Expanding Effective Report-back of Environmental Exposures in Clinic-Based Studies
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 163
- Locations
- 4
- Primary Endpoint
- Environmental health literacy as measured by pre-and post-tests (questionnaires).
Study Overview
Brief 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.
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Participants are of reproductive age
Exclusion Criteria
- •Under 18 years old or past reproductive age
Arms & Interventions
In-clinic report-back
200 participants receive their personal exposure results from a clinician
Intervention: In-clinic report-back (Behavioral)
Online
200 participants receive their personal exposure results from a website online
Intervention: In-clinic report-back (Behavioral)
Outcomes
Primary Outcomes
Environmental health literacy as measured by pre-and post-tests (questionnaires).
Time Frame: 2 weeks
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.
Knowledge Before and After Report-back Intervention.
Time Frame: Participants completed pre and post-surveys before and at least 2 weeks after report-back up to a maximum of 6 weeks.
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).
Satisfaction With Report-back After Report-back Intervention
Time Frame: Participants completed post-surveys at least 2 weeks after report-back up to a maximum of 6 weeks.
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).
Feelings About Report-back, Before and After Intervention
Time Frame: Participants completed pre and post-surveys before and at least 2 weeks after report-back up to a maximum of 6 weeks.
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.
Perceived Self-efficacy Before and After Report-back Intervention
Time Frame: Participants completed pre and post-surveys before and at least 2 weeks after report-back up to a maximum of 6 weeks.
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.
Behaviors Before and After Report-back Intervention
Time Frame: Participants completed pre and post-surveys before and at least 2 weeks after report-back up to a maximum of six weeks.
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.'
Secondary Outcomes
No secondary outcomes reported