SCIPUMT Gail PowellCope PhD ARNP FAAN Acting Director HSRampDRRampD Center of Excellence Tampa FL Gailpowellcopevagov Monitoring Pressure Ulcer Healing in Persons with Spinal Cord ID: 717511
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An Evidence-based Pressure Ulcer Monitoring Tool for Spinal Cord Injury/Disease (SCI-PUMT)
Gail Powell-Cope PhD, ARNP, FAANActing Director, HSR&D/RR&D Center of ExcellenceTampa, FLGail.powell-cope@va.govSlide2
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 Slide3
Investigators
Co-Principal InvestigatorsSusan S. Thomason DNP, MN, RN
Audrey Nelson PhD, RN, FAAN (Retired)
Co-Investigators
Steven Luther PhD
Jeffrey J. Harrow MD, PhD, FACPSlide4
Study Staff
Polly Placios, MS (Project/Data Manager)Data CollectorsStephanie McGovern, RNFrancis Hernandez, RN
Suk Tomlinson, RN
Olivia Monteso-Smithson, RN
Linda Smith, RN
Mary Reeder, BIS (Program Assistant)Slide5
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.Slide6
“Problems” (or challenges)
Clinical ProblemPressure ulcers are a high volume, high cost condition in Spinal Cord ImpairmentImplementationTranslating 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).Slide7Slide8
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) Slide9
PARiHS FrameworkPromoting 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
facilitatedSlide10
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
Innovation
Innovation
Facilitation
Facilitation
FacilitationSlide11
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. Slide12
Clinical Practice GuidelinesConsortium 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.Slide13
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…Slide14
SettingMichael Bilirakis
Spinal Cord Injury/Disorders CenterJames A. Haley Veterans HospitalTampa, Florida100 inpatient beds CARF-accredited)Large outpatient patient populationHome Care (CARF-accredited)Long Term CareSlide15
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 evaluationThese variations limit the ability to conduct comparable trials of interventionsSlide16
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?Slide17
SCI-PUMT Phases
Development of item poolDevelopment and testing of SCI-PUMTAnalysis and SCI-PUMT refinementAssessment of SCI-PUMT reliabilitySlide18
Development of item pool
Phase 1Slide19
Development of Item Pool
Expert Panel #1Aim: Identify measures and variables important and/or specific to PrU healing in SCI population1 day on-site, Tampa, Florida9 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 commentSlide20
Item Pool
Consisted of 30 itemsItems from two established PrU healing assessment tools (PUSH, BWAT)Additional items identified by Expert Panels Slide21
Development and Testing of SCI-PUMT
Phase IISlide22
SubjectsRecruited from Inpatient, Outpatient, Home Care
3-year longitudinal cohort studyAssessed 30 PrU variablesPrU unit of analysis Slide23
Inclusion CriteriaEnrolled in SCI/D Registry and receiving primary care from JAHVA SCI primary physician
Primary or secondary diagnosis of Stages II-IV PrUSCI duration more than 12 monthsSlide24
Exclusion Criteria
Immune compromised Severely mentally ill or cognitively impairedTerminally illSlide25
Subject
ProfileSample Size 66 Unique Patients167 Pressure Ulcers
Age
60 years (mean)
Gender
Male 98%
Level of
Injury
Tetra 49%; Para 46%
ASIA
A 58%; B 20%; Other 23%
Years since
SCI onset
23
Years (mean)
High School Graduate
80%Slide26
Pressure Ulcer
Characteristic
Findings
Number PrU / subject
1 – 9 (mean
2.5)
Previous PrU
77%
Prior PU surgery
53%
Location
Ischia
43%
Sacrococcygeal 26%
Trochanter 8%
Heel 8%
Stage
II 20%; III
38%;
IV 42%
Ulcer Pain
18%
Chronic Osteomyelitis
33%Slide27
Co-Morbidity
IncidenceDiabetes Mellitus26%
Anemia
24%
Peripheral
Vascular Disease
11%
Chronic Obstructive
Pulmonary
Disease
9%
Congestive
Heart Failure
8%
Heterotopic Ossification
8%Slide28
Other Baseline Factors
IncidenceImmunosuppressant Medications12%
Spasticity
Interference with Function
(1 = none; 5 = maximum)
2.4
mean (SD 1.6)
Spasticity
Modified Ashworth Scale
(1 = sl
ight ↑ tone; 5 = rigidity)
2.1 mean (SD 1.2)
Pain
(0
= none; 10 = severe)
3.9 (SD = 2.6)
Mean Body Weight
175 lb (SD 36.4)
Nicotine
Preceding Week
Substance Abuse
29%
6%Slide29
Data Collection6 Registered Nurse Data Collectors
