The Effects of a Fall Prevention Program on Falls, Patient Safety Culture and Patient-perceived Safety

January 31, 2019 updated by: Helse Møre og Romsdal HF

The Effects of a Fall Prevention Program on Falls, Patient Safety Culture and Patient-perceived Safety. Two Cross-sectional Studies in Two Orthopedic Departments

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.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

The interventions are multifaceted and include short and long-term activities to prevent falls. Fall screening, performed with the Norwegian version of the risk assessment tool for falls in elderly "STRATIFY (score 0 - 5), is the main tool. In patients with a score of 2 or more, a comprehensive individual plan for fall prevention has been worked out for each patient with risk of fall, documented in the medical records, and communicated to the staff responsible for the patient. The plan includes practical initiatives like adjusting the beds, proper illumination, instructions not to leave the bed unaided, and appropriate shoes. There are also long-term measures like the treatment of underlying diseases, changes in medication associated with risk of fall, physical training, and healthier dietary habits. During the intervention, the process is measured and reported to the national campaign. The national intervention was designed for use in hospitals, care facilities and patients living at home. Most of the proposed activities aim at preventing falls in a long time perspective.

Study Type

Observational

Enrollment (Actual)

3143

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Kristiansund, Norway
        • Dept of orthopedics
      • Ålesund, Norway
        • Dept of orthopedics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • n.a.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
fall prevention program time 1
orthopedic department in Kristiansund hospital before implementation of a fall prevention program
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.
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
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.
no fall prevention program time 2
orthopedic department in Ålesund hospital without fall prevention program

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
proportion of fallers during the registration period
Time Frame: 1 year registration period
1 year registration period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Espen Remme, Helse Møre og Romsdal HF

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2011

Primary Completion (ACTUAL)

October 31, 2014

Study Completion (ACTUAL)

October 31, 2014

Study Registration Dates

First Submitted

November 21, 2017

First Submitted That Met QC Criteria

November 24, 2017

First Posted (ACTUAL)

November 28, 2017

Study Record Updates

Last Update Posted (ACTUAL)

February 4, 2019

Last Update Submitted That Met QC Criteria

January 31, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 2015/2469

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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