18 20
in g
Developing an Intervention for Fall Related Injuries in Dementia
Sp r
The DIFRID study
BG
S
Dr Louise Allan
Clinical Senior Lecturer, Newcastle University
20
18
Why do we need a new intervention for people with dementia who fall?
BG
S
Sp r
in g
• Between 47% and 90% of PWD will have at least one fall in a twelve month period • PWD living in their own homes are around 10 times more likely to fall than other older people • They are less likely to recover well, more likely to be hospitalised, are hospitalised for longer and are more likely to require increased care • Some existing services exclude PWD • Past interventions aimed at PWD who fall have not worked very well
18
A feasibility study
20
Patient group:
Adults with dementia living in their own homes who have suffered a fallrelated injury
in g
Setting:
Community and hospital setting as appropriate
Control or comparator treatment: Intervention:
Sp r
Usual care: current UK practice
S
Develop and validate a complex intervention designed to improve outcomes following fall-related injury Use the updated framework developed by the MRC Consider the role of carers carefully
BG
Important outcomes:
Researchers should develop /define outcomes appropriate for the design of a future trial
18
in g
Work package 2: Understanding current practice• What ideas are there for an improved intervention? • How common is the problem? • What is usual care?
Sp r
Work package 1: Literature reviews • Systematic review • Realist synthesis
20
Overview of DIFRID
S
Work package 3: Development and validation of intervention
BG
Work package 4: Rehearsal of intervention with process evaluation
18 20
Sp r
in g
Developing an Intervention for Fall Related Injuries in Dementia
BG
S
Work Package 1
20
18
Systematic review
in g
• 7 studies were included.
Sp r
• 6 RCTs (Huusko et al., 2000; Kennie et al., 1988; Prieto-Alhambra et al., 2014; Shaw et al., 2003; Stenvall et al., 2012; Watne et al., 2014).
S
• 1 quasi-experimental design (McGilton et al., 2013).
BG
• 6/7 studies were of hip fracture • A majority of the interventions took place in a hospital setting
20
18
Systematic review
BG
S
Sp r
in g
• Multi-disciplinary care and early mobilisation showed short-term improvements for some outcomes. • Only an annual administration of zoledronic acid showed long-term reduction in recurrent fractures. • Due to high heterogeneity across the studies, definitive conclusions could not be reached. • Most post-fall interventions aimed at patients with dementia have shown little efficacy. • There is very little evidence in non-hip fracture injury
20
18
What is a realist synthesis - evidence Systematic review
Sp r
Realist review
Your ideas!
Findings from related fields
BG
S
All study types
in g
• Published RCTs • Meeting quality criteria • Focusing on a specific topic
Grey literature
Stakeholder views
18
20
What is a realist synthesis – questions?
Sp r
in g
x Does it work? x What works on average? What works for whom, under what circumstances and why?
BG
S
Context – mechanism – outcome configurations (programme theory)
18 20
Realist synthesis
in g
• We used data from interviews with professionals (WP2.1) to develop our initial CMOc framework
Sp r
• A comprehensive search of all literature describing interventions to improve outcomes for people with dementia who have sustained a fallrelated injury was conducted
BG
S
• Data was extracted and CMOcs refined • A second search plus additional targeted searching was carried out to address gaps and further refine CMOcs
Sp r
148 records excluded
BG
S
101 articles included for analysis
2908 records excluded
in g
3157 de-duplicated records screened on title and abstract
249 full-text articles screened for eligibility
159 documents used in CMOc development
18
26 records identified through additional purposive searching
807 records identified through database search 2
20
3060 records identified through database search 1
58 interviews and focus groups with professional stakeholders
18 20
Sp r
in g
Developing an Intervention for Fall Related Injuries in Dementia
