Association of Bisphosphonate Therapy With Incident of Lower Extremity Fractures in Persons With Spinal Cord Injuries or Disorders.

OBJECTIVE: To investigate the association between prescriptions for bisphosphonates; calcium and vitamin D supplements; and receipt of dual-energy x-ray absorptiometry (DXA) screening, and incident fracture risk in men and women with a spinal cord injury (SCI) or disorder (SCID). DESIGN: Propensity-matched case-control analyses. SETTING: United States Veterans Affairs (VA) facilities. PARTICIPANTS: A total of 7989 men and 849 women with an SCID included in VA administrative databases between October 1, 2005 and October 1, 2015 were identified (N=8838). Cases included 267 men and 59 women with a bisphosphonate prescription propensity matched with up to 4 controls. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Incident lower extremity fractures. RESULTS: There was no significant association between prescriptions for bisphosphonates and incident lower extremity fractures in men (odds ratio [OR], 1.04; 95% confidence interval [CI], 0.62-1.77) or women (OR, 1.02; 95% CI, 0.28-3.75). In men, similar null associations were seen among those who were adherent to bisphosphonate therapy (OR, 1.25; 95% CI, 0.73-2.16), were concomitant users of vitamin D and calcium and a bisphosphonate (OR, 1.05; 95% CI, 0.57-1.96), had more than 1 fracture on different dates during the study period (OR, 0.13; 95% CI, 0.02-1.16) and in those who had undergone DXA testing prior to the date of the bisphosphonate prescription and incident fracture (OR, 1.26; 95% CI, 0.69-2.32). CONCLUSIONS: In men with a traumatic SCI and women with a traumatic SCID, bisphosphonate therapies for osteoporosis do not appear to significantly affect fracture risk. Adequately powered randomized controlled trials are needed to definitively demonstrate efficacy of bisphosphonates for fracture prevention in this population. There is a compelling need to identify new medications to prevent fractures in this high-risk population.

Use of the PARIHS Framework for Retrospective and Prospective Implementation Evaluations.

BACKGROUND: The Promoting Action on Research Implementation in Health Services (PARIHS) framework has been used by implementation researchers to assess factors impacting implementation and to use that information to identify optimal interventions and implementation strategies. In this paper, two studies are presented demonstrating the utility of PARIHS as a tool for retrospective and prospective evaluation of implementation in the health care setting. STUDY DESIGN: Descriptive case study. METHODS: A qualitative consensus process was used to evaluate provider perceptions of PARIHS constructs of evidence, context, and facilitation and their subelements which were scored on a continuum of low to high. RESULTS: The first example demonstrates retrospective use of PARIHS which provided insight into the factors contributing to variations in implementation across sites in an ongoing program. Evidence was strong (high), whereas context noted some challenges in culture and measurement (mixed), and the presence of dedicated program facilitators was positive but dual roles limited their ability to fully support implementation (mixed). The second example demonstrates prospective use of PARIHS for evaluation which gathered information about intervention sites for the purposes of selecting implementation strategies responsive to site needs. Evidence supporting the intervention was limited (low), context noted that limited awareness of the intervention was a challenge (low), and that a strong internal facilitator supported implementation (high). LINKING EVIDENCE TO ACTION: The descriptive case study presented here underscores the value of a theory-guided approach to implementation and highlights that PARIHS can help implementers understand factors impacting implementation, identify areas for future intervention, and inform selection of strategies to support or enhance implementation efforts.

Difficulty in Identifying Factors Responsible for Pressure Ulcer Healing in Veterans With Spinal Cord Injury.

