Occupational therapist home assessment and modification for prevention of falls

Plain English Summary

Background and study aims
Falls are common in older people and can cause serious health problems. Most falls happen when people are at home. Hazards in the home, such as slippery floors or poor lighting, are important causes. A review of the current research looked at the effect that home visits by an occupational therapist had on falls. This research involved people who had been treated in hospital for a fall. During the visit the occupational therapist would look at potential hazards that could lead to falls in the home and suggest changes to try to avoid them happening. This review of research found people who were visited by an occupational therapist had fewer falls. Some members of our research team did a small study and found that people in the community who had not been admitted to hospital because of a fall, also had fewer falls when visited by an occupational therapist. To be more confident of these results, we wish to conduct a larger study to find out if people in the community would have fewer falls if they have a home hazard assessment by an occupational therapist. We also want to find out if this would be good value for money for the NHS.

Who can participate?
Community dwelling men and women aged 65 years and over who are at an increased risk of falling (i.e., who have either had at least one fall in the past 12 months or tell us that they worry about falling in their day-to-day lives) will be eligible to participate. Participants who are unable to walk 10 feet (with or without a walking aid), are unable to give informed consent (e.g. due to Alzheimer’s disease or dementia), live in a residential or nursing home, are unable to read or speak English and have no friend or relative who is able to translate/interpret for them, have had an OT assessment for falls prevention in the past previous 12 months, and/or are on a waiting list for an occupational therapy assessment or who have not completed one falls calendar in the three months prior to randomisation will be excluded.

What does the study involve?
Participants are randomly allocated to one of two groups. One group receives usual care from their GP or other healthcare professional and a falls prevention leaflet. In addition to usual care and a falls prevention leaflet, the other group receives a home environmental assessment by an occupational therapist to assess their home for dangers and make recommendations for changes. Four weeks after the home visit the therapist, or a member of the research team, rings the participant to find out if the recommendations made have been followed. Participants are asked, by filling in monthly falls calendars and postal questionnaires, if they’ve had a fall and if so how many, about their quality of life and how often they use NHS services. Within the main trial, four sub-studies are embedded to investigate whether i) the inclusion of a pen in recruitment packs increases the likelihood of participants taking part in the trial; ii) receiving an invitation letter with a hand-written name increases the likelihood of participants taking part in the trial relative to a letter with a printed name; and iii) receiving a personalised text message around the same time as the 4-month questionnaire increases response rates relative to receiving a non-personalised text message at the same time and iv) whether including a pen, a cover letter with social incentive text (i.e. inclusion of text and a table summarising previous
questionnaires returned), both interventions or neither intervention with the 12 month questionnaire, on 12 month postal questionnaire affects response rates of participants to the OTIS study.

What are the possible benefits and risks of participating?
We cannot promise that taking part in the study will help participants personally. However, it may help us find out how to reduce the number of falls older people have. We are not aware of any known risks to participants as the aim of the intervention being tested is to reduce falls.

Where is the study run from?
University of York, Department of Health Sciences, York Trials Unit (UK)

When is the study starting and how long is it expected to run for?
July 2016 to December 2019

Who is funding the study?
National Institute for Health Research - Health Technology Assessment Programme (UK)

Who is the main contact?
Sarah Cockayne
sarah.cockayne@york.ac.uk

Study website

https://www.york.ac.uk/healthsciences/research/trials/research/trials/otis/#tab-3

Type

Scientific

Contact name

Mrs Sarah Cockayne

ORCID ID

http://orcid.org/0000-0002-1288-5497

Contact details

University of York
Department Health Sciences
York Trials Unit
ARRC Building Lower Ground Floor
Heslington
York
YO10 5DD
United Kingdom
+44 (0)1904 321736
sarah.cockayne@york.ac.uk

EudraCT/CTIS number

IRAS number

ClinicalTrials.gov number

Protocol/serial number

HTA 14/49/149; 1.0

Scientific title

Does occupational therapist led home environmental assessment and modification reduce falls among high-risk older people?