BG
S
Work Package 2
20
18
The sites • Newcastle upon Tyne (Aug 16-Feb 17) • North Tees (Sept 16- Mar 17)
in g
• Teaching hospital, city based, high dementia diagnosis rate (QOF approx 2117)
Sp r
• District general hospital, urban and rural, very high diagnosis rate (QOF 2724)
• Norwich (Nov 16- May 17)
BG
S
• Teaching hospital, largely rural, low diagnosis rate (QOF 1566)
20
18
Qualitative data
• Integrative analysis
Sp r
in g
• Interviews & focus groups with professionals • Observation of current practice • Interviews with patients & carers
• Coding frames developed for each dataset
S
• Themes mapped across datasets
BG
• New integrated coding frame produced • Highlights similarities and differences across the datasets
20
18
Interview participants
Focus groups
Professionals
53
28
Patients
7
Carers
6
-
Total
66
28
BG
S
Sp r
in g
Interviews
-
Location Home
20
Phase
18
Observation
Elsewhere
Paramedics Non-medical emergency service Telecare
Post-acute
Facilitated discharge team & reablement Domiciliary occupational therapist
Paramedics ED Assessment suite
Longer term
BG
S
Sp r
in g
Acute
Facilitated discharge team In-patient wards Specialist in-patient rehabilitation unit Day hospital Exercise classes Outpatient falls clinic
18
in g
The CMOcs cover three broad areas:
20
CMOc themes identified
Sp r
• Ensure that the circumstances of rehabilitation are optimised for people with dementia (CMOc 3, 4, 8, 9)
BG
S
• Compensate for the reduced ability of people with dementia to selfmanage (CMOc 2, 5, 6) • Equip the workforce with the necessary skills and information to care for this patient group (CMOc 1, 7, 9)
CMOc1: Developing a detailed understanding of the patient
20
18
CMOcs
Context: cognitive impairment may limit the ability of people with dementia to pass on information Mechanism (resource): staff use multiple sources of information including carers and direct observation
in g
Mechanism (reasoning): staff gain a better understanding of the individual Outcome: staff are able to provide appropriate, tailored care
Sp r
CMOc2: Embedding interventions in day to day life
Context: cognitive impairment may limit the ability of people with dementia to comply with instructions and form habits Mechanism (resource): staff tailor the intervention (e.g. exercises) to the circumstances of people with dementia and embed it in their existing routines Mechanism (reasoning): intervention becomes routine and habitual
BG
CMOc3: Managing pain
S
Outcome: more successful rehabilitation can be achieved
Context: cognitive impairment may limit the ability of people with dementia to articulate pain Mechanism (resource): staff use non-verbal pain signifiers and/or give blanket pain relief Mechanism (reasoning): people with dementia are not in pain
Outcome: capacity to engage with an intervention increases
20
18
CMOcs CMOc4: Ensuring a supportive environment
Context: cognitive impairment may limit the ability of people with dementia to adapt to and cope with new environments Mechanism (resource): intervention assessment and delivery takes place in appropriate, accessible and familiar environments
in g
Mechanism (reasoning): people with dementia feel comfortable and less distracted
CMOc5: Providing ongoing support
Sp r
Outcome: anxiety and challenging behaviours are reduced
Context: cognitive impairment may limit the ability of people with dementia to self-manage changes in circumstances Mechanism (resource): ongoing follow-up is provided
Mechanism (reasoning): staff are able to reinforce previous interventions and adapt them to meet changing needs
S
Outcome: improvements in mobility are sustained and new falls risks reduced
BG
CMOc6: Involving carers in intervention delivery
Context: the burden on informal carers is high when caring for relatives or friends with dementia who are at risk of falling Mechanism (resource): carer support and education is provided Mechanism (reasoning): carer stress is reduced and skills increased Outcome: carers’ capacity to assist with the delivery of interventions increases
18
CMOcs
20
