Back to resultsEffect of Modality on Discharge Instruction in Patients Receiving Outpatient Antibiotic Prescriptions From the Emergency Department
Primary Purpose
Modality of Discharge Instructions
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Text Message
Voicemail
Sponsored by
About this trial
This is an interventional health services research trial for Modality of Discharge Instructions
Eligibility 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
Sites / Locations
- Hennepin County Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Experimental
Arm Label
Standard of Care
Text Message
Voicemail
Arm Description
Written discharge instructions only
Written discharge instructions plus a text message with antibiotic prescription instructions
Written discharge instructions plus a voicemail with antibiotic prescription instructions
Outcomes
Primary Outcome Measures
72-hour antibiotic pickup
Whether or not the patient picked up their antibiotic prescription at the pharmacy
Antibiotic compliance
If the patient completed the entire course of antibiotics
Secondary Outcome Measures
Full Information
NCT ID
NCT01775969
First Posted
January 23, 2013
Last Updated
October 24, 2013
Sponsor
Hennepin Healthcare Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT01775969
Brief Title
Effect of Modality on Discharge Instruction in Patients Receiving Outpatient Antibiotic Prescriptions From the Emergency Department
Official Title
Effect of Modality on Discharge Instruction in Patients Receiving Outpatient Antibiotic Prescriptions From the Emergency Department
Study Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hennepin Healthcare Research Institute
4. Oversight
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Modality of Discharge Instructions
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2874 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
Written discharge instructions only
Arm Title
Text Message
Arm Type
Experimental
Arm Description
Written discharge instructions plus a text message with antibiotic prescription instructions
Arm Title
Voicemail
Arm Type
Experimental
Arm Description
Written discharge instructions plus a voicemail with antibiotic prescription instructions
Intervention Type
Other
Intervention Name(s)
Text Message
Intervention Description
A text message with instructions is sent to the patient
Intervention Type
Other
Intervention Name(s)
Voicemail
Intervention Description
A voicemail with instructions is sent to the patient
Primary Outcome Measure Information:
Title
72-hour antibiotic pickup
Description
Whether or not the patient picked up their antibiotic prescription at the pharmacy
Time Frame
72 hours
Title
Antibiotic compliance
Description
If the patient completed the entire course of antibiotics
Time Frame
30 days
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James R Miner, MD
Organizational Affiliation
Hennepin Healthcare Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hennepin County Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55415
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effect of Modality on Discharge Instruction in Patients Receiving Outpatient Antibiotic Prescriptions From the Emergency Department
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