. Adv Wound Care. 1995;8:71–83
   • View In Article
2. Byrne DW, Salzberg CA. Major risk factors for pressure ulcers in the spinal cord disabled: a literature review. Spinal Cord. 1996;34:255–263
   • View In Article
   • MEDLINE
   • CrossRef
3. Relander M, Palmer B. Recurrence of surgically treated pressure sores. Scand J Plast Reconstr Surg. 1988;2:89–92
   • View In Article
4. Disa JJ, Carlton JM, Goldberg NH. Efficacy of operative cure in pressure sore patients. Plast Reconstr Surg. 1992;89:272–278
   • View In Article
   • MEDLINE
   • CrossRef
5. Baek S, Williams GD, McElhinney AJ, Simon BE. The gluteus maximus myocutaneous flap in the management of pressure sores. Ann Plast Surg. 1980;5:471–476
   • View In Article
   • MEDLINE
   • CrossRef
6. Rubayi S, Pompan D, Garland D. Proximal femoral resection and myocutaneous flap for treatment of PUs in spinal cord injury patients. Ann Plast Surg. 1983;27:132–137
   • View In Article
   • MEDLINE
   • CrossRef
7. Holmes SA, Rintala D, Garber SL, Friedman JD. Prevention of recurrent pressure ulcers after myocutaneous flap. [abstract] J Spinal Cord Med. 2002;25(Suppl 1):S23
   • View In Article
8. Rubak S, Sandbaek A, Lauritzen T, Christensen B. Motivational interviewing: a systematic review and meta-analysis. Br J Gen Pract. 2005;55:305–312
   • View In Article
   • MEDLINE
9. Burke BL, Arkowitz H, Menchola M. The efficacy of motivational interviewing: a meta-analysis of controlled clinical trials. J Consult Clin Psychol. 2003;71:843–861
   • View In Article
   • MEDLINE
   • CrossRef
10. Paralyzed Veterans of America. Pressure ulcer prevention and treatment following spinal cord injury: a clinical practice guideline for health-care professionals. Washington (DC): PVA; 2000;
    • View In Article
11. Miller WR, Rollnick S. Motivational interviewing: preparing people for change. 2nd ed.. New York: Guilford Pr; 2002;
    • View In Article
12. Miller WR, Rollnick S. Motivational interviewing. New York: Guilford; 1991;
    • View In Article