Preventing Pressure Ulcers With Repositioning Frequency and Precipitating Factors

Duke University

Status: Completed

Conditions: Pressure Ulcer

Treatments: Other: 4 hour repositioning; Other: 2 hour repositioning; Other: 3 hour repositioning

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02996331

PRO00069413

1R01NR016001-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The purpose of this study is to determine whether repositioning frequency can be extended for nursing home (NH) residents who are low, moderate, and high risk for pressure ulcer (PrU) development. The investigators will also determine how changes in medical severity interact with changes in risk level and repositioning schedule to predict PrU development. This study will advance knowledge about repositioning frequency and clinically assessed PrU risk-level in relation to medical severity. Outcomes of this research will contribute to future guidelines for more precise preventive nursing practices and refinement of PrU prevention guidelines.

Full description

The purpose of this 9 nursing homes (NH) cluster randomized study is to determine whether repositioning frequency can be extended for NH residents who are low, moderate, and high risk for pressure ulcer (PrU) development and on visco-elastic (VE) high-density foam support-surfaces without compromising PrU incidence. The investigators will also determine how changes in medical severity interact with changes in risk level and repositioning schedule to predict PrU development. PrUs result primarily from pressure over bony prominences that occlude blood flow to tissues. Current PrU prevention protocols recommend repositioning moderate, high, and severe risk residents a minimum of every 2 hours. The investigators propose to include low risk residents because studies suggest they too develop PrUs. New pressure redistribution mattresses may make 2 hour repositioning unnecessary, but optimal time between repositioning remains unclear. Aims are 1) determine differences in incidence of new PrUs in NH residents (low, moderate, high risk level) using VE surfaces and repositioned at 2, 3, and 4 hour frequencies; and 2) determine how medical severity components (measured by a modified Comprehensive Severity Index), changes in clinically assessed risk-level (low, moderate, high as measured by Braden Scale), repositioning schedule, and their interactions are associated with PrU development; and an Exploratory Aim: Evaluate PrU prevention intervention approach between NH groups repositioned at 2, 3, or 4 hour by: 1) comparing the intervention resource costs (VE surfaces, Leaf service/sensor use, fixed and variable labor costs for training and repositioning) and incremental cost-effectiveness ratio of cost per % reduction in PrUs, and 2) exploring staff and resident satisfaction with intervention approach. The investigators will randomly assign each NH to one of 3 study arms (2, 3, 4 hour) while providing standard nursing care. Leaf Patient Monitoring System will be used with sensor worn continuously to monitor repositioning. Periodic safety and care checks will be performed to ensure skin integrity. Residents admitted to study NHs for at least 3 days during the 6 week intervention, without an existing PrU, not using a specialty support surface, and of low, moderate, or high risk for PrU development will be included in analysis based on intention to treat. The outcome, no difference in PrU incidence, will determine whether repositioning frequency can be extended for low, moderate, high risk residents. Medical severity components and clinically assessed risk level will be examined for assessment to assessment change in relation to PrU development, thus identifying severity components associated with new PrUs. Data will be monitored by investigators daily. Data analysis and management will be performed by HSIR. NH staff and resident satisfaction with the intervention approach will be explored using focus groups. This study will advance knowledge about repositioning frequency and clinically assessed PrU risk-level in relation to medical severity. Outcomes of this research will contribute to future guidelines for more precise preventive nursing practices and refinement of PrU prevention guidelines.

Enrollment: 2,113 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• NH residents for a minimum of 3 days who use a VE-surface mattress, are without PrUs and are clinically assessed as low, moderate, or high risk for new PrU development will participate in their respective NH-wide repositioning frequency protocol.
• Participants will include residents at the time of study initiation and any newly admitted residents during the 6-week study period.

Exclusion criteria

• Newly admitted residents (less than 3 days)
• resident has been diagnosed with pre-existing pressure ulcer
• PrU Risk is severe (Braden score <= 9)
• the resident is cared for on a specialty bed (such as a bariatric bed)
• "do not turn" orders are present
• Allergy to adhesive

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,113 participants in 3 patient groups

2 hour arm

Active Comparator group

Description:

All participants in this arm are assigned a 2-hour repositioning interval.

Treatment:

Other: 2 hour repositioning

3 hour arm

Experimental group

Description:

All participants in this arm are assigned a 3-hour repositioning interval.

Treatment:

Other: 3 hour repositioning

4 hour arm

Experimental group

Description:

All participants in this arm are assigned a 4-hour repositioning interval.

Treatment:

Other: 4 hour repositioning