Enhancing Uptake of Preconception Care Services in Family Practice Clinics Using a Patient Centered Screening Tool

NCT ID: NCT06582160

Last Updated: 2025-12-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 286 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-23
• Study Completion Date: 2025-08-26

Brief Summary

Sixteen years have passed since the Centers for Disease Control recommended routine preconception screening and counseling in primary care settings, yet time constraints and low preconception counseling adherence have prevented widespread uptake. This innovative, self-selected preconception screening tool encourages participants to be active in their own care and eliminates the time burden associated with typical pre-selected screening in clinics. This project will generate important knowledge about the promise of utilizing a participant-selected preconception screening tool to promote preconception health behavior change during routine medical encounters for women of reproductive age.

Detailed Description

Women who make positive health behavior changes to protect their fetus typically do so after learning about the pregnancy, unaware that the period of maximum sensitivity to these changes has passed. Fewer than half of mothers enter pregnancy at a healthy weight and an increasing percentage of pregnancies are affected by chronic hypertension and other chronic health conditions. These risk factors are predictive of poor birth outcomes and increased risk to maternal health, yet they are difficult to modify after conception. Routine pre-onception screening and counseling is recommended for all women of reproductive age, yet adherence is low. More than sixteen years after the Centers for Disease Control (CDC) recommended routine preconception screening and counseling in primary care settings, fewer than one-fifth of primary care providers conduct this critical screening. Pioneering approaches are needed to increase preconception screening and improve patient adherence to preconception recommendations in primary care settings. This innovative, self-selected preconception screening tool encourages patients to be active participants in their own care and eliminates the time burden associated with typical pre-selected screening. Typical pre-selected risk screening tools ask patients a series of predetermined health-related questions to identify health risks. Pre-selected tools identify health information needs for the participant, based on the participant's response to the risk assessment. This study proposes a patient-selected screening tool, whereby the participant selects from a list of preconception counseling topics based on her own perceived need for information. This tool has fewer questions, reducing time burden. The first specific aim of this project is to compare topics identified for counseling and overall identification of risk between the two screening approaches. The second aim is to compare preconception knowledge, behavior change intention and self-efficacy between participant who receive participant-selected and pre-selected preconception screening. The third aim is to utilize a QUAN-qual sequential mixed methods design to explain quantitative results and identify novel options for preconception counseling. To accomplish this objective, a pilot study will be conduct in a mid-size primary care clinic located in a Midwest urban setting. Female participants of child-bearing age will be randomly assigned to receive: 1) pre-selected preconception screening; 2) participant-selected preconception risk screening; or 3) no screening. Participants will then be invited to a follow-up interview. Participants will be asked about their experiences with the preconception tools and how to better incorporate preconception screening and counseling into primary care settings. The findings from the quantitative pilot study will be integrated with the qualitative data using an explanatory sequential joint display. This project's results can demonstrate the relevance of utilizing a quicker and potentially more effective preconception screening tool for improving maternal and child health.

Conditions

Women; Reproductive Age

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Patient-centered Pre-conception Screening

A short form, 2 question screening form which asks participants which preconception health topics they would like to discuss with their doctor today. Includes an option for "None of these. I would not like to discuss how my health can affect fertility and any future pregnancies"

Group Type: EXPERIMENTAL

Patient-centered Pre-conception Screening

Intervention Type: OTHER

A short form, 2 question screening administered via tablet in health clinic waiting room. Offered to participants when checking-in for appointment.

Risk-based Pre-conception Screening

A long form questionnaire screening for a range of preconception health risk factors including: age, weight, exercise, diet, nutrition, health conditions, risky behaviors, immunization status, prescription medications, birth control use

Group Type: ACTIVE_COMPARATOR

Risk-Based Pre-conception Screening

Intervention Type: OTHER

A long form questionnaire screening questionnaire administered via tablet in health clinic waiting room. Offered to participants when checking-in for appointment.

Control

Participant is asked a single question: "Your health today can make a difference for the pregnancy you experience tomorrow. Do you agree with the statement above?"

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Risk-Based Pre-conception Screening

A long form questionnaire screening questionnaire administered via tablet in health clinic waiting room. Offered to participants when checking-in for appointment.

Intervention Type: OTHER

Patient-centered Pre-conception Screening

A short form, 2 question screening administered via tablet in health clinic waiting room. Offered to participants when checking-in for appointment.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Biologically female
• Child-bearing age
• Visiting the clinic for a routine or preventative appointment during the study period

Exclusion Criteria

• Under 19 or over 49 years of age
• Not biologically female

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Nebraska

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shannon I Maloney, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Nebraska

Locations

Nebraska Medicine - Fontenelle Clinic

Omaha, Nebraska, United States

Countries

United States

Other Identifiers

0422-22-EP

Identifier Type: -

Identifier Source: org_study_id