Assisted ambulation to improve health outcomes for older medical inpatients (AMBULATE): study protocol for a randomized controlled trial

Trials

Study Protocol

Ardeshir Hashmi¹  Toyomi Goto²  Michael B. Rothberg²  Glen B. Taksler³  Quinn R. Pack⁴  Peter K. Lindenauer⁴  Aaron C. Hamilton⁵  Joshua K. Johnson⁶  Bo Hu⁷  Robert J. Fox⁸  Lee Anne Siegmund⁹  Christian N. Burchill^1,10  Mary Stilphen^1,11 

[1] Center for Geriatric Medicine, Cleveland Clinic, Cleveland, OH, USA;Center for Value-Based Care Research, Cleveland Clinic, Cleveland, OH, USA;Center for Value-Based Care Research, Cleveland Clinic, Cleveland, OH, USA;Department of Quantitative Health Sciences, Cleveland Clinic, Cleveland, OH, USA;Population Health Research Institute, Case Western Reserve University at MetroHealth System, Cleveland, OH, USA;Department of Healthcare Delivery and Population Science, University of Massachusetts Medical School-Baystate, Springfield, USA;Department of Hospital Medicine, Cleveland Clinic, Cleveland, OH, USA;Department of Physical Medicine and Rehabilitation, Neurological Institute, Cleveland Clinic, Cleveland, OH, USA;Center for Value-Based Care Research, Cleveland Clinic, Cleveland, OH, USA;Department of Quantitative Health Sciences, Cleveland Clinic, Cleveland, OH, USA;Mellen Center for Treatment and Research in Multiple Sclerosis, Neurological Institute, Cleveland Clinic, Cleveland, OH, USA;Office of Nursing Research and Innovation, and Consultant Staff, Lerner Research Institute, Cleveland Clinic, Cleveland, OH, USA;Penn Medicine Lancaster General Hospital, Lancaster, PA, USA;Rehabilitation and Sports Therapy, Neurological Institute, Cleveland Clinic, Cleveland, OH, USA;

关键词: Ambulation;    Activity;    Mobility;    Older adults;    Geriatrics;    Hospital;    Inpatient;   

DOI  :  10.1186/s13063-023-07501-y

 received in 2023-05-23, accepted in 2023-06-28,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundHospitalized older adults spend as much as 95% of their time in bed, which can result in adverse events and delay recovery while increasing costs. Observational studies have shown that general mobility interventions (e.g., ambulation) can mitigate adverse events and improve patients’ functional status. Mobility technicians (MTs) may address the need for patients to engage in mobility interventions without overburdening nurses. There is no data, however, on the effect of MT-assisted ambulation on adverse events or functional status, or on the cost tradeoffs if a MT were employed. The AMBULATE study aims to determine whether MT-assisted ambulation improves mobility status and decreases adverse events for older medical inpatients. It will also include analyses to identify the patients that benefit most from MT-assisted mobility and assess the cost-effectiveness of employing a MT.MethodsThe AMBULATE study is a multicenter, single-blind, parallel control design, individual-level randomized trial. It will include patients admitted to a medical service in five hospitals in two regions of the USA. Patients over age 65 with mild functional deficits will be randomized using a block randomization scheme. Those in the intervention group will ambulate with the MT up to three times daily, guided by the Johns Hopkins Mobility Goal Calculator. The intervention will conclude at hospital discharge, or after 10 days if the hospitalization is prolonged. The primary outcome is the Short Physical Performance Battery score at discharge. Secondary outcomes are discharge disposition, length of stay, hospital-acquired complications (falls, venous thromboembolism, pressure ulcers, and hospital-acquired pneumonia), and post-hospital functional status.DiscussionWhile functional decline in the hospital is multifactorial, ambulation is a modifiable factor for many patients. The AMBULATE study will be the largest randomized controlled trial to test the clinical effects of dedicating a single care team member to facilitating mobility for older hospitalized patients. It will also provide a useful estimation of cost implications to help hospital administrators assess the feasibility and utility of employing MTs.Trial registrationRegistered in the United States National Library of Medicine clinicaltrials.gov (# NCT05725928). February 13, 2023.

【 授权许可】

CC BY   
© The Author(s) 2023

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