Condition category
Mental and Behavioural Disorders
Date applied
05/08/2019
Date assigned
15/08/2019
Last edited
18/11/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Going to the toilet in private is one of the most fundamental measures of human dignity, and incontinence can impact on feelings of being a person and their wider social status. When people with dementia are admitted to hospital wards, this requires the assistance of nurses or health care assistants. During our current study examining what happens when patients with dementia refuse hospital care, we have noticed that toileting is an important trigger that can lead to significant distress for patients (if immediate toileting assistance needs are not met), for families (who see their loved one in undignified circumstances) and for other patients (who may become afraid by the other person’s distress) and can increase the potential for dehumanization (staff not recognizing the person or their needs). When a patient with dementia is in hospital, it is often usual for staff to use incontinence pads or to insert a urinary catheter rather than help the person to go to the toilet. This is often because continence problems are a risk factor for falls. However, catheters can lead to significant risks of infection (that can become life-threatening) and not being able to independently go to the toilet, can reduce their opportunities to regain mobility and independence. This means that hospitals may be causing incontinence in patients with dementia.

Our consultations with carers identified that they had a lot of anger about continence care when their partner with dementia was in hospital. There was a general belief that catheterisation of patients with dementia was often for convenience, due to staff shortages, to prevent wet beds, and to reduce calls for help. Many reported that their partner with dementia, who was continent, became classified as incontinent within days of admission and required catheterisation.

In response, our study will conduct detailed research observing how ward staff and clinical teams care for patients with dementia during their admission. We will describe how toileting practices and routines impact on the care of people with dementia in acute hospital wards within three hospitals in different parts of England and Wales. During our observations we will carry out in-depth case studies of patients and interview them and their families about their experiences. Because there is very little published research on continence care for patients with dementia in hospitals, we will also review the literature to identify successful strategies used in other care settings. This will help us to bring together the knowledge that exists on how to promote the best ways to manage the toileting needs of patients with dementia in hospital wards.

At the end of the project we will provide a detailed understanding of how hospital care could change to improve care and the experiences of patients and their families. We will use this detailed research to develop new training and information for hospital staff and families. This will include raising awareness of the risks associated with current practices, and will have made this available across different organisations such as the Royal College of Nursing and open access formats accessible for anyone caring for a person with dementia via the Internet. We will also identify alternative ways to manage this important but neglected issue that can be implemented in wards and tested in future research studies. Our goal is to improve everyday care for patients with dementia in all hospitals.

Who can participate?
Patients with dementia, carers, family members and ward staff.

What does the study involve?
Patients with dementia, carers, family members and ward staff will be observed and interviewed over an 8-week period.

What are the possible benefits and risks of participating?
Benefits: participants will appreciate the interest and concern and the need for evidence to support the delivery of appropriate care for people living with dementia during a hospital admission.
Risks: there will be negligible risk to a participants physical health, but there is potential for intrusion, stress or distress as a result of being observed during data collection.

Where is the study run from?
Llanfrechfa Grange Hospital, UK

When is the study starting and how long is it expected to run for?
October 2018 to April 2020

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

Who is the main contact?
1. Dr Katie Featherstone
featherstonek@cardiff.ac.uk
2. Dr Sonia Vougioukalou
vougioukalous@cardiff.ac.uk

Trial website

http://www.storiesofdementia.com

Contact information

Type

Scientific

Primary contact

Dr Katie Featherstone

ORCID ID

http://orcid.org/0000-0003-4999-8425

Contact details

School of Healthcare Sciences
Cardiff University
13th Floor
35-43 Eastgate House

Newport Road
Cardiff
CF24 0AB
United Kingdom
+44 (0)29 2068 7689
featherstonek@cardiff.ac.uk

Type

Public

Additional contact

Dr Sonia Vougioukalou

ORCID ID

Contact details

School of Healthcare Sciences
Cardiff University
13th Floor
35-43 Eastgate House

Newport Road
Cardiff
CF24 0AB
United Kingdom
+44 (0)29 206 88575
vougioukalous@cardiff.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

4804

Study information

Scientific title

Understanding how to facilitate continence for people living with dementia in acute hospital settings: raising awareness and improving care

Acronym

Study hypothesis

Evidence is required to identify appropriate strategies and service improvements that can support and assist nurses and HCAs to deliver effective care to people living with dementia.

Ethics approval

Approved 19/04/2018, NHS REC Wales REC 3 (Health and Care Research Wales Support and Delivery Centre, Castlebridge 4, 15-19 Cowbridge Road East, Cardiff, CF11 9AB; +44 (0)2920785736; Wales.REC3@wales.nhs.uk), ref: 18/WA/0033

Study design

Observational qualitative study

Primary study design

Observational

Secondary study design

Case series

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Dementia

Intervention

This ethnography will examine everyday continence care for people with dementia (PWD) in acute hospital wards. An initial systematic narrative review to identify successful strategies for the organization and culture of continence care used across care settings that could inform innovations will (1) refine our approach to fieldwork and analysis (2) inform the development and feasibility of interventions to inform continence care in terms of possible mechanisms, content, delivery, and potential outcomes (3) provide an overarching conceptual model.

Data collection (observation, ethnographic and in-depth interviews) will take place in wards that exemplify the challenges of caring for a large number of PWD within 3 acute hospitals (1xMAU and 1x general medical, total: 6 wards). Potential impacts lie in the new learning drawn from the systematic and detailed observation of everyday continence care for PWD in acute wards.

