Summary of an article on a pressure injury prevention

Effect of Varying Repositioning Frequency on Pressure Injury Prevention in Nursing Home Residents: TEAM-UP Trial Results Tracey L. Yap, PhD, RN, CNE, WCC, FGSA, FAAN; Susan D. Horn, PhD; Phoebe D. Sharkey, PhD; Tianyu Zheng, MS; Nancy Bergstrom, PhD, RN, FAAN; Cathleen Colon-Emeric, MD; Valerie K. Sabol, PhD, MBA, ACNP, GNP, FAANP, FAAN; Jenny Alderden, PhD, APRN; Winston Yap, MD; and Susan M. Kennerly, PhD, RN, CNE, WCC, FAAN

Original Investigation

ABSTRACT OBJECTIVE: To investigate the clinical effectiveness of three nursing-home-wide repositioning intervals (2-, 3-, or 4-hour) without compromising pressure injury (PrI) incidence in 4 weeks. METHODS: An embedded pragmatic cluster randomized controlled trial was conducted in nine nursing homes (NHs) that were randomly assigned to one of three repositioning intervals. Baseline (12 months) and 4-week intervention data were provided during the TEAM-UP (Turn Everyone And Move for Ulcer Prevention) study. Intervention residents were without current PrIs, had PrI risk (Braden Scale score) ≥10 (not severe risk), and used viable 7-inch high-density foam mattresses. Each arm includes three NHs with an assigned single repositioning interval (2-, 3-, or 4-hour) as standard care during the intervention. A wireless patient monitoring system, using wearable single-use patient sensors, cued nursing staff by displaying resident repositioning needs on conveniently placed monitors. The primary outcome was PrI incidence; the secondary outcome was staff repositioning compliance fidelity. RESULTS: From May 2017 to October 2019, 1,100 residents from nine NHs were fitted with sensors; 108 of these were ineligible for some analyses because of missing baseline data. The effective sample size included 992 residents (mean age, 78 ± 13 years; 63% women). The PrI incidence during the intervention was 0.0% compared with 5.24% at baseline, even though intervention resident clinical risk scores were significantly higher (P < .001). Repositioning compliance for the 4-hour repositioning interval (95%) was significantly better than for the 2-hour (80%) or 3- hour (90%) intervals (P < .001). CONCLUSIONS: Findings suggest that current 2-hour protocols can be relaxed for many NH residents without compromising PrI prevention. A causal link was not established between repositioning interval treatments and PrI outcome; however, no new PrIs developed. Compliance improved as repositioning interval lengthened. KEYWORDS: compliance, cueing, geriatrics, nursing home, pressure injury, pressure ulcer, prevention, repositioning

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DOI: 10.1097/01.ASW.0000817840.68588.04

Tracey L. Yap, PhD, RN, CNE, WCC, FGSA, FAAN, is Associate Professor, Duke University School of Nu of Utah School of Medicine, Salt Lake City. Phoebe D. Sharkey, PhD, is Professor Emeritus, Loyola Univ Department of Population Health Sciences. Nancy Bergstrom, PhD, RN, FAAN, is Professor Emeritus, Un is Professor, Duke University School of Medicine. Valerie K. Sabol, PhD, MBA, ACNP, GNP, FAANP, FA Professor, Boise State University School of Nursing, Idaho. Winston Yap, MD, Carroll County Memorial East Carolina University College of Nursing, Greenville, North Carolina. Copyright © 2022 the Author(s). P the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where i changed in any way or used commercially without permission from the journal. Acknowledgments: The was funded by the National Institutes of Health, National Institute of Nursing Research (R01NR016001 necessarily represent the official views of the National Institutes of Health. The authors have disclosed December 23, 2021; published online ahead of print January 19, 2022.

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INTRODUCTION Pressure injuries (PrIs; localized damage to skin and/or underlying tissues over bony prominences from pres- sure or shear forces) are common, yet seemingly intrac- table geriatric conditions that are mostly preventable complications in nursing home (NH) residents,1 who are typically older, withmultiple comorbidities, mobility challenges, and severely compromised health.2–4 Annual PrI prevalence of 7.3% in long-stay and 2.3% in short- stay residents5 and incidence up to 59% have been re- ported,1 hence the emphasis on PrI prevention. Pressure injuries have severe negative impacts on patients (eg, pain, infection, death), healthcare settings, and insurers,1,6 poten- tially exceeding $26 billion in costs annually.7

Assessment of PrI risk is standard practice in NHs,8–10

but prevention has proved elusive.11 There is limited evi- dence for PrI prevention,12with support surfaces andman- ual repositioning having been the focus.High-specification foamalternatives to standard hospital foammattresses sig- nificantly reduce PrI incidence.2,13,14 Repositioning (“turn- ing people to change body position”11) reduces pressure duration and tissue hypoxia and has theoretical appeal as a preventive approach; however, it also increases nursing workload and disrupts sleep.1,11 No conclusive evidence for either an optimal repositioning frequency13,14

or angle/positionhas emerged,11 relegatingpractice settings to use status quo 2-hour intervals based on 60-year-old findings.15 Staff compliance with 2-hour repositioning is challenging to achieve; the impact of cueing staff to re- position on time is not established.

rsing, Durham, North Carolina, United States. Susan D. Horn, PhD, is Adjunct Professor, University ersity Maryland, Baltimore. Tianyu Zheng, MS, is Research Assistant, University of Utah iversity of Texas Health Science Center at Houston School of Nursing. Cathleen Colon-Emeric, MD, AN, is Professor, Duke University School of Nursing. Jenny Alderden, PhD, APRN, is Associate Hospital, Carrollton, Kentucky. Susan M. Kennerly, PhD, RN, CNE, WCC, FAAN, is Professor, ublished by Wolters Kluwer Health, Inc. This is an open-access article distributed under the terms of t is permissible to download and share the work provided it is properly cited. The work cannot be authors thank Judith Hayes, PhD, RN, and Elizabeth Flint, PhD, for editorial assistance. This project ; Yap, principal investigator). The content is solely the responsibility of the authors and does not no other financial relationships related to this article. Submitted December 5, 2021; accepted

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Table 1. INCLUSION CRITERIA FOR NURSING HOMES AND RESIDENTS Nursing Home Inclusion Criteria Resident Inclusion Criteria

>100 beds Aged ≥18 y

Standard use of high-density foam mattresses No pressure injury on admission or within 72 h

Adequate internet bandwidth capacity to support real-time data collection and storage

Braden Scale score ≥ 10

Full electronic health record capability No adhesive allergy or other clinical contraindications

The repositioning intervention of the clinical trial pro- tocol for the Turn Everyone And Move for Ulcer Preven- tion (TEAM-UP) trial16 was derived from the International Pressure Injury Prevention Guidelines1 every 2-hour stan- dard for repositioning residents that allows individuali- zation of repositioning intervals of up to 4 hours; the pro- tocol was used by all participating NHs. The TEAM-UP trial examines 2-, 3-, and 4-hour repositioning intervals (prompted by wearable patient position sensors) and the 28-day PrI incidence among NH residents using viable 7-inch high-density foam mattresses and having PrI risk scores of low, mild, moderate, or high (not severe) as mea- sured by the Braden Scale (≥10). The final study results were intended to provide evidence of overall repositioning effectiveness among the three repositioning intervals.

