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

Overview

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.

Interventions

• 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 t

Primary outcome measures

• Change in Short Physical Performance Battery (SPPB) from admission [Time frame: Up to 10 days]

Secondary outcome measures (12)

• Patient-Reported Outcomes Measurement Information System (PROMIS) physical function - mobility [Time frame: 30 days post enrollment]
• Activity Measure for Post-Acute Care (AM-PAC) basic mobility outpatient short form (SF) [Time frame: 30 days post enrollment]
• Hospital-Acquired Complications [Time frame: 10 days]
• Number of Patients with Readmission within 30 days [Time frame: 30 days after discharge]
• Activities of Daily Living [Time frame: 30 days post enrollment]
• Frailty [Time frame: 30 days post enrollment]
• Total episode cost [Time frame: Admission to 30 days post enrollment]
• Number of Patients Discharged to Home [Time frame: date of randomization to date of discharge, up to 30 days]
• Length of Stay [Time frame: date of admission to date of discharge, up to 30 days]
• Mortality [Time frame: 30 days from admission]
• Total episode cost [Time frame: Admission to 6 months after enrollment]
• Falls post-discharge [Time frame: 30 days from admission]

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 16-23
• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Prevention

Study locations

United States · 5 centers

• Baystate Medical Center — Springfield
• Fairview Hospital — Cleveland
• Cleveland Clinic- Main Campus — Cleveland
• Marymount Hospital — Garfield Heights
• Hillcrest Hospital — Mayfield Heights

Publications

• 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):1333-4 PMID 24825244
• 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. PMID 19293070
• 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. PMID 21314647
• Corcoran PJ. Use it or lose it--the hazards of bed rest and inactivity. West J Med. 1991 May;154(5):536-8. PMID 1866946
• 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. PMID 6955965
• 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. PMID 2123911
• 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. PMID 8629876
• 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. PMID 19682121

Identifiers

NCT: NCT05725928 · 22-426 · 1R01AG073278-01A1

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