Ignite Creation Date:
2024-05-06 @ 7:26 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06014554
Status:
RECRUITING
Last Update Posted:
2024-03-06
First Post:
2023-08-18
Brief Title:
Structured Tailored Rehabilitation After Hip Fragility Fracture
Sponsor:
Kings College London
Organization:
Kings College London
Study Overview
Official Title:
Structured Tailored Rehabilitation After Hip Fragility Fracture The STRATIFY Feasibility Randomised Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STRATIFY
Brief Summary:
Why the investigators are doing this study The best approach to rehabilitation after a broken hip is not known A new approach could improve outcomes by tailoring rehabilitation to patient needs This approach identifies subgroups of patients within a population who have different risks of poor outcomes These subgroups are then matched to treatments better tailored to their needs Survivors of a broken hip describe a tailored approach as key to recovery Further the NHS recommends this approach as central to healthcare progress
This study wants to see if it is possible for the NHS to deliver this new approach to rehabilitation for older adults who break their hip
What will be done The investigators worked with patients to plan this study Patients will keep helping the investigators during the study Sixty older people who had surgery to fix a broken hip will be invited to take part Participants will be given a level of risk low medium or high based on an online calculator wwwstratifyhipcouk
All 60 participants will get usual care provided locally Half selected by chance will get extra rehabilitation during their hospital stay including a self-managed exercise programme for the low-risk subgroup education a goal-orientated mobility programme and enhanced discharge planning for the medium-risk subgroup and education a goal-orientated activity of daily living programme orientation and enhanced assessment for the high-risk subgroup
The investigators will collect information from the 60 people taking part at the beginning middle and end of the study and again 12- weeks later
What will the next step be If this small study shows this extra rehabilitation can be provided in the NHS and it may help patients then the investigators plan to do a larger study The larger study will see if this extra rehabilitation works to help older people get back home and feel happier
This study wants to see if it is possible for the NHS to deliver this new approach to rehabilitation for older adults who break their hip
What will be done The investigators worked with patients to plan this study Patients will keep helping the investigators during the study Sixty older people who had surgery to fix a broken hip will be invited to take part Participants will be given a level of risk low medium or high based on an online calculator wwwstratifyhipcouk
All 60 participants will get usual care provided locally Half selected by chance will get extra rehabilitation during their hospital stay including a self-managed exercise programme for the low-risk subgroup education a goal-orientated mobility programme and enhanced discharge planning for the medium-risk subgroup and education a goal-orientated activity of daily living programme orientation and enhanced assessment for the high-risk subgroup
The investigators will collect information from the 60 people taking part at the beginning middle and end of the study and again 12- weeks later
What will the next step be If this small study shows this extra rehabilitation can be provided in the NHS and it may help patients then the investigators plan to do a larger study The larger study will see if this extra rehabilitation works to help older people get back home and feel happier
Detailed Description:
Each year United Kingdom UK hospitals admit 70000 men and women over the age of 60 years with hip fracture Even with surgery 30 of patients die within a year Among survivors 25 never walk again and 22 transition from independent living to nursing homes This led 81 global societies to endorse a call to action to improve acute multidisciplinary care after hip fracture
A recent Cochrane systematic review supports rehabilitation in hospital as an effective approach to reduce mortality after hip fracture However the nature of the rehabilitation interventions varied considerably limiting conclusions on the optimal components This uncertainty has translated to NICE guidance being limited to daily mobilisation and regular physiotherapy review
The generalisability of the evidence is also limited as many rehabilitation trials attempted to account for differences in the hip fracture population by targeting homogenous subgroups such as patients with cognitive impairment women or from nursing homes It is therefore uncertain whether interventions deemed effective are so for all patients or for the targeted subgroup This in turn poses challenges as to how these interventions may be implemented when subgroups compete for finite National Health Service NHS resources
An intervention based on stratified rehabilitation may provide answers to these uncertainties Stratified rehabilitation considers an entire population competing for resources to identify subgroups of patients with different risk of poor outcomes Subgroups are then matched to rehabilitation tailored to their needs to optimise outcomes across the entire population Hip fracture survivors recently described this tailored approach as key to successful recovery Further a stratified approach is regarded central to the progress of healthcare according to the NHS and House of Lords Science and Technology Committee Although an approach of matching rehabilitation to patient subgroups with different risks of poor outcomes is intuitive and effective for other conditions it has not been tested for rehabilitation after hip fracture
A stratified approach to rehabilitation after hip fracture was subsequently developed The study has been designed in collaboration with patients and carers healthcare professionals working in the hospital setting health services researchers and statisticians The protocol has been scientifically appraised through the funding application process with external peer review and by experts in the field of orthogeriatric rehabilitation research
First the investigators developed and validated a subgrouping tool the stratify hip algorithm based on three multivariable prediction models to identify patients at low- intermediate- and high-risk of death andor change in residence to a higher level of care using records for over 170000 patients admitted to one of 173 hospitals in England and Wales The approach requires website entry of 5 pieces of information age sex prefracture mobility prefracture residence and dementia diagnosis to generate a risk assignment
