Optimal Patient Turning for Reducing Hospital Acquired Pressure Ulcers (LS-HAPU)

Randomized Control Trial Evaluating Optimal Patient Turning Procedures for Reducing Hospital Acquired Pressure Ulcers

The purpose of this study is to test whether optimal patient turning, strictly every 2 hours with at least 15 minutes of tissue decompression, reduces the occurrence of hospital acquired pressure ulcers.

Study Overview

• Status: Completed
• Conditions: Pressure Ulcer
• Intervention / Treatment: Other: Optimal Turning; Other: Patient Sensor; Other: Standard Care Practices

Detailed Description

This single site, open label, two arm randomized control trial aims to evaluate whether optimal patient turning, strictly every 2 hours with at least 15 minutes of tissue decompression, reduces the occurrence of hospital acquired pressure ulcers. Optimal turning procedures will be obtained with the use of a patient monitoring system (Leaf Healthcare, Inc.) and compared to standard preventative care practices.

Sensors were placed on all participants as they were admitted to ICU. A nurse's user dashboard was turned on for participants in the Optimal Turning Group, but was not turned on for participants in the Standard Care group.

• Study Type: Interventional
• Enrollment (Actual): 1312
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94304
      • Stanford Health Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adults (>18 years of age)
• Admission to Intensive Care Unit

Exclusion Criteria:

• Children (<18 years of age)
• Adhesive allergy
• Physical limitation for sensor application

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment - Optimal Turning; All patients will have a sensor applied. Patients within this arm will receive care from nurses who have access to a User Dashboard that provides visual advisories for patient turning, based on data obtained from a wearable patient sensor (Leaf Healthcare, Inc.).	Other: Optimal Turning; Patients within this arm will receive optimal turning practices. Nurses caring for these patients will receive real-time quantitative measures of patient turning procedures from the User Dashboard and provide a visual advisory to the nurse for the time to next turn.; Other Names: Patient Turning; Pressure Ulcer Prevention; Other: Patient Sensor; A small sensor with adhesive backing is applied to the upper chest (midline) of the patient. Sensor tracks and records body movement and position, and displays this on a User Dashboard located on a computer at the bedside.; Other Names: Leaf Healthcare Patient Monitoring Sensor
Active Comparator: Control - Standard Care; All patients will have a sensor applied. Patients within this arm will receive care from nurses who DO NOT have access to a User Dashboard that provides visual advisories for patient turning. Instead, these patients will receive standard care practices, patient turning initiated by nurses as necessary.	Other: Patient Sensor; A small sensor with adhesive backing is applied to the upper chest (midline) of the patient. Sensor tracks and records body movement and position, and displays this on a User Dashboard located on a computer at the bedside.; Other Names: Leaf Healthcare Patient Monitoring Sensor; Other: Standard Care Practices; Patients within this arm will receive standard preventative care practices - that is, nurses will provide standard care as necessary, without the aid of visual advisories from a patient sensor.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Count of Participants With Pressure Ulcer According to the National Pressure Ulcer Advisory Panel (NPUAP) Criteria for Pressure Ulcers	NPUAP criteria include 4 stages and 2 unstaged criteria. The count of patients with pressure ulcer according to any of the criteria are reported.; Stage 1: Non-blanchable erythema of intact skin; Stage 2: Partial-thickness skin loss with exposed dermis; Stage 3: Full-thickness skin loss; Stage 4: Full-thickness skin and tissue loss; Unstageable: Obscured full-thickness skin and tissue loss; Suspected deep tissue injury: Persistent non-blanchable deep red, maroon or purple discoloration	Duration of ICU admission (average 1 week)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compliance With Patient Turning Procedures	Compliance is reported as the percentage of time during ICU admission that patients received turning every two hours.	Duration of ICU admission (average 1 week)

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: Leaf Healthcare, Inc.
• Investigators: Principal Investigator: David Pickham, PhD, Stanford Health Care

Publications and helpful links

General Publications

• Pickham D, Ballew B, Ebong K, Shinn J, Lough ME, Mayer B. Evaluating optimal patient-turning procedures for reducing hospital-acquired pressure ulcers (LS-HAPU): study protocol for a randomized controlled trial. Trials. 2016 Apr 6;17:190. doi: 10.1186/s13063-016-1313-5.

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: August 17, 2015
• First Submitted That Met QC Criteria: August 24, 2015
• First Posted (Estimate): August 27, 2015

Study Record Updates

• Last Update Posted (Actual): April 9, 2018
• Last Update Submitted That Met QC Criteria: September 13, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: Bed Sores; Bedsores; Decubitus Ulcer; Pressure Sore
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Skin Ulcer; Ulcer; Pressure Ulcer
• Other Study ID Numbers: 33144