Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04281550 |
| Other study ID # |
Think Drink |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 1, 2017 |
| Est. completion date |
March 31, 2019 |
Study information
| Verified date |
March 2020 |
| Source |
Northumbria University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The study aimed to provide evidence of the feasibility of implementing a multi-component
intervention for optimising hydration in people with dementia living in care homes.
To undertake a multi method feasibility study to investigate the suitability of methods and
outcome measures for future research.
Objectives:
1. Explore personal barriers experienced by people with dementia regarding drinking in care
home contexts
2. Explore professional and organisational perspectives of approaches to optimal hydration
of residents with dementia and the barriers in everyday practice
3. Develop a multi-component intervention to enhance hydration for residents in
collaboration with care home staff, mental health and geriatric specialists, and
residents' family
4. Assess the feasibility of implementing the intervention in care homes, and impact on
recommended daily intake of fluids
5. Explore the impact of the intervention on daily fluid intake, and designing suitable
secondary outcome measures - admission to hospital due to dehydration, falls, laxative
use, urinary tract infection, upper respiratory tract infection and skin breakdown.
Description:
Previous literature has shown that maintaining adequate hydration levels for residents with
dementia can be challenging. This is due to difficulties with swallowing, remembering to get
drinks or refusal to drink. Dehydration in people with dementia is a major problem and
significant cause of admission to hospital (Bourdel-Marchasson, 2004; Hodgkinson, Evans and
Woods, 2003). Despite this, there is limited research into hydration interventions for this
population, despite preliminary evidence suggesting the potential benefits of using
multi-component interventions (Bunn et al. 2015).
The primary aim of this feasibility study was to establish the feasibility and acceptability
of conducting a definitive RCT to evaluate the effectiveness of a multi-component hydration
intervention for people living with dementia in nursing care homes compared to usual care.
Secondary aims were to establish:
- Whether the Think Drink intervention can be delivered as planned within nursing care
homes for people living with dementia
- If the intervention is acceptable to care home staff
- If it is feasible to recruit and randomise care home sites and participants
- Barriers to the delivery of the Think Drink guide intervention.
- If the outcome measures are feasible to use within a care home setting
- If reliable data can be collected
- A sample size calculation for an RCT. This study was a three-phase multi-method design
consisting of analysis of the empirical grounds for the hydration intervention,
development of a multi-component hydration intervention and a feasibility cluster trial
of the intervention. The first phase constituted of a survey of care homes, a systematic
review-informed review of previous literature and collection of professional
perspectives. Second phase was the development the intervention through five workshop
events. Finally, the feasibility phase compared 6 intervention homes and 5 control homes
in North East England, over a 3-month period.
The literature review revealed three articles of limited quality and indicates that there has
been limited multi-component interventions promoting hydration care following Bunn et al.
(2015)'s original systematic review. Evidence available suggests the importance of combining
functional and awareness-raising approaches within multi-component interventions.
Professional perspectives also reinforced these findings. This was reflected in the
development of the Think Drink Guide that had three interacting components. The 'policy'
component was directed at the governance of the care home, whereas 'practice' components were
directed at hydration procedures and processes, and 'educational' components that provided
learning resources for care home staff to develop knowledge and understanding of hydration
care. Think Drink was implemented through a short awareness-raising educational programme and
accompanying information booklet detailing a range of practices (including organisational,
system and individual practice) designed to encourage hydration.
Key Findings A total of 87 residents were included in the study, 37 as part of the control
group and 50 in the intervention group. Overall, 45 care home staff from varied roles
participated in interviews to determine the acceptance, barriers and facilitators of the
Think Drink Intervention. No significant changes were found in terms of the primary outcome
for residents (overall hydration consumption over a seven-day period) following the
intervention. However, significant methodological concerns were noted over the use of care
home-recorded data, particularly as accurate recording was a key focus of the education
component and therefore not influenced in the control homes. It was noted from baseline that
resident fluid intakes are inconsistently recorded in terms of detail (e.g. 200mls for a cup
of tea offered, with no accurate recording of what was actually drunk). The change to more
accurate recording in the intervention homes may have influenced the findings.
