Impacts of Clinician-Mediated Report-Back

Health Knowledge, Attitudes, Practice Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06074159
• Other study ID #: 1R21ES032934-01A1b
• Secondary ID: 1R21ES032934-01A
• Status: Recruiting
• Phase: N/A
• Start date: August 25, 2023
• Est. completion date: December 20, 2023

Study information

• Verified date: October 2023
• Source: Silent Spring Institute
• Contact: Jennifer Ohayon, PhD
• Phone: 617.332.4288
• Email: ohayon[@]silentspring.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 20, 2023
• Est. primary completion date: December 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Participants are of reproductive age

Exclusion Criteria:

• Under 18 years old or past reproductive age

Related Conditions & MeSH terms

• Health Knowledge, Attitudes, Practice

Intervention

Behavioral:
• In-clinic report-back
Investigators measure whether report-back from a clinician improves environmental health literacy, including leading to greater shifts in exposure-reducing health behaviors

Locations

Country	Name	City	State
Puerto Rico	University of Puerto Rico Medical Sciences Campus	San Juan
United States	Harvard T.H Chan School of Public Health	Boston	Massachusetts

Sponsors (4)

Lead Sponsor	Collaborator
Silent Spring Institute	Harvard University, Northeastern University, University of Puerto Rico

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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