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

NCT02757131 | Completed

• 1 other identifier: 16-335
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Weakness; Hospital Acquired Condition

Keywords

Mobility; Elderly; Hospitalized patient

Outcome Measures

Primary Outcomes (2)

• Discharge disposition from hospitalization - from electronic health record

  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, 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 Outcomes (6)

• Patient in-hospital mortality

  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

  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

  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

  Will be measured at patient level for each admission and will end at discharge, up to six weeks

• Readmission within 30 days

  30 days after discharge

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

Ambulation OTHER

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.

Intervention

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Hospitalized for a medical illness
• Complete history and physical examination on file
• 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

You may not qualify if:

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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Related Publications (18)

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  PMID: 24967476 BACKGROUND

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  PMID: 1866946 BACKGROUND

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  PMID: 8629876 BACKGROUND

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  PMID: 2642284 BACKGROUND

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  PMID: 8227919 BACKGROUND

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• Jette DU, Stilphen M, Ranganathan VK, Passek SD, Frost FS, Jette AM. Validity of the AM-PAC "6-Clicks" inpatient daily activity and basic mobility short forms. Phys Ther. 2014 Mar;94(3):379-91. doi: 10.2522/ptj.20130199. Epub 2013 Nov 14.

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MeSH Terms

Conditions

Asthenia; Iatrogenic Disease

Interventions

Walking

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Locomotion; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise; Motor Activity

Study Officials

• Aaron Hamilton, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician

Study Record Dates

• First Submitted: April 19, 2016
• First Posted: April 29, 2016
• Study Start: July 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: August 10, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)