- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05957393
Improving Physician Vaccine Recommendation Using Social Norms, Trust, and Presumptive Language
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Brasília, Brazil
- (Any and all facilities) - Participants are recruited via market research company "Survey Healthcare Global"
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North Carolina
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Durham, North Carolina, United States, 27710
- (Any and all facilities) - The study team ask(s)/(ed) professional contacts, friends, and family members who are employed at various US Institutions to forward the recruitment announcement message via their respective networks
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Durham, North Carolina, United States, 27710
- Duke University Health System (all locations)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Participants must be physicians, advanced practice providers, medical students, nurses/nurse practitioners, or medical fellows.
- Must be in a position to be authorized to recommend vaccines to patients in their official professional capacities/responsibilities.
Exclusion Criteria:
- Students or employees under the supervision of the PI who meet inclusion criteria for the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Quantity (present) x Quality (present)
Participants will receive a social norm-based message (for quantity) and will learn the AIMS method, a trust-building method using presumptive language (for quality).
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The survey contains a messaging intervention using a 2x2 randomized factorial design, where the investigators attempt to increase the quantity and/or quality of physician and APP vaccination recommendations (Quantity (present vs. absent) x Quality (present vs. absent)).
The survey contains a messaging intervention using a 2x2 randomized factorial design, where the investigators attempt to increase the quantity and/or quality of physician and APP vaccination recommendations (Quantity (present vs. absent) x Quality (present vs. absent)).
|
Experimental: Quantity (present) x Quality (absent)
Participants will receive a social norm-based message (for quantity).
|
The survey contains a messaging intervention using a 2x2 randomized factorial design, where the investigators attempt to increase the quantity and/or quality of physician and APP vaccination recommendations (Quantity (present vs. absent) x Quality (present vs. absent)).
|
Experimental: Quantity (absent) x Quality (present)
Participants will learn the AIMS method, a trust-building method using presumptive language (for quality).
|
The survey contains a messaging intervention using a 2x2 randomized factorial design, where the investigators attempt to increase the quantity and/or quality of physician and APP vaccination recommendations (Quantity (present vs. absent) x Quality (present vs. absent)).
|
Experimental: Quantity (absent) x Quality (absent)
Control: Participants in this condition will receive general information about vaccines, including vaccine principles, uptake barriers, and guidelines.
This information will come directly from the CDC's Advisory Committee on Immunization Practices (ACIP) website.
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The survey contains a messaging intervention using a 2x2 randomized factorial design, where the investigators attempt to increase the quantity and/or quality of physician and APP vaccination recommendations (Quantity (present vs. absent) x Quality (present vs. absent)).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in proportion of patients that receive a vaccine recommendation
Time Frame: Day 1, Day 30, Day 60, Day 90
|
Proportion of patients that receive a vaccine recommendation = multiplication of the answer to the following two items: (1) "I (will) check(ed) whether a patient has/had gotten all indicated vaccines", (2) "If I saw/see a patient had not gotten an indicated vaccine, I (will) discuss(ed) getting it."
Both items are answered on a scale from 0% (never) to 100% (always).
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Day 1, Day 30, Day 60, Day 90
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Change in self-reported responsibility perception
Time Frame: Day 1, Day 30, Day 60, Day 90
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Self-reported responsibility perception = answer to the following item: (1) "Recommending indicated vaccines is within the scope of my professional responsibilities".
This item is answered on a scale from 0% (completely disagree) to 100% (completely agree).
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Day 1, Day 30, Day 60, Day 90
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Change in self-reported assessment of patient recommendation acceptance
Time Frame: Day 1, Day 30, Day 60, Day 90
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Self-reported assessment of patient recommendation acceptance = answer to the following item: (1) "If I recommend(ed) an indicated vaccine, my patient (will) accept(ed) that recommendation.".
This item is answered on a scale from 0% (never) to 100% (always).
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Day 1, Day 30, Day 60, Day 90
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Change in self-reported patient trust
Time Frame: Day 1, Day 30, Day 60, Day 90
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Self-reported patient trust = answer to the following item: (1) "Thinking about the last/next 30 days I provided care, I can say that my patients (will) trust(ed) me as their healthcare provider".
This item is answered on a scale from 0% (completely disagree) to 100% (completely agree).
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Day 1, Day 30, Day 60, Day 90
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Change in self-reported utilization of AIMS
Time Frame: Day 1, Day 30, Day 60, Day 90
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Composite score of the following items: (1) "I used/will use direct, declarative language, like: "You're due for your flu shot. We'll do that at the end of this visit"; (2) "If the patient showed/shows hesitancy about getting vaccinated, I (will) ask(ed) about their concerns, and then use(d) active listening to understand their thoughts"; (3) "If the patient showed/shows hesitancy about getting vaccinated, I (will) listen(ed) to the patient's reasoning and then summarize(d) the patient's reasoning back to them to show that I understood/understand"; (4) "If the patient still has concerns, I did/will not continue efforts to convince them." Each item is answered on a scale from 0% (never) to 100% (always). |
Day 1, Day 30, Day 60, Day 90
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Change in self-reported rate of patient vaccine uptake
Time Frame: Day 1, Day 30, Day 60, Day 90
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Answer to the following item: "Estimate what percentage of your patients is/will be fully vaccinated against […]" This item is answered on a scale from 0% to 100%. The question is being asked 8-10 times with the following name inserted for [...] in the above question: Flu COVID-19 Tetanus, Diphtheria, Pertussis HPV Hepatitis B Meningitis / Meningococcal Shingles Pneumococcal Other (which can be two other diseases that the respondent indicated) |
Day 1, Day 30, Day 60, Day 90
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in belief about patient autonomy
Time Frame: Day 1, Day 30, Day 60, Day 90
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Answer to the following item: "I stated / will state the patient's options - to vaccinate or not, and with which vaccine - so that they can make an informed decision."
This item is answered on a scale from 0% to 100%.
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Day 1, Day 30, Day 60, Day 90
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Change in proportion of patients that accept a recommendation
Time Frame: Day 1, Day 30, Day 60, Day 90
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Proportion of patients that accept a recommendation = multiplication of the answer to the following three items: (1) "I (will) check(ed) whether a patient has/had gotten all indicated vaccines", (2) "If I saw/see a patient had not gotten an indicated vaccine, I (will) discuss(ed) getting it.";
(3) "If I recommend(ed) an indicated vaccine, my patient (will) accept(ed) that recommendation."
All items are answered on a scale from 0% (never) to 100% (always).
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Day 1, Day 30, Day 60, Day 90
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Dan Ariely, PhD, Duke University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Pro00113696
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Personal information will be permanently removed from the data no later than two weeks after the distribution of the final study survey, after which study responses will no longer be able to be linked to an individual participant.
What specific individual participant data sets are to be shared: Answers to all questions in all surveys will be shared.
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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