Impacts of Clinician-Mediated Report-Back

Study Overview
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Brief Summary
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The study trains clinicians to return personal exposure results to study participants in pregnancy cohorts, and measures outcomes for environmental health literacy for both clinicians and study participants.

Detailed Description
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To design and implement clinic-based report-back for endocrine disrupting compounds and analyze the impacts of doing so, investigators train clinicians to report-back individual chemical results to study participants in two pregnancy cohorts and then evaluate outcomes for both clinicians and patients, including shifts in environmental health behaviors, using interviews and pre-and post-tests. All study participants will get a personal exposure report and 200 participants from each cohort (N Total= 400) are randomly selected and assigned equally to one of two groups: 1) those who only receive their personal results online and 2)those who receive them in-clinic to measure additional benefits of clinical report-back for participant learning, exposure-related behaviors, and relationships to the study and clinical care.

Official Title
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Expanding Effective Report-back of Environmental Exposures in Clinic-Based Studies

Conditions
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Health Knowledge, Attitudes, Practice

Intervention / Treatment
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* Behavioral: In-clinic report-back


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants are of reproductive age Exclusion Criteria: Under 18 years old or past reproductive age

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: All study participants in two pregnancy cohorts will get a personal exposure report for chemicals measured during their pregnancy. 200 participants from each cohort (N Total= 400) are randomly selected and assigned equally to one of two groups: 1) those who only receive their personal results online and 2)those who receive in-clinic to measure differences in participants' environmental health literacy. Pre-and post-tests are administered before and after report-back.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: In-clinic report-back<br>200 participants receive their personal exposure results from a clinician | Behavioral: In-clinic report-back<br>* Investigators measure whether report-back from a clinician improves environmental health literacy, including leading to greater shifts in exposure-reducing health behaviors<br>|
| Other: Online<br>200 participants receive their personal exposure results from a website online | Behavioral: In-clinic report-back<br>* Investigators measure whether report-back from a clinician improves environmental health literacy, including leading to greater shifts in exposure-reducing health behaviors<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Environmental health literacy as measured by pre-and post-tests (questionnaires). | 2 weeks after completing a pre-test and receiving their personal results, study participants will take a post-test. Pre-and post-tests include true and false, as well as scale questions that measure shifts in environmental health literacy before and after report-back. | 2 weeks |