Assisted Ambulation to Improve Health Outcomes for Older Medical Inpatients

Frailty Clinical Trial

Official title:

Randomized Trial of Assisted Ambulation to Improve Health Outcomes for Older Medical Inpatients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05725928
• Other study ID #: 22-426
• Secondary ID: 1R01AG073278-01A
• Status: Recruiting
• Phase: N/A
• Start date: May 15, 2023
• Est. completion date: October 11, 2026

Study information

• Verified date: November 2023
• Source: The Cleveland Clinic
• Contact: Michael Rothberg, M.D.
• Phone: 216-445-0719
• Email: rothbem[@]ccf.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: October 11, 2026
• Est. primary completion date: September 11, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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 16-22

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

Related Conditions & MeSH terms

• Frailty
• Hospital Acquired Condition
• Iatrogenic Disease
• Mobility Limitation
• Muscle Weakness
• Weakness, Muscle

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Cleveland Clinic- Main Campus	Cleveland	Ohio
United States	Fairview Hospital	Cleveland	Ohio
United States	Marymount Hospital	Garfield Heights	Ohio
United States	Hillcrest Hospital	Mayfield Heights	Ohio
United States	Baystate Medical Center	Springfield	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
The Cleveland Clinic	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & Publications (12)

Brown CJ, Redden DT, Flood KL, Allman RM. The underrecognized epidemic of low mobility during hospitalization of older adults. J Am Geriatr Soc. 2009 Sep;57(9):1660-5. doi: 10.1111/j.1532-5415.2009.02393.x. Epub 2009 Aug 4. — View Citation

Brown CJ, Roth DL, Allman RM, Sawyer P, Ritchie CS, Roseman JM. Trajectories of life-space mobility after hospitalization. Ann Intern Med. 2009 Mar 17;150(6):372-8. doi: 10.7326/0003-4819-150-6-200903170-00005. — View Citation

Campbell AJ, Borrie MJ, Spears GF. Risk factors for falls in a community-based prospective study of people 70 years and older. J Gerontol. 1989 Jul;44(4):M112-7. doi: 10.1093/geronj/44.4.m112. — View Citation

Corcoran PJ. Use it or lose it--the hazards of bed rest and inactivity. West J Med. 1991 May;154(5):536-8. — View Citation

Fisher SR, Kuo YF, Graham JE, Ottenbacher KJ, Ostir GV. Early ambulation and length of stay in older adults hospitalized for acute illness. Arch Intern Med. 2010 Nov 22;170(21):1942-3. doi: 10.1001/archinternmed.2010.422. No abstract available. — View Citation

Gillick MR, Serrell NA, Gillick LS. Adverse consequences of hospitalization in the elderly. Soc Sci Med. 1982;16(10):1033-8. doi: 10.1016/0277-9536(82)90175-7. — View Citation

Graf C. Functional decline in hospitalized older adults. Am J Nurs. 2006 Jan;106(1):58-67, quiz 67-8. doi: 10.1097/00000446-200601000-00032. — View Citation

Heit JA, Silverstein MD, Mohr DN, Petterson TM, O'Fallon WM, Melton LJ 3rd. Risk factors for deep vein thrombosis and pulmonary embolism: a population-based case-control study. Arch Intern Med. 2000 Mar 27;160(6):809-15. doi: 10.1001/archinte.160.6.809. — View Citation

Hirsch CH, Sommers L, Olsen A, Mullen L, Winograd CH. The natural history of functional morbidity in hospitalized older patients. J Am Geriatr Soc. 1990 Dec;38(12):1296-303. doi: 10.1111/j.1532-5415.1990.tb03451.x. — View Citation

Sager MA, Franke T, Inouye SK, Landefeld CS, Morgan TM, Rudberg MA, Sebens H, Winograd CH. Functional outcomes of acute medical illness and hospitalization in older persons. Arch Intern Med. 1996 Mar 25;156(6):645-52. — View Citation

Suter LG, Li SX, Grady JN, Lin Z, Wang Y, Bhat KR, Turkmani D, Spivack SB, Lindenauer PK, Merrill AR, Drye EE, Krumholz HM, Bernheim SM. National patterns of risk-standardized mortality and readmission after hospitalization for acute myocardial infarction, heart failure, and pneumonia: update on publicly reported outcomes measures based on the 2013 release. J Gen Intern Med. 2014 Oct;29(10):1333-40. doi: 10.1007/s11606-014-2862-5. Epub 2014 May 14. — View Citation

Zisberg A, Shadmi E, Sinoff G, Gur-Yaish N, Srulovici E, Admi H. Low mobility during hospitalization and functional decline in older adults. J Am Geriatr Soc. 2011 Feb;59(2):266-73. doi: 10.1111/j.1532-5415.2010.03276.x. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 10 days
Secondary	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)	30 days post enrollment
Secondary	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)	30 days post enrollment
Secondary	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.	10 days
Secondary	Number of Patients with Readmission within 30 days	All cause readmission within 30 days of discharge from the index hospitalization.	30 days after discharge
Secondary	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)	30 days post enrollment
Secondary	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)	30 days post enrollment
Secondary	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).	Admission to 30 days post enrollment
Secondary	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.	date of randomization to date of discharge, up to 30 days
Secondary	Length of Stay	Length of stay will be calculated as whole days from the time of admission to the time of discharge.	date of admission to date of discharge, up to 30 days
Secondary	Mortality	Patient's vital status will be ascertained from the EHR, Medicare claims or from follow-up phone calls.	30 days from admission
Secondary	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).	Admission to 6 months after enrollment