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

NCT06079905 | Unknown

• 1 other identifier: MEC-2023-0270
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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.

Conditions

Hip Fractures

Outcome Measures

Primary Outcomes (1)

• Nonoperative treatment

  6 weeks

Study Arms (1)

Frail elderly with limited life expectancy that fracture a hip

Frail elderly with limited life expectancy that fracture a hip

Other: Nonoperative treatment; Other: Operative treatment

Interventions

Nonoperative treatment OTHER

Nonoperative treatment

Frail elderly with limited life expectancy that fracture a hip

Operative treatment OTHER

Operative treatment

Frail elderly with limited life expectancy that fracture a hip

Eligibility Criteria

• Age: 70 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• \- None

Sponsors & Collaborators

• Dr. E.M.M. (Esther) Van Lieshout PhD MSc: lead

Study Sites (1)

Erasmus MC

Rotterdam, 3000 CA, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 38631829 DERIVED

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate professor Trauma Surgery

Study Record Dates

• First Submitted: October 8, 2023
• First Posted: October 12, 2023
• Study Start: October 8, 2023
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: October 12, 2023

Record last verified: 2023-10

Locations

NL (1)