- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06526663
Randomizing Vignettes to Understand Contributors to Trust in Primary Care Doctors
Study Overview
Detailed Description
The investigators will engage survey participants by recruiting from among the "Workers" registered with Amazon Mechanical Turk (MTurk). These are paid participants who chose to participate in this anonymous, low-risk activity. After pilot testing on a small set of Workers, the investigators will field the full survey using a randomized design to test hypotheses about the investigators ability to manipulate trust experimentally.
Individuals eligible as participants will be over the age of 18 years, able to read and respond in English, and have had one or more visits with a doctor in the past 3 years.
Survey
The survey has three parts. The investigators will use Qualtrics to develop the survey vignette and use the randomization feature of Qualtrics to randomize the participants when the participant clicks on the link to Qualtrics.
Vignette Participants will be randomized to view one of sixteen vignettes. The vignettes describe a clinical encounter and vary four attributes, each of which has two levels.
Duration of relationship with doctor: No previous relationship (episodic care, walk-in-care, on demand telemedicine) versus > 3 years; Connection: Physician is attending to computer versus Physician is attending to patient; Length of visit: 15 minutes versus 30 minutes; Shares information: Doctor does not explain the decision making versus Doctor shares what he/she knows that informed the decision
A sample vignette is presented here:
Imagine having low back pain that started 4 days ago and being very uncomfortable. For this visit, the patient sees a doctor at the usual practice that the patient has never met before. The doctor spends 30 minutes with the patient. He is primarily looking at the computer screen and not at the patient. At the end, the doctor tells the patient that no xrays are needed and makes recommendations for treating the patient's pain.
The investigators will do a test of attention quiz to assure that the participant read the vignette asking:
- Why did you go for care? (twisted ankle, back pain)
- Did the doctor make any recommendations? (recommended pain treatment, recommended a cast)
- Trust in Clinician Survey.
The investigators will use the Wake Forest Trust in Physician (WFTP) scale slightly modified to clarify that the investigators are inquiring about the clinician described in the vignette. Whereas the WFTP scale asks about "your doctor", the investigators will ask about "this doctor". The WFTP uses a 5-pt Likert scale. Items 2, 3, and 8 are reverse coded upon analysis (strongly agree, agree, neutral, disagree, strongly disagree).
The introduction will read:
Think about the visit described above. What do you think about this doctor?
- This doctor will do whatever it takes to get you all the care you need.
- Sometimes this doctor cares more about what is convenient for [him or her] than about the patient's medical needs.
- This doctor's medical skills are not as good as they should be.
- This doctor is extremely thorough and careful.
- You completely trust this doctors decisions about which medical treatments are best for you.
- This doctor is totally honest in telling you about all of the different treatment options available for the patient's condition.
- This doctor only thinks about what is best for you.
- Sometimes this doctor does not pay full attention to what you are trying to tell [him or her].
- The patient has no worries about putting the patient's life in this doctor's hands.
- All in all, the patient has complete trust in this doctor.
3) Demographics
The investigators will ask the respondents to describe themselves as follows:
Sex (Male, Female, Non-binary) Age (18-35, 36-50, 51-65, >=65) Race/Ethnicity (Black, White, Asian, Native American/Pacific Islander, Hispanic, Other) Choose all that apply How do you describe your health? Excellent, Very good, Good, Fair, Poor Do you have health insurance? Yes or No What is your highest level of education completed? Grade school, High School, college, post-graduate
Analysis The investigators will use descriptive statistics to describe the characteristics of the respondents and the distribution of the WFTP score, which is a quasi-continuous measure. The investigators will look for outliers defined as scores greater or less than 3.2 standard deviations from the mean. Linearity will be examined with scatterplots. The assumption of normality will be assessed by analyzing the skewness and kurtosis of the variables and with use of histograms. The investigators expect the WFTP to be normally distributed as it has been in other populations. If it is not, the investigators will consider log transformation. The investigators will describe the respondents by vignette assignment to confirm that randomization was successful.
Given the structure of MTurk, the investigators will not have a measure of survey response. The investigators will, however, be able to assess the pattern of missing variables across the responses and will incorporate this appropriately into the models.
In the validation study by Katz, she reports in a national sample, the Wake Forest Physician Trust Scale (WFPTS) had a mean score of 40.8 (SD = 6.2) for the national sample of 959 participants. In her study of fewer participants recruited from MTurk, the mean score for the WFPTS was 35.9 (SD = 6.12) for young adult participants and 36.1 (SD = 6.11) for older adult participants.
The investigators would like to be able to detect a 2 standard deviation (SD) difference between the lower trust vignettes and the higher trust vignettes. If the study has 36 individuals in each group, the investigators are able to detect, with a power of 0.8 and an alpha of 0.5, a difference of 4 points on the WFTP (38 (sd 6) vs 42 (sd 6)). The investigators will aim to have 36 respondents in each of 16 groups.
