Assisted Ambulation to Improve Health Outcomes for Older Medical Inpatients

Not Applicable

Recruiting

• Conditions: Weakness, Muscle; Mobility Limitation; Frailty; Hospital Acquired Condition
• Interventions: Behavioral: Mobility technician

• Registration Number: NCT05725928
• Lead Sponsor: The Cleveland Clinic

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.

Study Timeline

• Study First Submitted: 2023-01-11
• Study First Submitted QC: 2023-02-10
• Study First Posted: 2023-02-13
• Study Start: 2023-05-15
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-05
• Primary Completion: 2026-09-11
• Study Completion: 2026-10-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mobility Technician	Mobility technician	Designated mobility technicians (MT) will ambulate hospitalized medical patients up to 3 times daily, 7 days per week, until discharge or a maximum of 10 days. Each day, the MT will visit the patient 4 times or until the patient successfully ambulates 3 times that day. In cases where a PT has provided a recommendation in the patient's chart, the MT will follow the recommendation, if feasible. Otherwise, the MT will execute the standard mobility protocol. The mobility protocol will allow the MT to assist a patient with an appropriate out-of-bed activity based on their 6-clicks score from the immediately preceding session

Primary Outcome Measures

Name	Time	Method
Change in Short Physical Performance Battery (SPPB) from admission	Up to 10 days	Every patient will have an SPPB score on admission to the study. A blinded assessor will measure the SPPB again at discharge or on day 10 if the patient is still hospitalized. The primary outcome is change from admission to discharge. Investigators will also compare the percentage of patients who reach the minimal clinically important difference of 1 point.; SPPB minimum value= 0 SPPB maximum value= 12 (higher score indicates a better outcome). If no blinded team member is available, the evaluation may be carried out by any unblinded team member. The blinding status of the evaluator will be noted in REDCap.

Secondary Outcome Measures

Name	Time	Method
Patient-Reported Outcomes Measurement Information System (PROMIS) physical function - mobility	30 days post enrollment	Patients will complete the PROMIS physical function mobility bank via REDCap at 30 days post enrollment. PROMIS allows use of computer-adapted testing to measure patient-reported outcomes. The mobility question bank focuses on activities of physical mobility such as getting out of bed or a chair to walking up stairs. PROMIS measures were developed and validated with state-of-the-science methods supported by National Institutes of Health (NIH) funding. PROMIS was designed to enhance communication between clinicians and patients in diverse research and clinical settings and to be relevant across all conditions for the assessment of symptoms and functions.; PROMIS minimum value= 0 PROMISE maximum value= 100 (higher score indicates a better outcome)
Activity Measure for Post-Acute Care (AM-PAC) basic mobility outpatient short form (SF)	30 days post enrollment	Subjects will complete the AM-PAC at 30 days post enrollment and the score will be transformed using the t-scale. In addition to comparing AM-PAC scores at 30 days, the investigator will also compare change in t-score from admission. The AM-PAC 6-clicks (assessed in the hospital) and the AM-PAC outpatient SF are normed to the same t-scale, allowing for conversion from the one to the other. The 6-clicks is scored by a clinical proxy, while the SF AM-PAC is self-reported, allowing for initial assessment by the MT and 30-day self-report by the patient. Previous studies have demonstrated adequate validity of mobility assessment via the AM-PAC using clinical or family proxies. To improve interpretability, investigators will compare the percentage of patients who reach the minimal clinically important difference of 3 points on the t-scale.; AM-PAC minimum value= 29.41 AM-PAC maximum value= 80.30 (higher score indicates a better outcome)
Hospital-Acquired Complications	10 days	Composite outcome of venous thromboembolism, fall with injury, pressure ulcers or hospital-acquired pneumonia. Hospital-acquired complications will be identified from the electronic health record and from the falls reporting system. All falls will be examined, whether occurring during assisted ambulation or otherwise. Only falls with injury will be included in the hospital-acquired complications measure. Outcomes will be adjudicated by blinded reviewers. While investigators are primarily interested in the composite measure, investigators will also examine the individual components separately.
Number of Patients with Readmission within 30 days	30 days after discharge	All cause readmission within 30 days of discharge from the index hospitalization.
Activities of Daily Living	30 days post enrollment	Activities of daily living as measured by the Katz and Lawton scales.; Katz minimum value= 0 Katz maximum value= 6 (higher score indicates a better outcome) Lawton minimum value= 0 Lawton maximum value= 8 (higher score indicates a better outcome)
Frailty	30 days post enrollment	Frailty as measured by the Fatigue, Resistance, Ambulation,Illness, and Loss of weight (FRAIL) scale.; FRAIL minimum value= 0 FRAIL maximum value= 5 (higher score indicates a worse outcome)
Total episode cost	Admission to 6 months after enrollment	Investigators will estimate total cost of the episode of care including the index admission (from hospital cost accounting systems), the personnel costs for the MTs (using hourly wages plus benefits), and all non-medication costs for the 6 months post-enrollment (from Medicare claims).
Number of Patients Discharged to Home	date of randomization to date of discharge, up to 30 days	Based on the discharge disposition in the medical record, investigators will identify whether the patient was discharged to home.
Mortality	30 days from admission	Patient's vital status will be ascertained from the EHR, Medicare claims or from follow-up phone calls.
Falls post-discharge	30 days from admission	Whether the patient has fallen, whether it was multiple times and whether an injury occurred will be assessed via telephone
Length of Stay	date of admission to date of discharge, up to 30 days	Length of stay will be calculated as whole days from the time of admission to the time of discharge.

Trial Locations

Locations (5)

Fairview Hospital; 🇺🇸 Cleveland, Ohio, United States

Cleveland Clinic- Main Campus; 🇺🇸 Cleveland, Ohio, United States

Marymount Hospital; 🇺🇸 Garfield Heights, Ohio, United States

Hillcrest Hospital; 🇺🇸 Mayfield Heights, Ohio, United States

Baystate Medical Center; 🇺🇸 Springfield, Massachusetts, United States