- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06079905
Palliative NonOperative Management in Selected Elderly With a Limited Life Expectancy Who Sustained a Hip Fracture
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.
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Rotterdam, Netherlands, 3000 CA
- Erasmus MC
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Frail elderly with limited life expectancy that fracture a hip
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Nonoperative treatment
Operative treatment
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Nonoperative treatment
Time Frame: 6 weeks
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6 weeks
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MEC-2023-0270
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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