Use of Continence Care Protocol in UK Nursing Homes.

Use of Skin and Leakage Protocol and Its Impact on Continence Care at Nursing Homes in the UK.

This is a retrospective cohort study. In the investigation the clinical use of the Skin and leakage protocol (SLEP) is to be investigated. The SLEP is a generic digital diary form filled out to give information about the current status of continence care among care home residents. The SLEP tracks the number of leakage occurrences and daily skin health over a period of time with the purpose of assisting care staff in making decisions regarding continence care. The SLEP has been introduced at several United kingdom National Health Service care homes and with this investigation the investigators want to retrospectively analyse the data to determine the clinical usefulness of the form.

The primary objective of the study is to describe any changes in product leakage rate at the baseline and follow up time period.

Study Overview

• Status: Completed
• Conditions: Urinary Incontinence; Urinary Incontinence Due to Cognitive Impairment
• Intervention / Treatment: Other: Skin and leakage protocol

• Study Type: Observational
• Enrollment (Actual): 49

Contacts and Locations

Study Locations

• United Kingdom
  • Lincoln, United Kingdom, LN5 7JH
    • Lincolnshire Community Health Services NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Subjects to be evaluated will be subjects of the selected Care homes who meet all the required Inclusion and Exclusion criteria and who's data is available on the appropriate databases. Subjects will be considered eligible to participate in the study if:

All eligible subjects, that data is available for, cared for at the selected care homes and subjected to the protocol are to be assessed. Typically, all residents that use containment products are assessed at the care home.

Description

Inclusion Criteria:

• Subject is diagnosed with urinary incontinence managed with an absorbing incontinence product.
• The skin and leakage protocol have been used in the care of the subject and there is data from at least two measurements.
• Subject is cared for in a Residential care home using the skin and leakage protocol.
• Subject is over 18 years of age.

Exclusion Criteria:

• Subject is not using an absorbing incontinence product to manage incontinence.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Protocol arm; The skin and leakage protocol was used over a 5 day baseline period. The follow up was done 25 days later by another 5 day period of protocol use to observe any changes in continence care.

Other: Skin and leakage protocol; The skin and leakage protocol have been developed by the sponsor with the aim to offer a tool that can aid care providers in identifying problems in continence care and follow up the effect of any care interventions to remedy these problems. The protocol is a digital diary tool that tracks both the instances of urine leaking out of an absorbing incontinence product onto clothes and bedsheets, and any apparent skin changes in the area covered by the product. The protocol is in clinical use at the care homes were the subjects are residing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in leakage rate	Change in absorbing product leakage rate between baseline and follow up period	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subject care profile	The care needs profiles of the subjects using the skin and leakage protocol. According to specific criteria for degree of confusion and mobility subjects can be assigned one of 6 different profiles. The profiles are arranged on a scale from 1-6 were 1 is lowest level of care need and 6 is the highest.	28 days
Change in skin health score	Change in skin health assessment score between the baseline and follow up period. The skin assessment is conducted on a scale from 1-5 were 1 represents no presence of skin irritation and 5 represents severe skin problems.	28 days

Collaborators and Investigators

• Sponsor: Essity Hygiene and Health AB
• Collaborators: Lincolnshire Community Health Services NHS Trust
• Investigators: Principal Investigator: Debbie Jeffrey, Lincolnshire Community Health Services National Health Services Trust

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2022
• Primary Completion (Actual): February 2, 2023
• Study Completion (Actual): February 2, 2023

Study Registration Dates

• First Submitted: October 13, 2023
• First Submitted That Met QC Criteria: October 19, 2023
• First Posted (Actual): October 25, 2023

Study Record Updates

• Last Update Posted (Actual): October 25, 2023
• Last Update Submitted That Met QC Criteria: October 19, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Incontinence; Enuresis
• Other Study ID Numbers: LASTER

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No