Behavior, Coping Behavior, Fall, Motivation
Conditions
Keywords
Fall prevention, Motivational Interviewing
Brief summary
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.
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.
Interventions
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.
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Falls Self-Efficacy Scale-International (FES-I) Results | 3-, 6-, and 12-months | 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. |
| Fall Behavioral (FAB) Scale Results | 3-, 6-, and 12-months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Level of Importance to Prevent Falls | 3-, 6-, and 12-months | 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. |
| Balance Measure (Feet Side by Side) | 6- months | 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. |
| Balance Measure (Semi-tandem Stand) | 6- months | 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. |
| Patient Activation Measure Results | 3-, 6-, and 12-months | 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. |
| Balance Measure (One-leg Stand) | 6- months | 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. |
| 30-second Sit-to-stand Assessment | 6-months | 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. |
| Number of Participants With Self-reported Falls | 1-year | 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. |
| Balance Measure (Tandem Stand) | 6-months | 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. |
| Level of Confidence to Prevent Falls | 3-, 6-, and 12-months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Motivational Interviewing (MI) Group The MI experimental group will take part in the same study 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.
Motivational Interviewing: Study interventionists will conduct the remote MI sessions. The same person will complete participant follow-ups to establish rapport and consistency. Study staff will conduct study visits and phone calls. MI sessions will be audio recorded with participants' permission and MI session 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 specific fall prevention behaviors, the participant's goals with these behaviors, and promote readiness to change. | 90 |
| Control Group The control group participants will take part in study measurements at baseline, 3-, 6-, and 12-months after the benchmark STEADI clinic visit. | 95 |
| Total | 185 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 2 | 2 |
| Overall Study | Lost to Follow-up | 20 | 11 |
| Overall Study | Withdrawal by Subject | 26 | 15 |
Baseline characteristics
| Characteristic | Motivational Interviewing (MI) Group | Control Group | Total |
|---|---|---|---|
| 30-second Sit-to-Stand | 10 units on a scale STANDARD_DEVIATION 0.57 | 10.16 units on a scale STANDARD_DEVIATION 0.6 | 10.1 units on a scale STANDARD_DEVIATION 4 |
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 90 Participants | 95 Participants | 185 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 79.1 Years STANDARD_DEVIATION 7.6 | 80.9 Years STANDARD_DEVIATION 7.7 | 80.1 Years STANDARD_DEVIATION 7.7 |
| Balance Measure 1-legged stand balance | 6.71 units on a scale STANDARD_DEVIATION 3.88 | 5.71 units on a scale STANDARD_DEVIATION 3.86 | 6.24 units on a scale STANDARD_DEVIATION 3.88 |
| Balance Measure Semi-tandem stand balance | 9.96 units on a scale STANDARD_DEVIATION 0.28 | 9.74 units on a scale STANDARD_DEVIATION 1.37 | 9.86 units on a scale STANDARD_DEVIATION 0.97 |
| Balance Measure Side-by-side stand balance | 10 units on a scale STANDARD_DEVIATION 0 | 9.96 units on a scale STANDARD_DEVIATION 0.295 | 9.98 units on a scale STANDARD_DEVIATION 0.2 |
| Balance Measure Tandem stand balance | 9.33 units on a scale STANDARD_DEVIATION 1.83 | 8.13 units on a scale STANDARD_DEVIATION 3.35 | 8.77 units on a scale STANDARD_DEVIATION 2.7 |
| Fall Efficacy Scale International- Short | 13.33 units on a scale STANDARD_DEVIATION 4.46 | 13.83 units on a scale STANDARD_DEVIATION 5.59 | 13.59 units on a scale STANDARD_DEVIATION 5.07 |
| Falls Behavioral Scale | 3.04 units on a scale STANDARD_DEVIATION 0.46 | 2.96 units on a scale STANDARD_DEVIATION 0.46 | 3.00 units on a scale STANDARD_DEVIATION 0.46 |
| Patient Activation Measure | 67.61 units on a scale STANDARD_DEVIATION 12.86 | 66.69 units on a scale STANDARD_DEVIATION 13.89 | 67.14 units on a scale STANDARD_DEVIATION 13.37 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 3 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) White | 85 Participants | 86 Participants | 171 Participants |
| Region of Enrollment United States | 90 participants | 95 participants | 185 participants |
| Sex: Female, Male Female | 60 Participants | 65 Participants | 125 Participants |
| Sex: Female, Male Male | 30 Participants | 30 Participants | 60 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 101 | 2 / 99 |
| other Total, other adverse events | 54 / 101 | 62 / 99 |
| serious Total, serious adverse events | 11 / 101 | 13 / 99 |
Outcome results
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.
