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

NCT06582160 | Completed

• 1 other identifier: 0422-22-EP
• Study Type: interventional
• Target: 286
• Locations: 1 country
• Sites: 1

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.

Conditions

Women; Reproductive Age

Outcome Measures

Primary Outcomes (5)

• Risk Detection Rate

  Percentage of participants identified as having at least one preconception risk factor. Risk rate will be compared between the two types of screen tool (Group 1 - Short Form/Patient Centered and Group 2 - Long Form/Risk Based). Risk detection rates between the two screening methods will be compared against the benchmark risk as assessed in the post-visit questionnaire.

  18 month duration of study

• Screening Tool Completion Rate

  Rate of completion for each screening tool. Percent of participants with 75% completion of the screening tool will be compared across Group 1 (Short Form/Patient Centered) and Group 2 (Long Form/Risk Based).

  18 month duration of study

• Health Care Relationship Trust Scale - Revised

  Participants trust in their health care provider will be measured using the Health Care Relationship Trust Scale - Revised (HCR Trust Scale-R). HCR Trust Scale-R scores range from 0 to 52, which higher scores indicating greater levels of trust. The instrument will be administered in the post-visit questionnaire. Trust scores will be compared across intervention arms and against the control group.

  18 month duration of the study

• Preconception Health Behavior Intentions

  Intention to change health behavior and self-efficacy for change in response to identified health risks. Measured in the post-visit questionnaire, through the Patient Enablement Instrument (PEI). PEI scores range from 0 to 12, which higher scores indicating greater levels of patient enablement. Additionally, the research team developed two survey items. One item asks respondents if they have the knowledge and skills to improve their preconception health. Response options are yes or no. The second item asks how confident respondents feel that they will make at least one preconception health change. Response options follow Likert scale (1-4) ranging from \"Not at all confident\" to \"Extremely confident.\" Comparisons in preconception health behavior intention will be compared between both intervention arms, and against the control group.

  18 month duration of the study

• Preconception Knowledge

  Awareness of basic preconception health care was assessed through the post-visit questionnaire. To assess knowledge, participants read the following statement: \"The following are a set of statements about health and pregnancy. Please answer whether you agree, disagree or are unsure about these statements.\" This was followed by a series of statements about preconception health such as: \"Folic acid should be taken before pregnancy;\" \"A person\'s weight when they become pregnant can affect the pregnancy; and \"Certain health conditions, like diabetes and hypertension can increase the chances of pregnancy complications.\" Possible responses were "Agree," "Disagree," or "Unsure." Scores range from 0 to 10, with higher scores indicated higher knowledge. Preconception awareness will be compared across the two intervention groups and against the control group.

  18 month duration of the study

Study Arms (3)

Patient-centered Pre-conception Screening

EXPERIMENTAL

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"

Other: Patient-centered Pre-conception Screening

Risk-based Pre-conception Screening

ACTIVE COMPARATOR

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

Other: Risk-Based Pre-conception Screening

Control

NO INTERVENTION

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?"

Interventions

Risk-Based Pre-conception Screening OTHER

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

Risk-based Pre-conception Screening

Patient-centered Pre-conception Screening OTHER

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

Patient-centered Pre-conception Screening

Eligibility Criteria

• Age: 19 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

Nebraska Medicine - Fontenelle Clinic

Omaha, Nebraska, 68104, United States

Location

Study Officials

• Shannon I Maloney, PhD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are assigned to one of three conditions upon enrollment: 1) Long form screening; 2) Short form screening; 3) control

Study Record Dates

• First Submitted: August 26, 2024
• First Posted: September 3, 2024
• Study Start: September 23, 2023
• Primary Completion: August 26, 2025
• Study Completion: August 26, 2025
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)