CMOc7: Equipping staff members with appropriate skills Context: current staff knowledge of, and attitudes to, dementia are variable Mechanism (resource): increased dementia training is provided
Mechanism (reasoning): staff gain skills in and understanding of rehabilitation for people with dementia
CMOc8: Recognising and treating comorbidities
in g
Outcome: staff ability and willingness to engage with people with dementia is enhanced
Sp r
Context: the role of comorbidities may be underestimated in dementia
Mechanism (resource): holistic biopsychosocial assessment is employed Mechanism (reasoning): staff understand the range of factors contributing to falls and are able to treat comorbidities more effectively
S
Outcome: falls risk may be reduced and recovery enhanced in patients with dementia CMOc9: Improving pathways and referral
BG
Context: care pathways are often unclear
Mechanism (resource): a centralised, collaborative pathway is developed and disseminated Mechanism (reasoning): staff are better equipped to refer to the most appropriate services Outcome: service users receive better treatment
20
18
Diary study
Sp r
in g
• Aim: to quantify in 3 UK sites, PWD presenting to health services with a fall related injury. • In each site numbers of cases and availability of diagnoses will be measured in 3 settings which might be suitable for identifying recipients of an intervention:
BG
S
• primary care consultations • paramedic attendances at homes of PWD • attendances at the emergency department (ED)
Number of fall related injuries
Newcastle
67
North Tees
57
Norwich
156
TOTAL (all sites)
280
Number per week
Number per QOF patient per 26 weeks
Number agreeing to take part in diary study
2.58
0.0316
4
2.19
0.0209
6
6.00
0.0996
3
BG
S
Sp r
in g
Site
20
18
Incidence log
10.8
13 (4.6% of all participants on incidence log)
Age
Gender
Injury
Dementia
MOCA
1
ED
91
F
Superficial injury of head
AD
18
2
Paramedic
93
M
Open wound of elbow
VAD
15
3
ED
80
M
Open wound of head
AD
14
4
ED
94
F
Open wound of head
AD
12
5
ED
86
F
Injury unspecified
VAD
11
6
ED
88
M
Superficial injury of elbow and forearm
AD
11
7
ED
87
F
Superficial injury of knee and lower leg
VAD
9
8
ED
90
F
Injury unspecified
VAD
21
9
ED
77
M
Superficial injury of head
VAD
14
10
ED
86
F
Fracture of ribs, haematoma R arm, bruising to head
AD
11
11
ED
81
M
Fracture of clavicle
AD
7
12
ED
89
M
Injury to ear
VAD
16
13
ED
87
F
Open wound of head
AD
18
12 ED, 1 paramedic
Mean: 87
7 F, 6M
7 AD, 6 VAD
Mean: 13.6
BG
S
Sp r
in g
20
Setting
18
The diary participants
18
Early treatment and referrals
Referrals
1
Steristrips to head wound
Declined referral to falls unit
2
Wound cleaned by district nurse
3
Head wound stitched
4
Staples to laceration. Seen by PT at the ED
5
None
6
X rays at ED
7
Treatment for UTI
8
Seen by PT at the ED
9
None
10
X rays and liver scan
11
X ray at ED
GP visit. No further referral
12
Ear injury glued
None
13
Head injury glued
None
20
Early treatment
Referred for CT and X rays at ED. ED link nurse to visit. Already receiving reenablement and PT
in g
Already has falls unit referral in progress District nurse to visit. Not for further intervention
BG
S
Sp r
None Referred to PT Referred to PT and community liaison services Referred to PT and social worker None Referred to rehabilitation unit
18
Diary data
20
Healthcare input
Falls
Diaries
0
3
None further
2
Fall 1- admitted 7 days. Fall 4 Referred to rehabilitation centre. Later transferred to hospital AF, pneumonia for 16 days. Discharged and died 1 week later.
4
3
3
Respite care 2 days. 2 GP visits. 1 FASS visit. CICSH- referred for pacemaker and donepezil withheld until PPM
0
1
4
No diaries yet
5
No diaries
6
1 Physiotherapy visit
7
No diaries
8
1 GP visit. 1 nurse phone call. Carer took multiple urine samples to GP
1
1
9
Saw GP x2 and nurse x2. 3 OT visits. 1 visit by PD specialist nurse.
5
3
10
No diaries
11
None further
12 13
BG
S
Sp r
in g
1
0 0 1
3 0
0 0
1
5 GP visits, 5 nurse phone calls, 1 hospital visit for X ray (infection)
0
2
I visit by memory clinic nurse. I visit to primary care nurse.
