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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

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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

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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

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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)

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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.

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Problems (or challenges) 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).

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Options for Implementing Changes 1. Dissemination Alone (journal articles, distribution of printed materials, CME) (not effective) 2. Educational Outreach (Academic Detailing and Local Opinion Leaders) (promising and mixed evidence) 3. Computer-based decision support systems (mixed) 4. Audit and Feedback (mixed evidence) 5. Patient-mediated Interventions such as education, reminders (promising) 6. Patient-specific clinical reminders (promising)

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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 context in which the evidence is being introduced, and the way implementation is facilitated

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Evidence (Strong) Evidence (Weak) Context (Strong) Context (Weak) Ideal Situation for Implementation Innovation 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 10.1186/1748-5908-3-1 Innovation Facilitation

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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.

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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.

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Clinical Practice Guidelines National Pressure Ulcer Advisory Panel (NPUAP) European Pressure Ulcer Advisory Panel (EPUAP) (2009) Recommendations: Assess progress toward healinguse 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

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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

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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

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Research Questions 1. Is the SCI-PUMT valid for measuring PrU healing? 2. Is the SCI-PUMT reliable for measuring PrU healing? 3. How sensitive is the SCI-PUMT for measuring healing over time?

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SCI-PUMT Phases I. Development of item pool II. Development and testing of SCI-PUMT III. Analysis and SCI-PUMT refinement IV. Assessment of SCI-PUMT reliability

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DEVELOPMENT OF ITEM POOL Phase 1

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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

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

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DEVELOPMENT AND TESTING OF SCI-PUMT Phase II

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

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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

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Exclusion Criteria Immune compromised Severely mentally ill or cognitively impaired Terminally ill

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Subject Profile Sample Size 66 Unique Patients 167 Pressure Ulcers Age60 years (mean) GenderMale 98% Level of InjuryTetra 49%; Para 46% ASIAA 58%; B 20%; Other 23% Years since SCI onset23 Years (mean) High School Graduate80%

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Pressure Ulcer Characteristic Findings Number PrU / subject1 9 (mean 2.5) Previous PrU77% Prior PU surgery53% LocationIschia43% Sacrococcygeal 26% Trochanter 8% Heel 8% StageII 20%; III 38%; IV 42% Ulcer Pain18% Chronic Osteomyelitis33%

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Co-MorbidityIncidence Diabetes Mellitus26% Anemia24% Peripheral Vascular Disease11% Chronic Obstructive Pulmonary Disease 9% Congestive Heart Failure 8% Heterotopic Ossification 8%

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Other Baseline FactorsIncidence Immunosuppressant Medications12% Spasticity Interference with Function (1 = none; 5 = maximum) 2.4 mean (SD 1.6) Spasticity Modified Ashworth Scale (1 = slight tone; 5 = rigidity) 2.1 mean (SD 1.2) Pain (0 = none; 10 = severe) 3.9 (SD = 2.6) Mean Body Weight175 lb (SD 36.4) Nicotine Preceding Week Substance Abuse 29% 6%

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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

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VeV Measurement Documentation Software Digital images used to calculate: Volume

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Intra- and Inter-Rater Reliability Ranges 4 RN Data Collectors Intra-Rater Reliability 1 DC Same PrU Twice 1 hours apart Inter-Rater Reliability 4 DC Same PrU Consecutively TOOLIntra- Rater ICC Inter- Rater ICC PUSH0.88 0.996 0.76 0.96 BWAT0.87 0.99 0.69 0.91

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ANALYSIS AND SCI-PUMT REFINEMENT Phase III

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Statistical Analysis Construct validity Predictive validity Sensitivity to change Internal consistency reliability

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Construct Validity Exploratory 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)

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VariableSourceGeometric Factor Substance Factor DepthPUMT.82 - TunnelingPUMT.77 - Edges PSST.55- Undermining PUMT.48 Surface area PUSH.35.51 Necrotic amountPSST-.52 Exudate type PUMT-.40 * Factor loading < |.30| have been replaced with -for ease of reading Factor Analysis Results

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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

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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

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Comparison of Scales: Volume (by VeV) Regression SCI- PUMT PUSH (Pressure Ulcer Scale for Healing) BWAT (Bates-Jensen Wound Assessment Tool) R 2 (estimated based on proportional reduction in mean squared prediction error as per Snijders & Bosker, 1994) 59%57%24%

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ASSESSMENT OF SCI- PUMT RELIABILITY Phase IV

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Internal Consistency Reliability Cronbachs alpha = 0.74 (using study data)

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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 1 hours between assessments

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Results Clinician Reliability Intra-rater reliability 0.81 0.99 Inter-rater reliability 0.79 All reliability measures found to be above our established acceptability threshold

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VARIABLES AND SCORING SCI-PUMT

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Pressure Ulcer Site: Sacrum or Coccyx Trochanter Ischium Heel Other ______ Body Side: Right Left Midline Orientation: Medial Lateral Positioning Upper Leg Flexed When Turned: Yes No Surface Turned Onto: Right Left Back Abdomen Spinal Cord Impairment Pressure Ulcer Monitoring Tool (SCI-PUMT) Patient ___________________SS#______________________ Ulcer # ______

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VariableScore OptionsScore Geometric Factor Surface Area (L x W) 12345 1 - 2.5 - 5 - 10 - 15 - 25 - 35 - 55 - 85 cm 2 Depth 01234 0 cm>0 - 1 - 2 - 3 cm Edges 1 Indistinct, diffuse, none clearly visible Distinct, outline clearly visible, attached, even with ulcer base Well-defined, not attached to ulcer base 2 Well-defined, not attached to base, rolled under, thickened Well-defined, fibrotic, scarred, or hyperkeratotic Tunneling 0 None 1 2 cm 2 > 2 - 4 cm 3 >4 cm Undermining 0 None 1 2 cm 2 > 2 - 4 cm 3 >4 cm Sub-total Score Geometric Factor Substance Factor Exudate Type 0 None 1 Serous/Sanguineous 2 Green/Purulent Necrotic Tissue Amount 0 None 1 25% Sub-total Score Substance Factor TOTAL SCORE (Total of Geometric and Substance Sub-totals) _______________________________ ____________________ Maximum score = 26 The HIGHER the score, the more severe the ulcer. Evaluator: _________________________________________ Date ___________________________

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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

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Surface Area 40% Depth 14% Tunneling and Undermining 12% each Edges, Exudate, Necrotic Tissue 8% each SCI-PUMT Scoring

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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.

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

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

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Implications Allow for comparisons of healing rates within facilities and across sites. Contribute to performance improvement initiatives and local and national performance measures. Provide foundation to conduct treatment effectiveness studies of PrUs in multi-site VA SCI/D Center studies.

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Conclusions 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.

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The ChallengeFull Implementation of the SCI-PUMT in the VA!