Assisted Ambulation to Improve Health Outcomes for Older Medical Inpatients

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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

Первичные конечные точки

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

Вторичные конечные точки (12)

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

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Профилактика

Центры проведения

США · 5 центров

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

Публикации

• 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

Идентификаторы

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

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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