13 time points: 30 variables + VeV PhotographBaseline and 12 weeks orComplete healingPatient withdrawalHospital discharged and lived >40 milesPlastic surgery interventionSlide30
VeV Measurement Documentation Software
Digital images used to calculate:VolumeSlide31
Intra- and Inter-Rater Reliability Ranges
4 RN Data CollectorsIntra-Rater Reliability1 DCSame PrUTwice 1 ½ hours apartInter-Rater Reliability4 DC
Same PrU
Consecutively
TOOL
Intra-
Rater
ICC
Inter-Rater ICC
PUSH
0.88
0.996
0.76 – 0.96
BWAT
0.87 –
0.99
0.69 –
0.91Slide32
Analysis and SCI-PUMT Refinement
Phase IIISlide33
Statistical Analysis
Construct validityPredictive validitySensitivity to changeInternal consistency reliabilitySlide34
Construct ValidityExploratory Factor Analysis (EFA)
N = 167 PrUPrincipal factor extraction with Promax (orthogonal rotation)Items removed from analysis based on: Values in correlation matrixFactor loadings of similar items (from 2 tools)Items not well defined by factors (low communalities) Slide35
Variable
Source
Geometric Factor
Substance
Factor
Depth
PUMT
.82
-
Tunneling
PUMT
.77
-
Edges
PSST
.55
-
Undermining
PUMT
.48
Surface area
PUSH
.35
.51
Necrotic amount
PSST
-
.52
Exudate type
PUMT
-
.40
*
Factor loading < |.30| have been replaced with “-“for ease of reading
Factor Analysis ResultsSlide36
Predictive Validity
Outcome variables to represent PrU healing: Surface Area & Volume Criterion Validity - VeV MD Software (within limits)Correlates with the gold standardRegression analyses – SCI-PUMT at baselineSlide37
Predictive Validity
Explains outcome variationsDependent variable: Volume (VeV Camera)Predictor variables: Factor analysis itemsSCI PUMT explained an estimated59% of the variance in volume over the course of the studySlide38
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%Slide39
Assessment of SCI-PUMT Reliability
Phase IVSlide40
Internal Consistency Reliability
Cronbach’s alpha = 0.74 (using study data)Slide41
SCI-PUMT ReliabilityAim:
Evaluate intra- and inter-rater reliability of in a clinical setting 26 Nurses trained in SCI-PUMT at Tampa VA SCI/D CenterTwo months later, two sets of 3 SCI RNs evaluated 16 ulcers twice with an interval of 1½ hours between assessmentsSlide42
ResultsClinician Reliability
Intra-rater reliability 0.81 – 0.99Inter-rater reliability 0.79All reliability measures found to be above our established acceptability thresholdSlide43
Variables and Scoring
SCI-PUMTSlide44
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
# ______Slide45
Variable
Score Options
Score
Geometric
Factor
Surface Area
(L x W)
1
2
3
4
5
<
1 cm
2
>1 -
<
2.5 cm
2
>2.5 -
<
5 cm
2
>5 -
<
10 cm
2
>10 -
<
15 cm
2
6
7
8
9
10
>15 -
<
25 cm
2
>25 -
<
35 cm
2
>35 -
<
55 cm
2
>55 -
<
85 cm
2
>85 cm
2
Depth
0
1
2
3
4
0 cm
>0 -
<
1 cm
>1 -
<
2 cm
>2 -
<
3 cm
>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
S
ub-total
Score
Geometric Factor
Substance FactorExudate Type0None1Serous/Sanguineous2Green/PurulentNecrotic Tissue Amount0None1<25%2>25%Sub-total Score Substance FactorTOTAL SCORE (Total of Geometric and Substance Sub-totals)
_______________________________ ____________________
Maximum score =
26
The HIGHER the score, the more severe the ulcer.
Evaluator: _________________________________________ Date ___________________________Slide46
SCI-PUMT Scoring
Each variable assigned ordinal valueData & clinical judgment to develop cut-points and weights for individual items and total scales scoreDetermined total score for SCI-PUMT = 26Assigned proportion of total score to each sub-scaleSlide47
SCI-PUMT
ScoringSlide48
Study Limitations
Sample stratification excluded patients who had multiple etiologies of SCI; differentiation of ulcer etiology and ulcer stages were too small for computationHealing process could be altered by tissue type and ulcer depthSample included persons with SCI from one SCI/D Center.Slide49
Continuing Psychometric Analysis
Can results of regression model be replicated over timeDoes weighting of items improve the SCI-PUMT’s predictive value?Do subscale scores have clinical utility?Slide50
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.Slide51
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.Slide52
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.Slide53
The Challenge—Full Implementation of the SCI-PUMT in the VA!