Preventing Pressure Ulcers With Repositioning Frequency and Precipitating Factors

NCT02996331 | Completed DMC

• 2 other identifiers: PRO000694131R01NR016001-01A1
• Study Type: interventional
• Target: 2,113
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pressure Ulcer

Keywords

Ulcer; Pressure Ulcer; Pathologic Processes; Skin Ulcer; Skin Diseases

Outcome Measures

Primary Outcomes (1)

• Determine differences in PrU Incidence among NH in study arms.

  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.

  4 weeks

Secondary Outcomes (2)

• Determine how medical severity components, changes in clinically assessed risk level, repositioning schedule, and their interactions are associated with development of PrUs.

  4 weeks

• Evaluate cost-effectiveness of PrU prevention intervention approach between NH groups repositioned at 2, 3, or 4 hour intervals.

  4 weeks

Study Arms (3)

2 hour arm

ACTIVE COMPARATOR

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

Other: 2 hour repositioning

3 hour arm

EXPERIMENTAL

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

Other: 3 hour repositioning

4 hour arm

EXPERIMENTAL

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

Other: 4 hour repositioning

Interventions

2 hour repositioning OTHER

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.

2 hour arm

3 hour repositioning OTHER

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.

3 hour arm

4 hour repositioning OTHER

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.

4 hour arm

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

Quinnipiac Valley Center

Wallingford, Connecticut, 06492, United States

Location

Related Publications (4)

• Yap TL, Horn SD, Sharkey PD, Brooks KR, Kennerly S. The Nursing Home Severity Index and Application to Pressure Injury Risk: Measure Development and Validation Study. JMIR Aging. 2023 Feb 9;6:e43130. doi: 10.2196/43130.

  PMID: 36757779 DERIVED

• Yap TL, Alderden J, Sabol VK, Horn SD, Kennerly SM. Real-time Positioning Among Nursing Home Residents Living With Dementia: A Case Study. Wound Manag Prev. 2020 Jul;66(7):16-22.

  PMID: 32614327 DERIVED

• Sabol VK, Kennerly SM, Alderden J, Horn SD, Yap TL. Insight Into the Movement Behaviors of Nursing Home Residents Living With Obesity: A Report of Two Cases. Wound Manag Prev. 2020 May;66(5):18-29.

  PMID: 32401731 DERIVED

• Yap TL, Kennerly SM, Horn SD, Bergstrom N, Datta S, Colon-Emeric C. TEAM-UP for quality: a cluster randomized controlled trial protocol focused on preventing pressure ulcers through repositioning frequency and precipitating factors. BMC Geriatr. 2018 Feb 20;18(1):54. doi: 10.1186/s12877-018-0744-0.

  PMID: 29463211 DERIVED

MeSH Terms

Conditions

Pressure Ulcer; Ulcer; Pathologic Processes; Skin Ulcer; Skin Diseases

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases; Pathological Conditions, Signs and Symptoms

Study Officials

• Tracey Yap, PhD, RN

  Duke University School of Nursing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2016
• First Posted: December 19, 2016
• Study Start: May 16, 2017
• Primary Completion: October 10, 2019
• Study Completion: October 11, 2019
• Last Updated: February 24, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)