The Effectiveness of a Pressure Ulcer Prevention Programme for Older People in For-profit Private Nursing Homes

Prevention of Pressure Ulcers Clinical Trial

Official title:

The Effectiveness of a Pressure Ulcer (PU) Prevention Programme for Older People in For-profit Private Nursing Homes (NHs): a Cluster Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02270385
• Other study ID #: HSEARS20140223001
• Status: Completed
• Phase: N/A
• First received: September 16, 2014
• Last updated: May 23, 2017
• Start date: November 2, 2015
• Est. completion date: September 10, 2016

Study information

• Verified date: May 2017
• Source: The Hong Kong Polytechnic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to evaluate the effectiveness of a PU prevention programme for for-profit private nursing homes

Description:

The study will be conducted as a two-arm cluster randomized controlled trial, which will compare the efficacy of a PU prevention programme versus usual PU prevention for older people in eight for-profit private nursing homes in Hong Kong. For-profit private NHs recruited will be randomly assigned as experimental or control groups. The nursing homes in the experimental group will be implemented a PU prevention programme. The programme includes a training course which was tailor-made for health workers(HWs) and persona care workers (PCWs) and also a 16-week PU prevention protocol. The outcome measures are incidence and prevalence rate of PUs as well as level of PU knowledge and skill among care staff in the nursing homes. In data analysis, survival analysis will be adopted for identifying PU incidence and prevalence rate. GEE will be used to analyze the time and effect differences of PU knowledge and skills among the care staff between two groups.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1013
• Est. completion date: September 10, 2016
• Est. primary completion date: September 10, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria :

• For-profit private nursing homes having been classified as the category A2 homes in the Enhanced Bought Place Scheme and are eager to improve current pressure ulcer prevention care;

• For for-profit private nursing homes having a capacity of around 130-150 beds;

• For for-profit private nursing homes having no structured PU prevention protocol, and/or programmes in place;- Residents aged 60 or above

• Care staff including personal care workers, health workers and nurses who provide direct care to residents.

Exclusion Criteria:

• Care staffs who are not speak in Chinese.

Related Conditions & MeSH terms

• Pressure Ulcer
• Prevention of Pressure Ulcers
• Ulcer

Intervention

Behavioral:
• PU prevention programme
The PU prevention programme consists of two major components which are an intensive training course(a 2-hour lecture and two skill training sessions) and a PU prevention protocol.
• Usual PU prevention care
Usual PU prevention care that is a series of basic nursing care activities: repositioning of residents, moisturization , change of napkins to keep buttock dry.

Locations

Country	Name	City	State
China	Tung Wah College	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pressure ulcer incidence	The two RAs will inspect the skin of each residents three times a week to detect the first PUs ( those detected on residents without PUs) and the new PUs (those detected on residents already suffering from PUs), starting from one day before the staff training to the end of the protocol implementation (. The numbers, locations, and stages of the PUs detected will be recorded in the PU incidence form. The PU incidence will be then summed up for three periods of time as following. T0 to T1: one day before the commencement of the training course (T0) to the day immediately before the commencement of the protocol implementation (T1) .T1 to T2: the day immediately before the commencement of the protocol implementation (T1) to the eighth week after the commencement of the protocol implementation (T2).T2 to T3: the eighth week after the commencement of the protocol implementation (T2) to the sixteenth week of protocol implementation (T3).	The PUs incidence will be summed up for three periods of time, from T0 to T1, T1 to T2 and T2 to T3.