Qualitative data found that the training was well-received and valued by staff and care
homes, particular in its influence of encouraging more frequent availability of drinks and
greater variety of drinks offered. However, organisation and policy changes (such as the
development of a specific hydration care plan) were not found. A further methodological
concern was the lack of use of the Think Drink booklet, with staff suggesting they would
prefer more accessible prompts, such as posters.
An a priori power calculation was carried out for a future trial in this area and, including
attrition, it is estimated that 240 total participants would be required in a trial.
Key practice and policy recommendations
- Hydration care requires development for residents with dementia across the care home
sector. Although some aspects of this are being achieved within care homes and their
respective companies, the findings from this study indicated that several improvements
were achieved following implementation of the Think Drink intervention. It is
recommended that practice and service developments to hydration care continue to be
promoted.
- Analysis of existing care planning processes indicates that hydration is not given a
high enough priority, and where attention is given it often focuses on functional
aspects of hydration care. More detailed information on cognitive issues or personal
strategies for supporting hydration in individual residents could provide benefits in
the future, particularly considering high levels of staff turnover in this area and a
potential need for healthcare partners to access quick and accurate information about
residents.
- An important feature of the Think Drink guide was capturing hydration practices that are
implemented in care homes in 5 domains - assessment of hydration norms and problems;
hydration support and encouragement; drinking activities; drinking conducive
environment; drinking equipment. The researchers recommend that further consideration is
given to building on this range of hydration practices, and these aspects of hydration
care should be incorporated into care home policy and care home commissioning processes.
- Prior to future research further development of the format and presentation of the Think
Drink practices domains, and related resources, such as posters, hydration apps or
screensavers that can be displayed throughout a care home, to enable care home staff to
raise their awareness of different approaches to hydration care and adopt these in their
practice is required.
- The implementation of Think Drink in care homes requires a flexible approach that is
tailored to the care home setting. Care home-wide approaches (such as ordering a wide
variety of drinks and beverages), ensuring all staff across all care home departments
are competent to provide hydration care education (through inclusion of hydration
education in induction programmes), and cascade models to promote excellence in
hydration practice within a care home, should all be considered.
- Hydration education was an important part of implementing Think Drink in care homes. The
researchers recommend that care home staff receive hydration education, both during
induction to working in a care home and through ongoing regular updates to contribute to
proficiency in hydration care of residents.
- Hydration education should also be available to commissioners so that they can contract
and carry out quality inspection visits with understanding of the hydration requirements
of residents and the challenges that care home staff experience in supporting residents
to drink sufficient fluid.
- The importance of accurate fluid recording should be included in hydration education for
care home staff. Improvement in this aspect of practice will support care planning,
implementation of effective interventions for those identified as having inadequate
fluid intake, and communication with healthcare professionals when residents are
referred to primary care and out of hours services due to deteriorating health.
Research recommendations
- This was a feasibility study with the purpose of exploring issues of recruitment,
testing the intervention and appraising outcome measurement tools. A recommendation for
future research would be to increase the implementation period of Think Drink to 6
months to see if the shortâterm changes in hydration practice is maintained over time.
This may require a larger scale study, however, due to high levels of participant
attrition that is expected.
- The findings highlight that there is poor documentation of hydration care planning and
resident fluid intake. Some participating care homes developed novel approaches to
improve the accuracy of fluid intake. The researchers would recommend further research
to assess the feasibility of implementing these practices in other care home settings.
- There was difficulty in recruiting care homes to the feasibility study that involved
implementation of Think Drink and data collection over a 3-month period. In future
research the timeframe for recruiting homes should account for lengthy recruitment
processes.
- The results demonstrate that there is a high level of attrition of care home residents
and this should be considered when planning future research and in calculation of sample
sizes.
- Robustness of the data collected and outcome measures is a key consideration in the
testing of any intervention. This feasibility study highlighted inaccuracies in the
measurement of fluid intake and in any future study it is recommended that this is taken
into consideration in future research and that this is undertaken by research staff. If
research staff are present in care homes that provide services for people with dementia
this could be disruptive and distressing for residents, hence the research methodology
adopted in future research should enable researchers to participate in care whilst
undertaking data collection. This will impact significantly on the funding required to
undertake this type of research.
