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Headline
This trial found no evidence that an occupational therapist-delivered home assessment and modification reduced falls in community-dwelling people aged 65 years and over compared with usual care.
Abstract
Background:
Falls and fall-related fractures are highly prevalent among older people and are a major contributor to morbidity and costs to individuals and society. Only one small pilot trial has evaluated the effectiveness of a home hazard assessment and environmental modification in the UK. This trial reported a reduction in falls as a secondary outcome, and no economic evaluation was undertaken. Therefore, the results need to be confirmed and a cost-effectiveness analysis needs to be undertaken.
Objective:
To determine the clinical effectiveness and cost-effectiveness of a home hazard assessment and environmental modification delivered by occupational therapists for preventing falls among community-dwelling people aged ≥ 65 years who are at risk of falling, relative to usual care.
Design:
This was a pragmatic, multicentre, modified cohort randomised controlled trial with an economic evaluation and a qualitative study.
Setting:
Eight NHS trusts in primary and secondary care in England.
Participants:
In total, 1331 participants were randomised (intervention group, n = 430; usual-care group, n = 901) via a secure, remote service. Blinding was not possible.
Interventions:
All participants received a falls prevention leaflet and routine care from their general practitioner. The intervention group were additionally offered one home environmental assessment and modifications recommended or provided to identify and manage personal fall-related hazards, delivered by an occupational therapist.
Main outcome measures:
The primary outcome was the number of falls per participant during the 12 months from randomisation. The secondary outcomes were the proportion of fallers and multiple fallers, time to fall, fear of falling, fracture rate, health-related quality of life and cost-effectiveness.
Results:
The primary analysis included all 1331 randomised participants and indicated weak evidence of a difference in fall rate between the two groups, with an increase in the intervention group relative to usual care (adjusted incidence rate ratio 1.17, 95% confidence interval 0.99 to 1.38; p = 0.07). A similar proportion of participants in the intervention group (57.0%) and the usual-care group (56.2%) reported at least one fall over 12 months. There were no differences in any of the secondary outcomes. The base-case cost-effectiveness analysis from an NHS and Personal Social Services perspective found that, on average per participant, the intervention was associated with additional costs (£18.78, 95% confidence interval £16.33 to £21.24), but was less effective (mean quality-adjusted life-year loss –0.0042, 95% confidence interval –0.0041 to –0.0043). Sensitivity analyses demonstrated uncertainty in these findings. No serious, related adverse events were reported. The intervention was largely delivered as intended, but recommendations were followed to a varying degree.
Limitations:
Outcome data were self-reported by participants, which may have led to inaccuracies in the reported falls data.
Conclusions:
We found no evidence that an occupational therapist-delivered home assessment and modification reduced falls in this population of community-dwelling participants aged ≥ 65 years deemed at risk of falling. The intervention was more expensive and less effective than usual care, and therefore it does not provide a cost-effective alternative to usual care.
Future work:
An evaluation of falls prevention advice in a higher-risk population, perhaps those previously hospitalised for a fall, or given by other professional staff could be justified.
Trial registration:
Current Controlled Trials ISRCTN22202133.
Funding:
This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 46. See the NIHR Journals Library website for further project information.
Contents
- Plain English summary
- Scientific summary
- Chapter 1. Introduction
- Chapter 2. Methods
- Study design
- Public involvement
- Regulatory approvals and research governance
- Setting
- Participant recruitment
- Consenting participants
- Participant eligibility
- Sample size
- Randomisation
- Blinding
- Group allocation
- Participant follow-up
- Outcomes
- Participant withdrawal
- Trial completion and exit
- Data analysis
- Summary of changes to the protocol
- Chapter 3. Clinical effectiveness results
- Participant flow
- General practitioner mail-outs
- Yorkshire Health Study
- Existing trial cohorts
- Recruitment
- Randomisation
- Baseline data
- Number of falls calendars returned
- Participant questionnaire return rates
- Occupational therapist-delivered environmental assessment and modification visits
- Primary outcome
- Primary analysis
- Sensitivity analyses
- Subgroup analysis
- Secondary analyses
- Adverse events
- Chapter 4. Economic evaluation
- Chapter 5. Intervention fidelity
- Chapter 6. Discussion
- Acknowledgements
- References
- Appendix 1. Regulatory approvals
- Appendix 2. Recruitment methods
- Appendix 3. Unit costs of equipment items recommended/installed by occupational therapists at OTIS home visits
- Appendix 4. Unit costs of ‘other’ items recommended/installed
- Appendix 5. Number and proportion of participants with complete-case data by group
- Appendix 6. Additional missing data information
- Appendix 7. Completion and missingness of EQ-5D-5L questionnaires
- Appendix 8. Number of missing dimensions in invalid EQ-5D-5L questionnaires
- Appendix 9. Proportion reporting EQ-5D-5L levels 1 to 5 by dimension, group and time point
- Appendix 10. EQ-5D-5L visual analogue scale
- Appendix 11. Mean resource use for ‘other’ reason only (i.e. non-falls related), based on all available cases
- Appendix 12. Out-of-pocket expenditure
- Appendix 13. Cost-effectiveness acceptability curve and cost-effectiveness plane: secondary analysis of the societal perspective
- Appendix 14. Cost-effectiveness planes for sensitivity analyses 2–5
- Appendix 15. Cost-effectiveness acceptability curves for sensitivity analyses 2–5
- List of abbreviations
- List of supplementary material
About the Series
Declared competing interests of authors: Catherine E Hewitt declares membership of the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) Commissioning Sub-board (EOI) (2016–17). Sarah E Lamb was a member of Clinical Trial Units funded by NIHR and declares previous membership of the HTA Additional Capacity Funding Board (2012–15), the HTA End of Life Care and Add-on Studies Board (2015), the HTA Prioritisation Group Board and the HTA Trauma Board. Simon Gilbody declares that he was deputy chairperson of the NIHR HTA programme Commissioning Committee from 1 November 2016 to 30 October 2019. Joy Adamson is a member of HTA Commissioning Board (August 2017–present). David J Torgerson declares that he was a member of Clinical Trial Units funded by NIHR, a member of various HTA commissioning boards and a member of the NIHR Clinical Trial Units Standing Advisory Committee (2010–14). Avril Drummond declares that she is a member (June 2017–present) of the NIHR Academy, Clinical Lectureship and Senior Lectureship Panel and is now deputy chairperson (January 2020–present).
Article history
The research reported in this issue of the journal was funded by the HTA programme as project number 14/49/149. The contractual start date was in June 2016. The draft report began editorial review in January 2020 and was accepted for publication in July 2020. The authors have been wholly responsible for all data collection, analysis and interpretation, and for writing up their work. The HTA editors and publisher have tried to ensure the accuracy of the authors’ report and would like to thank the reviewers for their constructive comments on the draft document. However, they do not accept liability for damages or losses arising from material published in this report.
Last reviewed: January 2020; Accepted: July 2020.
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