OBJECTIVE: To identify characteristics associated with pressure ulcer (PrU) healing for individuals with spinal cord injury (SCI). DESIGN: Secondary analysis of a large clinical trial's data for healing PrUs in individuals with SCI; prospective Delphi process was conducted with SCI and/or PrU experts. SETTING: Spinal cord injury centers. PARTICIPANTS: There were 629 screening and 162 treatment participants (N=791); 185 SCI clinicians/national PrU/wound care experts participated in the Delphi process. INTERVENTIONS: None. MAIN OUTCOME MEASURE: PrU healing of 50% and 100% at weeks 4 and 12. RESULTS: Poisson regression models using the top Delphi-recommended factors found that only ulcer stage consistently predicted 50% and 100% healing at weeks 4 and 12. Additionally, ischial/perineal location was associated with 33% higher likelihood of 50% healing at week 4. Patient noncompliance with treatment recommendations, the top-ranked Delphi factor, did not predict healing at week 4 or 12. Expanded models found that at week 4, baseline PrU size, PrU stage IV, PrU pain, and American Spinal Injury Association grade A significantly predicted 100% healing, while at week 12, only PrU stage (IV) significantly predicted 100% healing. Significant predictors of 50% healing at week 4 included baseline PrU size, stage, ischial/perianal location body mass index >30kg/m2, foul odor, and signs of infection. At week 12, PrU duration, paraplegia predicted 50% healing. SCI center identifiers consistently showed 2- to 5-fold variation in predicting 50% PrU healing at weeks 4 and 12. CONCLUSIONS: Delphi panel-recommended factors (eg, patient compliance) did not predict PrU healing. Reducing center-level variability in wound healing by learning from best practices should be a health system goal. PrU healing in SCI is still poorly understood, and future studies should focus on as yet unidentified or underappreciated factors.

A Multisite Quality Improvement Project to Standardize the Assessment of Pressure Ulcer Healing in Veterans with Spinal Cord Injuries/Disorders.

OBJECTIVE: The objective was to implement the evidence-based Spinal Cord Impairment Pressure Ulcer Monitoring Tool (SCI-PUMT) in 23 Spinal Cord Injury/Disorders Centers (SCI/D) in the Veterans Health Administration (VHA). SETTING: A collaborative was held in Minnesota that was attended by key personnel from SCI/D Centers in the VHA. METHODS: This initiative was based on a 3-year longitudinal study that established the validity and reliability of a novel pressure ulcer monitoring tool for persons with spinal cord impairment. A multifaceted evidence-based strategy was used to implement the Institute for Healthcare Improvement's framework of Plan-Do-Study-Act. The plan was executed by clinical champions who implemented the tool in their respective SCI/D Centers following a conference that used both didactic and practicum approaches. OUTCOMES: A 15-item toolkit was developed to educate clinicians and patients regarding use of the SCI-PUMT. Toolkit elements were frequently accessed over the VA intranet (n = 3254). The 1.5-day national conference rolled out the new tool to the SCI/D Centers. Pre/post SCI-PUMT knowledge of the SCI-PUMT improved by 78% during the conference. Following the conference, periodic conference calls cemented the implementation efforts of the SCI-PUMT clinical champions and barriers were mitigated.

Comparing multicomponent interventions to improve skin care behaviors and prevent recurrence in veterans hospitalized for severe pressure ulcers.

OBJECTIVE: To compare a multicomponent motivational interviewing (MI)/self-management (SM) intervention with a multicomponent education intervention to improve skin-protective behaviors and prevent skin worsening in veterans with spinal cord injury (SCI) hospitalized for severe pressure ulcers (PrUs). DESIGN: Single-blinded, prospective, randomized controlled trial. SETTING: Six Veterans Affairs SCI centers. PARTICIPANTS: Veterans admitted for a severe (stage III/IV) PrU were followed up to 6 months postdischarge. INTERVENTION: Telephone-based individual MI counseling plus SM skills group (SM+MI; n=71) versus an active control group of telephone-based individual educational counseling plus group education (n=72). MAIN OUTCOME MEASURES: Self-reported skin-protective behaviors, objective skin worsening. RESULTS: Intention-to-treat analyses found nonsignificant increases in skin behaviors in the SM+MI versus education control intervention arms at 3 and 6 months. The difference in behaviors used between SM+MI and education control intervention participants was 4.6% (95% confidence interval [CI], -11.3 to 2.7) (0-3mo) and 3.0% (95% CI, -8.7 to 3.9) (0-6mo). High rates of skin worsening were observed (n=74, 51.7%), usually within 3 months postdischarge and most frequently within the month postdischarge. Skin worsening, skin-related visits, and readmissions did not differ by study arm. Study limitations are presented. CONCLUSIONS: For persons with chronic SCI and severe PrUs, complicated by multiple comorbidities, a primary focus on improving patient behavior is likely insufficient to address the complex problem of PrUs in SCI. More health care systems-level changes such as collaborative care may be needed to reduce PrU recurrence, especially in this era in which many people are discharged from the hospital unhealed or with little sitting tolerance.

Implementing a patient education intervention about Methicillin-resistant Staphylococcus aureus prevention and effect on knowledge and behavior in veterans with spinal cord injuries and disorders: a pilot randomized controlled trial.

