Hospitalized PatientsNCT03354468
The Effects of a Fall Prevention Program on Falls, Patient Safety Culture and Patient-perceived Safety
An observational study of Hospitalized Patients and Accidental Falls, run by Helse Møre og Romsdal HF at 2 sites in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hospitalized Patients, Accidental Falls
- What is being tested?
- fall prevention program
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 3,143 participants
- Where
- 2 sitesNorway
- Study dates
- 1 Nov 2011to 31 Oct 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
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.
Who may be able to join
- 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
Who cannot join
- n.a.
Trial locations and contacts
2 sites in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Hospitalized Patients, Accidental Falls
- Being tested
- fall prevention program
- Keywords
- Prevention and Control, Patient Safety, Aged, Risk Management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fall prevention programBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| fall prevention program time 1 | orthopedic department in Kristiansund hospital before implementation of a fall prevention program Receives: 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 Receives: Behavioral: fall prevention program | |
| no fall prevention program time 2 | orthopedic department in Ålesund hospital without fall prevention program |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of fallers during the registration period
Measured: 1 year registration period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2017
- Study start1 Nov 2011
- Primary completion31 Oct 2014
- Study completion31 Oct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hospitalized PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 3,143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helse Møre og Romsdal HF
- Sponsor type
- Other government
- Collaborators
- Norwegian University of Science and Technology, Sykehuset Innlandet HF
- Responsible party
- Sponsor
- Investigators
- Espen Remme, Study director, Helse Møre og Romsdal HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03354468
- Sponsor's protocol ID
- 2015/2469
- Status last verified
- Jan 2019
- First submitted
- 21 Nov 2017
- Last updated
- 4 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 30697039
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03354468
- Acronym / sponsor ID
- 2015/2469
- Conditions
- Hospitalized Patients, Accidental Falls
- Keywords
- Prevention and Control, Patient Safety, Aged, Risk Management
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,143 participants (actual)
- Lead sponsor
- Helse Møre og Romsdal HFOther government
- Collaborators
- Norwegian University of Science and Technology, Sykehuset Innlandet HF
- Study start
- 1 Nov 2011 (actual)
- Primary completion
- 31 Oct 2014 (actual)
- Study completion
- 31 Oct 2014 (actual)
- First posted
- 28 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| fall prevention program time 1 | – | Behavioral: fall prevention programorthopedic department in Kristiansund hospital before implementation of a fall prevention program |
| no fall prevention program time 1 | – | –orthopedic department in Ålesund hospital without fall prevention program |
| fall prevention program time 2 | – | Behavioral: fall prevention programorthopedic department in Kristiansund hospital after implementation of a fall prevention program |
| no fall prevention program time 2 | – | –orthopedic department in Ålesund hospital without fall prevention program |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- n.a.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fall prevention programfall 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. | Behavioural | fall prevention program time 1, fall prevention program time 2 |
Primary outcome
proportion of fallers during the registration period
Time frame: 1 year registration period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2019.
- Results publication: PubMed 30697039Royset 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Espen Remme study director
Helse Møre og Romsdal HF
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hospitalized Patients and Accidental Falls, run by Helse Møre og Romsdal HF at 2 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
proportion of fallers during the registration period (time frame: 1 year registration period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03354468, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2019.