An Evidence-based Pressure Ulcer Monitoring Tool for Spinal Cord Injury/Disease (SCI-PUMT)

1. An Evidence-based Pressure Ulcer Monitoring Tool for Spinal Cord Injury/Disease (SCI-PUMT) Gail Powell-Cope PhD, ARNP, FAAN Acting Director, HSR&D/RR&D Center of Excellence Tampa, FL Gail.powell-cope@va.gov

2. Monitoring Pressure Ulcer Healing in Persons with Spinal Cord Impairment • Funded by VA Health Services Research and Development Service (HSR&D) • Nursing Research Initiative 03-245, IRB#: 104145, 2006 – 2008 • These findings and conclusions do not necessarily represent the Department of Veteran Affairs or HSR&D

3. Investigators • Co-Principal Investigators • Susan S. Thomason DNP, MN, RN • Audrey Nelson PhD, RN, FAAN (Retired) • Co-Investigators • Steven Luther PhD • Jeffrey J. Harrow MD, PhD, FACP

4. Study Staff • Polly Placios, MS (Project/Data Manager) • Data Collectors • Stephanie McGovern, RN • Francis Hernandez, RN • Suk Tomlinson, RN • Olivia Monteso-Smithson, RN • Linda Smith, RN • Mary Reeder, BIS (Program Assistant)

5. Conclusion This study found that the SCI-PUMT was a reliable, valid, and sensitive instrument for measuring PrU healing in persons with SCI in a 100 bed VHA SCI/D Center.

6. “Problems” (or challenges) • Clinical Problem • Pressure ulcers are a high volume, high cost condition in Spinal Cord Impairment • Implementation • Translating consistent and quality pressure ulcer monitoring into clinical practice, across all 32 SCI/D Centers, is a challenge. • It takes 17 years from for new knowledge generated by a randomized controlled trial to be incorporated into practice, and even then, the application is highly uneven (Balas & Boren, 2000).

8. Options for Implementing Changes • Dissemination Alone (journal articles, distribution of printed materials, CME) (not effective) • Educational Outreach (Academic Detailing and Local Opinion Leaders) (promising and mixed evidence) • Computer-based decision support systems (mixed) • Audit and Feedback (mixed evidence) • Patient-mediated Interventions such as education, reminders(promising) • Patient-specific clinical reminders (promising)

9. PARiHS Framework • Promoting Action on Research Implementation in Health Services • Successful implementation is a function of: • the nature and type of evidence • qualities of the contextin which the evidence is being introduced, and • the way implementation is facilitated

10. Evidence (Strong) Ideal Situation for Implementation Innovation Facilitation Context(Weak) Context(Strong) Facilitation Facilitation Innovation Innovation Evidence(Weak) Kitson, A. L., et al., (2008). Evaluating the successful implementation of evidence into practice using the PARiHS framework: theoretical and practical challenges. Implementation Science: IS, 3, 1. doi:10.1186/1748-5908-3-1

11. Clinical Problem • Persons with spinal cord impairment (SCI) are at extreme risk for PrU due to immobility, lack of sensation, collagen degradation, moisture, nutritional status, transfers, decreased ability to self-perform pressure redistribution, pain, and other risk factors. • PrU prevalence is 14-32%. • PrU affect morbidity, mortality, function, quality of life, and economics.

12. Clinical Practice Guidelines Consortium for Spinal Cord Medicine (2000) Recommendations: • Modify the treatment plan if the ulcer shows no evidence of healing within 2-4 weeks. • Evaluate healing progress using an instrument or other quantitative measurements.

13. Clinical Practice Guidelines National Pressure Ulcer Advisory Panel (NPUAP) European Pressure Ulcer Advisory Panel (EPUAP) (2009) Recommendations: • Assess progress toward healing…use a validated tool… • Re-evaluate the PrU, the plan of care, and individual if the PrU does not show progress toward healing within 2 weeks…

14. Setting Michael Bilirakis Spinal Cord Injury/Disorders Center James A. Haley Veterans Hospital Tampa, Florida • 100 inpatient beds CARF-accredited) • Large outpatient patient population • Home Care (CARF-accredited) • Long Term Care

15. However… • Variations in how PrU healing is measured varies across sites. • Bates-Jensen Wound Assessment Tool (BWAT) • Pressure Ulcer Scale for Healing (PUSH) • Hybrid tools with little psychometric evaluation • These variations limit the ability to conduct comparable trials of interventions

16. Research Questions • Is the SCI-PUMT valid for measuring PrU healing? • Is the SCI-PUMT reliable for measuring PrU healing? • How sensitive is the SCI-PUMT for measuring healing over time?

