Effect of Modality on Discharge Instruction in Patients Receiving Outpatient Antibiotic Prescriptions From the Emergency Department

October 24, 2013 updated by: Hennepin Healthcare Research Institute
Outpatient antibiotics are frequently prescribed from the emergency department, and limited health literacy may impact compliance with recommended treatments. The investigators are looking to determine if patient preference for multimodality discharge instructions for outpatient antibiotic therapy varies by health literacy level, and if modality effected patient-reported antibiotic compliance and 72-hour antibiotic pick-up.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a prospective randomized trial that includes consenting patients discharged with outpatient antibiotics. Health literacy is assessed using a validated health literacy assessment, the Newest Vital Sign (NVS). Patients are randomized to a discharge instruction modality: 1) standard of care, typed and verbal medication and case-specific instructions; 2) standard of care plus text messaged instructions sent to the patient's cell phone; or 3) standard of care plus voicemailed instructions sent to the patient's cell phone. Antibiotic pick-up is verified with the patient's pharmacy at 72 hours. Patients are called at 30 days to determine antibiotic compliance.

Study Type

Interventional

Enrollment (Actual)

2874

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
    • Minnesota
      • Minneapolis, Minnesota, United States, 55415
        • Hennepin County Medical Center

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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Emergency department patient being prescribed an outpatient antibiotic or the parent of a patient under the age of 18 being prescribed on outpatient antibiotic

Exclusion Criteria:

  • Doesn't have a cell phone that can receive text messages and voicemail messages
  • Unable to provide informed consent
  • Prisoners

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: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Standard of Care
Written discharge instructions only
EXPERIMENTAL: Text Message
Written discharge instructions plus a text message with antibiotic prescription instructions
Other: Text Message
A text message with instructions is sent to the patient
EXPERIMENTAL: Voicemail
Written discharge instructions plus a voicemail with antibiotic prescription instructions
Other: Voicemail
A voicemail with instructions is sent to the patient

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
72-hour antibiotic pickup
Time Frame: 72 hours
Whether or not the patient picked up their antibiotic prescription at the pharmacy
72 hours
Antibiotic compliance
Time Frame: 30 days
If the patient completed the entire course of antibiotics
30 days

Collaborators and Investigators

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

Sponsor

Hennepin Healthcare Research Institute

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

May 1, 2011

Primary Completion (ACTUAL)

February 1, 2013

Study Completion (ACTUAL)

February 1, 2013

Study Registration Dates

First Submitted

January 23, 2013

First Submitted That Met QC Criteria

January 24, 2013

First Posted (ESTIMATE)

January 25, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

October 25, 2013

Last Update Submitted That Met QC Criteria

October 24, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-3329

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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