Protected Engagement Time (PET) for people with Dementia

ISRCTN	ISRCTN31919196
DOI	https://doi.org/10.1186/ISRCTN31919196
Secondary identifying numbers	14879

Submission date: 16/10/2013
Registration date: 13/02/2014
Last edited: 13/03/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Protected engagement time (PET) is an initiative adopted in some dementia wards in England. It is in response to feedback that ward staff may to be able to spend enough time with people suffering from dementia. The aim is to help ward staff to be able to prioritise this by reorganising ward routines so they can engage with patients individually or in groups. It is expected that, as a result, patients service users will experience less distress and require less psychiatric medication. The aim of this study is to examine whether the quality of life of patients is increased on wards where PET is implemented and whether it has any impact on other aspects of how patients and staff experience being on the wards.

Who can participate?
Patients who have been inpatients on the participating dementia wards for fourteen or more days will be eligible to take part. Relatives and staff will also be invited to take part.

What does the study involve?
There are a number of parts to the study. We will carry out a national telephone survey of all the dementia inpatient wards in England to find out where and how PET is being implemented. Ten wards over the three sites selected for the study have agreed to take part in providing information about life on the ward. Five of these wards offer PET whilst the other five do not. Measures will be taken from patients, relatives and staff on these participating wards through recognised questionnaires. We will also be speaking with and interviewing a number of patients, staff and relatives from PET wards to get more in-depth information about their views of PET. Finally we will devise a fidelity measure (to which extent the initiative is delivered as intended) from all the data collected from the other parts of the study.

What are the possible benefits and risks of participating?
Benefits include patients, staff and relatives having their views and experiences taken into consideration, helping to shape service developments. We do not anticipate many risks to taking part in the study but participants may become distressed during questioning. Researcher will be well trained to manage such situations should they occur. Participants will be able to complete the questionnaires and interviews in stages if required.

Where is the study run from?
The University of the West of England, Bristol is running the study. There are three participating sites: Avon and Wiltshire Mental Health Partnership NHS Trust, Norfolk and Suffolk Foundation Trust and Camden and Islington Foundation Trust (UK).

When is the study starting and how long is it expected to run for?
June 2013 to April 2015

Who is funding the study?
National Institute for Health Research (NIHR) (UK)

Who is the main contact?
Prof Richard Gray, Chief Investigator
Miss Emily Dodd, Trial Manager, emily3.dodd@uwe.ac.uk

Contact information

Miss Emily Dodd
Scientific

Faculty of Health & Life Sciences
University of the West of England (UWE)
Glenside Campus
Blackberry Hill
Bristol
BS16 1DD
United Kingdom

Email	emily3.dodd@uwe.ac.uk

Study information

Study design	Non-randomised mixed methodology design observational study single time point
Primary study design	Observational
Secondary study design	Other
Study setting(s)	Hospital
Study type	Quality of life
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	A preliminary comparison of wards for people with dementia using patient Protected Engagement Time (PET), with other wards delivering standard care alone
Study acronym	PET-Dementia
Study objectives	We wish to examine whether the quality of life of patients is increased on wards where PET is implemented and whether it has any impact on other aspects of how patients and staff experience being on the wards.
Ethics approval(s)	London - Camden and Islington NRES Ethics Committee, 25/03/2013, ref: 13/LO/0191
Health condition(s) or problem(s) studied	Dementia
Intervention	1. National telephone survey of all dementia inpatient wards in England to gather a detailed picture of the implementation of PET across the country 2. Administration of questionnaires to staff, patients and relatives on ten participating wards over three sites; five wards where PET is implemented (PET wards) and five wards (non-PET wards) delivering standard care alone
Intervention type	Other
Primary outcome measure	1. Quality of Life (DEMQOL) which measures health-related quality of life of people with dementia; Timepoint(s): Single observation at trial entry 2. Qualitative interviews with a sample of staff, patients and relatives from participating PET wards
Secondary outcome measures	1. Patients: 1.1. Client satisfaction questionnaire 1.2. Camden Content of Care questionnaire 1.3. EuroQol EQ-5D 2. Staff: 2.1. Maslach Burnout Inventory 2.1. Ward Atmosphere Scale 3. Relatives: 3.1. Carer burden Patients and staff on PET wards will also be asked specific questions about their experience of PET. All measures are taken once. There is no follow up.
Overall study start date	26/07/2013
Completion date	31/05/2015

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	Both
Target number of participants	Planned Sample Size: 596; UK Sample Size: 596
Key inclusion criteria	1. All patients with dementia who have been in hospital for fourteen days or more will be eligible to be included in this study as this will allow an adequate period in which to have experienced life on the ward. 2. Target Gender: Male & Female 3. Lower Age Limit 65 years
Key exclusion criteria	There are no exclusions listed.
Date of first enrolment	26/07/2013
Date of final enrolment	31/05/2015

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

University of the West of England (UWE)

Bristol
BS16 1DD
United Kingdom

Sponsor information

Norfolk and Waveney Mental Health NHS Foundation Trust (UK)
Hospital/treatment centre

80 St. Stephens Road
Norwich
NR1 3RE
England
United Kingdom

"ROR"	https://ror.org/03400ft78

Funders

Funder type

Government

National Institute for Health Research (NIHR) (UK) - CCF; Grant Codes: PB-PG-0110-21023
Government organisation / National government

Alternative name(s): National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	29/01/2016		Yes	No
Results article	results	01/04/2018		Yes	No
HRA research summary			28/06/2023	No	No

Editorial Notes

13/03/2020: Internal review.
11/12/2018: Publication reference added.
03/02/2016: Publication reference added.