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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05957393
Other study ID # Pro00113696
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 21, 2023
Est. completion date April 24, 2024

Study information

Verified date October 2023
Source Duke University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 447
Est. completion date April 24, 2024
Est. primary completion date April 24, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Quantity of vaccination recommendations
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 recommendations
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)).
Control
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)).

Locations

Country Name City State
Brazil (Any and all facilities) - Participants are recruited via market research company "Survey Healthcare Global" Brasília
United States (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
United States Duke University Health System (all locations) Durham North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Duke University

Countries where clinical trial is conducted

United States,  Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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 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%. Day 1, Day 30, Day 60, Day 90
Secondary 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). Day 1, Day 30, Day 60, Day 90
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