Engaging Older Adults in Fall Prevention Using Motivational Interviewing (MI)

This mixed-methods, two-arm, randomized controlled trial will evaluate the impact of Motivational Interviewing (MI) as a follow-up care to patients who received fall prevention recommendations at Oregon Health & Science University Internal Medicine and Geriatrics Clinic provided over 12 months.

Study Overview

• Status: Completed
• Conditions: Fall; Coping Behavior; Motivation; Behavior
• Intervention / Treatment: Behavioral: Motivational Interviewing

Detailed Description

The goal of this mixed-methods, two-arm, randomized controlled trial of MI intervention for fall prevention is to evaluate the impact of Motivational Interviewing (MI) as a follow-up care to patients who received fall prevention recommendations at Oregon Health & Science University Internal Medicine and Geriatrics Clinic provided over 12-months. Older adult participants (older than 65) who are at increased risk for falling will be enrolled into the study. Patients will be randomly assigned to two groups: MI and the standard of care group. All participants will have a baseline and 6-months study visit that will include self-report and physiologic assessment. In addition, all participants will receive study measurement phone call at 3-, and 12-months. MI will be provided via video, phone, or in-person one week after the initial visit and then monthly for 6 months. All MI sessions will be recorded and encounter notes will be completed. Purposefully selected participants' MI sessions will be transcribed for qualitative analysis.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Oregon Health & Science University (OHSU) Internal Medicine and Geriatrics Clinic patients
• 65 years old or older
• Moderate-to-high risk for falling using the STEADI fall screening and management algorithm
• Cognitively oriented (Mini-Cog≥ 3)
• Able to converse audibly and coherently in English
• Living independently in the community
• Able to receive study phone calls
• Ambulatory with or without assistive device use

Exclusion Criteria:

• Cognitively impaired patients (Mini-Cog< 2)
• Patients who have sensory difficulty with verbal communication (hard-of-hearing despite the use of hearing aids or speech is hard to understand despite a talking device)
• Living in institutions with 24-hour care such as skilled nursing facilities
• Unable to stand without assistance by others
• Life-expectancy of less than 3-months
• Patients participating in other studies that may impact fall-related behavior change

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Motivational Interviewing (MI) goup; The MI experimental group will receive the same measurements as the control group, and in addition, receive MI-based communication about fall prevention at eight occasions during the 6-month period. MI is an evidence-based communication approach for various health behavior change.	Behavioral: Motivational Interviewing; The PI and two study staff members (interventionists) will conduct study visits and phone calls. The same person will complete participant follow-ups to establish rapport and consistency. All of the study encounters will be audio recorded with participants' permission and study encounter notes will be completed by the interventionist. Interventionists will facilitate MI sessions using the MI guide and a participant handout. The goal of each MI session is to identify a specific fall prevention behavior, the participant's goal with this behavior, readiness to change, specific plan to move toward the goal, barriers and facilitators, and the participant's commitment level to change.
No Intervention: Control group; The control group participants will take part in study measurements (self-report and physiologic assessment) for 12-months. Primary assessment measures are at baseline, 6-, and 12-months and will be conducted via phone survey, video assessment, or mail-in calendar.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Falls Self-Efficacy Scale-International (FES-I) Results	A 7-item scale, 1-4 self-report rating, widely used to measure levels of concern related to preventing falls. Minimum value is 7 and maximum value is 28. Higher FES-I scores is a worse value since it has been positively correlated with decreased activities, future falls, and injury.	3-, 6-, and 12-months
Fall Behavioral (FAB) Scale Results	A 24-item, 1-4 self-report rating to measure frequency of protective strategies to prevent falling and risky behaviors that facilitate a fall. The average value is calculated with a minimum value of 1 and maximum value of 4. Higher FAB score is a better value since it indicates more consistent fall protective behaviors.	3-, 6-, and 12-months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Activation Measure Results	100-point, quantifiable scale determining patient engagement in healthcare. Minimum value is 0 and the maximum value is 100. Higher value is a better value since it is indicative of participant's activation with their healthcare.	3-, 6-, and 12-months
Level of Confidence to Prevent Falls	1-item 10-point scale response. Often used in motivational interviewing sessions to gauge an individual's readiness to engage in certain health behaviors. Higher levels of confidence are known to be associated with an increased rate of behavior change.	3-, 6-, and 12-months
Level of Importance to Prevent Falls	1-item 10-point scale response. Often used in motivational interviewing sessions to gauge an individual's readiness to engage in certain health behaviors. Higher levels of importance are known to be associated with an increased rate of behavior change.	3-, 6-, and 12-months
Balance Measure (Feet Side by Side)	Duration that participants can hold feet side-by-side stand (heel to toe standing positions) will be measured up to 10 seconds. Minimum value is 0 seconds and maximum score is 10 seconds. Higher value is a better value since it is indicative of participants' ability to hold balance.	6- months
Balance Measure (Semi-tandem Stand)	Duration that participants can hold semi-tandem stand (heel to toe standing positions) will be measured up to 10 seconds. Minimum value is 0 seconds and maximum score is 10 seconds. Higher value is a better value since it is indicative of participants' ability to hold balance.	6- months
Balance Measure (Tandem Stand)	Individuals are asked to hold a tandem stand (one foot in front of the other- heel touching toe). The minimum is 0 and the maximum is 10. A higher number is a better outcome.	6-months
Balance Measure (One-leg Stand)	Individuals are asked to hold a balance position for 10 sections without moving their feet or needing support. This position require standing on one foot. The minimum is 0 and the maximum is 10. A higher number is a better outcome.	6- months
30-second Sit-to-stand Assessment	Instances that participants can stand from a sitting position will be measured. Minimum value is 0 times. Higher value is a better value since it is indicative of participants' ability to sit-to-stand.	6-months
Number of Participants With Self-reported Falls	Individuals were asked to mail-in reports of falls every month. Participants reporting a fall at least once are counted as a faller. Minimum value is 0. Higher value is worse value as it is indicative that there were more participants who fell during the year.	1-year

Collaborators and Investigators

• Sponsor: Oregon Health and Science University
• Collaborators: National Institute of Nursing Research (NINR)
• Investigators: Principal Investigator: Hiroko Kiyoshi-Teo, PhD, Oregon Health and Science University

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2020
• Primary Completion (Actual): March 24, 2023
• Study Completion (Actual): September 28, 2023

Study Registration Dates

• First Submitted: October 8, 2020
• First Submitted That Met QC Criteria: October 27, 2020
• First Posted (Actual): November 3, 2020

Study Record Updates

• Last Update Posted (Actual): August 13, 2024
• Last Update Submitted That Met QC Criteria: July 22, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Motivational Interviewing; Fall prevention
• Other Study ID Numbers: IRB00008993; K23NR018672 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data to be shared with other researchers are: individual participant data that underlie the results reported in the publication after deidentification.
• IPD Sharing Time Frame: Beginning 9 months after and ending 36 months following the publication of the data.
• IPD Sharing Access Criteria: Investigators whose proposed use of data has been approved by an independent review committee. Proposal to use the data may be submitted up to 36 months following article publication. After 36 months, data will be available in OHSU data warehouse.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No