METHODS This study aimed to determine whether the reposition- ing interval can be extended from 2 to 3 or 4 hours for NH residents without compromising PrI incidence. An embedded pragmatic cluster randomized controlled trial designwas selected because these studies are designed to inform decision-makers regarding the comparative bal- ance of benefits, burdens, and risks of using biomedical or behavioral health interventions.17 The study was de- signed with input from healthcare stakeholders18 and was intended to represent the real-world NH environ- ment that included (1) a diverse representative study population, (2) an intervention that could be incorporated easily into routine clinical workflow as standard of care, (3) outcomes important to decision-makers (in this case, PrI and compliance), and (4) comprehensive data col- lected through standard documentation in an electronic health record (EHR) within the healthcare setting. Prior to NH selection, three arms (arm 1 = 2-hour,

arm 2 = 3-hour, arm 3 = 4-hour) were determined, with planned assignment of three NHs to each arm by applying a randomized sequencing of the arm assign- ments according to the chronologic order identified for NHs. The repositioning intervals were implemented in chronologic sequence after completing one round of arm 1, arm 2, and arm 3 to ensure all three intervals could be safely implemented; then, a predetermined se- quence was followed, resulting in NHs 1, 6, and 8 in arm 1; NHs 2, 4, and 9 in arm 2; and NHs 3, 5, and 7 in arm 3. Nine NHs from a large proprietary system in 34 states

met the eligibility requirements, accepted the invitation to participate, and were assigned to one of the three NH-wide repositioning interval arms as described pre- viously. The magnitude of within-cluster (arm) depen- dence was quantified by the intraclass correlation coeffi- cient (ICC), and the precision of this measure was quan- tified by its confidence interval (CI).

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During the intervention, a patient monitoring system cued staff to reposition residents and tracked events. Four-week incidence of new PrI was compared among the three arms, controlling for resident characteristics and staffing levels. Details of the trial design were published previously.16

Study Setting, Residents, and Procedures All Medicare-certified NHs providing intermediate and skilled nursing care within the proprietary company (n = 473) were eligible for randomization. Inclusion criteria for NHswere: over 100 beds; standard use of high-density foam mattresses determined to be viable or replaced within 2 months of study implementation; adequate in- ternet bandwidth capacity to support real-time data col- lection and storage; and full EHR capability including activities of daily living, laboratory, and radiology re- sults (Table 1). The requirement for NHs to have full elec- tronic record capabilitieswas essential to facilitate data col- lection and ensured that the study would have robust data sets. Investigators invited 83 eligible NHs meeting eligibil-

ity to participate in the trial, which required mandatory staff in-service training to explain the study and patient monitoring system implementation. The sample size power requirement (95%) was satisfied by the first nine NHs that agreed to participate based on total residents to be recruited. The nine study NHs (1) had the same standard care delivery policies, (2) were of typical size and characteristics of the other eligible sites, (3) signed implementation agreements, (4) received a nominal sti- pend to support project implementation, and (5) were randomized via a predetermined random sequencing procedure16 to one of three repositioning intervals (arms). Eligible study participants met the following criteria:

18 years or older, without PrIs (on admission or within 72 hours), Braden Scale score ≥ 10 (assessed weekly), and without adhesive allergy or other clinical contrain- dications (paranoia, dermatitis, personal defibrillator garment andmonitor, or “do-not-turn” order). Residents

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at severe PrI risk (Braden Scale score < 10)were excluded because of unique repositioning and surface needs. Available electronic historic data for study residents

were retrieved for the 12-month baseline period prior to the intervention start at eachNH. Residents with both intervention and baseline EHR, Minimum Data Set, and NH Risk Management System data formed the effective sample for pre-post analyses.

Intervention Each arm included three NHs assigned a NH-wide repo- sitioning interval (2, 3, or 4 hours) during the 4-week intervention. A wireless patient monitoring system using a wearable, resident-specific sensor worn on the upper chest tracked position/movement and cued staff com- pliance with the prescribed NH-wide repositioning in- terval.19 Health Insurance Portability and Accountabil- ity Act-compliant visual cues displayed each resident’s time-stamped repositioning history and status on unit desk and hallway monitors. Patient monitoring system fidelity checks (6 per week) ensured accuracy. Standard PrI prevention care other than repositioning

intervals was provided in all three arms in accordance with International Pressure Injury Prevention Guidelines1

(head-of-bed elevation, position angle, and duration and use of pillows/wedges tomaintain position, turning sheets, and lift devices as appropriate).1 Staff assisted non-bedfast residents to stand/move/reposition and used preventive seating cushions as needed. All residents/families received information about the study, repositioning protocol, and their right to refuse care and/or receive a more fre- quent repositioning interval.

Outcomes The primary outcome was PrI incidence during the in- tervention. Daily and weekly NH staff skin assessments were recorded using NH system policies.1 Certified nurs- ing assistants observed skin daily over bony prominences, between skin folds, in genitalia/buttocks areas, and at sensor sites. Change in skin appearance was reported to licensed staff with oversight for repositioning, safety, weekly skin care checks, and EHR documentation re- lated to PrI status (stage and manifestations). Safety al- gorithms were published previously.16

The secondary outcome was fidelity of staff reposi- tioning compliance tracked by wearable patient sensors, enhanced by NH-mandated in-service training for full- and part-time RNs, LPNs, and Certified Nursing Assis- tants (79% participation). The required education focused on PrI etiology, Braden Scale risk assessment, evidence- based prevention practices, repositioning benefits, roles and responsibilities, staff workflow, trial protocol, and pa- tient monitoring system information. A researcher visited the NH each shift duringweek 1 and at least daily during

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the second through fourth weeks to ensure the patient monitoring system was functioning, answer staff ques- tions, and stock supplies.

