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临床试验/NCT06079905
NCT06079905Enrolling By Invitation不适用

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

Dr. E.M.M. (Esther) Van Lieshout PhD MSc1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2023年10月8日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
1,000
试验地点
1
主要终点
Nonoperative treatment

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
70 Years 至 110 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 未提供

结局指标

主要结局

Nonoperative treatment

时间窗: 6 weeks

次要结局

未报告次要终点

研究者

发起方
Dr. E.M.M. (Esther) Van Lieshout PhD MSc
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Dr. E.M.M. (Esther) Van Lieshout PhD MSc

Associate professor Trauma Surgery

Erasmus Medical Center

研究点 (1)

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