Next matched interventions were designed for each subgroup identified by the algorithm These interventions were informed by qualitative interviews with patients physiotherapists and the multidisciplinary team an umbrella review of systematic reviews of older adults who underwent rehabilitation interventions in the acute setting recent systematic including Cochrane reviews international guidelines consultation with our public and patient involvement group TROOP further detail of TROOP available at wwwppitroopcouk and an intervention development workshop and survey following a nominal group technique to prioritize components with key stakeholders The interventions comprise self-managed exercise low risk subgroup education a goal orientated mobility programme and enhanced discharge planning medium risk subgroup and education a goal orientated activities of daily living programme and enhanced assessment high risk subgroup Carers of participants in the medium and high risk subgroups will be invited to take part to receive training in supporting participants with their programmes
The overarching purpose of a future main study is to determine the clinical- and cost-effectiveness of adding an intervention to usual care designed to improve outcomes of acute care for older adults after hip fracture Several uncertainties will first be addressed through this randomised feasibility trial
The primary objective of this feasibility and pilot randomised trial is to determine the treatment fidelity of the proposed intervention
Secondary objectives seek to determine
1 The acceptability of the intervention to participants carers and therapists
2 Barriers and enablers to intervention delivery
3 Count of screened eligible approached recruited and retained participants and carers
4 Acceptability completeness and descriptive comparison of outcome data collection
5 Count of inadvertent unblinding of outcome assessors
6 Count of adverse events AE and serious adverse events SAE
7 Indicative sample size for a definitive trial
Sixty participants will be recruited 30 per treatment arm with assessments at baseline intervention end and 12-week follow up The intervention will start within 72 hours of surgery and end on discharge from the acute hospital Feasibility criteria have been specified a priori to determine whether the trial will progress to a definitive trial
A recent Cochrane systematic review supports rehabilitation in hospital as an effective approach to reduce mortality after hip fracture However the nature of the rehabilitation interventions varied considerably limiting conclusions on the optimal components This uncertainty has translated to NICE guidance being limited to daily mobilisation and regular physiotherapy review
The generalisability of the evidence is also limited as many rehabilitation trials attempted to account for differences in the hip fracture population by targeting homogenous subgroups such as patients with cognitive impairment women or from nursing homes It is therefore uncertain whether interventions deemed effective are so for all patients or for the targeted subgroup This in turn poses challenges as to how these interventions may be implemented when subgroups compete for finite National Health Service NHS resources
An intervention based on stratified rehabilitation may provide answers to these uncertainties Stratified rehabilitation considers an entire population competing for resources to identify subgroups of patients with different risk of poor outcomes Subgroups are then matched to rehabilitation tailored to their needs to optimise outcomes across the entire population Hip fracture survivors recently described this tailored approach as key to successful recovery Further a stratified approach is regarded central to the progress of healthcare according to the NHS and House of Lords Science and Technology Committee Although an approach of matching rehabilitation to patient subgroups with different risks of poor outcomes is intuitive and effective for other conditions it has not been tested for rehabilitation after hip fracture
A stratified approach to rehabilitation after hip fracture was subsequently developed The study has been designed in collaboration with patients and carers healthcare professionals working in the hospital setting health services researchers and statisticians The protocol has been scientifically appraised through the funding application process with external peer review and by experts in the field of orthogeriatric rehabilitation research
First the investigators developed and validated a subgrouping tool the stratify hip algorithm based on three multivariable prediction models to identify patients at low- intermediate- and high-risk of death andor change in residence to a higher level of care using records for over 170000 patients admitted to one of 173 hospitals in England and Wales The approach requires website entry of 5 pieces of information age sex prefracture mobility prefracture residence and dementia diagnosis to generate a risk assignment
Next matched interventions were designed for each subgroup identified by the algorithm These interventions were informed by qualitative interviews with patients physiotherapists and the multidisciplinary team an umbrella review of systematic reviews of older adults who underwent rehabilitation interventions in the acute setting recent systematic including Cochrane reviews international guidelines consultation with our public and patient involvement group TROOP further detail of TROOP available at wwwppitroopcouk and an intervention development workshop and survey following a nominal group technique to prioritize components with key stakeholders The interventions comprise self-managed exercise low risk subgroup education a goal orientated mobility programme and enhanced discharge planning medium risk subgroup and education a goal orientated activities of daily living programme and enhanced assessment high risk subgroup Carers of participants in the medium and high risk subgroups will be invited to take part to receive training in supporting participants with their programmes
The overarching purpose of a future main study is to determine the clinical- and cost-effectiveness of adding an intervention to usual care designed to improve outcomes of acute care for older adults after hip fracture Several uncertainties will first be addressed through this randomised feasibility trial
The primary objective of this feasibility and pilot randomised trial is to determine the treatment fidelity of the proposed intervention
Secondary objectives seek to determine
1 The acceptability of the intervention to participants carers and therapists
2 Barriers and enablers to intervention delivery
3 Count of screened eligible approached recruited and retained participants and carers
4 Acceptability completeness and descriptive comparison of outcome data collection
5 Count of inadvertent unblinding of outcome assessors
6 Count of adverse events AE and serious adverse events SAE
7 Indicative sample size for a definitive trial
Sixty participants will be recruited 30 per treatment arm with assessments at baseline intervention end and 12-week follow up The intervention will start within 72 hours of surgery and end on discharge from the acute hospital Feasibility criteria have been specified a priori to determine whether the trial will progress to a definitive trial
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None