Assessments All NHs and eligible residents were assessed retrospec- tively for the baseline period (maximum 365 days) be- fore the intervention start date and prospectively for the 4-week intervention period. The NH parent com- pany provided all EHR, Minimum Data Set, and Risk Management System data for the full 28-day interven- tion period regardless of the number of days reposition- ing was monitored. Assessments of all eligible residents were extracted from the EHR, Minimum Data Set, or NH Risk Management System. The EHR provided de- mographic characteristics, medical diagnoses as Interna- tional Classification of Diseases version 9 (baseline period data) and/or International Classification of Diseases ver- sion 10 codes (most frequently occurring codes were grouped into the most common diagnosis categories), height/weight, vital signs, and laboratory data. The EHR data were supplemented by the Minimum

Data Set, a federally mandated, comprehensive, stan- dardized assessment of NH residents’ functional and health needs conducted quarterly and/or at condition change. The NH assessments (location, specialty units, Medicare-certified beds, census, occupancy, staff hours, and payor type) for intervention and baseline were ex- tracted as reported to the CMS. Braden Scale assessments produced the only data for which the data extraction/ collection schedule varied between baseline and interven- tion periods. During baseline, Braden Scale risk scores (10–12, high; 13–14, moderate; 15–18, mild; 19–23, low) were assessed on admission, four times weekly, quarterly, and upon condition change. During the intervention, Braden Scale scores were assessed weekly; no residents were withdrawn because of a Braden Scale score of 9 or less. The PrI incidence for eligible residents during the

12-month baseline period was extracted retrospectively from the NH Risk Management System and supple- mented by the Minimum Data Set and EHR, as previ- ously described.16 The PrI incidence was determined through standard weekly licensed nursing staff skin as- sessments for the 4-week intervention, directly reported to researchers, and documented as an adverse event through the NH company’s Risk Management System. Researchers ensured study fidelity by randomly verify- ing assessments and receipt in real time of secure email notification triggered by the reported event. The patient monitoring system served as a reposition-

ing fidelitymeasure and assessed several factors for each resident: days with active sensors worn, number of Turn Alert cues, Turn Alert overdue hours, and degree angle of repositioning with ±2.5% accuracy. Turn Alert cues

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appeared on screens to notify staff that a resident had not had a position change andwas due for repositioning within the allocated interval. Turn Alert overdue hours counted time beyond prescribed repositioning interval that a resident remained in the same position. The 24-hour on-time repositioning compliance was calculated as (1 − [# Turn Alert overdue hours for period of interest]/ [total hours monitored for period of interest]) and indi- cated the degree to which the expected repositioning in- terval was being achieved.

Statistical Analysis Primary analyses of PrI outcomes were performed ac- cording to the intention-to-treat principle. Analyses were conducted using Statistical Analysis Software (SAS version 9.4, Cary, North Carolina). Analysis of InterventionOutcomes. The initial analy-

sis plan to test whether the PrI rate during intervention was higher for 3- or 4-hour repositioning compared with 2-hour is reported elsewhere.16 Overlap between the 95% CIs of rates of PrI and the 2-hour repositioning would confirm the hypothesis for no group difference. However, given that no PrIs developed during the inter- vention, the trial’s original analysis plan was modified to report the trial’s characteristics and pre-post comparative analyses by testing baseline (pretest, 2-hour repositioning) versus intervention (posttest, 3-hour, and 4-hour protocols) PrI rates. Analysis ofDifferences in Baseline and Intervention

Risk. Propensity score logistic regression analysis based on baseline datawas used to account for an imbalance in PrI risk associated with significant differences in NH and resident characteristics across arms. The adequacy of the fi- nal model fit was ensured by generating a 70% random sample to train/build themodel anda 30%randomsample to validate themodel. Regression coefficients from the fitted training data set model provided unbiased risk predictions of developing a PrI during the intervention.Contribution of each variable to likelihood of developing a PrI was deter- mined by odds ratios (ORs) generated from the model. C statistics were used to assess goodness of fit. Differences in first Braden Scale scores and mean total

Braden Scale scores across arms within the intervention period were compared separately using either analysis of variance orχ2 analyses. Paired t tests evaluated differ- ences inmean total Braden Scale scores between baseline and intervention cohorts by arm. Two-sided tests (P < .05) were used for all analyses. Power Analyses. Statistical power and sample size

analyses are published elsewhere.16 The expected PrI inci- dence for this study’s 4-week intervention was 3.5% based on the TURN study’s13 highest rate (for moderate-risk patients) during that 3-week intervention. Target sample size was 951 residents (≥317 per arm) to detect minimum

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detectable effect size of 0.38 difference between study arms with a power of 0.95 based on a one-sided rather than a two-sided test to determine if PrI incidence with 3- or 4-hour repositioning frequency was greater than with 2-hour repositioning; detection of a decrease in PrI was not of concern. Stopping boundaries were main- tained during the trial as described in the Data Safety Monitoring Plan; no safety concerns were identified, and the trial was completed. Powerwas adjusted postin- tervention after taking into consideration the ICC of the NHs in the three treatment arms. Intraclass correlation coefficient and its CI were calculated.

Ethics The trial was approved by Duke University Institutional Review Board (#Pro00069413). The Board approved a waiver of informed consent per the US Department of Health and Human Services guidelines 21 CFR 46 be- cause (1) an NH-wide repositioning schedule was pro- vided to the entire cluster of low-, mild-, moderate-, and high-risk residents; (2) the intervention-assigned re- positioning interval was adopted as part of NH-wide practice that standardized the repositioning workflow; (3) minimal risk was involved in the arm-level interven- tion, and (4) a coded data set was created with assigned study identification (ID) number for resident data ex- tracted from the patient monitoring system database, Minimum Data Set, and EHR, and the coded data set was placed directly into a secured network folder. Also, fliers summarizing the project notingNHMedical Direc- tor approval were mailed to residents and their family member/responsible party informing them of the op- tion to choose not to participate; the principal investiga- tor’s mobile phone number was included for concerns and questions. The principal investigator guided on- site data collection with the project director, who was re- sponsible for implementation fidelity. The research team was responsible for data quality control/analyses. A busi- ness associates’ agreement was signed between the NH corporation and patient monitoring system company. All methods were performed in accordance with the rele- vant guidelines and regulations (Declaration of Helsinki). Data Sharing Statement. The data used in this publica-

tion include protected health information and therefore cannot be freely shared. Data sharing will be possible with case-by-case approval from the authors’ institutional review board; requests may be directed to the principal investigator.

RESULTS Repositioning intervals were implemented in the ran- domly ordered sequence as planned to ascertain whether repositioning interval could be extended from 2 to 3 or 4 hours forNH residents.No PrIs developed among par- ticipating residents, even though the preintervention PrI

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incidence at the nine NHs ranged from 2.3% to 18.3%. Intervention results are described related to NH and res- ident characteristics and primary and secondary out- comes. Additional analyses were performed to examine PrI risk and repositioning compliance.

Nursing Homes Characteristics of the three NHs in each arm during baseline are presented in Table 2; the ICC and its CI are 0.056 (CI, −0.78 to 0.89). The NHs were primarily subur- ban, with 126 to 238 Medicare-certified beds; some NHs had dementia and/or transitional resident specialty units. The average census ranged from approximately 143 to 162 residents, with Medicare-certified bed occu- pancy between 79% and 90%. Certified Nursing Assis- tants provided most care hours to residents, who were primarily Medicaid supported.

