Depression, Disabled, Disabling Medical Events
Conditions
Keywords
Physical Therapy, Occupational Therapy, Rehabilitation, Older adults, Depression, Physical Functioning
Brief summary
The purpose of this study is to provide evidence that Enhanced Medical Rehabilitation is an effective treatment for older adults after disabling medical events.
Detailed description
The intervention involves physical and occupational therapy for patients who have been admitted to a skilled nursing facility for therapy following a disabling medical event. Participants in this study will be randomly assigned to receive either Enhanced or standard of care therapy, meaning they will either receive their PT (Physical Therapy)& OT(Occupational Therapy) from therapists who have been specially trained in the study intervention or from therapists with normal training. Participants will be assessed at baseline, 30, 60, and 90 days after baseline, and at the date of their discharge from the skilled nursing facility.
Interventions
BEHAVIORALEnhanced Medical Rehabilitation
Daily PT/OT provided by therapists trained in Enhanced Medical Rehabilitation. This training focuses on improved communication, patient engagement, and intensity.
BEHAVIORALStandard of Care Rehabilitation
Daily PT/OT provided by therapists not trained in the treatment intervention.
Sponsors
National Institutes of Health (NIH)
National Institute of Mental Health (NIMH)
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 65 and older * Admitted to a skilled nursing facility for post-acute care from PT and OT for 2 weeks or more.
Exclusion criteria
* Language, visual or hearing barriers to participation * Medical illness preventing study participation or accurate data collection * Moderate-severe dementia (demonstrated by chart diagnosis and/or short blessed score greater than 13) * Progressive neurological condition such that recovery of function is not feasible * Patient did not have the ability to walk prior to hospitalization (e.g. paraplegic) * Schizophrenia or other chronic or current psychotic disorder.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Barthel Index Score | Baseline and Discharge, an average of 24 days. | Barthel Index scores range from 0 to 100, with higher scores indicating greater levels of function. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gait Speed (Determined by 4 or 10 Meter Walk Test) | Discharge, an average of 24 days after baseline. | Meters walked per second. |
| Distance Ambulated in 6-Minute Walk Test | Discharge, an average of 24 days after baseline. | Feet walked during 6 minute interval. |
| Self-reported Barthel Index | 30, 60, and 90 Days Post Admission to the SNF | Barthel Index scores range from 0 to 100, with higher scores indicating greater levels of function. Conducted as a self-report at timepoints where patient was not in an institutional setting. |
| Discharge Disposition | Discharge, an average of 24 days after baseline. | Number of participants discharged from skilled nursing facility to home |
| Rehospitalizations | Days 30, 60, and 90 post admission to a SNF as well as at Discharge | Assesses whether the participant was readmitted to the hospital. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from 2 skilled nursing facilities in the St. Louis, Missouri metropolitan area from July 29, 2014 through March 22, 2018.
Participants by arm
| Arm | Count |
|---|---|
| Standard of Care Rehabilitation Standard of Care Rehabilitation: Daily PT/OT provided by therapists not trained in the treatment intervention. | 115 |
| Enhanced Medical Rehabilitation Enhanced Medical Rehabilitation: Daily PT/OT provided by therapists trained in Enhanced Medical Rehabilitation. This training focuses on improved communication, patient engagement, and intensity. | 114 |
| Total | 229 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 6 | 11 |
| Overall Study | Lost to Follow-up | 4 | 6 |
| Overall Study | Physician Decision | 0 | 2 |
| Overall Study | Withdrawal by Subject | 9 | 5 |
Baseline characteristics
| Characteristic | Total | Standard of Care Rehabilitation | Enhanced Medical Rehabilitation |
|---|---|---|---|
| Age, Continuous | 79.3 years STANDARD_DEVIATION 8 | 79.2 years STANDARD_DEVIATION 7.7 | 79.5 years STANDARD_DEVIATION 8.2 |
| Barthel Index Total Score (Admission) | 33.5 units on a scale STANDARD_DEVIATION 13 | 34.7 units on a scale STANDARD_DEVIATION 12.8 | 32.3 units on a scale STANDARD_DEVIATION 13.1 |
| Barthel Index Total Score (Premorbid) | 95.6 units on a scale STANDARD_DEVIATION 8.1 | 95.1 units on a scale STANDARD_DEVIATION 9 | 96.1 units on a scale STANDARD_DEVIATION 6.9 |
| CIRS-G Score | 16.9 units on a scale STANDARD_DEVIATION 5.2 | 17.1 units on a scale STANDARD_DEVIATION 5.4 | 16.8 units on a scale STANDARD_DEVIATION 5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 228 Participants | 114 Participants | 114 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Impairment Type Heart | 60 Participants | 29 Participants | 31 Participants |
| Impairment Type Musculoskeletal/Integument | 80 Participants | 44 Participants | 36 Participants |
| Impairment Type Neurologic | 10 Participants | 5 Participants | 5 Participants |
| Impairment Type Other/Unknown | 41 Participants | 22 Participants | 19 Participants |
| Impairment Type Renal | 14 Participants | 7 Participants | 7 Participants |
| Impairment Type Respiratory | 43 Participants | 18 Participants | 25 Participants |
| MADRS Score | 8.6 units on a scale STANDARD_DEVIATION 7.8 | 8.4 units on a scale STANDARD_DEVIATION 8 | 8.8 units on a scale STANDARD_DEVIATION 7.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 51 Participants | 26 Participants | 25 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 177 Participants | 89 Participants | 88 Participants |
| Sex: Female, Male Female | 149 Participants | 75 Participants | 74 Participants |
| Sex: Female, Male Male | 80 Participants | 40 Participants | 40 Participants |
| Short Blessed Test Score | 4.1 units on a scale STANDARD_DEVIATION 3.4 | 3.8 units on a scale STANDARD_DEVIATION 3.2 | 4.4 units on a scale STANDARD_DEVIATION 3.6 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 6 / 115 | 11 / 114 |
| other Total, other adverse events | 0 / 115 | 0 / 114 |
| serious Total, serious adverse events | 6 / 115 | 11 / 114 |
Outcome results
Primary
Change in Barthel Index Score
Barthel Index scores range from 0 to 100, with higher scores indicating greater levels of function.
