- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02879396
Preventing Avoidable Admissions Among Assisted Living Elders (PA4LE)
Preventing Avoidable Admissions Among Assisted Living Elders (PA4LE)
Study Overview
Detailed Description
Saint Luke Home (SLH) is the only nondenominational, nonprofit academic assisted living center (ALC) for low-income seniors who are ≥ 55 years old and in need of supervisory level assistance in Tucson, Arizona. SLH residents have high behavioral health overlay with presence of cognitive decline for some elders. Arizona Center on Aging and University of Arizona Health Sciences have established an academic partnership with SLH. Currently, interprofessional student teams conduct monthly screening clinics at SLH, but these visits are limited to education, simple screening measures, and making general recommendations to the elder's primary care provider via fax. Elders living at SLH have multiple providers for their chronic conditions, and those providers may not be trained in geriatric care.
The documentation from incident reports shows that emergency medical service (EMS) calls are made from SLH (capacity 64) approximately 60 times each year with emergency department (ED) visits and hospital admissions following the incidences. In 2014, a total of 70 calls were made, whereas 49 calls were made in 2015. The Director, who is a nurse by training, and staff reported that many of these calls are medication-related and may be avoidable. As a quality improvement process, a root-cause analysis was conducted by the PharmD fellows interested in geriatric care and research with results reported. From the period of March 2015 to March 2016, a total of 65 calls were made to 911 from SLH that resulted in 39 ED visits and 6 hospitalizations by SLH elders. This was approximately 2 incidences/elder.
We believe forming an interprofessional team to bridge care and decrease EMS calls, ED visits and hospitalizations can make a difference, a program entitled Preventing Avoidable Admissions Among Assisted Living Elders (PA4LE). The interprofessional team will consist of PI (PharmD with board certification in Geriatric Pharmacy), two doctor of pharmacy fellows, Psychiatric nurse practitioner (NP), SLH director (nurse by training), and SLH resident manager. All clinical activities will be supervised by a faculty team of geriatric attendings - Dr. Fain (MD), Dr. Mohler (NP), and Dr. Lee (PI, PharmD). The PA4LE program will consist of bi-weekly, 2-hour sessions, which will include home or clinic visits (elder preference), educational sessions, and staff training at the SLH.
The purpose of the PA4LE program is to prevent EMS calls, ED visits and hospital admissions from avoidable causes and decrease the use of high-risk medications among elders at the SLH. We are modeling the current study intervention in part after the Coleman Care Transitions Model, which is a patient and family-centered care transitions program from hospital to community. The components of the model will be translated into use for ED/Hospital to ALC transitions to avoid EMS calls, ED visits and hospital admissions/readmissions. To identify avoidable causes for admissions, we used the study by Ouslander et al. that determined frequency, causes and costs of potentially avoidable hospitalizations among nursing home residents. A maximum of 50 participants will be enrolled in the study per the inclusion and exclusion criteria.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Arizona
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Tucson, Arizona, United States, 85705
- St. Luke's Home
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- One or more EMS calls made, ED visit or hospital admission in the past year, as determined by the incidence report at SLH
Exclusion Criteria:
- A score of ≤ 22 out of 30 on the Montreal Cognitive Assessment (MoCA) during initial assessment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Study Participants
A maximum of 50 participants will be enrolled in the study per the inclusion and exclusion criteria.
The participants will be residents of SLH who are 55 years old or older.
They will have had one or more EMS calls made, ED visit or hospital admission in the past year, as determined by the incidence report at SLH.
The study participants will receive PA4LE program.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
EMS calls
Time Frame: 12 months
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Reduce the number of EMS calls from avoidable causes by high-utilizers (≥ 4 calls) by 50%
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12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
ED visits
Time Frame: 12 months
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Reduce the number of ED visits and hospital admissions for avoidable causes by high utilizers (≥ 2/year) by 50%
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12 months
|
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Beers criteria medications
Time Frame: 12 months
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Reduce the number of Beers Criteria medications (inappropriate for older adults) by 15% among high-users (≥2)
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12 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jeannie K Lee, PharmD, University of Arizona
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1608799126
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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