Residents FromMay2017 toOctober 2019, 1,100 residentswere fitted with sensors; 108 of thesewere ineligible for some analyses because of missing baseline data or other disqualifying conditions. The effective sample size included 992 resi- dents. The NH enrollment and randomization, resident assessment and allocation, follow-up, and analysis are shown in the Figure and were developed according to

Table 2. NURSING HOME (N = 9) CHARACTERISTICS AT BAS

Characteristics Arm 1 2 ha (n =

Location S, S, S

Specialty units None, D/

No. of Medicare-certified beds per facility, mean (range) 181.0 (18

Patient census,b mean (SD) 143.2 (37

% Occupancyb (census-certified beds), mean (SD) 79.2 (17.6

No. of staff hours per resident, db meanc (SD)

RN 1.6 (0.20)

LPN 2.9 (0.70)

Certified nursing assistant 6.5 (1.40)

Resident payor type, mean (% coverage by payor type)

Managed care 3.8 (2.6)

Medicaid 112.7 (78

Medicare A 17.9 (12.5

Private pay 4.5 (3.2)

Other payor 4.3 (3.0)

Abbreviations: D, dementia unit; NH, nursing home; S, suburban; T, transitional care unit; U, urban. Note: Percentages may not sum to 100 because of rounding. aRepositioning interval for each intervention arm. bBaseline values are for the 6-month period prior to the intervention. cNo. of monthly hours/NH monthly census, by staff category.

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the cluster trial’s extension of the CONSORT (Consoli- dated Standards of Reporting Trials) Statement. Table 3 presents characteristics of the 1,100 residents

allocated to the three intervention arms; 108 residents were excluded from the pre-post analyses, and the re- maining 992 residents were analyzed by arms. The 108 excluded residents did not form a PrI; they were signifi- cantly younger (P < .001), were primarily men (P = .002) and had less cerebrovascular disease (P = .004), gastro- esophageal reflux disease (P = .026), Alzheimer disease and related dementias (P < .001), and difficulty swallow- ing (P < .001), but had more hypertension (P < .001) and diabetes (P = .003) than the 992 residents analyzed in the intervention population. Differences in age, race, ethnicity, diagnosis categories,

and intervention length of stay (LOS) were statistically significant across arms (Table 3); this imbalance was ad- dressed using propensity analyses (Table 4). Black resi- dents comprised 53% of arm 2 compared with less than 18% in arms 1 and 3. Fifty-two residents (27% of whom were Black) had one or more incident baseline PrIs that healed prior to intervention start (untabled). Total LOS reflects the time from admission that could have oc- curred during or before baseline period until the inter- vention end date or resident discharge from NH. The LOS for only the intervention period (intervention-only LOS) was 1 day shorter in arm 3, which was statistically

ELINE BY ARM

319) Arm 2 3 ha (n = 323)

Arm 3 4 ha (n = 350)

S, U, S S, U, S

T, D T, D, T D/T, T, T

0–183) 178.7 (176–180) 180.3 (126–238)

.9) 161.5 (4.3) 159.1 (47.7)

) 90.3 (2.3) 88.5 (3.0)

2.1 (0.53) 2.4 (0.53)

2.6 (0.49) 2.7 (0.93)

7.5 (0.36) 7.6 (0.57)

7.9 (4.9) 11.2 (7.0)

.7) 131.9 (81.7) 115.4 (72.5)

) 10.1 (6.2) 18.4 (11.6)

5.4 (3.4) 3.3 (2.1)

6.2 (3.8) 10.8 (6.8)

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Figure. NURSING HOME ENROLLMENT AND RANDOMIZATION, RESIDENT ASSESSMENT AND ALLOCATION, FOLLOW-UP, AND ANALYSIS

Abbreviation: NH, nursing home.

significant, but a single-day difference is not considered clinically relevant to the outcome.

PrI Risk Across and Within Arms Baseline. Table 4 presents clinical risk (Braden Scale) comparisons, predicted propensity, and observed PrI inci- dence among residents at baseline and during the inter- vention. At baseline, neither first nor mean total Braden Scale scores differed significantly by arm, although risk dif- fered slightly acrossmean Braden categories (P = .03). Pro- pensity for a resident to develop a PrI at baseline (Table 4) was significantly higher in arm 2 (P< .001) than either arm 1 or 3 (Tukey honestly significant difference, P≤ .05); arms 1 and 3 did not differ significantly. The ORs for PrI devel- opment during baseline (propensity model C statistic, 0.76) included: Black race (OR, 2.24; CI, 1.04–4.80); mild Braden risk category (OR, 3.96; CI, 1.57–9.94); and mod- erate Braden risk category (OR, 4.69; CI, 1.48–14.91). No other resident characteristics (age, sex, diagnoses) orNH or staffing characteristics were significant predictors for developing a PrI. Observed annual PrI incidence across all NHs during baseline was 5.24% (52/992; range, 2.3%– 18.3% across NHs); the overall monthly expected number of PrIs was 4.33. Intervention.No new PrIs developed during the inter-

vention regardless of NH allocation to 2-, 3-, or 4-hour

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repositioning interval. Despite significant differences in propensity to develop PrIs, the incidence was 0.0% across all arms, which included 52 residents with a prior baseline PrI that had healed before the start of the inter- vention. Propensity to develop a PrI during the interven- tion was significantly greater (50%) at 3 hours (Tukey honestly significant difference,P≤ .05) than at 2 or 4 hours, which were not different. During the intervention, neither first nor mean Braden

total risk scores differed by arm. However, both first (P = .003) and mean (P = .001) Braden Scale score cate- gories (low, mild, moderate, high) differed significantly by arm. Arm 2 included fewer residents at high risk than arms 1 and 3. BaselineVersus InterventionAcross andWithinArms.

