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Hip FracturesNCT06079905

Palliative NonOperative Management in Selected Elderly With a Limited Life Expectancy Who Sustained a Hip Fracture

An observational study of Hip Fractures, run by Dr. E.M.M. (Esther) Van Lieshout PhD MSc at 1 site in Netherlands.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The primary and main aim of this study is to implement PNOM in all hospitals in the Netherlands, so that the selected frail elderly people with a limited life expectancy who fracture a hip receive the care that best meets their needs in the last phase of life. Read more about this study

Who is it for?
Ages 70 to 110 years
Conditions the study is for
Hip Fractures
What is being tested?
Nonoperative treatment and Operative treatment
How many people
1,000 participants
Where
1 siteNetherlands
Study dates
8 Oct 2023to 31 May 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 70 to 110 years
  • All sexes
  • No healthy volunteers
  • Older adult

Study population: frail (institutionalized) elderly who have a limited life expectancy and fracture their proximal femur

Who may be able to join

  • Frail institutionalized elderly person (i.e., 70 years or older, living in a nursing home or receiving similar care at the same level while living elsewhere pretrauma, who either are malnourished (cachexia or BMI<18.5 kg/m2), or had mobility issues (FAC 2 or less), or have an ASA class of 4 or 5)
  • Acute proximal femoral fracture, confirmed on X-ray or CT-scan

Who cannot join

  • None

Trial locations and contacts

1 site in 1 country.

Netherlands1 site
  • Erasmus MC

    Rotterdam, 3000 CA

Other trials in Netherlands

About this study

Official title: Palliative NonOperative Management (PNOM) in Selected Elderly With a Limited Life Expectancy Who Sustained a Proximal Femoral Fracture (PNOM-Implementation); an Implementation Study

The primary and main aim of this study is to implement PNOM in all hospitals in the Netherlands, so that the selected frail elderly people with a limited life expectancy who fracture a hip receive the care that best meets their needs in the last phase of life. The treatment decision is made through shared decision-making.

Study design: This project is an implementation project, consisting of 4 phases. The main design is a multicenter prospective cohort study.

Read more

Study population: The target population are frail (institutionalized) elderly who have a limited life expectancy and fracture their proximal femur. The population that meets this criterion are persons of 70 years or older, who either live in a nursing home or receive a similar level of care at home or in another type institution, and have at least one of the following characteristics: 1) are malnourished (cachexia or a Body Mass Index, BMI, of <18.5 kg/m2); 2) mobility issues with increased risk of falling pretrauma (Functional Ambulation Category, FAC, 2 or less); or 3) have severe comorbidities (American Society of Anesthesiologists, ASA, class 4 or 5).

Methods:

Phases 3 and 4: Installation of a local implementation team, followed by PNOM protocol implementation. Data collection for patients eligible for PNOM by automated data extraction from the national hip fracture audit.

Read the detailed description

Rationale: A hip fracture in a select group of frail elderly people can indicate an approaching end of life. These patients do not benefit from an operative treatment that aims to restore mobility. The FRAIL-HIP study has shown that palliative non-operative management (PNOM) can be a good alternative for this group. By shared decision making between the patient/family and the medical specialists involved, surgery or PNOM was chosen. Half of the patients opted for PNOM. Quality of life was valued equally by patients in both groups. The majority of the next of kin in both groups rated the quality of dying as very good. The aim of this project is to implement PNOM in all Dutch hospitals as part of shared decision-making in a select group of frail patients with a hip fracture.

Objective(s): The primary and main aim of this study is to implement PNOM in all hospitals in the Netherlands, so that the selected frail elderly people with a limited life expectancy who fracture a hip receive the care that best meets their needs in the last phase of life. The treatment decision is made through shared decision-making. Secondary aims, needed to achieve the main aim, are: 1) to enriching the draft version of the PNOM protocol, and test results of the PNOM protocol draft; 2) to develop educational modules for the curriculum of residents Surgery and Orthopedics; 3) to create awareness and a sense of urgency for PNOM implementation in this select group of patients by organizing PNOM informational sessions during annual conferences of the scientific associations involved; 4) to improve the PNOM protocol on a smaller scale based on implementation of the PNOM protocol in selected hospitals across the country; and 5) to facilitate the scaling up of the implementation of the PNOM protocol to all hospitals in the Netherlands that treat the targeted patient group Study design: This project is an implementation project, consisting of 4 phases. The main design is a multicenter prospective cohort study.

