Enhancing Uptake of Preconception Care Services in Family Practice Clinics Using a Patient Centered Screening Tool
NCT Number: NCT06582160
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Women|Reproductive Age
Interventions: OTHER: Preconception Screening Questionnaire with Counseling
Sponsor: University of Nebraska
Sex: FEMALE
Age: ADULT
Enrollment: 300
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2023-09-23
Completion Date: 2025-08
Locations: Nebraska Medicine - Fontenelle Clinic, Omaha, Nebraska, 68104, United States

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 patients to be active participants in their own care and eliminates the time burden associated with typical preselected screening in clinics. This project will generate important knowledge about the promise of utilizing a patient-selected preconception screening tool to promote preconception health behavior change during routine medical encounters for women of reproductive age.

Primary Outcome Measures: Risk Detection Rate, Percentage of patients 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 patients 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|Trust in Health Care, Patients trust in their health care provider will be measured using the Health Care Provider Trust instrument. 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 Knowledge Questionnaire, Awareness of basic preconception health care, adapted from Women's Preconception Health Survey and administered through the post-visit questionnaire. Questions ask participants to agree or disagree with preconception health statements, covering topics like age, nutrition, medications, alcohol use, weight and pregnancy prevention. Preconception awareness will be compared across the two intervention groups 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 and through two researcher developed survey items which ask about perceived knowledge, skills and confidence to change behavior. Comparisons in preconception health behavior intention will be compared between both intervention arms, and against the control group., 18 month duration of the study