This study aimed to determine whether repositioning interval can be extended from 2 to 3 or 4 hours for NH residents without compromising pressure injury incidence. An embedded pragmatic cluster randomized trial design was selected to represent the real-world nursing home environment that includes: 1) a diverse representative study population, 2) an intervention that could be incorporated easily into routine clinical workflow as standard of care, 3) outcomes (pressure injury and compliance) important to decision-makers, 4) comprehensive data collected through standard documentation in an electronic health record within the health care setting, and 5) design input from health care stakeholders.17 Prior to nursing home selection, 3 Arms (Arm 1 = 2-hour, Arm 2 = 3-hour, Arm 3 = 4-hour) were determined with planned assignment of 3 NHs to each Arm applying a randomized sequencing of the Arm assignments according to the chronological order identified for NHs. The repositioning intervals were implemented in chronological sequence after completing one round of Arm 1, Arm 2, and Arm 3 to ensure all 3 intervals could be safely implemented; then, a predetermined sequence was followed resulting in Nursing Homes 1, 6, 8 in Arm 1; Nursing Homes 2, 4, 9 in Arm 2; and Nursing Homes 3, 5, 7 in Arm 3. Nine nursing homes 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 nursing-home-wide repositioning interval Arms as described above. The magnitude of within-cluster dependence was quantified by the Intraclass Correlation Coefficient and the precision of this measure was quantified by its confidence interval.
A patient monitoring system cued staff (during the Intervention) to reposition residents and tracked events. Four-week incidence of new pressure injury 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 nursing homes providing intermediate and skilled nursing care within the proprietary company (n = 473) were eligible for randomization. Inclusion criteria for nursing homes were: >100 beds; standard use of high density foam mattresses determined to be viable or replaced within two months of study implementation; adequate internet bandwidth capacity to support real-time data collection and storage; and full electronic health record capability including activities of daily living, laboratory, and radiology results. The requirement for nursing homes to have full electronic record capabilities was essential to facilitate data collection and ensured that the study would have robust data sets. Eighty-three nursing homes meeting eligibility requirements were invited to participate in the trial, which required mandatory staff in-service training to explain the study and patient monitoring system implementation. Sample size power requirement (95%) was satisfied by the first 9 nursing homes assenting to participate based on total residents to be recruited. The 9 study nursing homes 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 stipend 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, without pressure injuries (on admission or within 72 hours), Braden score ≥ 10 (assessed weekly), and without adhesive allergy or other clinical contraindications (paranoia, dermatitis, personal defibrillator garment and monitor, or ‘do-not-turn’ order). Residents at severe pressure injury risk (Braden < 10) were excluded because of unique repositioning and surface needs. Available electronic historical data for study residents were retrieved for the 12-month Baseline period prior to the Intervention start at each nursing home. Residents with both Intervention and Baseline electronic health record, Minimum Data Set, and nursing home Risk Management System data formed the effective sample for pre-post analyses.
INTERVENTION
Each Arm included three nursing homes assigned a nursing-home-wide repositioning interval (2, 3, or 4 hours) during the 4-week Intervention. A wireless patient monitoring system using a wearable resident specific sensor worn on upper chest, tracked position/movement and cued staff compliance with prescribed nursing-home-wide repositioning interval.18 Health Insurance Portability and Accountability Act compliant visual cues displayed each resident’s time-stamped repositioning history and current status on unit desk and hallway screens. Patient monitoring system fidelity checks (6/week) ensured accuracy.
Pressure injury 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 to maintain 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 frequent repositioning interval.
Outcomes
The primary outcome was pressure injury incidence during the Intervention. Daily and weekly nursing home staff skin assessments were recorded using nursing home system policies.1 Certified Nursing 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 electronic health record documentation related to pressure injury status (stage and manifestations). Safety algorithms were published previously.16
The secondary outcome was fidelity of staff repositioning compliance tracked by wearable patient sensors, enhanced by nursing home mandated in-service training for full- and part-time registered nurses, licensed practical nurses, and Certified Nursing Assistants (79% participation rate). The required education focused on pressure injury etiology, Braden scale risk assessment refresher, evidence-based prevention practices, repositioning benefits, roles and responsibilities, staff workflow, trial protocol, and patient monitoring system information. A researcher visited the nursing home each shift during Week 1 and at least daily during Weeks 2–4 to ensure the patient monitoring system was functioning, answer staff questions, and stock supplies.
