Clinical trial NCT02757131: Dedicated Ambulator-assisted Physical Activity to Improve Hospital Outcome Measures in Elderly Patients
Official title: Dedicated Ambulator-assisted Physical Activity to Improve Hospital Outcome Measures in Elderly Patients: A Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weakness
Hospital Acquired Condition
Keywords: Mobility
Elderly
Hospitalized patient
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2016-04-29
Enrollment: 102
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 description: 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, utilizing an existing mechanism for assessing baseline functional capacity, the 6-Clicks score, will eliminate the time and personnel requirements for evaluation of patient eligibility. This score has been validated as a mechanism to assess patient mobility limitations in an acute care setting and is currently used on all patients seen by physical therapy on the inpatient medicine services.

This pilot study will enable the investigators to identify which patients would tolerate the intervention and what degree of participation would be meaningful to improve the outcomes measured. The study will begin by enrolling patients with 6-Clicks scores of 16-20, as these patients will experience the greatest benefit from an ambulation protocol. At present, such patients do not receive any PT intervention and ambulation by nurses occurs only sporadically as time allows. Additionally, the pilot will help to bring clarity to the direct impact of aggressive mobilization of medical inpatients on important outcomes that are directly tied to healthcare cost. Results of this work will inform feasibility and power calculations for a larger randomized trial. Results of that trial could directly impact the approach to the medical inpatient in terms of prioritizing and resourcing mobilization strategies.

Preliminary findings from this pilot study demonstrating the feasibility of a dedicated ambulator-assisted physical activity protocol and its potential impact on hospital outcomes will provide the justification for external funding of a larger randomized clinical trial. Lessons learned from the pilot study will allow us to optimize the ambulation protocol and target population for a larger study. Such a study would investigate the effect of the ambulator-assisted physical activity protocol on patient mobility associated health care costs. This work could shift the current paradigm that aggressive mobilization is reserved for post-acute care settings and could serve as a model for improving the value of care provided to elderly patients in acute care facilities.

Eligibility criteria: Inclusion Criteria:

1. Men or women 60 years of age or older admitted as inpatients to floors G80, H80, H81 and G81 in the Medicine Institute, Cleveland Clinic Main Campus during the study time period
2. Hospitalized for a medical illness
3. Complete history and physical examination on file
4. Physical therapy consult and 6-Clicks score between 16-20 a. This is based on a usual care assessment ordered by a physician that will happen prior to any study recruitment - it is entirely independent of the study

Exclusion Criteria:

1. Observational status
2. Admission to ICU
3. Surgical patients
4. Patients diagnosed with: decompensated heart failure, unstable angina, other medical conditions precluding participation in exercise/ambulation
5. Comfort care measures only

Primary outcomes:
measure: Discharge disposition from hospitalization - from electronic health record
timeFrame: Will be measured at time of discharge for each patient through study completion, up to six weeks
measure: Length of stay in days for participant's hospitalization
timeFrame: Will be measured at the time of discharge for each patient through study completion, up to six weeks
Secondary outcomes:
measure: Patient in-hospital mortality
timeFrame: Will be measured for the episode of care associated with the admission the patient was enrolled in the study, up to six weeks
measure: Admission to Intensive care unit after initiation of intervention - from electronic health record
timeFrame: Will be measured at patient level at the completion of each patient discharge, up to six weeks
measure: Participant inpatient falls - binary yes/no extracted from the safety event reporting system which closely tracks all inpatient falls
timeFrame: Will be measured at the time of discharge for the patient and will include any fall during the index admission
measure: New onset of stroke, Deep Vein Thrombosis, Pulmonary embolus or pneumonia during hospitalization as determined by billing codes for participants
timeFrame: Will be measured at patient level for each admission and will end at discharge, up to six weeks
measure: Readmission within 30 days
timeFrame: 30 days after discharge
measure: 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
timeFrame: Will be measured at patient level for each admission and will end at discharge, up to six weeks
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Aaron Hamilton, MD
role: PRINCIPAL_INVESTIGATOR
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