Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT06079905 |
| Other study ID # |
MEC-2023-0270 |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 8, 2023 |
| Est. completion date |
May 31, 2025 |
Study information
| Verified date |
October 2023 |
| Source |
Erasmus Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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. 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.
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.
