Impacts of Clinician-Mediated Report-Back

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

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.

Study Overview

• Status: Completed
• Conditions: Health Knowledge, Attitudes, Practice
• Intervention / Treatment: Behavioral: In-clinic report-back

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 163
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Puerto Rico
  • San Juan, Puerto Rico, 00936
    • University of Puerto Rico Medical Sciences Campus
• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Harvard T.H Chan School of Public Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Participants are of reproductive age

Exclusion Criteria:

• Under 18 years old or past reproductive age

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: In-clinic report-back; 200 participants receive their personal exposure results from a clinician	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
Other: Online; 200 participants receive their personal exposure results from a website online	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knowledge Before and After Report-back Intervention.	Participants were asked to respond to a series of 9-11 statements about environmental exposures and select if they were true, probably true, probably false, or false. Responses were re-coded to indicate correctness, and index score was calculated as the fraction of correct responses across all questions for each participant (0-1). Pre-survey knowledge indices were subtracted from post-survey indices to calculate the change after report-back (i.e., pre-post-survey change in knowledge is reported below). A larger reported mean below would indicate that report-back mode resulted in a larger knowledge gain (a better outcome).	Participants completed pre and post-surveys before and at least 2 weeks after report-back up to a maximum of 6 weeks.
Satisfaction With Report-back After Report-back Intervention	Participants were asked to rank their agreement with four satisfaction questions at the post-survey using a Likert-scale from 1 (strongly disagree) to 5 (strongly agree). Responses to all four questions were summed to calculate post-report-back sum satisfaction from 4-20. A higher score indicates more satisfaction (a better outcome).	Participants completed post-surveys at least 2 weeks after report-back up to a maximum of 6 weeks.
Feelings About Report-back, Before and After Intervention	Participants ranked the strength of each feeling using a Likert-scale from 1 (not at all) to 6 (very strong). Pre-survey responses were subtracted from post-survey responses to calculate the change after report-back. A higher score for outcomes measures such as empowered and respected indicates a better outcome.	Participants completed pre and post-surveys before and at least 2 weeks after report-back up to a maximum of 6 weeks.
Perceived Self-efficacy Before and After Report-back Intervention	Participants were asked to respond to a series of seven statements and rate confidence in their abilities using a Likert-scale from 0 (cannot do it at all) to 6 (highly certain I can do it). Responses to all seven questions were summed to calculate a perceived self-efficacy scale from 0-42. Pre-survey scales were subtracted from post-survey scales to calculate the change after report-back. A higher scores indicates a better outcome.	Participants completed pre and post-surveys before and at least 2 weeks after report-back up to a maximum of 6 weeks.
Behaviors Before and After Report-back Intervention	Participants were asked to rate how frequently they engaged in exposure-related behaviors during the previous two weeks using a Likert-scale from 0 (never) to 3 (Always/almost every day). Pre-survey responses were subtracted from post-survey responses to calculate the change after report-back. A higher score indicates a better outcome for questions such as 'look for information about chemical ingredients', whereas a lower score indicates a better outcome for questions such as 'microwave food in plastic containers.'	Participants completed pre and post-surveys before and at least 2 weeks after report-back up to a maximum of six weeks.

Collaborators and Investigators

• Sponsor: Silent Spring Institute
• Collaborators: Harvard University; University of Puerto Rico; Northeastern University
• Investigators: Principal Investigator: Jennifer Ohayon, PhD, Silent Spring Institute

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2023
• Primary Completion (Actual): December 20, 2024
• Study Completion (Actual): December 20, 2024

Study Registration Dates

• First Submitted: September 14, 2023
• First Submitted That Met QC Criteria: October 6, 2023
• First Posted (Actual): October 10, 2023

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavior
• Other Study ID Numbers: 1R21ES032934-01A1b; 1R21ES032934-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No