Dedicated Ambulator-assisted Physical Activity to Improve Hospital Outcome Measures in Elderly Patients
NCT ID: NCT02757131
Last Updated: 2017-08-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
102 participants
INTERVENTIONAL
2016-07-31
2017-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
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.
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.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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
60 Years
ALL
No
Sponsors
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The Cleveland Clinic
OTHER
Responsible Party
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Aaron Hamilton
Staff Physician
Principal Investigators
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Aaron Hamilton, MD
Role: PRINCIPAL_INVESTIGATOR
The Cleveland Clinic
Locations
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Cleveland Clinic Foundation
Cleveland, Ohio, United States
Countries
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References
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National Center for Health Statistics (US). Health, United States, 2013: With Special Feature on Prescription Drugs. Hyattsville (MD): National Center for Health Statistics (US); 2014 May. Report No.: 2014-1232. Available from http://www.ncbi.nlm.nih.gov/books/NBK209224/
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Zisberg A, Shadmi E, Sinoff G, Gur-Yaish N, Srulovici E, Admi H. Low mobility during hospitalization and functional decline in older adults. J Am Geriatr Soc. 2011 Feb;59(2):266-73. doi: 10.1111/j.1532-5415.2010.03276.x.
Gillick MR, Serrell NA, Gillick LS. Adverse consequences of hospitalization in the elderly. Soc Sci Med. 1982;16(10):1033-8. doi: 10.1016/0277-9536(82)90175-7.
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Sager MA, Franke T, Inouye SK, Landefeld CS, Morgan TM, Rudberg MA, Sebens H, Winograd CH. Functional outcomes of acute medical illness and hospitalization in older persons. Arch Intern Med. 1996 Mar 25;156(6):645-52.
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Lazarus BA, Murphy JB, Coletta EM, McQuade WH, Culpepper L. The provision of physical activity to hospitalized elderly patients. Arch Intern Med. 1991 Dec;151(12):2452-6.
McVey LJ, Becker PM, Saltz CC, Feussner JR, Cohen HJ. Effect of a geriatric consultation team on functional status of elderly hospitalized patients. A randomized, controlled clinical trial. Ann Intern Med. 1989 Jan 1;110(1):79-84. doi: 10.7326/0003-4819-110-1-79.
Said CM, Morris ME, Woodward M, Churilov L, Bernhardt J. Enhancing physical activity in older adults receiving hospital based rehabilitation: a phase II feasibility study. BMC Geriatr. 2012 Jun 8;12:26. doi: 10.1186/1471-2318-12-26.
Inouye SK, Wagner DR, Acampora D, Horwitz RI, Cooney LM Jr, Tinetii ME. A controlled trial of a nursing-centered intervention in hospitalized elderly medical patients: the Yale Geriatric Care Program. J Am Geriatr Soc. 1993 Dec;41(12):1353-60. doi: 10.1111/j.1532-5415.1993.tb06487.x.
Timmerman RA. A mobility protocol for critically ill adults. Dimens Crit Care Nurs. 2007 Sep-Oct;26(5):175-9; quiz 180-1. doi: 10.1097/01.DCC.0000286816.40570.da.
Morris PE, Goad A, Thompson C, Taylor K, Harry B, Passmore L, Ross A, Anderson L, Baker S, Sanchez M, Penley L, Howard A, Dixon L, Leach S, Small R, Hite RD, Haponik E. Early intensive care unit mobility therapy in the treatment of acute respiratory failure. Crit Care Med. 2008 Aug;36(8):2238-43. doi: 10.1097/CCM.0b013e318180b90e.
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.
Other Identifiers
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16-335
Identifier Type: -
Identifier Source: org_study_id
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