Pairwise comparisons of baseline and intervention mean total Braden Scale scores were calculated for each arm (Table 4). Mean Braden Scale score was significantly worse (PrI risk was higher) during the intervention: arm 1 (t = −0.544, P < .001); arm 2 (t = −0.224, P = .015); and arm 3 (t = −0.643, P < .001). Residents were more likely to score as high-risk during the intervention overall (n = 66 [6.7%]) than in baseline overall (n = 14 [1.4%]). The baseline PrIs showed that the majority of PrIs

were among residents with mild and moderate Braden risk. Mean Braden risk score categories of baseline

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Table 3. DEMOGRAPHIC AND CLINICAL CHARACTERISTICS OF RESIDENTS ALLOCATED TO INTERVENTION (N = 1,100) AND INCLUDED IN PRE-POST ANALYSES

Resident Characteristicsa

Allocated to Intervention Arms (N = 1,100)

Excluded from Pre-Post Analysesb

(n = 108)

Residents Eligible for Pre-Post Analysisb (N = 992) Arm 1 2 hc (n = 319)

Arm 2 3 hc (n = 323)

Arm 3 4 hc (n = 350) Pd

F Statistic or χ2

Resident age, mean (SD), y 77.39 (13.23) 73.17 (14.06) 76.23 (13.32) 79.42 (12.84) 77.87 (12.86) .008 4.84e

Mean differences by arm (CI)f 1–2; −3.20 (−5.61, −0.78)

2–3; 1.56 (−0.80, 3.91)

1–3; −1.64 (−4.00, 0.73)

Resident age distribution, n (%)

≤64 y 201 (18.27) 34 (31.48) 57 (17.87) 46 (14.24) 64 (18.29)

65–70 y 130 (11.82) 12 (11.11) 41 (12.85) 38 (11.76) 39 (11.14)

71–80 y 257 (23.36) 21 (19.44) 92 (22.29) 66 (20.43) 78 (28.84) .046 18.61g

81–85 y 147 (13.36) 16 (14.81) 41 (12.85) 43 (13.31) 47 (13.43)

86–89 y 134 (12.18) 10 (9.26) 34 (10.66) 40 (12.38) 50 (14.29)

≥90 y 231 (21.00) 15 (13.89) 54 (16.93) 90 (27.86) 72 (20.57)

Sex, n (%)

Female 681 (61.91) 52 (48.15) 207 (64.89) 201 (62.23) 221 (63.14) .51 0.78g

Male 419 (38.09) 56 (51.85) 112 (35.11) 122 (37.77) 129 (36.86)

Race,h n (%)

Asian 3 (0.27) 2 (1.85) 0 (0.00) 1 (0.31) 0 (0.00)

Black 293 (26.64) 26 (24.07) 55 (17.24) 170 (52.63) 42 (12.00) <.001 168.94g

White 738 (67.09) 61 (56.48) 248 (77.74) 146 (45.20) 283 (80.86)

Other, unknown 66 (6.00) 19 (17.59) 16 (5.03) 6 (1.86) 25 (7.14)

Ethnicity, n (%)

Hispanic or Latino 24 (2.18) 0 (0.00) 7 (2.19) 3 (0.93) 14 (4.00) .033 6.18g

Not Hispanic or Latino 1076 (97.82) 108 (100.00) 312 (97.81) 320 (99.07) 336 (96.00)

Top diagnoses for intervention sample, n (%)

Difficulty walking 939 (85.36) 96 (88.89) 249 (78.06) 278 (86.07) 316 (90.29) <.001 20.00g

Muscle weakness/wasting 903 (82.09) 87 (80.56) 264 (82.76) 239 (73.99) 313 (89.43) <.001 27.50g

Difficulty with swallowing or speech 594 (54.00) 26 (24.07) 213 (66.77) 143 (44.27) 212 (60.57) <.001 35.62g

Hypertension 516 (46.91) 72 (66.67) 149 (46.71) 183 (56.66) 112 (32.00) <.001 42.03g

Atherosclerotic heart disease 483 (43.91) 52 (48.15) 149 (46.71) 150 (46.44) 132 (37.71) .027 7.24g

Alzheimer disease or related dementias 320 (29.09) 12 (11.11) 110 (34.48) 136 (42.11) 62 (17.71) <.001 49.27g

Gastroesophageal reflux disease 315 (28.64) 21 (19.44) 124 (38.87) 105 (32.51) 65 (18.57) <.001 34.87g

Depression 257 (23.36) 25 (23.15) 80 (25.08) 94 (29.10) 58 (16.57) <.001 15.91g

Type 2 diabetes 236 (21.45) 35 (32.41) 73 (22.88) 77 (23.84) 51 (14.57) .004 10.93g

Cerebrovascular disease 228 (20.73) 11 (10.19) 54 (16.93) 74 (22.91) 89 (25.43) .025 7.36g

Intervention-only length of stay, mean (SD), d

25.79 (5.85) 17.80 (7.89) 26.99 (4.09) 27.07 (4.18) 25.98 (5.89) .0047 5.39e

Mean differences by arms (CI)f 1–2; −0.081 (−0.975, 0.814)

2–3; 1.091 (0.217, 1.966)

1–3; 1.011 (0.133, 1.888)

Total length of stay, mean (SD), d 1,122.11 (1,299.14) 18.25 (7.95) 1,288.60 (1,435.59) 1,214.55 (1,262.10) 1,225.69 (1,243.45) .7424 0.30e

Mean differences by arms (CI)f 1–2; 74.04 (−169, 318) 2–3; −11.13 (−249, 227) 1–3; 62.91 (−176, 302)

Abbreviation: CI, confidence interval. aPercentages may not sum to 100 because of rounding. bEligibility for pre-post analyses required data from both baseline and intervention time periods. The 108 residents not included in pre-post analyses did not have baseline data. cIndicates repositioning interval for each Intervention arm. Each arm included 3 nursing homes. dDenotes arm differences. eAnalysis of variance used to test for differences among arms. fMean difference displayed pairwise: arm “x” − arm “y”; value of actual pairwise mean difference; confidence interval (a, b). gχ2 Used to test for differences among arms. hAmerican Indian/Alaska Native, 0%; more than one race, 0%; Native Hawaiian or Other Pacific Islander, 0%.

WWW.ASWCJOURNAL.COM 321 ADVANCES IN SKIN & WOUND CARE • JUNE 2022

Ta bl e 4. PR E- PO

ST CO

M PA

RI SO

N OF

PR ED IC TE D AN

D OB

SE RV

ED RI SK

OF PR ES SU

RE IN JU

RY FO R RE SI DE NT

S AT

BA SE LI NE

AN D IN TE RV

EN TI ON

BY AR

M (N

= 99 2)

Re si de nt

Ch ar ac te ris tic sa

Ba se lin eb

In te rv en tio nc

Ar m 1

2 hd

(n = 31 9)

Ar m 2

3 hd

(n = 32 3)

Ar m 3

4 hd

(n = 35 0)

P/ F St at is tic

or χ 2

Ar m 1

2 hd

(n = 31 9)

Ar m 2

3 hd

(n = 32 3)

Ar m 3

4h rd (n = 35 0)

P/ F St at is tic

or χ 2

Fir st to ta lB ra de n Sc al e sc or e, m ea n (S D)

18 .4 0 (3 .0 4)

18 .1 0 (2 .6 2)

18 .2 1 (2 .5 7)

.3 8/ 0. 97

e 17 .4 8 (3 .3 9)

17 .3 4 (2 .9 4)

17 .3 7 (3 .0 2)

.8 4/ 0. 18

e

M ea n di ffe re nc e in fir st to ta lB ra de n Sc al e sc or e by

ar m s (C I)f

1– 2; 0. 29 9

(− 0. 21 0, 0. 80 8)

