Dedicated Ambulator-assisted Physical Activity to Improve Hospital Outcome Measures in Elderly Patients

August 9, 2017 updated by: Aaron Hamilton, The Cleveland Clinic

Dedicated Ambulator-assisted Physical Activity to Improve Hospital Outcome Measures in Elderly Patients: A Randomized, Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

102

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention

Patients randomized to the intervention group will be asked to participate in the ambulation protocol outlined by the Physical Therapy (PT) staff 3 times daily under the supervision of the dedicated ambulator PCNA.

The ambulator will be trained by the physical therapy team on how to implement the protocol prior to initiation of the study.
Other: Ambulation

Patients randomized to the intervention group will be asked to participate in the ambulation protocol outlined by the PT staff 3 times daily under the supervision of the dedicated ambulator PCNA. This protocol will involve four exercise levels (mobilization, standing, walking, stairs) that may be implemented depending on the current physical capacity of the patient. The cohort of patients randomized to "ambulator protocol" will also receive the usual care by primary nursing.

In an effort to best characterize mobility in these patients, the team will collect Braden Scale Activity data from the electronic health record, and provide each patient a mobility tracking device to directly record daily steps taken while the patient is in the hospital. Daily step counts will be collected on a weekly basis from each device. The Braden Scale is entered by nursing on each patient at least daily and measures current activity level on a 4-point scale.
No Intervention: Control
The cohort of patients randomized to "usual care" will not be seen by the dedicated ambulator, but will not otherwise be restricted in nursing's baseline ability to execute nursing specific recommendations placed by the PT team.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Will be measured at time of discharge for each patient through study completion, up to six weeks
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
Will be measured at the time of discharge for each patient through study completion, up to six weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
Will be measured at patient level at the completion of each patient discharge, up to six weeks
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
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.
Will be measured at patient level for each admission and will end at discharge, up to six weeks
Readmission within 30 days
Time Frame: 30 days after discharge
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
Will be measured at patient level for each admission and will end at discharge, up to six weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Cleveland Clinic

Investigators

  • Principal Investigator: Aaron Hamilton, MD, The Cleveland Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2016

Primary Completion (Actual)

July 1, 2017

Study Completion (Actual)

July 1, 2017

Study Registration Dates

First Submitted

April 19, 2016

First Submitted That Met QC Criteria

April 27, 2016

First Posted (Estimate)

April 29, 2016

Study Record Updates

Last Update Posted (Actual)

August 10, 2017

Last Update Submitted That Met QC Criteria

August 9, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-335

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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