Assisted Ambulation to Improve Health Outcomes for Older Medical Inpatients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorThe Cleveland Clinic
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥65 years of age
Admitted to a medical service
Complete history and physical examination on file
6-Clicks score of 16-23
Disqualifiers
Significant language barrier that requires a translator (other than Spanish at Baystate site only)
Discharge planned for that day or the following day
Observation status
Surgical procedure planned
Trial design
Design model
Parallel
Treatments tested in this trial
Mobility technician
BehavioralDesignated 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.
Treatment groups
3,000 Participants
are divided into 2 treatment groupsGroup A: Usual CareNo intervention 0 interventions
Group B: Mobility TechnicianExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change 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 daysSecondary outcomes
1
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 enrollment2
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 enrollment3
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 days4
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 dischargeSponsors and contacts
Click on the lead sponsor to view all of their trials.
The Cleveland Clinic
Lead sponsor
National Institute on Aging (NIA)
Collaborator
Source ClinicalTrials.gov