Time frame: 3-, 6-, and 12-months
Population: We used mixed-effect modeling to measure changes over time, which includes all participants who have outcome measure in at least one time-point. Thus, the analytic sample in the table below looks different from the participant flow data. We conducted intent-to-treat analysis (including participants regardless of drop out. No list-wise deletion.)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Motivational Interviewing (MI) Group | Fall Behavioral (FAB) Scale Results | 3-months | 3.16 units on a scale | Standard Error 0.05 |
| Motivational Interviewing (MI) Group | Fall Behavioral (FAB) Scale Results | 6-months | 3.23 units on a scale | Standard Error 0.05 |
| Motivational Interviewing (MI) Group | Fall Behavioral (FAB) Scale Results | 12-months | 3.17 units on a scale | Standard Error 0.05 |
| Control Group | Fall Behavioral (FAB) Scale Results | 3-months | 3.08 units on a scale | Standard Error 0.05 |
| Control Group | Fall Behavioral (FAB) Scale Results | 6-months | 3.11 units on a scale | Standard Error 0.05 |
| Control Group | Fall Behavioral (FAB) Scale Results | 12-months | 3.14 units on a scale | Standard Error 0.05 |
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.
Time frame: 3-, 6-, and 12-months
Population: We used mixed-effect modeling to measure changes over time, which includes all participants who have outcome measure in at least one time-point. Thus, the analytic sample in the table below looks different from participant flow data. We conducted intent-to-treat analysis (including participants regardless of drop out. No list-wise deletion.)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Motivational Interviewing (MI) Group | Falls Self-Efficacy Scale-International (FES-I) Results | 3-months | 13.07 units on a scale | Standard Error 0.57 |
| Motivational Interviewing (MI) Group | Falls Self-Efficacy Scale-International (FES-I) Results | 6-months | 13.41 units on a scale | Standard Error 0.59 |
| Motivational Interviewing (MI) Group | Falls Self-Efficacy Scale-International (FES-I) Results | 12-months | 13.01 units on a scale | Standard Error 0.67 |
| Control Group | Falls Self-Efficacy Scale-International (FES-I) Results | 3-months | 13.71 units on a scale | Standard Error 0.54 |
| Control Group | Falls Self-Efficacy Scale-International (FES-I) Results | 6-months | 14.35 units on a scale | Standard Error 0.56 |
| Control Group | Falls Self-Efficacy Scale-International (FES-I) Results | 12-months | 13.82 units on a scale | Standard Error 0.53 |
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.
Time frame: 6-months
Population: Some participants were unable to complete the physical assessment due to physical limitations, access to a video platform, or a support person.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Motivational Interviewing (MI) Group | 30-second Sit-to-stand Assessment | 11.01 units on a scale | Standard Deviation 0.64 |
| Control Group | 30-second Sit-to-stand Assessment | 9.5 units on a scale | Standard Deviation 0.61 |
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.
Time frame: 6- months
Population: We used mixed-effect modeling to measure changes over time, which includes all participants who have outcome measure in at least one time-point. Thus, the analytic sample in the table below differs from participant flow data. We conducted intent-to-treat analysis (including participants regardless of drop out. No list-wise deletion.)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Motivational Interviewing (MI) Group | Balance Measure (Feet Side by Side) | 10 seconds | Standard Error 0 |
| Control Group | Balance Measure (Feet Side by Side) | 10 seconds | Standard Error 0 |
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.
Time frame: 6- months
Population: We used mixed-effect modeling to measure changes over time, which includes all participants who have outcome measure in at least one time-point. Thus, the analytic sample in the table below differs from participant flow data. We conducted intent-to-treat analysis (including participants regardless of drop out. No list-wise deletion.)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Motivational Interviewing (MI) Group | Balance Measure (One-leg Stand) | 6.84 seconds | Standard Error 0.68 |
| Control Group | Balance Measure (One-leg Stand) | 5.28 seconds | Standard Error 0.67 |
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.
Time frame: 6- months
Population: The number analyzed differed by time point because of the loss to follow-up and participant withdrawal as indicated in the participant flow data, and participants' willingness and ability to participate in the measurements.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Motivational Interviewing (MI) Group | Balance Measure (Semi-tandem Stand) | 10 seconds | Standard Deviation 0.17 |
| Control Group | Balance Measure (Semi-tandem Stand) | 9.79 seconds | Standard Deviation 0.15 |
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.
