NCT07687108

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
29mo left

Started Oct 2026

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 24, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 7, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2026

Expected
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 7, 2028

5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 7, 2029

Last Updated

July 7, 2026

Status Verified

June 1, 2026

Enrollment Period

1.9 years

First QC Date

June 24, 2026

Last Update Submit

June 29, 2026

Conditions

Keywords

functional outcomesfrailtydecision aidshared decision makingqualitativesemi-structured interviewsroutinely collected datahip fracturequality of lifefunctionmobility

Outcome Measures

Primary Outcomes (1)

  • Change in functional status

    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.

    At 3 months, 6 months, and 12 months after hip fracture date

Secondary Outcomes (4)

  • 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

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Phase 1 1. Older adults (aged over 65) with fragility fractures of the hip Phase 2 1. Older adults with fragility fractures of the hip 2. Relatives and carers of older adults with fragility fractures of the hip 3. UK health professionals caring for older adults with fragility fractures of the hip 4. European health professionals caring for older adults with fragility fractures of the hip Phase 3 1\. Older adults with fragility fractures of the hip admitted to University Hospital Southampton

You may qualify if:

  • Aged ≥65
  • 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

You may not qualify if:

  • Age \<65
  • Femoral shaft or distal femur fractures, periprosthetic fractures, and pathological fractures.
  • PHASE 2 ELIGIBILITY CRITERIA
  • Group 1 - Patients
  • Age ≥65
  • Admitted to a trauma and orthopaedic ward at University Hospital Southampton following a fragility fracture of the hip
  • 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
  • Age ≥18
  • Carer or next of kin for a person meeting the eligibility criteria for group 1
  • \- Do not have the capacity to consent to participation in the study.
  • Group 3 - Local healthcare professionals
  • 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
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Southampton NHS Foundation Trust

Southampton, Hampshire, SO16 6YD, United Kingdom

Location

MeSH Terms

Conditions

Hip FracturesFrailty

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg InjuriesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Liam L Jones, BMBS, MRCP (UK)

    University of Southampton

    STUDY CHAIR

Central Study Contacts

Liam L Jones, BMBS

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctoral Research Student and Specialty Registrar in Geriatric Medicine

Study Record Dates

First Submitted

June 24, 2026

First Posted

July 7, 2026

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

September 7, 2028

Study Completion (Estimated)

February 7, 2029

Last Updated

July 7, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will share

Locations