People living with dementia are also at significant risk of developing incontinence and classified as incontinent during an acute hospital admission. However, incontinence has important implications for patient outcomes. It is a common risk factor for falls and infections, which in turn are associated with prolonged hospitalisation, re-admission and increased mortality. Enhancing the opportunities for people living with dementia to keep control over their most private of functions can enhance independence, rehabilitation and reduce lengths of stay. Although new approaches are needed, the research agenda lags behind. While there is a larger body of work providing the evidence base for continence treatment and care management interventions in long-term care settings, no UK studies have examined toileting practices or continence care in acute hospital wards.

Ethnographic observation will focus on the visible work of nurses and healthcare assistants (HCAs) involved in continence care (30 x days/shifts per ward, total = 180 days) to explore how staff respond to continence needs for people living with dementia. Within each acute hospital ward we will carry out 8 weeks of detailed data collection, followed by a further 8 weeks follow-up (case study interviews and additional observation) to examine the implications of continence care practices for PWD discharge and care trajectories. Fieldwork will always preserve patient dignity (this study will not and does not need to go ‘behind the screens’ to observe intimate care.
Short ethnographic interviews with ward staff (20-30 per ward, total = 120-180) as they are caring for this patient group (focus on nurses, HCAs, including the medical team (FY1/2, StRs, consultants), AHPs (physiotherapy, OT) when relevant to continence care). This allows us to question routine practice and decision making when interacting with PWD.

Routine data (from ward managers and patient records) about staffing levels, work allocation, bed occupancy, patient acuity, turnover and the recorded levels of incontinence and catheterization, to provide context and an understanding of workload.
Case studies with people living with dementia and family carers will be identified using purposive sampling will be followed from admission through to discharge and short term care pathways into the community (2 x PWD per ward, total = 12) to examine the impacts and consequences of continence care on patient experiences and discharge pathways. Interviews with PWD (12) and family carers (12-24) (total= 24-36) and observation of decision-making processes, (e.g. multidisciplinary meetings) to examine the implications for discharge planning.

Analysis will follow the analytic tradition of grounded theory and employ the constant comparative method and theoretical sampling whereby data collection and analysis are interrelated and occur concurrently. Analysis of observational data will be triangulated with patient, carer, and staff interviews.

Intervention type

Other

Phase

Drug names

Primary outcome measure

1. A systematic narrative review to identify strategies to inform the organization and culture of continence care that could inform innovations in continence care for people living with dementia in the acute hospital setting
2. Ethnographic observation will focus on the visible work of nurses and healthcare assistants involved in continence care to explore how staff respond to continence needs for people living with dementia
3. Short ethnographic interviews with ward staff will allow us to question routine practice and decision making when interacting with people living with dementia
4. Case studies with people living with dementia and family carer to examine the impacts and consequences of continence care on patient experiences and discharge pathways

Secondary outcome measures

None

Overall trial start date

01/11/2017

Overall trial end date

30/04/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Diagnosis of dementia present in medical records

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

120 ward staff, 12 PWD, 12 carers and family members

Total final enrolment

108

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/10/2018

Recruitment end date

31/10/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Aneurin Bevan University Health Board
Llanfrechfa Grange Hospital Llanfrechfa
Cwmbran
NP44 8YN
United Kingdom

Sponsor information

Organisation

Cardiff University

Sponsor details

Research and Innovation Services
Cardiff University
30-36 Newport Road
Cardiff
CF24 0DE
United Kingdom
+44(0)29 2087 9131
resgov@cardiff.ac.uk

Sponsor type

University/education

Website

https://www.cardiff.ac.uk

Funders

Funder type

Government

Funder name

Health Services and Delivery Research Programme

Alternative name(s)

Health Services and Delivery Research (HS&DR) Programme, NIHR Health Services and Delivery Research (HS&DR) Programme, NIHR Health Services and Delivery Research Programme, HS&DR Programme, HS&DR

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Outputs will focus on service organisation and training. Development will be in close collaboration with our Carers Steering Group and participating NHS acute hospitals to establish relevance and feasibility within acute wards, and their utility and transferability to acute hospitals with different organisational contexts:
- Ward based structured tools (evidence-based care bundles, identification and assessment tools) on how to organize and deliver appropriate continence care for PWD.
- Update existing ward-based recommendations for models of care and the organisation of nursing and HCAs work to ensure they support the quality and humanity of continence care (e.g. integrating continence care within existing risk assessment (falls), rehabilitation strategies and discharge planning).
- Identification of factors in organisation and ward culture (practices, routines and interactional styles) that can improve or worsen the experiences and outcomes of PWD who have continence needs. This may include approaches to facilitate the integration of key elements within handovers, observation rounds.
- Training to support continence care for people living with dementia targeted at acute staff (nurses, HCAs, AHPs), carers and families will include organisational and interactional techniques that facilitate the quality and humanity of continence care:
- Short accessible factsheets targeting acute care staff (nurses, HCAs, AHPs), carers and families, available to download via online forums.
- Masterclasses (via video and factsheets) for hospital staff on continence care, decision- making and care of people living with dementia.
- Develop and deliver nationwide online training for nurses.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are not expected to be made available. For reasons of participant anonymity, the full dataset for this study will be stored privately and securely by Cardiff University and destroyed after 15 years in line with Cardiff University’s data management rules. Anonymised sections of data will be published where appropriate, for example in academic journals.

Intention to publish date

30/04/2021

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

18/11/2019: The following changes were made to the trial record: 1. Total final enrolment number added. 2. Intention to publish date changed from 01/05/2020 to 30/04/2021. 22/10/2019: The recruitment end date was changed from 30/09/2019 to 31/10/2019. 06/08/2019: Trial’s existence confirmed by National Institute for Health Research (NIHR)