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

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ClinicalTrials.gov Identifier: NCT01775969
Recruitment Status : Completed
First Posted : January 25, 2013
Last Update Posted : October 25, 2013
Sponsor:
Information provided by (Responsible Party):
Minneapolis Medical Research Foundation

Brief Summary:
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.

Condition or disease Intervention/treatment
Modality of Discharge Instructions Other: Text Message Other: Voicemail

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  (Clinical Trial)
Actual Enrollment : 2874 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Effect of Modality on Discharge Instruction in Patients Receiving Outpatient Antibiotic Prescriptions From the Emergency Department
Study Start Date : May 2011
Primary Completion Date : February 2013
Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics
U.S. FDA Resources

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



Primary Outcome Measures :
  1. 72-hour antibiotic pickup [ Time Frame: 72 hours ]
    Whether or not the patient picked up their antibiotic prescription at the pharmacy

  2. Antibiotic compliance [ Time Frame: 30 days ]
    If the patient completed the entire course of antibiotics



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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01775969


Locations
United States, Minnesota
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415
Sponsors and Collaborators
Minneapolis Medical Research Foundation
Investigators
Principal Investigator: James R Miner, MD Minneapolis Medical Research Foundation

Responsible Party: Minneapolis Medical Research Foundation
ClinicalTrials.gov Identifier: NCT01775969     History of Changes
Other Study ID Numbers: 11-3329
First Posted: January 25, 2013    Key Record Dates
Last Update Posted: October 25, 2013
Last Verified: October 2013

Additional relevant MeSH terms:
Emergencies
Disease Attributes
Pathologic Processes
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents