NCT03354468

Brief Summary

The incidence of fractures in Norway is among the highest in the world, and falls are the sixth major contributor to years lived with disability. In elderly, a large part of 900 deaths from unintentional injuries per 100000 inhabitants per year, are due to falls and fractures. Fractures, especially hip fractures among the elderly, often result in pain, ailments, and reduced quality of life. In Norway, 11 % of all reports from the specialized health services were incidents related to falls. Worldwide, falls are among the most commonly reported adverse events in hospitals with prevalence rates in the order of 10 per 1000 patient days or 5-15 % of the patients, and are associated with both minor and major injuries. The results of preventive measures are conflicting. In January 2011, the Norwegian health minister launched a national patient safety campaign called "In Safe hands". The campaign had three aims: 1) Reduce patient related adverse events, 2) Build sustainable systems and structures for patient safety, and 3) Improve the patient safety culture. Hospitals and primary care units were invited to participate in 16 specific and measurable areas for improvement. One out of four orthopedic departments at Møre og Romsdal Hospital Trust, Norway participated actively in a fall prevention program. This study compares the changes in fall rates, the employees' perceived patient safety culture and the patient experienced safety before and after implementation of the fall prevention program at the orthopedic department in one hospital in the Møre \& Romsdal Hospital Trust, and at the same time points i another hospital in the same Trust but not having implemented the program.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3,143

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2011

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2014

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

November 21, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 28, 2017

Completed
Last Updated

February 4, 2019

Status Verified

January 1, 2019

Enrollment Period

3 years

First QC Date

November 21, 2017

Last Update Submit

January 31, 2019

Conditions

Keywords

Prevention and ControlPatient SafetyAgedRisk Management

Outcome Measures

Primary Outcomes (1)

  • proportion of fallers during the registration period

    1 year registration period

Study Arms (4)

fall prevention program time 1

orthopedic department in Kristiansund hospital before implementation of a fall prevention program

Behavioral: fall prevention program

no fall prevention program time 1

orthopedic department in Ålesund hospital without fall prevention program

fall prevention program time 2

orthopedic department in Kristiansund hospital after implementation of a fall prevention program

Behavioral: fall prevention program

no fall prevention program time 2

orthopedic department in Ålesund hospital without fall prevention program

Interventions

fall prevention program in orthopedic department, consisting of 1) Seven examples of risk factors which might cause falls (diseases and medications, movement, cognitive behavior, vision, continence, nutrition, and the room and surroundings), 2) Methods to detect the risk factors, and 3) Measures to avoid falls or protect the patient in case of a fall.

fall prevention program time 1fall prevention program time 2

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study included all patients above 64 years of age admitted to the orthopedic departments at Kristiansund Hospital and Ålesund Hospital during the two registration periods from November 1, 2011 to October 31, 2012; and from November 1, 2013 to October 31, 2014 and with a stay in the hospital of at least 24 hours' duration.

You may qualify if:

  • admitted to the orthopedic department at Kristiansund Hospital or Ålesund Hospital
  • admitted during one the two registration periods: from November 1, 2011 to October 31, 2012; or from November 1, 2013 to October 31, 2014
  • a stay in the hospital of at least 24 hours' duration

You may not qualify if:

  • n.a.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Dept of Orthopedics

Ålesund, Norway

Location

Dept of Orthopedics

Kristiansund, Norway

Location

Related Publications (1)

  • Royset B, Talseth-Palmer BA, Lydersen S, Farup PG. Effects of a fall prevention program in elderly: a pragmatic observational study in two orthopedic departments. Clin Interv Aging. 2019 Jan 15;14:145-154. doi: 10.2147/CIA.S191832. eCollection 2019.

Study Officials

  • Espen Remme

    Helse Møre og Romsdal HF

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2017

First Posted

November 28, 2017

Study Start

November 1, 2011

Primary Completion

October 31, 2014

Study Completion

October 31, 2014

Last Updated

February 4, 2019

Record last verified: 2019-01

Locations