NCT02879396

Brief Summary

Saint Luke Home (SLH) is a home for low-income seniors who are ≥ 55 years and in need of basic living help in Tucson, Arizona. Reports shows that emergency calls are made from SLH (64 residents) around 60 times each year with emergency department (ED) visits and hospital admissions that follow. In 2014, a total of 70 calls were made, and in 2015, 49 calls. The Director, who is a nurse by training, and staff report that many of these calls are related to medications and may be avoidable. Therefore, we believe we can make a difference and decrease emergency calls, ED visits and hospitalizations that can be avoided with a program to teach the elders and staff at SLH. The program is called Preventing Avoidable Admissions Among Assisted Living Elders (PA4LE) and will consist of a 2-hour session every two weeks including home or clinic visits (elder preference), educational sessions, and staff training.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

August 22, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 25, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

November 1, 2018

Status Verified

October 1, 2018

Enrollment Period

2 years

First QC Date

August 22, 2016

Last Update Submit

October 30, 2018

Conditions

Keywords

Older adultsAvoidable admissionsAssisted living homeEmergency service callsHeading Assisted Living Facilities

Outcome Measures

Primary Outcomes (1)

  • EMS calls

    Reduce the number of EMS calls from avoidable causes by high-utilizers (≥ 4 calls) by 50%

    12 months

Secondary Outcomes (2)

  • ED visits

    12 months

  • Beers criteria medications

    12 months

Study Arms (1)

Study Participants

EXPERIMENTAL

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.

Behavioral: PA4LE Program

Interventions

PA4LE ProgramBEHAVIORAL

1. Medication self-management including medication reconciliation, therapy recommendations, and education by pharmacist (chronic conditions and medications including Beers Criteria) 2. Use of a patient-centered health record that helps guide patients through the care process (portable, health and medication record for elders) 3. Primary care provider and specialist follow-up (patient awareness of discharge action plan and follow-up) 4. Patient understanding of "red flag" indicators of worsening condition and appropriate next steps 5. Behavioral interventions - Adherence, Lifestyle modifications, Mindfulness \& Lovingkindness meditations to combat anxiety, insomnia and other behavioral symptoms

Study Participants

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • One or more EMS calls made, ED visit or hospital admission in the past year, as determined by the incidence report at SLH

You may not qualify if:

  • A score of ≤ 22 out of 30 on the Montreal Cognitive Assessment (MoCA) during initial assessment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Luke's Home

Tucson, Arizona, 85705, United States

Location

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jeannie K Lee, PharmD

    University of Arizona

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 22, 2016

First Posted

August 25, 2016

Study Start

August 1, 2016

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

November 1, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations