HealthyNCT05957393
Improving Physician Vaccine Recommendation Using Social Norms, Trust, and Presumptive Language
A study testing Quantity of vaccination recommendations and Quality of vaccination recommendations in people with Healthy, run by Duke University at 3 sites in 2 countries.
Trial summary
This research examines vaccination recommendation perceptions and behaviors of physicians and advanced practice providers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Quantity of vaccination recommendations and Quality of vaccination recommendations
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 447 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 21 Sep 2023to 24 Apr 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Students or employees under the supervision of the PI who meet inclusion criteria for the study
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
(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
Durham, North Carolina, 27710
Duke University Health System (all locations)
Durham, North Carolina, 27710
Brazil1 site
(Any and all facilities) - Participants are recruited via market research company "Survey Healthcare Global"
Brasília
About this study
This research examines vaccination recommendation perceptions and behaviors of physicians and advanced practice providers.
- Conditions
- Healthy
- Being tested
- Quantity of vaccination recommendations, Quality of vaccination recommendations, Control
- Keywords
- Physicians, Vaccination Recommendation, Social Norms, Trust, Presumptive Recommendation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantity of vaccination recommendationsOther
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)).
Quality of vaccination recommendationsOther
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)).
ControlOther
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)).
| Study group | Role | What they receive |
|---|---|---|
| Quantity (present) x Quality (present) | Experimental | 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). Receives: Other: Quantity of vaccination recommendations; Other: Quality of vaccination recommendations |
| Quantity (present) x Quality (absent) | Experimental | Participants will receive a social norm-based message (for quantity). Receives: Other: Quantity of vaccination recommendations |
| Quantity (absent) x Quality (present) | Experimental | Participants will learn the AIMS method, a trust-building method using presumptive language (for quality). Receives: Other: Quality of vaccination recommendations |
| Quantity (absent) x Quality (absent) | Experimental | 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. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in proportion of patients that receive a vaccine recommendation
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).
Measured: Day 1, Day 30, Day 60, Day 90
Change in self-reported responsibility perception
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).
Measured: Day 1, Day 30, Day 60, Day 90
Change in self-reported assessment of patient recommendation acceptance
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).
Measured: Day 1, Day 30, Day 60, Day 90
Change in self-reported patient trust
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).
Measured: Day 1, Day 30, Day 60, Day 90
Change in self-reported utilization of AIMS
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).
Measured: Day 1, Day 30, Day 60, Day 90
Change in self-reported rate of patient vaccine uptake
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)
Measured: Day 1, Day 30, Day 60, Day 90
Secondary outcomes (2)
Change in belief about patient autonomy
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%.
Measured: Day 1, Day 30, Day 60, Day 90
Change in proportion of patients that accept a recommendation
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).
Measured: Day 1, Day 30, Day 60, Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2023
- Study start21 Sep 2023
- Primary completion24 Apr 2024
- Study completion24 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 447 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dan Ariely, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05957393
- Sponsor's protocol ID
- Pro00113696
- Status last verified
- Oct 2023
- First submitted
- 14 Jul 2023
- Last updated
- 1 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Physician Vaccine Recommendation Using Social Norms, Trust, and Presumptive Language
- ClinicalTrials.gov ID
- NCT05957393
- Acronym / sponsor ID
- Pro00113696
- Conditions
- Healthy
- Keywords
- Physicians, Vaccination Recommendation, Social Norms, Trust, Presumptive Recommendation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 447 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 21 Sep 2023 (actual)
- Primary completion
- 24 Apr 2024 (actual)
- Study completion
- 24 Apr 2024 (actual)
- First posted
- 24 Jul 2023 (actual)
- 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.
This research examines vaccination recommendation perceptions and behaviors of physicians and advanced practice providers.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Quantity (present) x Quality (present) | Experimental | Other: Quantity of vaccination recommendations, Other: Quality of vaccination recommendationsParticipants will receive a social norm-based message (for quantity) and will learn the AIMS method, a trust-building method using presumptive language (for quality). |
| Quantity (present) x Quality (absent) | Experimental | Other: Quantity of vaccination recommendationsParticipants will receive a social norm-based message (for quantity). |
| Quantity (absent) x Quality (present) | Experimental | Other: Quality of vaccination recommendationsParticipants will learn the AIMS method, a trust-building method using presumptive language (for quality). |
| Quantity (absent) x Quality (absent) | Experimental | Other: ControlControl: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Students or employees under the supervision of the PI who meet inclusion criteria for the study
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 |
|---|---|---|
| Quantity of vaccination recommendationsThe 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)). | Other | Quantity (present) x Quality (absent), Quantity (present) x Quality (present) |
| Quality of vaccination recommendationsThe 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)). | Other | Quantity (absent) x Quality (present), Quantity (present) x Quality (present) |
| ControlThe 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)). | Other | Quantity (absent) x Quality (absent) |
Primary outcome
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).
Change in self-reported responsibility perception
Time frame: Day 1, Day 30, Day 60, Day 90
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).
Change in self-reported assessment of patient recommendation acceptance
Time frame: Day 1, Day 30, Day 60, Day 90
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).
Change in self-reported patient trust
Time frame: Day 1, Day 30, Day 60, Day 90
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).
Change in self-reported utilization of AIMS
Time frame: Day 1, Day 30, Day 60, Day 90
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).
Change in self-reported rate of patient vaccine uptake
Time frame: Day 1, Day 30, Day 60, Day 90
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)
2 secondary outcomes
Change in belief about patient autonomy
Time frame: Day 1, Day 30, Day 60, Day 90
Change in proportion of patients that accept a recommendation
Time frame: Day 1, Day 30, Day 60, Day 90
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 1 May 2024.
- Individual participant dataSharing planned: Yes. 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.
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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.
Dan Ariely, PhD principal investigator
Duke University
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quantity of vaccination recommendations and Quality of vaccination recommendations in people with Healthy, run by Duke University at 3 sites in 2 countries.
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 1 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Brazil. 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?
Change in proportion of patients that receive a vaccine recommendation (time frame: Day 1, Day 30, Day 60, Day 90). The study lists 6 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 1 May 2024.