0
1
18 20 in g
Sp r
Developing an Intervention for Fall Related Injuries in Dementia
BG
S
Work Package 3
18
Observational study
Views & experiences of existing services
Understanding current practice
Sp r
in g
20
Qualitative studies
BG
The existing evidence base
Intervention development
S
Literature reviews
Expert consensus panel
DIFRID Intervention
18 20 in g
Sp r
Developing an Intervention for Fall Related Injuries in Dementia
BG
S
Work Package 4
20
18
Sites and Settings • 3 UK sites • each including 7 settings:
S
Sp r
primary care consultations and letters to patients on QOF register paramedic attendances Emergency department (ED) attendances community services supported discharge teams telecare services. Research registers
BG
• • • • • • •
in g
• Newcastle, Stockton, Norwich
20
18
Population • 10 per site • 5 per site in qualitative study
• Carers of those PWD
in g
• PWD presenting with falls with or without an injury
Sp r
• 5 per site in the qualitative study
• Professionals delivering the intervention
S
• up to 6 • up to 9
BG
• Professionals in related services
20
18
Inclusion criteria
BG
S
Sp r
in g
• known diagnosis of dementia, made prior to entry into the study, by a specialist in dementia care (Geriatrician, Neurologist or Old Age Psychiatrist). • Diagnosis must be confirmed within 2 weeks by the patient’s GP who will be asked to confirm that the potential participant is on the practice’s QOF register of people with dementia • must have sustained at least one fall with or without injury within one month prior to their identification as a potential study participant. • must be dwelling in the community at the time of the index fall and returning to the community at the time of the intervention. • must have a family member or other carer available to assist with completion of the diaries. • Able to communicate in English • Either has capacity to consent to participation or has personal consultee who is able to give proxy consent
20
18
Exclusion criteria
Sp r
in g
• diagnosis of dementia cannot be confirmed by consultation with the GP or via the secondary care notes within 2 weeks of their being identified as a potential participant.
S
• participant found to be dwelling in residential or nursing care, or to have been hospital inpatient at the time of the index fall.
BG
• participant refuses consent or lacks capacity and does not have personal consultee.
20
18
Intervention
BG
S
Sp r
in g
• Multidisciplinary intervention primarily delivered in the participant’s home. • Tailored to the abilities of the participant, their likes and dislikes for activities • To achieve goals agreed between the therapists and the participant and their carer. • Delivered over a total period of 12 weeks.
20
18
Clinical Assessment
BG
S
Sp r
in g
• 2 assessment visits described in a manual for professionals • Structured and holistic • Considering the perspective of the patient, carer and other professionals involved with the patient • Assessment of likes and dislikes, routines and activity preferences • Discussion of potential goals • Physiotherapist and Occupational therapist examinations • Timed Up and Go test • Lying and standing BP?
20
18
Therapy visits
BG
S
Sp r
in g
• Tailored to the abilities of the participant, their likes and dislikes for activities • Include strength and balance exercises, dual tasking and functional activities, embedded if preferred • Targeted at goals agreed between the therapist and the participant and their carer. • The number of sessions will be tailored to the needs of the participant, up to a maximum of 24 sessions. • Up to 22 therapy sessions will be delivered over a total period of 12 weeks. • The therapy procedures will be described in a manual for professionals.
20
18
Primary outcomes
Sp r
• Number of fallers/ non-fallers • Fall rate per person year
in g
• Intervention study:
BG
S
• Qualitative study: Qualitative analysis of interview transcripts
20
18
Secondary outcomes
BG
S
Sp r
in g
• Health related Quality of life: Quality of life in Alzheimer’s disease (QOL AD), European Quality of Life Instrument (EQ5D-5L) • Activities of daily living: Disability assessment in dementia (DAD) • Psychological consequences of falling: Modified Falls Efficacy Scale • Carer burden: Zarit Burden interview • Physical Activity: wearable physical activity monitor • Goal setting: Goal Attainment scaling • Strength and balance: Timed Up and Go test
20
18
Secondary outcomes
• Assessment of feasibility of Intervention study
BG
S
Sp r
in g
• Did recruitment adhere to target at each site? • What factors influenced eligibility and what proportion of those approached were eligible? • Did participants consent? • Did professionals adhere to the study manual? • Did participants adhere to the intervention? • Was it possible to calculate intervention costs? • Were outcome assessments completed using the data collection tool?
20
in g
Co-investigators: • Claire Bamford • Chris Fox • Steve Parry • Robert Barber • Lynn Rochester • Jim Connolly • Louise Robinson
Sp r
BG
S
Research team: • Alison Wheatley • Miriam Boyles • Caroline Shaw • Fiona Beyer • Shannon Robalino • Elizabeth Flynn • Amy Smith • Beth Edgar
18
Acknowledgement
• Denise Howel • Tara Homer • Lynne Corner
20
18
Acknowledgement
BG
S
Sp r
in g
This study is supported by the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme (grant number HTA - 13/78/02). The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health.