Time frame: Baseline and Discharge, an average of 24 days.
Population: One Standard of Care participant did not have a baseline Barthel completed. Otherwise, all other 228 participants were included in the analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Standard of Care Rehabilitation | Change in Barthel Index Score | 28.48 score on a scale | Standard Error 1.68 |
| Enhanced Medical Rehabilitation | Change in Barthel Index Score | 34.92 score on a scale | Standard Error 1.66 |
Comparison: This Primary analysis used a marginal model with time (baseline and discharge), condition (EMR vs SOC), and time x condition as fixed effects, with an unstructured covariance structure specified, based on Bayesian information criteria (BIC).p-value: 0.007Marginal Model
Secondary
Discharge Disposition
Number of participants discharged from skilled nursing facility to home
Time frame: Discharge, an average of 24 days after baseline.
Population: Any participant with a discharge disposition of either 'to home' or 'to institution' were included in the analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard of Care Rehabilitation | Discharge Disposition | 89 Participants |
| Enhanced Medical Rehabilitation | Discharge Disposition | 94 Participants |
p-value: 0.37Chi-squared
Secondary
Distance Ambulated in 6-Minute Walk Test
Feet walked during 6 minute interval.
Time frame: Discharge, an average of 24 days after baseline.
Population: All participants able to perform a 6-minute walk at discharge were included in the analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard of Care Rehabilitation | Distance Ambulated in 6-Minute Walk Test | 210 feet |
| Enhanced Medical Rehabilitation | Distance Ambulated in 6-Minute Walk Test | 170 feet |
p-value: 0.91Wilcoxon (Mann-Whitney)
Secondary
Gait Speed (Determined by 4 or 10 Meter Walk Test)
Meters walked per second.
Time frame: Discharge, an average of 24 days after baseline.
Population: All participants with a gait speed at discharge were included in the analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Standard of Care Rehabilitation | Gait Speed (Determined by 4 or 10 Meter Walk Test) | 0.45 meters per second |
| Enhanced Medical Rehabilitation | Gait Speed (Determined by 4 or 10 Meter Walk Test) | 0.35 meters per second |
p-value: 0.11Wilcoxon (Mann-Whitney)
Secondary
Rehospitalizations
Assesses whether the participant was readmitted to the hospital.
Time frame: Days 30, 60, and 90 post admission to a SNF as well as at Discharge
Population: Any participant with at least one re-hospitalization at day 30, day 60, day 90 or at discharge was included in the analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard of Care Rehabilitation | Rehospitalizations | 43 Participants |
| Enhanced Medical Rehabilitation | Rehospitalizations | 42 Participants |
p-value: 0.85Chi-squared
Secondary
Self-reported Barthel Index
Barthel Index scores range from 0 to 100, with higher scores indicating greater levels of function. Conducted as a self-report at timepoints where patient was not in an institutional setting.
Time frame: 30, 60, and 90 Days Post Admission to the SNF
Population: Any participant with data at either 30 days, 60 days, 90 days, or at discharge were included in the analyses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard of Care Rehabilitation | Self-reported Barthel Index | Day 30 | 78.95 score on a scale | Standard Error 2.08 |
| Standard of Care Rehabilitation | Self-reported Barthel Index | Day 60 | 85.01 score on a scale | Standard Error 1.94 |
| Standard of Care Rehabilitation | Self-reported Barthel Index | Day 90 | 84.67 score on a scale | Standard Error 2.16 |
| Enhanced Medical Rehabilitation | Self-reported Barthel Index | Day 30 | 78.79 score on a scale | Standard Error 2.08 |
| Enhanced Medical Rehabilitation | Self-reported Barthel Index | Day 60 | 84.27 score on a scale | Standard Error 1.99 |
| Enhanced Medical Rehabilitation | Self-reported Barthel Index | Day 90 | 83.65 score on a scale | Standard Error 2.2 |
Comparison: This Primary analysis used a marginal model with time (baseline and discharge), condition (EMR vs SOC), and time x condition as fixed effects, with an unstructured covariance structure specified, based on Bayesian information criteria (BIC).p-value: 0.96Mixed Models Analysis