Time frame: 6-months
Population: We used mixed-effect modeling to measure changes over time, which includes all participants who have outcome measure in at least one time-point. Thus, the analytic sample in the table below differs from participant flow data. We conducted intent-to-treat analysis (including participants regardless of drop out. No list-wise deletion.)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Motivational Interviewing (MI) Group | Balance Measure (Tandem Stand) | 8.46 units on a scale | Standard Error 0.56 |
| Control Group | Balance Measure (Tandem Stand) | 7.47 units on a scale | Standard Error 0.55 |
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.
Time frame: 3-, 6-, and 12-months
Population: We used mixed-effect modeling to measure changes over time, which includes all participants who have outcome measure in at least one time-point. Thus, the analytic sample in the table below differs from participant flow data. We conducted intent-to-treat analysis (including participants regardless of drop out. No list-wise deletion.)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Motivational Interviewing (MI) Group | Level of Confidence to Prevent Falls | 3-months | 8.09 units on a scale | Standard Error 0.18 |
| Motivational Interviewing (MI) Group | Level of Confidence to Prevent Falls | 6-months | 8.04 units on a scale | Standard Error 0.18 |
| Motivational Interviewing (MI) Group | Level of Confidence to Prevent Falls | 12-months | 7.56 units on a scale | Standard Error 0.24 |
| Control Group | Level of Confidence to Prevent Falls | 3-months | 7.74 units on a scale | Standard Error 0.17 |
| Control Group | Level of Confidence to Prevent Falls | 6-months | 7.79 units on a scale | Standard Error 0.17 |
| Control Group | Level of Confidence to Prevent Falls | 12-months | 7.67 units on a scale | Standard Error 0.21 |
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.
Time frame: 3-, 6-, and 12-months
Population: We used mixed-effect modeling to measure changes over time, which includes all participants who have outcome measure in at least one time-point. Thus, the analytic sample in the table below differs from participant flow data. We conducted intent-to-treat analysis (including participants regardless of drop out. No list-wise deletion.)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Motivational Interviewing (MI) Group | Level of Importance to Prevent Falls | 6-months | 9.62 units on a scale | Standard Error 0.12 |
| Motivational Interviewing (MI) Group | Level of Importance to Prevent Falls | 3-months | 9.68 units on a scale | Standard Error 0.12 |
| Motivational Interviewing (MI) Group | Level of Importance to Prevent Falls | 12-months | 9.60 units on a scale | Standard Error 0.12 |
| Control Group | Level of Importance to Prevent Falls | 3-months | 9.41 units on a scale | Standard Error 0.11 |
| Control Group | Level of Importance to Prevent Falls | 6-months | 9.63 units on a scale | Standard Error 0.1 |
| Control Group | Level of Importance to Prevent Falls | 12-months | 9.59 units on a scale | Standard Error 0.11 |
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.
Time frame: 1-year
Population: One participant in the MI group had an unreliable reporting of falls due to his unstable memory (ID 1277). Based on the discussion with the Safety Monitoring Council, his data was considered an outlier and removed from the analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Motivational Interviewing (MI) Group | Number of Participants With Self-reported Falls | 56 Participants |
| Control Group | Number of Participants With Self-reported Falls | 50 Participants |
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.
Time frame: 3-, 6-, and 12-months
Population: We used mixed-effect modeling to measure changes over time, which includes all participants who have outcome measure in at least one time-point. Thus, the analytic sample in the table below differs from participant flow data. We conducted intent-to-treat analysis (including participants regardless of drop out. No list-wise deletion.)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Motivational Interviewing (MI) Group | Patient Activation Measure Results | 3-months | 70.6 score on a scale | Standard Error 1.5 |
| Motivational Interviewing (MI) Group | Patient Activation Measure Results | 6-months | 70.23 score on a scale | Standard Error 1.52 |
| Motivational Interviewing (MI) Group | Patient Activation Measure Results | 12-months | 70.44 score on a scale | Standard Error 1.83 |
| Control Group | Patient Activation Measure Results | 3-months | 71.59 score on a scale | Standard Error 1.44 |
| Control Group | Patient Activation Measure Results | 6-months | 67.33 score on a scale | Standard Error 1.45 |
| Control Group | Patient Activation Measure Results | 12-months | 68.21 score on a scale | Standard Error 1.63 |