Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:11 AM
Study NCT ID:
NCT06079905
Status:
UNKNOWN
Last Update Posted:
2023-10-12
First Post:
2023-10-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Palliative NonOperative Management in Selected Elderly With a Limited Life Expectancy Who Sustained a Hip Fracture
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006620', 'term': 'Hip Fractures'}], 'ancestors': [{'id': 'D005264', 'term': 'Femoral Fractures'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D025981', 'term': 'Hip Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2023-10-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2025-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-08', 'studyFirstSubmitDate': '2023-10-08', 'studyFirstSubmitQcDate': '2023-10-08', 'lastUpdatePostDateStruct': {'date': '2023-10-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Nonoperative treatment', 'timeFrame': '6 weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hip Fractures']}, 'referencesModule': {'references': [{'pmid': '38631829', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nStudy design: This project is an implementation project, consisting of 4 phases. The main design is a multicenter prospective cohort study.\n\nStudy 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).\n\nMethods:\n\nPhases 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.', 'detailedDescription': "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.\n\nObjective(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.\n\nStudy 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).\n\nMethods: This study will use mixed methods in the different phases of the study.\n\nPhase 1: interviews with health care professionals and a panel from an elderly person's organization (i.e., patient representatives).\n\nPhase 2: Interviews with patient representatives, development of educational modules for hospitals and residents (Orthopedic) Surgery, and design of a website.\n\nPhases 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.\n\nIn 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '110 Years', 'minimumAge': '70 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'frail (institutionalized) elderly who have a limited life expectancy and fracture their proximal femur', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 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)\n2. Acute proximal femoral fracture, confirmed on X-ray or CT-scan\n\nExclusion Criteria:\n\n\\- None'}, 'identificationModule': {'nctId': 'NCT06079905', 'briefTitle': 'Palliative NonOperative Management in Selected Elderly With a Limited Life Expectancy Who Sustained a Hip Fracture', 'organization': {'class': 'OTHER', 'fullName': 'Erasmus Medical Center'}, 'officialTitle': 'Palliative NonOperative Management (PNOM) in Selected Elderly With a Limited Life Expectancy Who Sustained a Proximal Femoral Fracture (PNOM-Implementation); an Implementation Study', 'orgStudyIdInfo': {'id': 'MEC-2023-0270'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Frail elderly with limited life expectancy that fracture a hip', 'description': 'Frail elderly with limited life expectancy that fracture a hip', 'interventionNames': ['Other: Nonoperative treatment', 'Other: Operative treatment']}], 'interventions': [{'name': 'Nonoperative treatment', 'type': 'OTHER', 'description': 'Nonoperative treatment', 'armGroupLabels': ['Frail elderly with limited life expectancy that fracture a hip']}, {'name': 'Operative treatment', 'type': 'OTHER', 'description': 'Operative treatment', 'armGroupLabels': ['Frail elderly with limited life expectancy that fracture a hip']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000 CA', 'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'Erasmus MC', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr. E.M.M. (Esther) Van Lieshout PhD MSc', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate professor Trauma Surgery', 'investigatorFullName': 'Dr. E.M.M. (Esther) Van Lieshout PhD MSc', 'investigatorAffiliation': 'Erasmus Medical Center'}}}}