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

Sponsor
King Abdullah University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05815875
Collaborator
Jordan University of Science and Technology (Other)
70
1
2
6
11.6

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Combination Product: STEADI Program
  • Other: Routine care
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
70 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
This study will be conducted using a 1-month prospective quasi-experimental design. The study sample will be 70 neurosurgical patients at King Abdullah University Hospital. The study sample will be non-randomly divided into a control group (35 patients) and an intervention group (35 patients).This study will be conducted using a 1-month prospective quasi-experimental design. The study sample will be 70 neurosurgical patients at King Abdullah University Hospital. The study sample will be non-randomly divided into a control group (35 patients) and an intervention group (35 patients).
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
The Effect of The STEADI Program on Falls and Falls Prevention in Neurosurgical Patients in Jordan
Actual Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
Jul 31, 2023
Anticipated Study Completion Date :
Aug 31, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. The Stay Independent Brochure (SIB) [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.

  2. The clinician's 3 key questions [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.

  3. Time Up and Go (TUG) [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.

  4. 30-Second Chair Stand [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.

  5. The 4-Stage Balance test [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.

  6. Actual falls [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Jehad Rababah Irbid Jordan 22110

Sponsors and Collaborators

  • King Abdullah University Hospital
  • Jordan University of Science and Technology

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Jehad Rababah, Associate Professor, King Abdullah University Hospital
ClinicalTrials.gov Identifier:
NCT05815875
Other Study ID Numbers:
  • 92-2023
First Posted:
Apr 18, 2023
Last Update Posted:
Apr 18, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Jehad Rababah, Associate Professor, King Abdullah University Hospital

Study Results

No Results Posted as of Apr 18, 2023