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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
3,000
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.
Baystate Medical Center
Springfield, Massachusetts, United States
RECRUITINGFairview Hospital
Cleveland, Ohio, United States
RECRUITINGCleveland Clinic- Main Campus
Cleveland, Ohio, United States
RECRUITINGMarymount Hospital
Garfield Heights, Ohio, United States
RECRUITINGHillcrest Hospital
Mayfield Heights, Ohio, United States
RECRUITINGChange in Short Physical Performance Battery (SPPB) from admission
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.
Time frame: Up to 10 days
Patient-Reported Outcomes Measurement Information System (PROMIS) physical function - mobility
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)
Time frame: 30 days post enrollment
Activity Measure for Post-Acute Care (AM-PAC) basic mobility outpatient short form (SF)
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)
Time frame: 30 days post enrollment
Hospital-Acquired Complications
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.
Time frame: 10 days
Number of Patients with Readmission within 30 days
All cause readmission within 30 days of discharge from the index hospitalization.
Time frame: 30 days after discharge
Activities of Daily Living
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)
Time frame: 30 days post enrollment
Frailty
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)
Time frame: 30 days post enrollment
Total episode cost
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 30 days post-enrollment (from Medicare claims).
Time frame: Admission to 30 days post enrollment
Number of Patients Discharged to Home
Based on the discharge disposition in the medical record, investigators will identify whether the patient was discharged to home.
Time frame: date of randomization to date of discharge, up to 30 days
Length of Stay
Length of stay will be calculated as whole days from the time of admission to the time of discharge.
Time frame: date of admission to date of discharge, up to 30 days
Mortality
Patient's vital status will be ascertained from the EHR, Medicare claims or from follow-up phone calls.
Time frame: 30 days from admission
Total episode cost
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).
Time frame: Admission to 6 months after enrollment
Falls post-discharge
Whether the patient has fallen, whether it was multiple times and whether an injury occurred will be assessed via telephone
Time frame: 30 days from admission
RCSQ (Richards Campbell Sleep Questionnaire)
Five question sleep survey which measures overall quality of sleep. Patients in both study arms will complete the questionnaire each morning regarding the previous night's sleep.
Time frame: Days 1-10
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