Assessments
Nursing homes and eligible residents were assessed retrospectively for Baseline period (maximum 365 days) before Intervention start date and prospectively for 4-week Intervention period. The nursing home parent company provided all electronic health record, Minimum Data Set, and Risk Management System data for the full 28-day Intervention period regardless of number of days repositioning was monitored. Assessments of all eligible residents were extracted from electronic health record, Minimum Data Set, or nursing home Risk Management System. The electronic health record provided demographic characteristics, medical diagnoses as International Classification of Disease-9 (Baseline period data) and/or International Classification of Disease-10 codes (most frequently occurring codes were grouped into the most common diagnosis categories), height/weight, vital signs, and laboratory data. Electronic health record data were supplemented by the Minimum Data Set, a federally mandated, comprehensive, standardized assessment of nursing home residents’ functional and health needs conducted quarterly and/or at condition change. Nursing home assessments (location, specialty units, Medicare-certified beds, census, occupancy, staff hours, and payor type) for Intervention and Baseline were extracted as reported to Centers for Medicare and Medicaid Services. Braden assessments produced the only data that for which the data extraction/collection schedule varied between Baseline and Intervention periods. During Baseline, Braden risk scores (10–12 = high, 13–14 = moderate, 15–18 = mild, 19–23 = low) were assessed on admission, weekly x 4, quarterly, and upon condition change. During Intervention, Braden risk was assessed weekly; no residents were withdrawn because of Braden score ≤ 9.
Pressure injury incidence for eligible residents during the 12-month Baseline period was extracted retrospectively from the nursing home Risk Management System and supplemented by the Minimum Data Set and electronic health record, as previously described.16 Pressure injury incidence was determined through standard weekly licensed nursing staff skin assessments for the 4-week Intervention, directly reported to researchers, and documented as an adverse event through the nursing home company’s Risk Management System. Researchers ensured study fidelity by randomly verifying assessments and receipt in real-time of secure email notification triggered by the reported event.
The patient monitoring system served as a repositioning fidelity measure, which 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 appeared on screens to notify staff that a resident had not had a position change and was 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 indicated the degree to which the expected repositioning interval was being achieved.
Statistical Analysis
Primary analyses of pressure injury outcomes were performed according to intention-to-treat principle. Analyses were conducted using Statistical Analysis Software (SAS version 9.4).
Analysis of Intervention Outcomes
The initial analysis plan to test whether the pressure injury rate during Intervention was higher for 3-hour or 4-hour repositioning compared to 2-hour is reported elsewhere.16 Overlap between the 95% confidence intervals of rates of pressure injury and the 2-hour repositioning would confirm the hypothesis for no group difference. However, given that no pressure injuries developed during the Intervention, the trial’s original analysis plan was modified to report the trial’s characteristics and pre-post comparative analyses by testing Baseline (pre-test, 2 hour repositioning) versus Intervention (post-test, 3 and 4 hour protocols) pressure injury rates.
Additional Analyses
Analysis of Differences in Baseline and Intervention Risk. Propensity score Logistic Regression analysis based on Baseline data was used to account for an imbalance in pressure injury risk associated with significant differences in nursing home and resident characteristics across Arms. Adequacy of the final model fit was ensured by generating a 70% random sample to train/build the model and a 30% random sample to validate the model. Regression coefficients from our fitted training dataset model provided unbiased risk predictions of developing a pressure injury during the Intervention. Contribution of each variable to likelihood of developing a pressure injury was determined by odds ratios generated from the model. C statistics were used to assess goodness of fit.
Differences in First Braden and Mean Braden total risk scores across Arms within the Intervention period were compared separately using either ANOVA or Chi Square analyses. Paired t-tests evaluated differences in Mean Braden total risk scores between Baseline and Intervention cohorts by Arm. Two-sided tests (p‐value < 0.05) were used for all analyses.
Power Analyses
Statistical power and sample size analyses are published elsewhere16. The expected pressure injury incidence rate 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 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 pressure injury incidence with 3 or 4 hour repositioning frequency was greater than with 2-hour repositioning; detection of a decrease in pressure injury was not of concern. Stopping boundaries were maintained during the trial as described in the Data Safety Monitoring Plan; no safety concerns were identified, and the trial was completed. Power was adjusted post-Intervention after taking into consideration the Intraclass Correlation Coefficient of the nursing homes in the three treatment Arms. Intraclass Correlation Coefficient and its confidence interval were calculated.