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Assisted Ambulation to Improve Health Outcomes for Older Medical Inpatients

Primary Purpose

Mobility Limitation, Frailty, Hospital Acquired Condition

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mobility technician
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Mobility Limitation

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Participants must meet all of the inclusion criteria listed below to participate in this study: ≥65 years of age Admitted to a medical service Complete history and physical examination on file 6-Clicks score of 16-22 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: 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 Patients diagnosed with unstable angina or other medical conditions precluding participation in exercise/ambulation Permanent residence in a skilled nursing facility Comfort care measures only >48 hours since admission Active infection with COVID-19 Other active infection requiring contact or droplet precautions Order for bedrest

Sites / Locations

  • Baystate Medical CenterRecruiting
  • Fairview HospitalRecruiting
  • Marymount HospitalRecruiting
  • Hillcrest HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual Care

Mobility Technician

Arm Description

No intervention

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)
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)
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.
Number of Patients with Readmission within 30 days
All cause readmission within 30 days of discharge from the index hospitalization.
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)
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)
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).
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.
Length of Stay
Length of stay will be calculated as whole days from the time of admission to the time of discharge.
Mortality
Patient's vital status will be ascertained from the EHR, Medicare claims or from follow-up phone calls.
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).

Full Information

First Posted
January 11, 2023
Last Updated
September 28, 2023
Sponsor
The Cleveland Clinic
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT05725928
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 15, 2023 (Actual)
Primary Completion Date
September 11, 2026 (Anticipated)
Study Completion Date
October 11, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Cleveland Clinic
Collaborators
National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mobility Limitation, Frailty, Hospital Acquired Condition, Weakness, Muscle

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
3000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
No intervention
Arm Title
Mobility Technician
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Mobility technician
Intervention Description
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 Measure Information:
Title
Change in Short Physical Performance Battery (SPPB) from admission
Description
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)
Time Frame
Up to 10 days
Secondary Outcome Measure Information:
Title
Patient-Reported Outcomes Measurement Information System (PROMIS) physical function - mobility
Description
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
Title
Activity Measure for Post-Acute Care (AM-PAC) basic mobility outpatient short form (SF)
Description
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
Title
Hospital-Acquired Complications
Description
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
Title
Number of Patients with Readmission within 30 days
Description
All cause readmission within 30 days of discharge from the index hospitalization.
Time Frame
30 days after discharge
Title
Activities of Daily Living
Description
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
Title
Frailty
Description
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
Title
Total episode cost
Description
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
Title
Number of Patients Discharged to Home
Description
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
Title
Length of Stay
Description
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
Title
Mortality
Description
Patient's vital status will be ascertained from the EHR, Medicare claims or from follow-up phone calls.
Time Frame
30 days from admission
Title
Total episode cost
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants must meet all of the inclusion criteria listed below to participate in this study: ≥65 years of age Admitted to a medical service Complete history and physical examination on file 6-Clicks score of 16-22 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: 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 Patients diagnosed with unstable angina or other medical conditions precluding participation in exercise/ambulation Permanent residence in a skilled nursing facility Comfort care measures only >48 hours since admission Active infection with COVID-19 Other active infection requiring contact or droplet precautions Order for bedrest
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Rothberg, M.D.
Phone
216-445-0719
Email
rothbem@ccf.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Rothberg, M.D.
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baystate Medical Center
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01199
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Quinn Pack, MD
Phone
413-794-7137
Email
quinn.pack@baystatehealth.org
Facility Name
Fairview Hospital
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44111
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Rothberg, MD
Phone
216-445-0719
Email
rothbem@ccf.org
Facility Name
Marymount Hospital
City
Garfield Heights
State/Province
Ohio
ZIP/Postal Code
44125
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Rothberg, MD
Phone
216-445-0719
Email
rothbem@ccf.org
Facility Name
Hillcrest Hospital
City
Mayfield Heights
State/Province
Ohio
ZIP/Postal Code
44124
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aaron Hamilton, MD
Phone
440-312-3000
Email
HAMILTA3@ccf.org

12. IPD Sharing Statement

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Results Reference
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Assisted Ambulation to Improve Health Outcomes for Older Medical Inpatients

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