Clinical trial NCT05725928: Assisted Ambulation to Improve Health Outcomes for Older Medical Inpatients
Official title: Randomized Trial of Assisted Ambulation to Improve Health Outcomes for Older Medical Inpatients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mobility Limitation
Frailty
Hospital Acquired Condition
Weakness, Muscle
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2023-02-13
Enrollment: 3000
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigator proposes to conduct a randomized trial of supervised ambulation delivered by mobility technician (MT) up to three times daily, including weekends, to hospitalized medical patients. The aims of the study are to compare the short and intermediate-term outcomes of patients randomized to the intervention versus those patients randomized to receive usual care, to identify patients who are most likely to benefit from the intervention and to assess whether the intervention increases or decreases overall costs of an episode of care, including the cost of the MTs, the index hospitalization and the first 30 days post enrollment.

Detailed description: The investigator proposes to conduct a large randomized trial to test the impact of MTs (Mobility Technicians) on short and intermediate term outcomes for 3000 patients aged 65 years and older at 5 hospitals in 2 health systems. Patients will be randomized to receive supervised ambulation up to 3 times daily with a MT or to receive usual care. All participants will wear an accelerometer on their wrist to track their movement throughout the hospital stay. The study has 3 aims. First, the study will compare the mobility of patients at discharge (or 10 days) to assess the impact of the MTs on this outcome. Of particular interest is whether the use of MTs will increase the proportion of patients who can go home vs.post-acute care, and whether the improvements in mobility are sustained at 30 days. Second, the study will use predictive modeling to identify which patients are most likely to benefit from this intervention. Third, the study will assess the impact of the intervention on overall costs associated with the episode of care, including inpatient costs and the 30 days post enrollment. This information will be important to convince health systems to adopt this approach.

Eligibility criteria: Inclusion Criteria:

Participants must meet all of the inclusion criteria listed below to participate in this study:

1. ≥65 years of age
2. Admitted to a medical service
3. Complete history and physical examination on file
4. 6-Clicks score of 16-23
5. Insurance with Traditional Medicare or Medicare Advantage

Exclusion Criteria:

Any patient meeting any of the exclusion criteria listed below at baseline will be excluded from study participation:

1. Significant language barrier that requires a translator (other than Spanish at Baystate site only)
2. Discharge planned for that day or the following day
3. Observation status
4. Surgical procedure planned
5. Patients diagnosed with unstable angina or other medical conditions precluding participation in exercise/ambulation
6. Permanent residence in a skilled nursing facility
7. Comfort care measures only
8. \>48 hours since admission
9. Active infection with COVID-19
10. Other active infection requiring contact or droplet precautions
11. Order for bedrest

Primary outcomes:
measure: Change in Short Physical Performance Battery (SPPB) from admission
timeFrame: Up to 10 days
Secondary outcomes:
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) physical function - mobility
timeFrame: 30 days post enrollment
measure: Activity Measure for Post-Acute Care (AM-PAC) basic mobility outpatient short form (SF)
timeFrame: 30 days post enrollment
measure: Hospital-Acquired Complications
timeFrame: 10 days
measure: Number of Patients with Readmission within 30 days
timeFrame: 30 days after discharge
measure: Activities of Daily Living
timeFrame: 30 days post enrollment
measure: Frailty
timeFrame: 30 days post enrollment
measure: Total episode cost
timeFrame: Admission to 30 days post enrollment
measure: Number of Patients Discharged to Home
timeFrame: date of randomization to date of discharge, up to 30 days
measure: Length of Stay
timeFrame: date of admission to date of discharge, up to 30 days
measure: Mortality
timeFrame: 30 days from admission
measure: Total episode cost
timeFrame: Admission to 6 months after enrollment
measure: Falls post-discharge
timeFrame: 30 days from admission
Other outcomes:
Locations:
city: Springfield
country: United States
facility: Baystate Medical Center
state: Massachusetts
city: Cleveland
country: United States
facility: Fairview Hospital
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic- Main Campus
state: Ohio
city: Garfield Heights
country: United States
facility: Marymount Hospital
state: Ohio
city: Mayfield Heights
country: United States
facility: Hillcrest Hospital
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Michael Rothberg, M.D.
role: PRINCIPAL_INVESTIGATOR
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