Preventing Pressure Ulcers With Repositioning Frequency and Precipitating Factors



Status:Enrolling by invitation
Conditions:Skin and Soft Tissue Infections, Gastrointestinal
Therapuetic Areas:Dermatology / Plastic Surgery, Gastroenterology
Healthy:No
Age Range:Any
Updated:8/10/2018
Start Date:May 16, 2017
End Date:March 2020

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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.

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.

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
We found this trial at
1
site
55 Kondracki Lane
Wallingford, Connecticut 06492
?
mi
from
Wallingford, CT
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