The investigators will test hypotheses about the vignettes and the reported trust in the physician.
For the second round of the survey, investigators will randomize to only 4 arms depending on the results of the first round. The investigators will randomize 100 individuals (50 men and 50 women) to each of the 4 arms.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21205
- Johns Hopkins University
-
-
Virginia
-
Blacksburg, Virginia, United States, 24061
- Virginia Tech
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Participants will be over the age of 18 years,
- able to read and respond in English, and
- have had one or more visits with a doctor in the past 3 years
- will be registered MTURK workers
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Vignette1
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|
Participants will be randomized to be exposed to one of 16 written vignettes that vary four elements of the primary care experience. The four attributes can take two levels. In the second round, individuals will be randomized to only 4 different vignettes. |
|
Active Comparator: Vignette2
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|
Participants will be randomized to be exposed to one of 16 written vignettes that vary four elements of the primary care experience. The four attributes can take two levels. In the second round, individuals will be randomized to only 4 different vignettes. |
|
Active Comparator: Vignette3
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|
Participants will be randomized to be exposed to one of 16 written vignettes that vary four elements of the primary care experience. The four attributes can take two levels. In the second round, individuals will be randomized to only 4 different vignettes. |
|
Active Comparator: Vignette4
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|
Participants will be randomized to be exposed to one of 16 written vignettes that vary four elements of the primary care experience. The four attributes can take two levels. In the second round, individuals will be randomized to only 4 different vignettes. |
|
Active Comparator: Vignette5
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|
Participants will be randomized to be exposed to one of 16 written vignettes that vary four elements of the primary care experience. The four attributes can take two levels. In the second round, individuals will be randomized to only 4 different vignettes. |
|
Active Comparator: Vignette6
baab
|
Participants will be randomized to be exposed to one of 16 written vignettes that vary four elements of the primary care experience. The four attributes can take two levels. In the second round, individuals will be randomized to only 4 different vignettes. |
|
Active Comparator: Vignette7
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|
Participants will be randomized to be exposed to one of 16 written vignettes that vary four elements of the primary care experience. The four attributes can take two levels. In the second round, individuals will be randomized to only 4 different vignettes. |
|
Active Comparator: Vignette8
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|
Participants will be randomized to be exposed to one of 16 written vignettes that vary four elements of the primary care experience. The four attributes can take two levels. In the second round, individuals will be randomized to only 4 different vignettes. |
|
Active Comparator: Vignette9
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|
Participants will be randomized to be exposed to one of 16 written vignettes that vary four elements of the primary care experience. The four attributes can take two levels. In the second round, individuals will be randomized to only 4 different vignettes. |
|
Active Comparator: Vignette10
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|
Participants will be randomized to be exposed to one of 16 written vignettes that vary four elements of the primary care experience. The four attributes can take two levels. In the second round, individuals will be randomized to only 4 different vignettes. |
|
Active Comparator: Vignette11
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|
Participants will be randomized to be exposed to one of 16 written vignettes that vary four elements of the primary care experience. The four attributes can take two levels. In the second round, individuals will be randomized to only 4 different vignettes. |
|
Active Comparator: Vignette12
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|
Participants will be randomized to be exposed to one of 16 written vignettes that vary four elements of the primary care experience. The four attributes can take two levels. In the second round, individuals will be randomized to only 4 different vignettes. |
|
Active Comparator: Vignette13
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|
Participants will be randomized to be exposed to one of 16 written vignettes that vary four elements of the primary care experience. The four attributes can take two levels. In the second round, individuals will be randomized to only 4 different vignettes. |
|
Active Comparator: Vignette14
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|
Participants will be randomized to be exposed to one of 16 written vignettes that vary four elements of the primary care experience. The four attributes can take two levels. In the second round, individuals will be randomized to only 4 different vignettes. |
|
Active Comparator: Vignette15
abab
|
Participants will be randomized to be exposed to one of 16 written vignettes that vary four elements of the primary care experience. The four attributes can take two levels. In the second round, individuals will be randomized to only 4 different vignettes. |
|
Active Comparator: Vignette16
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|
Participants will be randomized to be exposed to one of 16 written vignettes that vary four elements of the primary care experience. The four attributes can take two levels. In the second round, individuals will be randomized to only 4 different vignettes. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Wake Forest Physician Trust Scale (10 item survey)
Time Frame: Immediately upon completing exposure to the vignette
|
Scores range from 10-50 with higher scores indicating higher trust
|
Immediately upon completing exposure to the vignette
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jodi Segal, MD, MPH, Johns Hopkins 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
- IRB00447825
- K24AG049036 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
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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