Acronym

OTIS

Study hypothesis

Current hypothesis as of 14/02/2018:
Main OTIS trial hypothesis: The null hypothesis is that there is no difference in the number of falls people over the age of 65 years who are of high risk of falling, have in the 12 months post randomisation between the two trial groups. The intervention group will receive an occupational therapist led home environmental assessment and modification, and a falls prevention leaflet as well as usual care from their GP and/or other healthcare professionals. The control group will receive the falls prevention leaflet and usual care from their GP and/or other healthcare professionals.

Pen sub-study hypothesis: The null hypothesis is that there is no difference in the proportion of participants allocated to receive a pen with their trial invitation pack who go on to be randomised to the main OTIS trial, than in the group who do not receive a pen.

Invitation letter sub-study hypothesis: The null hypothesis is that there is no difference in the proportion of participants who are randomised for the OTIS study between those who receive an invitation letter with their name handwritten on compared with a printed name.

Text sub-study hypothesis: The null hypothesis is that there is no difference in the proportion of participants returning their 4-month questionnaire between the group that receive a personalised text message when their questionnaire is due and those that receive a non-personalised text message.

Added 12/06/2020: Social incentive cover letter and/or pen sub-study hypothesis: The null hypothesis is that there is no difference in postal response rates between participants in the main OTIS trial who received either a pen alone, a pen and cover letter containing social incentive text, no pen and a standard cover letter or a social incentive cover letter alone.

Previous hypothesis:
Main OTIS trial hypothesis: The null hypothesis is that there is no difference in the number of falls people over the age of 65 years who are of high risk of falling, have in the 12 months post randomisation between the two trial groups. The intervention group will receive an occupational therapist led home environmental assessment and modification, and a falls prevention leaflet. The control group will receive the falls prevention leaflet and usual care from their GP and/or other healthcare professionals.

Pen sub-study hypothesis: The null hypothesis is that there is no difference in the proportion of participants allocated to receive a pen with their trial invitation pack who go on to be randomised to the main OTIS trial, than in the group who do not receive a pen.

Text sub-study hypothesis: The null hypothesis is that there is no difference in the proportion of participants returning their 4-month questionnaire between the group that receive a personalised text message when their questionnaire is due and those that receive a standard text message.

Ethics approval(s)

1. West of Scotland REC 3 committee, 08/08/2016, ref: 16/WS/0154
2. University of York, Department of Health Sciences Research Governance Committee, 20/05/2016
Added 14/02/2018: 3. West of Scotland REC 3 committee approved the invitation letter sub-study on 20/03/2017

Study design

Current study design as of 12/06/2020:
Multicentre open modified cohort randomised controlled trial with an embedded qualitative study, economic evaluation and four studies within a trial (SWATs).

Previous study design as of 14/02/2018:
Multicentre open modified cohort randomised controlled trial with an embedded qualitative study, economic evaluation and three studies within a trial (SWATs)

Previous study design:
Multicentre open randomised controlled trial with an embedded qualitative study, economic evaluation and two studies within a trial (SWATs)

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Study setting(s)

Community

Study type

Prevention

Patient information sheet

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

Condition

Falls prevention

Intervention

Current interventions as of 14/02/2018:
Main OTIS trial: Participants will be randomly allocated 2:1 in favour of the control group to receive either:

1. Usual care from their GP or other healthcare professional and a falls prevention leaflet; or

2. One home environmental assessment and modification to identify personal fall related hazards by an occupational therapist, in addition to usual care and a falls prevention leaflet.

Up to 12 participants from a particular site will be randomised at a time in a single block according to when sites state they have capacity to undertake intervention appointments and for how many participants. The allocation ratio used may go up to 3:1 in a block if the OTs have reduced capacity to carry out the assessments.

Pen sub-study: Participants will be randomised in a 2:1 ratio in favour of the control group to receive no pen or to receive a pen with their trial invitation pack.

