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NCT05725928NARecruiting

Assisted Ambulation to Improve Health Outcomes for Older Medical Inpatients

The Cleveland Clinic

Start Date

5/15/2023

Completion Date

12/1/2026

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

Age Range: 65 years to No maximum

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

Interventions

BEHAVIORAL

Mobility technician

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Conditions

Mobility LimitationFrailtyHospital Acquired ConditionWeakness, Muscle

Locations

Baystate Medical Center

Springfield, Massachusetts 01199

United States

Fairview Hospital

Cleveland, Ohio 44111

United States

Cleveland Clinic- Main Campus

Cleveland, Ohio 44195

United States

Marymount Hospital

Garfield Heights, Ohio 44125

United States

Hillcrest Hospital

Mayfield Heights, Ohio 44124

United States