Modality of Discharge InstructionsNCT01775969
Effect of Modality on Discharge Instruction in Patients Receiving Outpatient Antibiotic Prescriptions From the Emergency Department
A study testing Text Message and Voicemail in people with Modality of Discharge Instructions, run by Hennepin Healthcare Research Institute at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Modality of Discharge Instructions
- What is being tested?
- Text Message and Voicemail
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,874 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Feb 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Emergency department patient being prescribed an outpatient antibiotic or the parent of a patient under the age of 18 being prescribed on outpatient antibiotic
Who cannot join
- Doesn't have a cell phone that can receive text messages and voicemail messages
- Unable to provide informed consent
- Prisoners
Trial locations and contacts
1 site in 1 country.
United States1 site
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
About this study
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.
Read the 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.
- Conditions
- Modality of Discharge Instructions
- Being tested
- Text Message, Voicemail
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Text MessageOther
A text message with instructions is sent to the patient
VoicemailOther
A voicemail with instructions is sent to the patient
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | No intervention | Written discharge instructions only |
| Text Message | Experimental | Written discharge instructions plus a text message with antibiotic prescription instructions Receives: Other: Text Message |
| Voicemail | Experimental | Written discharge instructions plus a voicemail with antibiotic prescription instructions Receives: Other: Voicemail |
What is being measured
The primary outcome is the main question the study is designed to answer.
72-hour antibiotic pickup
Whether or not the patient picked up their antibiotic prescription at the pharmacy
Measured: 72 hours
Antibiotic compliance
If the patient completed the entire course of antibiotics
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2013 (estimated)
- Study startMay 2011
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Modality of Discharge InstructionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,874 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hennepin Healthcare Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James R Miner, MD, Principal investigator, Hennepin Healthcare Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01775969
- Sponsor's protocol ID
- 11-3329
- Status last verified
- Oct 2013
- First submitted
- 23 Jan 2013
- Last updated
- 25 Oct 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Modality on Discharge Instruction in Patients Receiving Outpatient Antibiotic Prescriptions From the Emergency Department
- ClinicalTrials.gov ID
- NCT01775969
- Acronym / sponsor ID
- 11-3329
- Conditions
- Modality of Discharge Instructions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,874 participants (actual)
- Lead sponsor
- Hennepin Healthcare Research InstituteUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 25 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | No intervention | –Written discharge instructions only |
| Text Message | Experimental | Other: Text MessageWritten discharge instructions plus a text message with antibiotic prescription instructions |
| Voicemail | Experimental | Other: VoicemailWritten discharge instructions plus a voicemail with antibiotic prescription instructions |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Emergency department patient being prescribed an outpatient antibiotic or the parent of a patient under the age of 18 being prescribed on outpatient antibiotic
Key exclusion criteria (3 listed)
- Doesn't have a cell phone that can receive text messages and voicemail messages
- Unable to provide informed consent
- Prisoners
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Text MessageA text message with instructions is sent to the patient | Other | Text Message |
| VoicemailA voicemail with instructions is sent to the patient | Other | Voicemail |
Primary outcome
72-hour antibiotic pickup
Time frame: 72 hours
Whether or not the patient picked up their antibiotic prescription at the pharmacy
Antibiotic compliance
Time frame: 30 days
If the patient completed the entire course of antibiotics
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2013.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James R Miner, MD principal investigator
Hennepin Healthcare Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Text Message and Voicemail in people with Modality of Discharge Instructions, run by Hennepin Healthcare Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
72-hour antibiotic pickup (time frame: 72 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2013.