Invitation letter sub-study: Participants due to be sent an invitation pack in the first mail out from the Yorkshire Health Study will be randomised 1:1 to receive either an invitation letter with their name handwritten on or an invitation letter with their name printed.

Text sub-study: Trial participants will be randomised 1:1 to receive either a personalised text message or a non-personalised text message from the York Trials Unit at the time their four month follow-up questionnaire is due to be received.

Added 12/06/2020: Social incentive sub-study: Participants will be randomised in a 1:1:1:1 ratio to receive either a pen alone, a pen and cover letter containing social incentive text, no pen and a standard cover letter or a social incentive cover letter alone.


Previous interventions:
Main OTIS trial: Participants will be randomly allocated 2:1 in favour of the control group to either:
1. Usual care from their GP or other healthcare professional and a falls prevention leaflet
2. In addition to usual care and a falls prevention leaflet, the intervention group will receive one home environmental assessment and modification to identify personal fall related hazards by an occupational therapist.

Pen sub-study: Participants will be randomised in a 2:1 ratio in favour of the control group to receive either no pen or to receive a pen with their trial invitation pack.

Text sub-study: Trial participants will be randomised in a 1:1 ratio to receive either a personalised text or a standard text from the York Trials Unit at the time their four month follow-up questionnaire is due to be received.

Intervention type

Other

Primary outcome measure

Current primary outcome measures as of 14/02/2018:
Main OTIS trial: Number of falls experienced in the 12 months following randomisation, where a fall is defined as “an unexpected event in which the participant comes to rest on the ground, floor, or lower level”, as collected prospectively via participant-reported monthly falls calendars.

Pen sub-study: The proportion of participants who go on to be randomised into the main OTIS trial.

Invitation letter sub-study: The proportion of participants who go on to be randomised to the main OTIS trial.

Text sub-study: The proportion of four-month questionnaires returned to the York Trials Unit.

Added 12/06/2020: Social incentive cover letter and/or pen sub-study hypothesis: The primary outcome was response rate, defined as the proportion of participants in each group who returned the 12-month questionnaire.


Previous primary outcome measures:
Main OTIS trial: Number of falls experienced in the 12 months following randomisation, where a fall is defined as “an unexpected event in which the participant comes to rest on the ground, floor, or lower level”, as collected prospectively via participant-reported monthly falls calendars.

Pen sub-study: The proportion of participants sent a trial invitation pack who go on to be randomised into the main OTIS trial.

Text sub-study: The proportion of four-month questionnaires returned to the York Trials Unit.

Secondary outcome measures

Current secondary outcome measures as of 14/02/2018:
Main OTIS trial:
1. Health-related Quality of Life as measured by the EQ5D-5L at 4, 8 and 12 months
2. Proportion of participants reporting at least one fall in the 12 months from randomisation
3. Proportion of participants reporting multiple (2 or more) falls in the 12 months from randomisation
4. Time to first fall from date of randomisation, with censoring at date of withdrawal, death or end of 12 month follow-up
5. Fear of falling at 4, 8 and 12 months
6. Fall-related injuries and costs over the 12 months post randomisation
7. Patient self-reported fractures over the 12 months post randomisation

Pen sub-study:
1. The proportion of participants who return a screening form
2. Time to return screening form
3. The proportion of participants who fulfil the eligibility criteria apart from the criterion relating to falls within the past 12 months or fear of falling
4. The proportion of participants eligible for randomisation
5. The proportion of participants who remain in the trial for 3 months post randomisation.

Invitation letter sub-study:
1. The proportion of participants who return a screening form
2. Time to return screening form
3. The proportion of participants who fulfil the eligibility criteria apart from the criterion relating to falls within past 12 months or fear of falling
4. The proportion of participants who are eligible for randomisation
5. The proportion of participants who remain in the trial for 3 months post randomisation.