OBJECTIVES: To assess the feasibility and effect of a nurse-administered patient educational intervention about Methicillin-resistant Staphylococcus aureus (MRSA) prevention on knowledge and behavior of Veterans with spinal cord injuries and disorders (SCI/D). DESIGN: Blinded, block-randomized controlled pilot trial. SETTING: Two Department of Veterans Affairs (VA) SCI Centers. PARTICIPANTS: Veterans were recruited March-September 2010 through referral by a healthcare provider from inpatient, outpatient, and residential care settings. INTERVENTION: Thirty participants were randomized to the nurse-administered intervention and 31 to the usual care group. The intervention included a brochure and tools to assist nurses in conducting the education. OUTCOME MEASURES: Pre- and post-intervention measurement of knowledge and behaviors related to MRSA and prevention strategies and feasibility measures related to implementation. RESULTS: Participants were primarily male (95.1%), white (63.9%), with tetraplegia (63.9%) and mean age and duration of injury of 64.3 and 20.5 years, respectively. The intervention groups mean knowledge score significantly increased between pre- and post-test (mean change score = 1.70, 95% confidence interval, CI 0.25-3.15) while the usual care groups score did not significantly change (mean change score = 1.45, 95% CI -0.08-2.98). However, the mean knowledge change between intervention and usual care groups was not significantly different (P = 0.81). Overall behavior scores did not significantly differ between treatment groups; however, the intervention group was more likely to report intentions to clean hands (90.0% vs. 64.5%, P = 0.03) and asking providers about MRSA status (46.7% vs. 16.1%, P = 0.01). Nurse educators reported that the quality of the intervention was high and could be implemented in clinical care. CONCLUSIONS: A targeted educational strategy is feasible to implement in SCI/D clinical practices and may improve some participants' knowledge about MRSA and increase intentions to improve hand hygiene and engagement with providers about their MRSA status.

Colonoscopy is high yield in spinal cord injury.

OBJECTIVES/BACKGROUND: Colorectal cancer (CRC) can be prevented by routine colonoscopy. CRC screening in special populations, e.g. spinal cord injury and disorders, presents unique barriers and, potentially, a higher risk of complications. We were concerned about potentially higher risks of complications and sought to determine the safety of colonoscopy. METHODS: Retrospective observational design using medical record review for 311 patients who underwent 368 colonoscopies from two large VA SCI centers from 1997-2008. Patient demographics and peri-procedural characteristics, including indication, bowel prep quality, and pathological findings are presented. Descriptive statistics are presented. RESULTS: The population was predominantly male and Caucasian, and 199 (64%) had high-level injuries (T6 or above). Median age at colonoscopy was 61 years (interquartile range 53-69). Just <1/2 of the colonoscopies were diagnostic, usually for evidence of rectal bleeding. Although a majority of colonoscopies were reported as poorly prepped, the proportion that were adequately prepped increased over time (from 3.7 to 61.3%, P = <0.0001). Of the 146 polyps removed, 101 (69%) were adenomas or carcinomas. Ten subjects had 11 complications, none of which required surgical intervention. CONCLUSIONS: Although providing quality colonoscopic care in this population is labor intensive, the data suggests that it appears safe and therapeutically beneficial. The results indicate that the risk of screening is outweighed by the likelihood of finding polyps. Recognition of the benefit of colonoscopy in this population may have improved bowel prep and reporting over time. Spinal cord injury providers should continue to offer screening or diagnostic colonoscopy to their patients when indicated, while being aware of the special challenges that they face.

Patient and provider perspectives on methicillin-resistant Staphylococcus aureus: a qualitative assessment of knowledge, beliefs, and behavior.