2– 3; −0 .1 15

(− 0. 61 2, 0. 38 2)

1– 3; 0. 18 4

(− 0. 31 5, 0. 68 3)

1– 2; 0. 13 9

(− 0. 43 9, 0. 71 7)

2– 3; −0 .0 28

(− 0. 59 3, 0. 53 7)

1– 3; 0. 11 1

(− 0. 45 6, 0. 67 8)

19 – 23

(Lo w ris k),

n (% )

16 7 (5 2. 4)

14 5 (4 4. 9)

17 6 (5 0. 3)

.0 9/ 11 .0 7g

13 8 (4 3. 3)

10 9 (3 3. 8)

13 4 (3 8. 3)

.0 03 /2 0. 01

g

15 – 18

(M ild

ris k),

n (% )

11 9 (3 7. 3)

14 9 (4 6. 1)

15 3 (4 3. 7)

11 0 (3 4. 5)

15 8 (4 8. 9)

15 0 (4 2. 9)

13 – 14

(M od er at e ris k),

n (% )

23 (7 .2 )

23 (7 .1 )

18 (5 .1 )

44 (1 3. 8)

43 (1 3. 3)

36 (1 0. 3)

10 – 12

(H ig h ris k),

n (% )

10 (3 .1 )

6 (1 .9 )

3 (0 .9 )

27 (8 .5 )

13 (4 .0 )

30 (8 .6 )

M ea n to ta lB ra de n Sc al e sc or e, m ea n (S D)

18 .0 7 (2 .7 7)

17 .7 3 (2 .2 5)

17 .8 9 (2 .5 1)

.2 3/ 1. 45

e 17 .5 3 (3 .3 2)

17 .5 1 (2 .7 9)

17 .2 5 (2 .9 4)

.4 0/ 0. 92

e

M ea n di ffe re nc e in m ea n to ta lB ra de n Sc al e sc or e by

ar m s (C I)f

1– 2; 0. 33 8

(− 0. 12 8, 0. 80 4)

2– 3; −0 .1 57

(− 0. 61 3, 0. 29 8)

1– 3; 0. 18 1

(− 0. 27 6, 0. 63 8)

1– 2; 0. 01 4

(− 0. 54 5, 0. 57 4)

2– 3; 0. 26 5

(− 0. 28 2, 0. 81 2)

1– 3; 0. 28 0

(− 0. 26 9, 0. 82 8)

19 – 23

(Lo w ris k),

n (% )

13 5 (4 2. 3)

10 4 (3 2. 2)

13 2 (3 7. 7)

.0 3/ 14 .0 1g

12 6 (3 9. 5)

11 1( 34 .4 )

11 3 (3 2. 3)

.0 01 /2 4. 08

g

15 – 18

(M ild

ris k),

n (% )

13 9 (4 3. 6)

18 1 (5 6. 0)

16 7 (4 7. 7)

11 8 (3 7. 0)

16 0 (4 9. 5)

16 3 (4 6. 6)

13 – 14

(M od er at e ris k),

n (% )

39 (1 2. 2)

37 (1 1. 5)

44 (1 2. 6)

52 (1 6. 3)

43 (1 3. 3)

40 (1 1. 4)

10 – 12

(H ig h ris k),

n (% )

6 (1 .9 )

1 (0 .3 )

7 (2 .0 )

23 (7 .2 )

9 (2 .8 )

34 (9 .7 )

Pr es su re in ju ry pr op en sit y sc or e fo rs am

pl e du rin g tim

e pe rio dh

0. 04 4

0. 06 6

0. 04 8

<. 00 1/ 17 .8 1e

0. 04 4

0. 06 3

0. 04 5

<. 00 1/ 13 .9 4e

M ea n di ffe re nc e in pr es su re in ju ry pr op en sit y sc or e by

ar m s (C I)f

1– 2; −0 .0 23

(− 0. 03 2, −0 .0 13 ) 2– 3; 0. 01 9 (0 .0 09 ,0 .0 28 )

1– 3; −0 .0 04

(− 0. 01 3, 0. 00 5)

1– 2; −0 .0 18

(− 0. 02 8, −0 .0 09 ) 2– 3; 0. 01 7 (0 .0 08 ,0 .0 26 ) 1– 3; −0 .0 01

(− 0. 01 0, 0. 00 8)

Ov er al lp re ss ur e in ju ry in cid

en ce

fo r9

sit es ,n

(% )

52 (5 .2 4)

0 (0 )

Pr es su re in ju ry in cid

en ce

by ar m ,n

(% )

13 (4 .0 8)

23 (7 .1 2)

16 (4 .5 7)

.1 8/ 1. 74

g 0 (0 )

0 (0 )

0 (0 )

No ta pp lic ab le i

M ea n di ffe re nc e in pr es su re in ju ry in cid en ce

by ar m s (C I)f

1– 2; −3 .0 46

(− 7. 17 4, 1. 08 3)

2– 3; 2. 54 9

(− 1. 48 6, 6. 58 5)

1– 3; −0 .4 96

(− 4. 54 5, 3. 55 2)

Pr es su re in ju ry in cid

en ce

by m ea n to ta lB ra de n Sc al e sc or e ca te go ry by

ar m

19 – 23

(Lo w ris k),

n (% )

3 (2 .2 )

3 (2 .9 )

1 (0 .8 )

.4 7/ 5. 62

g 0 (0 )

0 (0 )

0 (0 )

No ta pp lic ab le i

15 – 18

(M ild

ris k),

n (% )

6 (4 .3 )

16 (8 .8 )

11 (6 .6 )

0 (0 )

0 (0 )

0 (0 )

13 – 14

(M od er at e ris k),

n (% )

3 (7 .7 )

4 (1 0. 8)

4 (9 .1 )

0 (0 )

0 (0 )

0 (0 )

10 – 12

(H ig h ris k),

n (% )

1 (1 6. 7)

0 (0 )

0 (0 )

0 (0 )

0 (0 )

0 (0 )

Ab br ev ia tio n: CI ,c on fid en ce

in te rv al .

a P er ce nt ag es

m ay

no ts um

to 10 0 be ca us e of ro un di ng .

b B as el in e va lu es

ar e fo rt he

12 -m on th pe rio d pr io rt o th e st ar to ft he

in te rv en tio n.

c In te rv en tio n va lu es

ar e fo rt he

4- w ee k in te rv en tio n pe rio d.

d R ep os iti on in g in te rv al fo re ac h in te rv en tio n ar m .E ac h ar m in clu de d th re e nu rs in g ho m es .

e A na lys is of va ria nc e us ed

to te st fo rd iff er en ce s am

on g ar m s.

f M ea n di ffe re nc e di sp la ye d pa irw

ise :a rm

“x ” − ar m “y ”; va lu e of ac tu al pa irw

ise m ea n di ffe re nc e; CI (a ,b ).

g χ 2 Us ed

to te st fo rd iff er en ce s am

on g ar m s.

h P ro pe ns ity

sc or e de riv ed

fro m lo gi st ic re gr es sio

n w ith

C- st at ist ic = 0. 76 2.

i Te st in g is no ta pp lic ab le to pr es su re in ju ry in cid en ce

du rin g th e in te rv en tio n be ca us e te st in g in cid en ce

of ze ro ev en ts is no tp os sib

le .

