NCT05957393

Brief Summary

This research examines vaccination recommendation perceptions and behaviors of physicians and advanced practice providers.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
447

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Sep 2023

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 14, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 24, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

September 21, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 24, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 24, 2024

Completed
Last Updated

May 1, 2024

Status Verified

October 1, 2023

Enrollment Period

7 months

First QC Date

July 14, 2023

Last Update Submit

April 30, 2024

Conditions

Keywords

PhysiciansVaccination RecommendationSocial NormsTrustPresumptive Recommendation

Outcome Measures

Primary Outcomes (6)

  • 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).

    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).

    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).

    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).

    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).

    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)

    Day 1, Day 30, Day 60, Day 90

Secondary Outcomes (2)

  • Change in belief about patient autonomy

    Day 1, Day 30, Day 60, Day 90

  • Change in proportion of patients that accept a recommendation

    Day 1, Day 30, Day 60, Day 90

Study Arms (4)

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).

Other: Quantity of vaccination recommendationsOther: Quality of vaccination recommendations

Quantity (present) x Quality (absent)

EXPERIMENTAL

Participants will receive a social norm-based message (for quantity).

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).

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.

Other: Control

Interventions

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)).

Quantity (present) x Quality (absent)Quantity (present) x Quality (present)

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)).

Quantity (absent) x Quality (present)Quantity (present) x Quality (present)
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)).

Quantity (absent) x Quality (absent)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

(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, United States

Location

Duke University Health System (all locations)

Durham, North Carolina, 27710, United States

Location

(Any and all facilities) - Participants are recruited via market research company "Survey Healthcare Global"

Brasília, Brazil

Location

Study Officials

  • Dan Ariely, PhD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2023

First Posted

July 24, 2023

Study Start

September 21, 2023

Primary Completion

April 24, 2024

Study Completion

April 24, 2024

Last Updated

May 1, 2024

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
SAP
Time Frame
After data from the last participant is collected, we'll take 6 months for analysis before data becomes available. Data will be available indefinitely.
Access Criteria
Disaggregated data will be uploaded to the Open Science Framework research portal.

Locations