Text message sub-study:
1. Time to response i.e. number of days between the questionnaire being mailed out to the participant and the questionnaire recorded as being returned to York Trials Unit
2. The proportion of participants requiring a reminder
3. Completeness of questionnaires
4. Cost effectiveness of the text message intervention

Added 12/06/2020: Social incentive cover letter and/or pen sub-study:
1. Time to return 12-month questionnaire
2. The completeness of the 12-month questionnaire
3. The requirement for a reminder letter to be sent
4. Cost effectiveness


Previous secondary outcome measures:
Main OTIS trial:
1. Health-related Quality of Life as measured by the EQ5D-5L at 4, 8 and 12 months
2. Proportion of participants reporting at least one fall in the 12 months from randomisation
3. Proportion of participants reporting multiple (2 or more) falls in the 12 months from randomisation
4. Time to first fall from date of randomisation, with censoring at date of withdrawal, death or end of 12 month follow-up
5. Fear of falling at 4, 8 and 12 months
6. Fall-related injuries and costs over the 12 months post randomisation
7. Patient self-reported fractures over the 12 months post randomisation

Pen sub-study:
1. Proportion of patients retained in the trial at 3 months post randomisation defined as returning at least the first 3 months’ worth of falls calendars from the date of randomisation
2. Number of ineligible participants

Text sub-study:
1. Time to response i.e. number of days between the questionnaire being mailed out to the participant and the questionnaire recorded as being returned to York Trials Unit
2. The proportion of participants requiring a reminder
3. Completeness of questionnaires
4. Cost effectiveness of the text message intervention

Overall study start date

01/07/2016

Overall study end date

31/12/2019

Reason abandoned (if study stopped)

Participant inclusion criteria

Current participant inclusion criteria as of 14/02/2018:
Main OTIS study:
1. Aged 65 years and over
2. Willing to receive a home visit from an Occupational Therapist
3. Community dwelling
4. Have at least one risk factor for a fall in the next 12 months i.e., either one fall in the past 12 months or report a fear of falling on their screening questionnaire
If a respondent is initially assessed as being ineligible because they have not had a fall within the past 12 months and do not report a fear of falling, but otherwise fulfil the eligibility criteria and consent to being re-contacted, they will be rescreened at a later date and given the opportunity to take part in the study if they subsequently have a fall or report a fear of falling and therefore, meet the inclusion criteria.

OTIS qualitative study: Occupational Therapists delivering the OTIS intervention, clinical leads who run falls prevention services/care of older people services and services external to the trial will be eligible to be involved in the qualitative study.

Pen sub-study: Any patient identified in the GP mail out as eligible to receive an OTIS trial invitation pack will be entered into the pen sub-study.

Invitation letter sub-study: Participants who are due to be mailed out an invitation pack about the OTIS trial in the first mailout by the Yorkshire Health Study will be entered into the invitation latter sub-study.

Text sub-study: Participants who provide a mobile phone number and consent to be contacted by this method, and who are due to be sent their four month follow-up questionnaire, will be included in this sub-study.

Added 12/06/2020: Social incentive cover letter and/or pen sub-study: Any participant due to receive their 12-month questionnaire


Previous inclusion criteria:
Main OTIS study:
1. Aged 65 years and over
2. Willing to receive a home visit from an Occupational Therapist
3. Community dwelling
4. Have at least one risk factor for a fall in the next 12 months i.e., either one fall in the past 12 months or report a fear of falling on their screening questionnaire or be a former REFORM trial participant

OTIS qualitative study: Occupational Therapists delivering the OTIS intervention, clinical leads who run falls prevention services/care of older people services and services external to the trial.

Pen sub-study: Any patient identified in the GP mail out as eligible to receive an OTIS trial invitation pack will be entered into the pen sub-study.

Text sub-study: Participants who provide a mobile phone number and consent to be contacted by this method, and who are due to be sent their four month follow-up questionnaire will be included in this sub-study.