BACKGROUND: Methicillin-resistant Staphylococcus aureus (MRSA) is a frequent cause of healthcare-associated infection. Individuals with spinal cord injuries and disorders (SCI/D) are at high risk of MRSA colonization and infection. The Department of Veterans Affairs (VA) released guidelines to prevent the spread of MRSA in Veterans with SCI/D; however, available patient educational materials did not address the unique issues for this population. OBJECTIVE: To assess perceptions of SCI/D providers and Veterans with SCI/D regarding MRSA and their educational needs about MRSA prevention, with an ultimate goal of developing patient educational materials that address the issues unique to SCI/D. METHODS: Purposive samples of SCI/D providers (six groups) and Veterans with SCI/D (one group) at two VA facilities participated in 60-90-minute focus group sessions. Qualitative data were analyzed using latent content and constant comparative techniques to identify focal themes. PARTICIPANTS: Thirty-three providers (physicians and nurses working in inpatient, outpatient, and homecare settings) and eight Veterans participated. RESULTS: Three overarching themes emerged from the analysis: knowledge about MRSA, hand hygiene, and barriers to educating Veterans with SCI/D. CONCLUSIONS: SCI/D providers and Veterans with SCI/D identified gaps in general MRSA knowledge, gaps in knowledge of good hand hygiene practices and of required frequency of hand hygiene, and barriers to educating Veterans with SCI/D during inpatient stays. Future educational materials and strategies should address these gaps.

Potentially modifiable risk factors among veterans with spinal cord injury hospitalized for severe pressure ulcers: a descriptive study.

CONTEXT/OBJECTIVE: Pressure ulcers (PrUs) are a serious, costly and potentially life-long complication of spinal cord injury (SCI). Co-morbid conditions increase PrU risk, adding to the health behavior challenges faced by people with SCI. Little is known about medical co-morbidities, health beliefs, risk, protective behaviors, and readiness to improve skin care behaviors in people with SCI. This study describes the potentially modifiable medical and behavioral risk factors among veterans with SCI and severe (Stage III/IV) PrUs. DESIGN: Cross-sectional observational design. SETTING: 6 VA SCI Centers. PARTICIPANTS: Convenience sample from a larger intervention study of 148 veterans hospitalized for PrUs. INTERVENTIONS: Not applicable. OUTCOME MEASURES: Knowledge, PrU risk, skin protective behaviors, health beliefs, and practices, health locus of control, skin worsening. RESULTS: Most ulcers were stage IV (73%) and about half had 2+ PrUs. Participants reported a mean of 6.7 co-morbid conditions (respiratory, gastrointestinal, renal disease/urinary tract infection, autonomic dysreflexia, diabetes, bowel/bladder incontinence). Potential intervention opportunities include proactive assistance with management of multiple chronic conditions, substance abuse, nutrition, adherence to skin protective behaviors, readiness to change, and access to resources. Overall knowledge about PrUs was low, especially for how to prevent PrUs and what to do if skin breakdown occurs. CONCLUSION: Future research should address whether comprehensive models that include patient self-management, decision support and health care system, and proactive behavior change assistance for patients help reduce PrU incidence and recurrence in persons with SCI. TRIAL REGISTRATION: http://clinicaltrials.gov/ct2/show/NCT00105859.

Assessing the feasibility of subepidermal moisture to predict erythema and stage 1 pressure ulcers in persons with spinal cord injury: a pilot study.

BACKGROUND: Persons with spinal cord injury (SCI) are at high risk for pressure ulcers (PrUs) throughout their lifetime due to decreased mobility, lack of sensation, and other physiological changes. The high prevalence and recurrence rates, and costs associated with PrUs in veterans with SCI indicate the need for a reliable and practical method of detecting early PrUs. OBJECTIVE: To assess the feasibility of obtaining biophysical measures of sub-epidermal moisture (SEM) using a handheld dermal phase meter to predict PrUs. DESIGN/METHODS: Prospective observational design. Thirty-four veterans at two VA SCI centers (Hines, Long Beach) received daily (n = 12) or weekly (n = 22) SEM and concurrent visual skin assessment (VSA) across nine anatomic locations for up to 6 weeks. Outcome measures: SEM, visual skin assessment (VSA), and stage I PrUs. FINDINGS/RESULTS: SEM was lowest for normal skin (39.3 dermal phase units (DPU), SD = 12.6) and higher for erythema/stage 1 PrUs (40.8 DPU, SD = 10.4) across all anatomic sites. Buttocks SEM were different between normal skin (40.5 DPU, SD = 10.3) and erythema/stage1 PrUs (43.8, SD = 9.5). SEM taken at heels were lower across all skin conditions (normal skin 28.2 DPU; erythema/stage 1 PrUs 34.7 DPU). SEM was taken when generalized edema present was lower than without generalized edema. CONCLUSIONS: Preliminary results of using SEM to detect early PrU damage may translate from nursing home (NH) residents to persons with SCI. This study provides a foundation for a larger study to implement and assess SEM use as a method of prevention of PrUs.