Clinical Trial: Dedicated Ambulator-assisted Physical Activity to Improve Hospital Outcome Measures in Elderly Patients
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Dedicated Ambulator-assisted Physical Activity to Improve Hospital Outcome Measures in Elderly Patients: A Randomized, Controlled Trial
Brief Summary: Bedrest and lack of mobility in the inpatient hospital setting hastens the functional decline of elderly patients and is associated with increased risk of complications such as falls, delirium, venous thrombosis, and skin breakdown. These adverse health effects drive increased cost as patients spend additional time in both the acute (hospital) and post-acute care settings. Physical activity is thus widely recognized as an important factor for improving outcomes in hospitalized patients; however, numerous challenges to its implementation exist. Specifically, although it has been found that with small increases in physical activity such as increasing number of steps by only 600 daily for inpatients, length of stay can be reduced by nearly 2 days, usual care in many hospitals, including the Cleveland Clinic, does not include exercise, and physicians do not all regularly order physical activity for their hospitalized patients. Even when activity is recommended or ordered, compliance and execution of the orders has been spotty and/or negligible. It is therefore clear that the current system for the provision of ambulation is ineffective. The investigators hypothesize that a graded protocol of ambulation which can be implemented by a dedicated patient care nursing assistant (PCNA) multiple times daily will provide significant benefit to patients without the labor and cost requirements of full-time nursing and physical therapy expertise. The objective of this study is to assess the feasibility and effectiveness of dedicated ambulator-assisted physical activity in elderly inpatients. The primary hypothesis is that an ambulator-assisted intervention for hospitalized elderly inpatients will prove feasible and may result in improved hospital outcomes, including less need for inpatient rehabilitation and shorter length of stay in the hospital. This study will provide pilot data for a larger randomized trial.
Detailed Summary:
Specific Aims
Aim 1: To determine the feasibility of implementing an ambulator-assisted exercise intervention in elderly patients on an inpatient medicine service.
The investigators will work closely with the physical therapy team to develop a graded ambulation protocol that can be implemented multiple times daily per enrolled patient by a PCNA. Investigators will work closely with the medicine units to recruit eligible patients and assess protocol implementation including recruitment, patient cooperation, and scheduling.
Aim 2: To determine the effects of an ambulator-assisted exercise intervention on discharge disposition, length of stay and cost.
The investigators will measure the proportion of patients in the intervention and usual care group who are discharged to home vs. acute rehabilitation facilities. Length of stay and cost will be obtained from hospital billing records.
Research Strategy
The investigators propose the development of a feasible program to assist in improving the physical capacity of elderly inpatients. Such improvements may translate to cost savings in the form of decreased length of stay, improved discharge disposition, and fewer hospital-related complications, but establishing that is not the purpose of this study. The investigators propose that the most feasible and cost-effective implementation of such a program will utilize a patient care nursing assistant (PCNA) dedicated to carrying out a graded ambulation protocol in eligible patients multiple times daily. A simple and standardized protocol for ambulation will reduce the need for the expertise of a dedicated physical therapist. Additionally, ut
Sponsor: The Cleveland Clinic
Current Primary Outcome:
- Discharge disposition from hospitalization - from electronic health record [ Time Frame: Will be measured at time of discharge for each patient through study completion, up to six weeks ]The investigators will track the care setting patients are discharged to from the inpatient stay. This will include home, home with home health care, skilled nursing facility, acute rehab, nursing home, hospice
- Length of stay in days for participant's hospitalization [ Time Frame: Will be measured at the time of discharge for each patient through study completion, up to six weeks ]Time, in days, elapsed from patient admission to discharge
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Patient in-hospital mortality [ Time Frame: Will be measured for the episode of care associated with the admission the patient was enrolled in the study, up to six weeks ]
- Admission to Intensive care unit after initiation of intervention - from electronic health record [ Time Frame: Will be measured at patient level at the completion of each patient discharge, up to six weeks ]Participants enrolled in the study will be followed and if their care is escalated to an intensive care unit, the investigators will track
- Participant inpatient falls - binary yes/no extracted from the safety event reporting system which closely tracks all inpatient falls [ Time Frame: Will be measured at the time of discharge for the patient and will include any fall during the index admission ]
- New onset of stroke, Deep Vein Thrombosis, Pulmonary embolus or pneumonia during hospitalization as determined by billing codes for participants [ Time Frame: Will be measured at patient level for each admission and will end at discharge, up to six weeks ]Participants with billing codes for the above conditions that are not present on admission will be included in the outcome measure.
- Readmission within 30 days [ Time Frame: 30 days after discharge ]
- Change in 6-Clicks score from admission to discharge - as measured by the physical therapy team with each visit - this is extracted from our electronic health record [ Time Frame: Will be measured at patient level for each admission and will end at discharge, up to six weeks ]The 6-clicks score is a validated marker of mobility for inpatients
Original Secondary Outcome: Same as current
Information By: The Cleveland Clinic
Dates:
Date Received: April 19, 2016
Date Started: July 2016
Date Completion: July 2017
Last Updated: May 11, 2017
Last Verified: May 2017