Participant type(s)

Mixed

Age group

Senior

Lower age limit

65 Years

Sex

Both

Target number of participants

Main OTIS trial: 1299 (n=433 Intervention group; n=866 Usual Care group); OTIS qualitative study n=30; SWATs: Added 14/02/2018: targets for pen and text sub studies constrained by number of participants mailed out to via GP mail outs and those remaining in the trial at 4 months post randomisation; and those remaining in the trial at 12 months, respectively. 314 participants will be included in the invitation letter sub-study. Added 12/06/2020: 779 participants will be included in the social incentive cover letter and/or pen sub-study

Total final enrolment

1331

Participant exclusion criteria

Current exclusion criteria as of 14/02/2018:
Main OTIS trial:
1. Unable to walk 10 feet today, even with a walking aid if needed
2. Unable to give informed consent e.g., due to suffering from dementia or Alzheimer’s disease
3. Living in residential or nursing home
4. Unable to read or speak English and have no friend or relative who is able to translate/interpret for them
5. Had an OT assessment for falls prevention in the previous 12 months
6. Are on a waiting list for an occupation therapy assessment
7. Have not returned one completed falls calendar in the 3 months prior to randomisation

Pen sub-study: Participants in the REFORM, CASPER and Yorkshire Health Study cohorts and the SCOOP study will be excluded from the sub-study.

Text sub-study: Participants who withdraw from the OTIS main trial follow-up before their 4-month questionnaire is due will be excluded from this sub-study.

Invitation letter sub-study: Participants who have not agreed to be contacted about future studies.

Previous exclusion criteria:
Main OTIS trial:
1. Unable to walk 10 feet today, with a walking aid if needed
2. Unable to give informed consent e.g., due to suffering from dementia or Alzheimer’s disease
3. Living in residential or nursing home
4. Do not speak English
5. Had a home assessment in the previous 12 months as a result of falling
6. Are on a waiting list for an occupation therapy assessment
7. Have not completed one falls calendar in the 3 months prior to randomisation

Pen sub-study: Participants in the REFORM, CASPER and Yorkshire Health Study cohorts and the SCOOP study will be excluded from the sub-study.

Text sub-study: Participants who withdraw from the OTIS main trial follow-up before their 4-month questionnaire is due will be excluded from the mail out.

Recruitment start date

01/08/2016

Recruitment end date

02/08/2018

Countries of recruitment

England, United Kingdom

Study participating centre

Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield
S10 2JF
United Kingdom

Study participating centre

Harrogate Hospital
Harrogate
HG2 7SX
United Kingdom

Study participating centre

NHS Humber
Hull
HU10 6ED
United Kingdom

Study participating centre

East Sussex Healthcare NHS Trust
Seaford
BN25 1DH
United Kingdom

Study participating centre

East Coast Community Healthcare
Lowestoft
NR32 1DE
United Kingdom

Study participating centre

North Lincolnshire and Goole NHS Foundation Trust
Scunthorpe
DN15 7BH
United Kingdom

Study participating centre

Leeds Community Healthcare NHS Trust
Leeds
LS12 5SG
United Kingdom

Study participating centre

York Teaching Hospital NHS Foundation Trust
York
YO31 8HE
United Kingdom

Organisation

University of York (UK)

Sponsor details

Contracts and Sponsorship Manager
Research and Enterprise
University of York
Innovation Centre
York Science Park
York
YO10 5DG
England
United Kingdom
+44 (0)1904 435154
michael.barber@york.ac.uk

Sponsor type

University/education

Website

ROR

https://ror.org/04m01e293

Funder type

Government

Funder name

Health Technology Assessment Programme

Alternative name(s)

NIHR Health Technology Assessment Programme, HTA

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

United Kingdom

Publication and dissemination plan

The main trial results and study protocol will form the basis of academic papers in peer-reviewed journals.
The outcomes of the trial will be presented as a conference paper on completion of the trial.

Intention to publish date

14/01/2020

Individual participant data (IPD) sharing plan

IPD sharing plan summary

Available on request

Study outputs