Study population: The target population are frail (institutionalized) elderly who have a limited life expectancy and fracture their proximal femur. The population that meets this criterion are persons of 70 years or older, who either live in a nursing home or receive a similar level of care at home or in another type institution, and have at least one of the following characteristics: 1) are malnourished (cachexia or a Body Mass Index, BMI, of <18.5 kg/m2); 2) mobility issues with increased risk of falling pretrauma (Functional Ambulation Category, FAC, 2 or less); or 3) have severe comorbidities (American Society of Anesthesiologists, ASA, class 4 or 5).

Methods: This study will use mixed methods in the different phases of the study.

Phase 1: interviews with health care professionals and a panel from an elderly person's organization (i.e., patient representatives).

Phase 2: Interviews with patient representatives, development of educational modules for hospitals and residents (Orthopedic) Surgery, and design of a website.

Phases 3 and 4: Installation of a local implementation team, followed by PNOM protocol implementation. Data collection for patients eligible for PNOM by automated data extraction from the national hip fracture audit.

In phase 3, the following additional data will be collected: 1) interviews with health care professionals in the hospital before and at 6 months after start of PNOM implementation; and 2) interviews with patients/proxy/next of kin about their view on the implementation.

Conditions
Hip Fractures
Being tested
Nonoperative treatment, Operative treatment
Medical subject headings
Hip Fractures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nonoperative treatmentOther

    Nonoperative treatment

  • Operative treatmentOther

    Operative treatment

Study groups in NCT06079905
Study groupRoleWhat they receive
Frail elderly with limited life expectancy that fracture a hipFrail elderly with limited life expectancy that fracture a hip
Receives: Other: Nonoperative treatment; Other: Operative treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Nonoperative treatment

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Oct 2023
  2. Study start8 Oct 2023 (estimated)
  3. Primary completion31 May 2025 (estimated)
  4. Study completion31 May 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06079905
Sponsor's protocol ID
MEC-2023-0270
Status last verified
Oct 2023
First submitted
8 Oct 2023
Last updated
12 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Oosterwijk PC, Zeelenberg ML, Schuijt HJ, Van der Velde D, Den Hartog D, Gosens T, Joosse P, Loggers SAI, Nijdam TMP, van Delden JJM, Wijnen HH, Verhofstad MHJ, Van Lieshout EMM, Willems HC; NOM-Implementation study group. Satisfaction regarding shared decision-making for operative and non-operative hip fracture treatment in frail older adults from a proxy-perspective: a mixed methods study. BMJ Open. 2026 Oct 6;16(10):e117789. doi: 10.1136/bmjopen-2026-117789.

    PubMed 42838576
  • Zeelenberg ML, Oosterwijk PC, Willems HC, Gosens T, Den Hartog D, Joosse P, Loggers SAI, Nijdam TM, Pel-Littel RE, Polinder S, Schuijt HJ, Wijnen HH, Van der Velde D, Van Lieshout EMM, Verhofstad MHJ; NOM-Implementation study group. Shared decision-making for non-operative management versus operative management of hip fractures in selected frail older adults with a limited life expectancy: a protocol for a nationwide implementation study. BMJ Open. 2024 Apr 17;14(4):e083429. doi: 10.1136/bmjopen-2023-083429.

    PubMed 38631829

Questions about this trial

What is this clinical trial studying?

An observational study of Hip Fractures, run by Dr. E.M.M. (Esther) Van Lieshout PhD MSc at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Nonoperative treatment (time frame: 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06079905, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2023.

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