NCT05680714

Brief Summary

The goal of this controlled before and after study is to evaluate a new patient pathway for patients 65 years and older who have suffered a fall injury. The main questions the study aims to answer are whether this preventive initiative with improved care coordination reduces risk of subsequent hip fractures, admittance to nursing homes or death. Researchers will compare two boroughs in Oslo who implemented the new patient pathway with the 13 other boroughs who did not reorganize their follow-up, but continued their care as usual.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
121,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2012

Longer than P75 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

December 13, 2022

Completed
29 days until next milestone

First Posted

Study publicly available on registry

January 11, 2023

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

January 11, 2023

Status Verified

January 1, 2023

Enrollment Period

8 years

First QC Date

December 13, 2022

Last Update Submit

January 9, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • Hip fracture

    A new hip fracture registered in the Norwegian Patient registry

    2012-2019

  • Admission to nursing home

    Long-term admission to nursing home

    2012-2019

  • Death

    Total mortality

    2012-2019

Secondary Outcomes (1)

  • Subsequent fall injuries

    2012-1019

Study Arms (3)

FALLERS IN THE INTERVENTION BOROUGHS

Fallers 65+ years from the borough of Nordstrand from January 1. 2015 Fallers 65+ years from the borough of Østensjø from September 1. 2016 Fall injury will be included as a time-varying exposure variable. The individuals are all registered as non-fallers until they are registered with a fall injury in the NPR database, when they shift status to fallers.

Other: Implement coordination of care with multifactorial falls- and fracture risk assessment and tailored intervention

FALLERS IN THE CONTROL BOROUGHS

Fallers 65+ years from all the 13 other boroughs of Oslo. Fall injury will be included as a time-varying exposure variable. The individuals are all registered as non-fallers until they are registered with a fall injury in the NPR database, when they shift status to fallers.

NON-FALLERS

All non-fallers 65+ years from all Oslo boroughs.

Interventions

Also known as: Needs assessment and user involvement, Casefinding with identifying high risk individuals, Single point of entry to care in the boroughs, Cross sectoral plan for follow-up with role clarification, Interdisciplinary teams, Tools for multifactorial falls and fracture risk assessment (checklists for GP, home visits, injury clinic, osteoporosis), Information sharing, Primary and specialist care referral pathways, Targeted interventions (Ex: exercise, home safety, osteoporosis treatment, deprescribing, medical assessment), Champions to create enthusiasm and carry the intervention forward, Collaborative education of health professionals, Technology enablers in the electronic patients records
FALLERS IN THE INTERVENTION BOROUGHS

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

Total population in Oslo 65 years or older in the period 2012 - 2019.

You may qualify if:

  • years or older
  • Living on Oslo, Norway in the period January 1. 2012 - December 31. 2019

You may not qualify if:

  • Hip fracture before baseline
  • Living in nursing home at baseline

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hip Fractures

Interventions

Needs AssessmentPatient Care TeamChecklistHouse CallsDeprescriptions

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

Health Services ResearchHealth PlanningHealth Care Economics and OrganizationsDelivery of Health CareHealth Care Quality, Access, and EvaluationPatient Care ManagementHealth Services AdministrationData CollectionHealth Care Evaluation MechanismsQuality of Health CareProfessional PracticeOrganization and AdministrationDrug TherapyTherapeutics

Study Officials

  • Gro Idland, PhD

    Municipality of Oslo, Department of Health

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
8 Years
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Senior Medical Officer, Professor in Epidemiology and Preventive Medicine

Study Record Dates

First Submitted

December 13, 2022

First Posted

January 11, 2023

Study Start

January 1, 2012

Primary Completion

December 31, 2019

Study Completion

December 1, 2024

Last Updated

January 11, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share