ADVANCES IN SKIN & WOUND CARE • JUNE 2022 322 WWW.ASWCJOURNAL.COM

residentswith PrIs that healed prior to continuing into the intervention (n = 52) were low (n = 7), mild (n = 33), mod- erate (n = 11), or high (n = 1) risk.

Compliance with Repositioning Schedule Fidelity to the assigned repositioning interval is pre- sented in Table 5. Of the 992 included residents, 369wore sensors without interruption for 28 days and 623 wore sensors intermittently because of skin irritation, short- term discharge, refusal, permanent discharge, or death. Intervention residents wore patient monitoring system sensors for an average of 16.06 to 17.44 days. However, all intervention residents were observed for PrI develop- ment as part of standard care throughout the 28-day in- tervention period (Table 3).

Table 5. REPOSITIONING CHARACTERISTICS OF RESIDENTS

Repositioning Characteristics Arm 1 2 ha (n = 319)

No. of days sensor worn,b mean (SD) 16.35 (10.86)

Mean difference by arm (CI)d 1–2; −1.096 (−3.098, 0.906)

Overall resident daily (24 h) average no. of repositioning Turn Alert cues, mean (SD)

4.98 (3.41), n =

Mean difference by arm (CI)d 1–2; 1.899 (1.4

Overall resident daily average repositioning Turn Alert overdue hours per 24 h, mean (SD)

5.14 (3.59), n =

Mean difference by arm (CI)d 1–2; 1.711 (1.1

Overall resident daily (24 h) on–time repositioning compliance,b,f

mean (SD) 0.80 (0.15)

Mean difference by arm (CI)d 1–2; −0.095 (−0.116, −0.074

Overall resident daily (24 h) on–time repositioning complianceb,f (by Braden risk category

Braden Scale score 19–23 (low risk) 0.86 (0.10)

Mean difference by arm (CI)d 1–2; −0.068 (−0.094, −0.043

Braden Scale score 15–18 (mild risk) 0.79 (0.16)

Mean difference by arm (CI)d 1–2; −0.099 (−0.133, −0.065

Braden Scale score 13–14 (moderate risk) 0.73 (0.16)

Mean difference by arm (CI)d 1–2; −0.149 (−0.218, −0.080

Braden Scale score 10–12 (high risk) 0.72 (0.16)

Mean difference by arm (CI)d 1–2; −0.169 (−0.261, −0.076

Abbreviation: CI, confidence interval. aRepositioning interval for each intervention arm. Each arm included 3 nursing homes. bTotal N = 988 because of missing movement data for four residents: arm 2 missing three residents cAnalysis of variance used to test for differences among arms. dMean difference displayed pairwise: arm “x” − arm “y”; value of actual pairwise mean difference; C eNo. of residents with one or more overdue repositioning Turn Alert cues. fMean compliance values imputed for four missing residents after determining there is no difference gBraden Scale risk category determined from baseline Braden Scale risk scores for the week prior to

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Overall, 24-hour average repositioning cues and aver- age overdue hours were significantly higher for the 2- hour arm compared with less frequent repositioning in- tervals (P < .001). Overdue hours were twice as high, and Turn Alert cues were more than twice as high for 2-hour compared with 4-hour repositioning. Daily on-time repositioning compliance was signifi-

cantly better as the assigned hourly repositioning interval lengthened. That is, NHs allocated to the 4-hour interval had significantly greater compliance (95%) compared with 3-hour (90%) or 2-hour (80%) intervals (P < .001). Daily average on-time repositioning compliance was lower across all Braden Scale risk categories for the 2-hour arm compared with 3- or 4-hour repositioning schedules (P < .001).

(N = 992) DURING THE 4-WEEK INTERVENTION PERIOD Arm 2 3 ha (n = 323)

Arm 3 4 ha (n = 350) P F Statistic

17.44 (10.52) 16.06 (10.95) .224 1.50c

2–3; 1.381 (−0.578, 3.339)

1–3; 0.285 (−1.675, 2.245)

297e 3.08 (1.72), n = 292e 1.98 (1.12), n = 281e <.001 124.07c

50, 2.347) 2–3; 1.096 (0.641, 1.551) 1–3; 2.995 (2.542, 3.448)

297e 3.43 (2.48), n = 292e 2.54 (1.79), n = 281e <.001 67.66c

81, 2.240) 2–3; 0.889 (0.351, 1.426) 1–3; 2.599 (2.064, 3.134)

0.90 (0.11) 0.95 (0.07) <.001 134.50c

) 2–3; −0.047 (−0.067, −0.026)

1–3; −0.141 (−0.162, −0.121)

g), mean (SD)

0.93 (0.10) 0.97 (0.05) <.001 54.03c

) 2–3; −0.038 (−0.064, −0.012)

1–3; −0.106 (−0.131, −0.082)

0.89 (0.11) 0.95 (0.06) <.001 59.86c

) 2–3; −0.059 (−0.090, −0.028)

1–3; −0.158 (−0.192, −0.124)

0.88 (0.13) 0.89 (0.10) <.001 18.32c

) 2–3; −0.009 (−0.082, 0.063)

1–3; −0.159 (−0.230, −0.087)

0.89 (0.09) 0.93 (0.06) <.001 24.86c

) 2–3; −0.040 (−0.131, 0.051)

1–3; −0.209 (−0.282, −0.136)

(n = 320); arm 3 missing one resident (n = 349).

I (a, b).

in statistical significance between the analysis of variance results with and without imputation. the Intervention.

