Preventing Pressure Ulcers With Repositioning Frequency and Precipitating Factors
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|ClinicalTrials.gov Identifier: NCT02996331|
Recruitment Status : Enrolling by invitation
First Posted : December 19, 2016
Last Update Posted : August 13, 2019
|Condition or disease||Intervention/treatment||Phase|
|Pressure Ulcer||Other: 2 hour repositioning Other: 3 hour repositioning Other: 4 hour repositioning||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1386 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Preventing Pressure Ulcers With Repositioning Frequency and Precipitating Factors|
|Actual Study Start Date :||May 16, 2017|
|Estimated Primary Completion Date :||March 2020|
|Estimated Study Completion Date :||March 2020|
Active Comparator: 2 hour arm
All participants in this arm are assigned a 2-hour repositioning interval.
Other: 2 hour repositioning
Current PrU prevention protocols recommend repositioning moderate, high, and severe risk residents a minimum of every 2 hours. We 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. Aim is to 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.
Experimental: 3 hour arm
All participants in this arm are assigned a 3-hour repositioning interval.
Other: 3 hour repositioning
It is expected that 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. This intervention will include a 3 hour repositioning interval.
Experimental: 4 hour arm
All participants in this arm are assigned a 4-hour repositioning interval.
Other: 4 hour repositioning
It is expected that 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. This intervention will include a 4 hour repositioning interval.
- Determine differences in PrU Incidence among NH in study arms. [ Time Frame: 4 weeks ]Determine differences in the incidence of new PrUs in NH residents at low, moderate, and high risk using VE surfaces and repositioned at 2, 3, or 4 hour frequencies, in nine randomly assigned NHs over a 4-week period. We hypothesize that there will be no significant difference in PrU incidence between the 3 treatment arms in the study using three risk level groups: high risk (Braden Scale Score, 10-12), moderate risk (Braden Scale Score, 13-14), and low risk (Braden Scores >14). The hypothesis of no group-difference will be tested by examining whether the 95% confidence intervals of the rates of PrU and the 2-hour repositioning overlap. If they do, the hypothesis for no group-difference will be confirmed. Cumulative Incidence rate = [(# of residents with 1 or more new PrUs during intervention period) ÷ (# of residents participating in intervention for 3 or more days)] x 100; calculated for the full 4-week intervention period.
- Determine how medical severity components, changes in clinically assessed risk level, repositioning schedule, and their interactions are associated with development of PrUs. [ Time Frame: 4 weeks ]Calculated severity score resulting from distillation of over 2,000 potential elements using the modified Comprehensive Severity Index (CSI) risk adjustment system. The more abnormal the signs/symptoms, the higher the severity score: Level 1 (normal to mild) - Level 4 (catastrophic, life-threatening, or likely to result in organ failure). PrU development will be examined and the PrU incidence rate will be modeled as a binary outcome. Additionally, generalized estimating equations (GEEs) will be used with model fit assessed using the quasi-likelihood information criterion (QIC). Robust standard errors, clustered at the facility level, will be employed to account for covariance among residents within facilities over time. To test the robustness of models, non-linear mixed models using PROC GLIMMIX will be employed as another option for modeling the data.
- Evaluate cost-effectiveness of PrU prevention intervention approach between NH groups repositioned at 2, 3, or 4 hour intervals. [ Time Frame: 4 weeks ]Comparing the intervention resource costs and incremental cost-effectiveness ratio of cost per % reduction in PrUs. Intervention cost will include labor cost, such as training time multiplied by wage & fringe rates of training participants and number of repositionings for each NH and study arm and time to conduct repositioning collected by Leaf system; multiplied by nurse wage & fringe rate. Non-labor cost inputs will include market prices paid fully depreciated over their respective useful life will be used to calculate daily equipment cost rates. Intervention cost by NH and study arm and incremental cost-effectiveness ratios (ICERs) will be calculated and compared for cost per % reduction in PrUs. Sensitivity analysis will be conducted with the range of observed repositioning times, nurse salaries, and market prices for non-labor inputs to assess the robustness of the ICERs and their sensitivity to labor and non-labor input prices.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02996331
|United States, Connecticut|
|Quinnipiac Valley Center|
|Wallingford, Connecticut, United States, 06492|
|Principal Investigator:||Tracey Yap, PhD, RN||Duke University School of Nursing|