17. SCI-PUMT Phases • Development of item pool • Development and testing of SCI-PUMT • Analysis and SCI-PUMT refinement • Assessment of SCI-PUMT reliability

18. Phase 1 Development of item pool

19. Development of Item Pool • Expert Panel #1 • Aim: Identify measures and variables important and/or specific to PrU healing in SCI population • 1 day on-site, Tampa, Florida • 9 interdisciplinary experts (MDs, RNs, OT, PT, RD) • Variables then sent to EP for comment • Expert Panel #2 • Aim: Obtain content validity (all relevant concepts) for item pool • 11 interdisciplinary experts (MDs, RNs, RD) • Aggregated variables sent to EP for comment

20. Item Pool • Consisted of 30 items • Items from two established PrU healing assessment tools (PUSH, BWAT) • Additional items identified by Expert Panels

21. Phase II Development and Testing of SCI-PUMT

22. Subjects • Recruited from Inpatient, Outpatient, Home Care • 3-year longitudinal cohort study • Assessed 30 PrU variables • PrU unit of analysis

23. Inclusion Criteria • Enrolled in SCI/D Registry and receiving primary care from JAHVA SCI primary physician • Primary or secondary diagnosis of Stages II-IV PrU • SCI duration more than 12 months

24. Exclusion Criteria • Immune compromised • Severely mentally ill or cognitively impaired • Terminally ill

29. Data Collection • 6 Registered Nurse Data Collectors • 13 time points: 30 variables + VeV Photograph • Baseline and 12 weeks or • Complete healing • Patient withdrawal • Hospital discharged and lived >40 miles • Plastic surgery intervention

30. VeV Measurement Documentation Software Digital images used to calculate: Volume

31. Intra- and Inter-Rater Reliability Ranges 4 RN Data Collectors Intra-Rater Reliability • 1 DC • Same PrU • Twice 1 ½ hours apart Inter-Rater Reliability • 4 DC • Same PrU • Consecutively

32. Phase III Analysis and SCI-PUMT Refinement

33. Statistical Analysis • Construct validity • Predictive validity • Sensitivity to change • Internal consistency reliability

34. Construct ValidityExploratory Factor Analysis (EFA) • N = 167 PrU • Principal factor extraction with Promax (orthogonal rotation) • Items removed from analysis based on: • Values in correlation matrix • Factor loadings of similar items (from 2 tools) • Items not well defined by factors (low communalities)

35. Factor Analysis Results * Factor loading < |.30| have been replaced with “-“for ease of reading

36. Predictive Validity • Outcome variables to represent PrU healing: Surface Area & Volume • Criterion Validity - VeV MD Software (within limits) • Correlates with the gold standard • Regression analyses – SCI-PUMT at baseline

37. Predictive Validity • Explains outcome variations • Dependent variable: Volume (VeV Camera) • Predictor variables: Factor analysis items • SCI PUMT explained an estimated59% of the variance in volume over the course of the study

38. Comparison of Scales:Volume (by VeV) Regression

39. Phase IV Assessment of SCI-PUMT Reliability

40. Internal Consistency Reliability • Cronbach’s alpha = 0.74 (using study data)

41. SCI-PUMT Reliability • Aim: Evaluate intra- and inter-rater reliability of in a clinical setting • 26 Nurses trained in SCI-PUMT at Tampa VA SCI/D Center • Two months later, two sets of 3 SCI RNs evaluated 16 ulcers twice with an interval of 1½ hours between assessments

42. ResultsClinician Reliability • Intra-rater reliability 0.81 – 0.99 • Inter-rater reliability 0.79 • All reliability measures found to be above our established acceptability threshold

43. SCI-PUMT Variables and Scoring

44. Spinal Cord Impairment Pressure Ulcer Monitoring Tool (SCI-PUMT) Patient ___________________SS#______________________ Ulcer # ______

45. _______________________________ ____________________ • Maximum score = 26 The HIGHER the score, the more severe the ulcer. • Evaluator: _________________________________________ Date ___________________________

46. SCI-PUMT Scoring • Each variable assigned ordinal value • Data & clinical judgment to develop cut-points and weights for individual items and total scales score • Determined total score for SCI-PUMT = 26 • Assigned proportion of total score to each sub-scale

47. SCI-PUMT Scoring

48. Study Limitations • Sample stratification excluded patients who had multiple etiologies of SCI; differentiation of ulcer etiology and ulcer stages were too small for computation • Healing process could be altered by tissue type and ulcer depth • Sample included persons with SCI from one SCI/D Center.

49. Continuing Psychometric Analysis • Can results of regression model be replicated over time • Does weighting of items improve the SCI-PUMT’s predictive value? • Do subscale scores have clinical utility?

50. Implications • SCI-PUMT can: • Help to improve communication among SCI healthcare providers. • Form basis for outcomes monitoring of PrUhealing in persons with SCI. • Assist clinician in critical decisions affecting overall PrU management.