The Effect of The STEADI Program on Falls and Falls Prevention in Neurosurgical Patients in Jordan

September 5, 2023 updated by: Jehad Rababah, King Abdullah University Hospital
The goal of this interventional study will be to evaluate the effectiveness of the STEADI Program on falls and falling prevention compared with routine falling assessment in neurosurgical patients in Jordan. The researchers will compare the effectiveness of the STEADI intervention in the intervention group. Participants in the intervention group will be assessed for falls risk using well-established tools as recommended by the Centers for Disease Control and Prevention (CDC). The control group participants will receive regular falling assessment which involves using Morse Fall Scale.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The STEADI (Stopping Elderly Accidents, Deaths & Injuries) program was developed by the Centers for Disease Control and Prevention (CDC) to help healthcare providers address falls among older adults. The STEADI program provides healthcare providers with tools and resources to screen their older patients for fall risk, assess risk factors, and develop and implement an individualized fall prevention plan. The STEADI program is an evidence-based approach to fall prevention and has been shown to reduce falls among older adults. However, evidence regarding the effectiveness and usefulness of the STEADI among neurosurgery patients is lacking. The investigators of the current research will conduct a 2-hour educational session to train healthcare providers in a neurosurgery unit on using the STEADI tools and algorithm. Then, the investigators will collect data to assess whether applying the STEADI decreases the risk for falls in neurosurgery patients.

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

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

  • Jordan
      • Irbid, Jordan, 22110
        • Jehad Rababah

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Newly admitted patients to the neurosurgery unit as a case of neurosurgery, have ≥4 scores on the Stay Independent Brochure (SIB), 18 years old or older.

Exclusion Criteria:

  • Bedridden and unconscious/comatose patients

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

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
The STEADI program will be applied to this group of participants. The STEADI involves frequent assessment of patients' risk for falls and making appropriate changes to decrease the risk for falls.
Combination product: STEADI Program
The investigators will conduct STEADI Algorithm for Falls Prevention educational sessions for healthcare providers in the neurosurgery unit, including doctors, nurses, physical therapists, and pharmacists. All healthcare providers in the neurosurgery unit will be invited to attend the educational sessions. Their participation will be voluntary and no obligations will be made, though. Healthcare providers will be invited to attend one 2-hour educational session. In each session, The investigators will have between 8-10 healthcare providers. The educational sessions will be delivered in the classroom available in the neurosurgery unit to facilitate the healthcare providers' access. PowerPoint presentations, videos, quizzes, case studies, and in-class discussions will be used to deliver learning content during the educational sessions. Healthcare providers will then be asked to apply the STEADI interventions on a group of patients.
Active Comparator: Control
The STEADI program will not be applied to the control group participants. This group will receive the usual care provided to the patients in the hospital.
Other: Routine care
The control group participants will receive routine care. Routine care involves only assessing for falls using Morse Falls Scale (MFS). MFS assesses a patient's fall risk upon admission, following a change in status, and at discharge or transfer to a new setting.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Stay Independent Brochure (SIB)
Time Frame: Change from baseline to 5-days and 1-month
The Stay Independent Brochure (SIB) will be used to assess the risk for falls as recommended by the CDC's STEADI. The SIB involves 12 items, and each item has a potential response of "No" (= 0) or "Yes" (= 1). Scoring relies on the number of "yes" answers to each question item, with a total possible score of 12. Participants are considered to be at risk of fall based on the following criteria: answer "yes" to 4 or more out of 12 questions, otherwise not at risk.
Change from baseline to 5-days and 1-month
The clinician's 3 key questions
Time Frame: Change from baseline to 5-days and 1-month
The clinician's 3 key questions will also be used to assess the risk for falls as recommended by the CDC's STEADI. The three questions used are "fell in the past year?" "feel unsteady when standing or walking?" and "worries about walking?" Participants with a "yes" answer to any of the 3 key questions will be considered at risk of falls, and those with all "no" answers will be considered not at risk for falls.
Change from baseline to 5-days and 1-month
Time Up and Go (TUG)
Time Frame: Change from baseline to 5-days and 1-month
The TUG is designed to evaluate mobility skills, balance, and fall risk. TUG performance is measured as the time taken to complete the test, with a longer completion time indicating poorer functional mobility and higher fall risk.
Change from baseline to 5-days and 1-month
30-Second Chair Stand
Time Frame: Change from baseline to 5-days and 1-month
The 30-S Chair Stand assesses lower extremity strength and endurance. This test uses a chair with a straight back without armrests and a seat height of 17 inches. The participant will sit in a chair with their arms crossed over their chest. When the investigator says "go," the participant will stand up and sit down again. And repeat this for 30 seconds. The investigator will count how many times a participant can do this. A lower number may mean the participant is at higher risk for a fall.
Change from baseline to 5-days and 1-month
The 4-Stage Balance test
Time Frame: Change from baseline to 5-days and 1-month
The 4-Stage Balance test is an assessment of static balance in four different positions and increasingly challenging positions: (1) feet together, (2) instep of foot advanced to toe of other foot, (3) foot in front of other foot (tandem), and (4) and single-leg stance. Without being able to stand or lasting less than 10 seconds, all 4 types are considered to be at risk for falls, standing for 10 seconds or more is considered not at risk for falls.
Change from baseline to 5-days and 1-month
Actual falls
Time Frame: At final (1-month) assessment
The actual number of falls will be recorded for all patients. Results will be reported as an average number of falls.
At final (1-month) assessment

Collaborators and Investigators

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

Sponsor

King Abdullah University Hospital

Collaborators

Jordan University of Science and Technology

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.

General Publications

Helpful Links

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)

March 1, 2023

Primary Completion (Actual)

July 31, 2023

Study Completion (Actual)

August 31, 2023

Study Registration Dates

First Submitted

March 17, 2023

First Submitted That Met QC Criteria

April 4, 2023

First Posted (Actual)

April 18, 2023

Study Record Updates

Last Update Posted (Actual)

September 6, 2023

Last Update Submitted That Met QC Criteria

September 5, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 92-2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The IPD will not be shared with other researchers. Only aggregate data will be disseminated.

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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