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

• Sponsor: Stanford University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02533726
• Collaborator: Leaf Healthcare, Inc. (Industry)
• Enrollment: 1,312
• Location: 1
• Arms: 2
• Duration (Months): 6
• Patients Per Site Per Month: 217

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Pressure Ulcer	Other: Optimal Turning; Other: Standard Care Practices; Other: Patient Sensor	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 1312 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Randomized Control Trial Evaluating Optimal Patient Turning Procedures for Reducing Hospital Acquired Pressure Ulcers
• Study Start Date: Aug 1, 2015
• Actual Primary Completion Date: Feb 1, 2016
• Actual Study Completion Date: Feb 1, 2016

Arms and Interventions

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: 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.; 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

Outcome Measures

Primary Outcome Measures

1. Count of Participants With Pressure Ulcer According to the National Pressure Ulcer Advisory Panel (NPUAP) Criteria for Pressure Ulcers [Duration of ICU admission (average 1 week)]

   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

Secondary Outcome Measures

1. Compliance With Patient Turning Procedures [Duration of ICU admission (average 1 week)]

   Compliance is reported as the percentage of time during ICU admission that patients received turning every two hours.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford Health Care	Stanford	California	United States	94304

Sponsors and Collaborators

• Stanford University
• Leaf Healthcare, Inc.

Investigators

• Principal Investigator: David Pickham, PhD, Stanford Health Care

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: David Pickham, Clinical Assistant Professor, Stanford University
• ClinicalTrials.gov Identifier: NCT02533726
• Other Study ID Numbers: 33144
• First Posted: Aug 27, 2015
• Last Update Posted: Apr 9, 2018
• Last Verified: Sep 1, 2017

• Keywords provided by David Pickham, Clinical Assistant Professor, Stanford University: Bed Sores; Bedsores; Decubitus Ulcer; Pressure Sore
• Additional relevant MeSH terms: Pressure Ulcer; Ulcer

Study Results

Participant Flow

Arm/Group Title	Treatment - Optimal Turning	Control - Standard Care
Arm/Group Description	All patients had a sensor applied. Patients within this arm received care from nurses who had access to a User Dashboard that provided visual advisories for patient turning, based on data obtained from the wearable patient sensor.	All patients had a sensor applied. Patients within this arm received care from nurses who did not have access to a User Dashboard that provided visual advisories for patient turning. Instead, these patients received standard care practices, patient turning initiated by nurses as necessary.
Period Title: Initial Allocation
STARTED	659	653
COMPLETED	659	653
NOT COMPLETED	0	0
Period Title: Initial Allocation
STARTED	709	603
Per Protocol Population	671	555
COMPLETED	709	603
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Treatment - Optimal Turning	Control - Standard Care	Total
Arm/Group Description	All patients had a sensor applied. Patients within this arm received care from nurses who had access to a User Dashboard that provided visual advisories for patient turning, based on data obtained from the wearable patient sensor.	All patients had a sensor applied. Patients within this arm received care from nurses who did not have access to a User Dashboard that provided visual advisories for patient turning. Instead, these patients received standard care practices, patient turning initiated by nurses as necessary.	Total of all reporting groups
Overall Participants	671	555	1226
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	60 (17)	60 (18)	60 (17)
Sex: Female, Male (Count of Participants)
Female	298 44.4%	253 45.6%	551 44.9%
Male	373 55.6%	302 54.4%	675 55.1%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	113 16.8%	82 14.8%	195 15.9%
Not Hispanic or Latino	538 80.2%	458 82.5%	996 81.2%
Unknown or Not Reported	20 3%	15 2.7%	35 2.9%

Outcome Measures

1. Primary Outcome

Title	Count of Participants With Pressure Ulcer According to the National Pressure Ulcer Advisory Panel (NPUAP) Criteria for Pressure Ulcers
Description	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
Time Frame	Duration of ICU admission (average 1 week)

Outcome Measure Data

Analysis Population Description

Per protocol population according to treatment received (met minimum monitoring period (>2h) and did not receive both interventions)

Arm/Group Title	Treatment - Optimal Turning	Control - Standard Care
Arm/Group Description	All patients had a sensor applied. Patients within this arm received care from nurses who had access to a User Dashboard that provided visual advisories for patient turning, based on data obtained from the wearable patient sensor.	All patients had a sensor applied. Patients within this arm received care from nurses who did not have access to a User Dashboard that provided visual advisories for patient turning. Instead, these patients received standard care practices, patient turning initiated by nurses as necessary.
Measure Participants	671	555
Count of Participants [Participants]	5 0.7%	15 2.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Treatment - Optimal Turning, Control - Standard Care
	Comments	Per-protocol (PP) analysis, consistent with regulatory guidance (FDA).
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.012
	Comments
	Method	Fisher Exact
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	.27
	Confidence Interval	(2-Sided) 95%; .1 to .75
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Treatment - Optimal Turning, Control - Standard Care
	Comments	Per protocol analysis adjusted for admitting team, unit of admission, and risk for pressure injury.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.015
	Comments
	Method	Fisher Exact
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.20
	Confidence Interval	(2-Sided) 95%; 0.06 to 0.74
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Per protocol population according to treatment received (met minimum monitoring period (>2h) and did not receive both interventions)

Arm/Group Title	Treatment - Optimal Turning	Control - Standard Care
Arm/Group Description	All patients had a sensor applied. Patients within this arm received care from nurses who had access to a User Dashboard that provided visual advisories for patient turning, based on data obtained from the wearable patient sensor.	All patients had a sensor applied. Patients within this arm received care from nurses who did not have access to a User Dashboard that provided visual advisories for patient turning. Instead, these patients received standard care practices, patient turning initiated by nurses as necessary.
Measure Participants	671	555
Mean (Standard Deviation) [percentage of time]	67 (19.5)	54 (22.3)

Adverse Events

Time Frame	Duration of ICU admission (average 1 week)
Adverse Event Reporting Description	Adverse events are reported according to treatment received
Arm/Group Title	Treatment - Optimal Turning		Control - Standard Care
Arm/Group Description	All patients had a sensor applied. Patients within this arm received care from nurses who had access to a User Dashboard that provided visual advisories for patient turning, based on data obtained from the wearable patient sensor.		All patients had a sensor applied. Patients within this arm received care from nurses who did not have access to a User Dashboard that provided visual advisories for patient turning. Instead, these patients received standard care practices, patient turning initiated by nurses as necessary.
All Cause Mortality
	Treatment - Optimal Turning		Control - Standard Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Treatment - Optimal Turning		Control - Standard Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/709 (0%)		0/603 (0%)
Other (Not Including Serious) Adverse Events
	Treatment - Optimal Turning		Control - Standard Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/709 (0%)		0/603 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.