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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03354468
Recruitment Status : Completed
First Posted : November 28, 2017
Last Update Posted : February 4, 2019
Sponsor:
Collaborators:
Norwegian University of Science and Technology
Sykehuset Innlandet HF
Information provided by (Responsible Party):
Helse Møre og Romsdal HF

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.


Condition or disease Intervention/treatment
Hospitalized Patients Accidental Falls Behavioral: fall prevention program

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.

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Study Type : Observational
Actual Enrollment : 3143 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: The Effects of a Fall Prevention Program on Falls, Patient Safety Culture and Patient-perceived Safety. Two Cross-sectional Studies in Two Orthopedic Departments
Actual Study Start Date : November 1, 2011
Actual Primary Completion Date : October 31, 2014
Actual Study Completion Date : October 31, 2014

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
fall prevention program time 1
orthopedic department in Kristiansund hospital before implementation of a fall prevention program
Behavioral: 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
Behavioral: 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



Primary Outcome Measures :
  1. proportion of fallers during the registration period [ Time Frame: 1 year registration period ]


Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03354468


Locations
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Norway
Dept of Orthopedics
Kristiansund, Norway
Dept of Orthopedics
Ålesund, Norway
Sponsors and Collaborators
Helse Møre og Romsdal HF
Norwegian University of Science and Technology
Sykehuset Innlandet HF
Investigators
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Study Director: Espen Remme Helse Møre og Romsdal HF
Publications of Results:
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Responsible Party: Helse Møre og Romsdal HF
ClinicalTrials.gov Identifier: NCT03354468    
Other Study ID Numbers: 2015/2469
First Posted: November 28, 2017    Key Record Dates
Last Update Posted: February 4, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Helse Møre og Romsdal HF:
Prevention and Control
Patient Safety
Aged
Risk Management