Structured Tailored Rehabilitation After Hip Fragility Fracture: The 'STRATIFY' Feasibility Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Treatment fidelity (supervised intervention)
研究概览
简要总结
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 (www.stratifyhip.co.uk).
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.
详细描述
Each year, United Kingdom (UK) hospitals admit 70,000 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •We will include adults
- •aged 60 years or more.
- •admitted to hospital for surgical repair of a hip fracture.
- •who are willing and able to provide consent or assent depending on the level of cognitive impairment.
排除标准
- •We will exclude adults
- •less than 60 years, to align with the National Hip Fracture Databases definition of the target population.
- •not surgically treated, as this treatment approach is reserved for around 2% of patients in the UK who are often at the end of life.
- •who broke their hip in hospital following admission for a different illness/injury as their anticipated care pathway and outcomes will vary from those who are admitted for hip fracture.
- •participating in other treatment trials and without agreement of both trial teams.
结局指标
主要结局
Treatment fidelity (supervised intervention)
时间窗: At the end of the intervention when the participant is discharged from the ward (average length of inpatient stay is 16 days)
measured through assessment of treatment logs
Treatment fidelity (unsupervised intervention)
时间窗: At the end of the intervention when the participant is discharged from the ward (average length of inpatient stay is 16 days)
measured through assessment of patient diary
次要结局
- Acceptability and completeness of Short Falls Efficacy Scale-International(Baseline, at the end of the intervention when the participant is discharged from the ward (average length of inpatient stay is 16 days), and 12-week follow-up)
- Count of screened, eligibly, approached, recruited and retained participants(screening through to 12-week follow-up)
- Acceptability of intervention to participants, carers and therapists(At the end of the intervention when the participant is discharged from the ward (average length of inpatient stay is 16 days))
- Acceptability and completeness of EuroQoL EQ-5D-5L(Baseline, at the end of the intervention when the participant is discharged from the ward (average length of inpatient stay is 16 days), and 12-week follow-up)
- Acceptability and completeness of Numeric Rating Scale(Baseline, at the end of the intervention when the participant is discharged from the ward (average length of inpatient stay is 16 days), and 12-week follow-up)
- Acceptability and completeness of New Mobility Score(Baseline, at the end of the intervention when the participant is discharged from the ward (average length of inpatient stay is 16 days), and 12-week follow-up)
- Acceptability and completeness of non-validated resource use questionnaire(Baseline, at the end of the intervention when the participant is discharged from the ward (average length of inpatient stay is 16 days), and 12-week follow-up)
- Barriers and enablers to intervention delivery(At the end of the intervention when the participant is discharged from the ward (average length of inpatient stay is 16 days))
- Acceptability and completeness of Barthel Index(Baseline, at the end of the intervention when the participant is discharged from the ward (average length of inpatient stay is 16 days), and 12-week follow-up)
- Acceptability and completeness of Nottingham Extended Activities of Daily Living(Baseline, at the end of the intervention when the participant is discharged from the ward (average length of inpatient stay is 16 days), and 12-week follow-up)
- Acceptability and completeness of University of Alabama Life Space Assessment(Baseline, at the end of the intervention when the participant is discharged from the ward (average length of inpatient stay is 16 days), and 12-week follow-up)
- Completeness of Living status(Baseline, at the end of the intervention when the participant is discharged from the ward (average length of inpatient stay is 16 days), and 12-week follow-up)
- Completeness of Mortality(At the end of the intervention when the participant is discharged from the ward (average length of inpatient stay is 16 days), and 12-week follow-up)
- Completeness of Readmission(12-week follow-up)
- Completeness of Length of stay(At the end of the intervention when the participant is discharged from the ward (average length of inpatient stay is 16 days))
- Count of inadvertent unblinding of outcome assessors(At the end of the intervention when the participant is discharged from the ward (average length of inpatient stay is 16 days), and 12-week follow-up)
- Count of adverse and serious adverse events(From randomisation to 12-week follow-up)