Seasonal InfluenzaNCT01206686
The Effect of Time-Slot Scheduling on Flu Vaccination Rates
A study testing Planning Prompt and Default Appointment in people with Seasonal Influenza, run by University of Pennsylvania at 1 site in United States.
Trial summary
The goal of this project is to see if encouraging an individual to privately choose in advance a narrow time window in which to obtain a flu vaccination shot affects the likelihood that he or she will become vaccinated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Seasonal Influenza
- What is being tested?
- Planning Prompt and Default Appointment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50,000 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Jul 2012
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- seasonal influenza vaccine indications according to the CDC
- employees of partner corporations executing study
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Effect of Time-Slot Scheduling on Flu Vaccination Rates
The goal of this project is to see if encouraging an individual to privately choose in advance a narrow time window in which to obtain a flu vaccination shot affects the likelihood that he or she will become vaccinated.
Read the detailed description
Influenza causes 36,000 U.S. deaths per year, but influenza immunization rates average just 28%. Behavioral "nudges" may increase the effectiveness of immunization reminder mailers at little or no added cost. Past psychology research has demonstrated that prompting people to form an implementation plan of the form, "When situation x arises, I will implement response y," increases attainment of desired goals because the desired behavior is linked to a concrete future moment. We study whether adding a planning prompt to a vaccination reminder mailer increases immunization rates.
- Conditions
- Seasonal Influenza
- Being tested
- Planning Prompt, Default Appointment, Control
- Keywords
- seasonal influenza, behavioral economics, nudge, implementations intentions, vaccination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Planning PromptBehavioural
Patients were prompted to write down a planned date (and in some cases time) for receiving a flu shot.
Default AppointmentBehavioural
Patients were given a suggested date and time for receiving a flu shot.
ControlBehavioural
Patients were provided with basic information (present in all conditions) about when and where they could receive a flu shot, but they were given no further treatment.
| Study group | Role | What they receive |
|---|---|---|
| 1 Hour Planning Prompt | Experimental | Not described Receives: Behavioral: Planning Prompt |
| 2 Hour Planning Prompt | Experimental | Not described Receives: Behavioral: Planning Prompt |
| 1 Day Planning Prompt | Experimental | Not described Receives: Behavioral: Planning Prompt |
| Default Planning Prompt | Experimental | Not described Receives: Behavioral: Default Appointment |
| Control | Active comparator | Not described Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Receipt of seasonal influenza vaccination
Measured: up to 30 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2010 (estimated)
- Study startSep 2009
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Seasonal InfluenzaStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Harvard University, Yale University, Stanford University
- Responsible party
- Sponsor
- Investigators
- Katherine L Milkman, Ph.D., Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01206686
- Sponsor's protocol ID
- 810589
- Status last verified
- Aug 2016
- First submitted
- 14 Sep 2010
- Last updated
- 17 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Time-Slot Scheduling on Flu Vaccination Rates
- ClinicalTrials.gov ID
- NCT01206686
- Acronym / sponsor ID
- 810589
- Conditions
- Seasonal Influenza
- Keywords
- seasonal influenza, behavioral economics, nudge, implementations intentions, vaccination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50,000 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Harvard University, Yale University, Stanford University
- Study start
- Sep 2009
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 22 Sep 2010 (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.
The goal of this project is to see if encouraging an individual to privately choose in advance a narrow time window in which to obtain a flu vaccination shot affects the likelihood that he or she will become vaccinated.
Detailed description
Influenza causes 36,000 U.S. deaths per year, but influenza immunization rates average just 28%. Behavioral "nudges" may increase the effectiveness of immunization reminder mailers at little or no added cost. Past psychology research has demonstrated that prompting people to form an implementation plan of the form, "When situation x arises, I will implement response y," increases attainment of desired goals because the desired behavior is linked to a concrete future moment. We study whether adding a planning prompt to a vaccination reminder mailer increases immunization rates.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 Hour Planning Prompt | Experimental | Behavioral: Planning Prompt |
| 2 Hour Planning Prompt | Experimental | Behavioral: Planning Prompt |
| 1 Day Planning Prompt | Experimental | Behavioral: Planning Prompt |
| Default Planning Prompt | Experimental | Behavioral: Default Appointment |
| Control | Active comparator | Behavioral: Control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- seasonal influenza vaccine indications according to the CDC
- employees of partner corporations executing study
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| Planning PromptPatients were prompted to write down a planned date (and in some cases time) for receiving a flu shot. | Behavioural | 1 Day Planning Prompt, 1 Hour Planning Prompt, 2 Hour Planning Prompt |
| Default AppointmentPatients were given a suggested date and time for receiving a flu shot. | Behavioural | Default Planning Prompt |
| ControlPatients were provided with basic information (present in all conditions) about when and where they could receive a flu shot, but they were given no further treatment. | Behavioural | Control |
Primary outcome
Receipt of seasonal influenza vaccination
Time frame: up to 30 weeks
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 17 Aug 2016.
Related trials for Seasonal Influenza
RecruitingPhase 1
A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1010 in Healthy Children
Seasonal Influenza
Active, not recruitingPhase 3
A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 With Influenza Vaccine in Adults ≥ 50 Years of Age
Pneumococcal Disease
RecruitingPhase 1
Evaluating the Dose, Safety, Tolerability, and Immunogenicity of Mosaic Hexavalent Influenza Vaccine VRCFLUMOS0116-00-VP (FluMos-v2) With and Without ALFQ Adjuvant in Healthy Adults
Influenza Prevention, Seasonal Influenza
Not yet recruitingPhase 1
Phase I Clinical Trial of Trivalent Inactivated Split Influenza Virus Vaccine (MDCK Cell)
Seasonal Influenza
Not yet recruitingPhase 4
A Study of Updated mRNA Seasonal Influenza Vaccines
Seasonal Influenza
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.
Katherine L Milkman, Ph.D. principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Planning Prompt and Default Appointment in people with Seasonal Influenza, run by University of Pennsylvania 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 2 inclusion and 1 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 17 Aug 2016. 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?
Receipt of seasonal influenza vaccination (time frame: up to 30 weeks). 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 17 Aug 2016.