ADVANCES IN SKIN & WOUND CARE • JUNE 2022

DISCUSSION No PrIs developed during the intervention in this em- bedded pragmatic cluster randomized trial involving staff cued to reposition NH residents at 2-, 3-, or 4-hour interval. This represents a decrease from baseline 4.33 PrI monthly incidence to zero in the intervention despite significantly greater risk (ie, lower mean total Braden Scale scores), a greater number of Braden Scale high-risk residents than in baseline, and 52 residents (27% Black) who had previously healed PrIs. The null hypothesis of no increase in PrI rates when extending the repositioning interval to 3 or 4 hours cannot be rejected. Despite this, propensities for PrI development across

arms coupled with absence of PrIs during the interven- tion suggest the potential to safely extend repositioning requirements from every 2 hours to every 3 or even 4 hours for most residents, thus facilitating uninter- rupted sleep, which is critical to overall health.20 Two- hour repositioning is the standard of care implemented during the baseline. Thus, the 2-hour intervention arm could not be directly compared with 3- or 4-hour proto- col because no change occurred in its repositioning inter- val between baseline and intervention. However, study results support relaxation of this 2-hour arm protocol based on its similar propensity for PrI development compared with the 4-hour arm. The TEAM-UP study suggests that resident reposition-

ing intervals can be safely extended up to every 4 hours without increasing PrI incidence among residents at a wide range of clinical risk, if residents are supported by viable high-density foammattresses and staff are compli- ant with repositioning. Defloor and colleagues14 found that those turned every 4 hours on high-density foam mattresses experienced significantly fewer PrIs than those turned every 2 or 3 hours on standard hospital mat- tresses. Prior research studying only moderate- and high-risk residents using high-density foam mattresses found no significant difference in PrI incidence with re- positioning at 2, 3, or 4 hours.13 Residents deemed to be low risk are not commonly studied; yet, these resi- dents develop PrIs;13–15 thus, low/mild-risk residents were included in TEAM-UP. Fifty-two residents with healed baseline PrIswho participated in the intervention included 77% who were of low or mild risk. The TEAM-UP study supports evidence for the effi-

cacy of high-density foam mattresses in preventing PrIs for 28 days, even with extended repositioning intervals that were associated with significantly better staff com- pliance. Also, on-time repositioning was supported by staff education and cueing. Education sessions refreshed staff on the etiology of PrIs, the importance of tissue off- loading, and proper repositioning techniques, leading to a heightened awareness of prevention standard proto- cols already in place. This increased awarenesswas pres-

ADVANCES IN SKIN & WOUND CARE • JUNE 2022 324

ent across all study arms; yet, compliance was lower in the 2-hour interval because nursing staff had difficulty achieving that frequency. A variety of cueing reminders have been used to im-

prove staff repositioning compliance, for example, bed- side logs,14 musical cues,21 and paper clocks.13 Cueing used in TEAM-UP is thought to be a factor that helped facilitate nursing staff in repositioning on time. A compar- ison of repositioning compliance between the monitored every-2-hour intervention interval and the nonmonitored baseline repositioning was not possible. However, a prior pilot study by Yap and colleagues19 that used the same patient monitoring system reported a mean of 61.4% repositioning compliance during a 3-day blinded every 2-hour repositioning baseline without cueing. Reposi- tioning compliance improved to 81.5% during 18 days of monitoring with cueing, which is similar to TEAM-UP finding of mean 80% repositioning compliance for the 2-hour arm. Also, Pickham and colleagues22 found a 54% repositioning compliance in a 2-hour control group of hos- pitalized acutely ill adults. Similar to TEAM-UP, staff repo- sitioning compliance for hospitalized acutely ill adults was improved by displaying on monitors (visual cues) reposi- tioning information received from wearable sensors.22

Limitations Cluster trials in a healthcare setting without extensive preliminary analyses have a large degree of uncertainty related to the within-cluster correlation and between cluster variation. Small differences in an ICC can result in substantial differences in estimates of the required sample size and number of clusters. The ICC estimate in- dicated that this study required five NHs per arm; how- ever, the wide CI (−0.78 to 0.89) is evidence of a lack of precision in this measure and does not provide sufficient guidance to determine the optimum number of required NHs. The use of many NHs is problematic when the goal is to efficiently test multiple repositioning intervals in a real-world setting. Accordingly, the number of NHs in the TEAM-UP trial was limited to nine to adhere to the 5-year study period and budget parameters imposed by the fundingmechanismwhile ensuring that the embed- ded pragmatic cluster randomized trial design require- mentsweremet. Thiswas especially true for implementing the NH-wide intervention that could be incorporated eas- ily into routine clinical workflow as standard of care. Propensity score analysis partially addressed differ-

ences in resident characteristics between NHs in arms 1, 2, and 3. One source of imbalance in arms was associ- ated with Black residents being more likely to develop a PrI; yet, no PrIs developed among Black residents dur- ing the intervention. Propensity analysis did not control for variation in a resident’s LOS. Potential bias that might have been introduced by differences in short-

WWW.ASWCJOURNAL.COM

stay (LOS <100 days) and long-stay (LOS >100 days) res- idents as defined according to the CMS could not be fully identified based on available data. This trial excluded NH residents with severe PrI risk

because their care delivery is highly individualized using specialized surfaces and repositioning intervals. Evidence regarding median time to PrI development varies; for example, recent acute care evidence shows a 2- to 5-day median time to PrI development when using high-density foammattresses and 4-hour repositioning.23

The TEAM-UP’s 28-day follow-up period was longer than prior NH randomized controlled trials’ interven- tion periods.13,14 Prior research supports the adequacy of the 4-week intervention time period to permit devel- opment of PrIs in the sample studied.13,14 However, this may still be insufficient time to fully demonstrate PrI outcomes, precluding using time-to-development as an analysis strategy, as in the PRESSURE2 study.24

Itwasnotpossible toblindnursing staff to the intervention. Staff knowledge of the NH-wide repositioning interval was essential but may have contributed to a Hawthorne ef- fect because the patient monitoring system made staff continually aware of resident repositioning needs.

CONCLUSIONS This study found that a large group of residents could have repositioning protocols relaxedwithout compromis- ing PrI incidence, although this embedded cluster ran- domized clinical trial could not establish a true causal link between three repositioning interval treatments and PrI outcomes. This trial is the third study to demonstrate that PrI incidence is not compromised by repositioning most NH residents at 3- or 4-hour interval;13,14,16 also, the in- tervention periodwas longer than that in previous stud- ies. Residents did not develop new PrIs while using via- ble high-density foammattresses, and staff were cued to perform scheduled repositioning, demonstrating, as in prior research,19,25 that consistently implemented pre- vention strategies can be effective. Successful applica- tion of these results NH-wide would free staff for addi- tional care activities and reduce resident sleep disrup- tions. Additional research is needed to identify specific factors of race and risk differences in PrI incidence. Es- tablishing PrI causative factors will enhance quality of NH care delivery.•

WWW.ASWCJOURNAL.COM 325

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18. Weinfurt K. What is a pragmatic clinical trial: the embedded pragmatic clinical trial ecosystem. NIH Health Care Systems Research Collaboratory. In: Rethinking Clinical Trials: A Living Textbook of Pragmatic Clinical Trials Website. https://rethinkingclinicaltrials.org/chapters/pragmatic-clinical-trial/ what-is-a-pragmatic-clinical-trial-2. 2021. Last accessed January 3, 2022.

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ADVANCES IN SKIN & WOUND CARE • JUNE 2022