The DECIDE-HIP Study: Improving Shared DECISion-making in oldEr Hip Fracture Patients Living With Frailty
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Change in functional status
研究概览
简要总结
Title Improving shared decision-making in older hip fracture patients living with frailty
Aim To use routinely information normally collected by the NHS, and interviews with patients, families, and healthcare professionals, to produce an aid to help patients make decisions about hip fracture treatment that reflects what is important to them.
Background Breaking a hip after a fall is common in older adults. The risk of dying is high after a hip fracture, especially if the person does not have surgery. Most UK patients have surgery even if they are very frail. Patients who are at a very high risk of dying still have surgery to help control the pain. However, this is not the same in all countries and recent studies show pain can be well controlled with medications and nerve-numbing drugs.
Whilst the risk of dying is still much higher without surgery, to some frail older adults there are more important things to them than living longer like being able to walk and look after themselves. Some people may choose end-of-care instead of an operation if surgery means they won't be able to do these things afterwards. To help frail older people make the decision that is best for them, they need information about all treatment options and what their life is likely to be like after. This information needs to be easy to understand.
Why the research is important This research will give frail older people with hip fractures the information they need to make decisions that focus on what is most important to them. We will make a guide to present the information in a way that is easy to understand and will help patients make decisions alongside healthcare professionals.
Design
We will complete 4 Work Packages (WPs):
WP1: What do we already know about the link between frailty and the ability for older people to move and look after themselves after hip fracture? • We will review all current studies that look at what frail older peoples' lives are like after having a hip fracture and combine all the information in these studies. This will stop us from repeating work already done and show us any gaps in knowledge.
WP2: Can we use how frail someone is and other information to predict their ability to move and look after themselves after a hip fracture?
• We will use data the NHS collects to explore links between frailty, health and social issues, and a person's ability to move, walk, and care for themselves after hip fracture. I will see if these factors predict which people will do better after a hip fracture.
WP3: What factors affect treatment decisions in frail adults with a hip fracture? • We will interview older hip fracture patient with frailty, families, and healthcare staff to explore how decisions are made about hip fractures and how we can improve this.
WP4: Creating and testing an aid to help older patients with frailty make decisions about hip fracture treatment
• We will work with patients to design a decision aid to improve shared decision-making in hip fracture care. We will test out the aid on orthopaedic wards in Southampton and improve it based on feedback.
详细描述
WP1 - Functional outcomes and quality of life following hip fracture in older adults living with different degrees of frailty: A systematic review Aim To synthesise the literature on the relationship between frailty and functional and QoL outcomes in patients presenting with hip fracture.
Rationale Existing literature on the link between frailty and function after hip fracture is limited. This review will guide WP2's design, ensuring it addresses current gaps.
Methods and design I will work with my supervisory team and university librarians to develop a search strategy. Databases searched will include Embase, MEDLINE, CINAHL, and Web of Science Core Collection. Grey literature (e.g. conference abstracts) will be searched using Grey Matters. Bibliographies of included studies will be screened, and all databases searched from earliest record to present.
Inclusion and exclusion criteria Inclusion Criteria Exclusion Criteria Population Age ≥65 Frailty as measured by a validated screening tool Diagnosed with an acute hip fracture including proximal femoral shaft, head, and neck fractures whether this results in admission or not Age <65 Studies that do not report frailty status Distal femoral fractures, impacted femoral head fractures, periprosthetic fractures, pathological fractures Exposure Frailty defined by a validated scoring system within the study No measure of frailty Outcomes Mortality, Mobility, Functional status, Health-related QoL, Discharge destination Studies that do not report at least one of the relevant outcomes Study design Observational studies including prospective and retrospective cohort studies, Randomised controlled trials Case reports, review articles, animal and in vitro studies, editorials, book chapters or extracts Table 1. Inclusion and exclusion criteria for WP1 Data extraction Abstracts will be double screened by 2 researchers in Rayyan.ai, with duplicates removed and disagreements resolved by my supervisor. Full abstract texts will then be double screened against criteria. Extracted data will include title, journal, publication year, authors, study country, design, participant details, study aims, sample size, outcomes, measurement tools, results, and statistical analyses.
Assessment of bias The Joanna Briggs Institute (JBI) critical appraisal checklists for the respective study types included will be used to summarise the risk of bias for the included studies.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PHASE 1 ELIGIBILITY CRITERIA
- •Inclusion Criteria:
- •Fragility fracture of the proximal femur defined as a fall from standing height or less from August 2021 to present
- •Electronic frailty index (eFI) or eFI2 score in the 12 months preceding hip fracture for CPRD data; American Society of Anesthesiologists (ASA) Physical Status grade for NHFD data
排除标准
- •Femoral shaft or distal femur fractures, periprosthetic fractures, and pathological fractures.
- •PHASE 2 ELIGIBILITY CRITERIA
- •Group 1 - Patients
- •Inclusion criteria:
- •Admitted to a trauma and orthopaedic ward at University Hospital Southampton following a fragility fracture of the hip
- •Exclusion criteria:
- •Distal femoral shaft fractures, periprosthetic fractures, pathological fractures
- •Non-fragility fractures, defined as a fracture due to a force greater than falling from a standing height
- •Group 2 - Families and carers
- •Inclusion criteria:
- •Carer or next of kin for a person meeting the eligibility criteria for group 1
- •Exclusion criteria:
- •- Do not have the capacity to consent to participation in the study.
- •Group 3 - Local healthcare professionals
- •Inclusion criteria:
- •Registered healthcare professionals involved in acute hip fracture management decisions including physicians, orthopaedic surgeons, anaesthetists, nurses and allied health professionals.
- •Currently work or have worked within the past 6 months at University Hospital Southampton
- •Group 4 - European healthcare professionals
- •Inclusion criteria
- •Registered healthcare professionals involved in acute hip fracture management decisions including physicians, orthopaedic surgeons, nurses and allied health professionals.
- •Currently work or have worked within the past 6 months in trauma and orthopaedics or orthogeriatrics at a European hospital
- •Eligibility criteria - Phase 3
- •Inclusion criteria:
- •Admitted to a trauma and orthopaedic ward at University Hospital Southampton following a fragility fracture of the hip
- •Exclusion criteria:
- •Distal femoral shaft fractures, periprosthetic fractures, pathological fractures
- •Non-fragility fractures, defined as a fracture due to a force greater than falling from a standing height
- •Do not have the capacity to consent in accordance with the Mental Capacity Act 2005
结局指标
主要结局
Change in functional status
时间窗: At 3 months, 6 months, and 12 months after hip fracture date
Change in the numbers of healthcare record codes before and after hip fracture indicating difficulties with activities of daily living (ADLs) and physical disability as markers of functional status.
次要结局
- Mortality(Mortality rate at 1 year post hip fracture.)
- Days alive and at home(90 and 365 days from date of hip fracture)
- Discharge destination(Residential location day 1 after acute hospital discharge following hip fracture)
- Residential location(3, 6, and 12 months following hip fracture date)
研究者
Liam Jones
Doctoral Research Student and Specialty Registrar in Geriatric Medicine
University of Southampton