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

NCT ID: NCT01775969

Last Updated: 2013-10-25

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2874 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2013-02-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Modality of Discharge Instructions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Standard of Care

Written discharge instructions only

Group Type NO_INTERVENTION

No interventions assigned to this group

Text Message

Written discharge instructions plus a text message with antibiotic prescription instructions

Group Type EXPERIMENTAL

Text Message

Intervention Type OTHER

A text message with instructions is sent to the patient

Voicemail

Written discharge instructions plus a voicemail with antibiotic prescription instructions

Group Type EXPERIMENTAL

Voicemail

Intervention Type OTHER

A voicemail with instructions is sent to the patient

Interventions

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Text Message

A text message with instructions is sent to the patient

Intervention Type OTHER

Voicemail

A voicemail with instructions is sent to the patient

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hennepin Healthcare Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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James R Miner, MD

Role: PRINCIPAL_INVESTIGATOR

Hennepin Healthcare Research Institute

Locations

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Hennepin County Medical Center

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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11-3329

Identifier Type: -

Identifier Source: org_study_id