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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Minneapolis Medical Research Foundation
ClinicalTrials.gov Identifier:
NCT01775969
First received: January 23, 2013
Last updated: October 24, 2013
Last verified: October 2013
  Purpose

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 Intervention
Modality of Discharge Instructions
Other: Text Message
Other: Voicemail

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Minneapolis Medical Research Foundation:

Primary Outcome Measures:
  • 72-hour antibiotic pickup [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
    Whether or not the patient picked up their antibiotic prescription at the pharmacy

  • Antibiotic compliance [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    If the patient completed the entire course of antibiotics


Enrollment: 2874
Study Start Date: May 2011
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Minneapolis Medical Research Foundation
ClinicalTrials.gov Identifier: NCT01775969     History of Changes
Other Study ID Numbers: 11-3329
Study First Received: January 23, 2013
Last Updated: October 24, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 25, 2014