Clinical trial NCT06582160: Enhancing Uptake of Preconception Care Services in Family Practice Clinics Using a Patient Centered Screening Tool
Official title: Enhancing Uptake of Preconception Care Services in Family Practice Clinics Using a Patient Centered Screening Tool: A Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Women
Reproductive Age
Lead sponsor: University of Nebraska
Sponsor class: OTHER
First posted: 2024-09-03
Enrollment: 300
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are assigned to one of three conditions upon enrollment: 1) Long form screening; 2) Short form screening; 3) control
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Risk Detection Rate
timeFrame: 18 month duration of study
measure: Screening Tool Completion Rate
timeFrame: 18 month duration of study
measure: Health Care Relationship Trust Scale - Revised
timeFrame: 18 month duration of the study
measure: Preconception Health Behavior Intentions
timeFrame: 18 month duration of the study
measure: Preconception Knowledge
timeFrame: 18 month duration of the study
Secondary outcomes:
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Nebraska Medicine - Fontenelle Clinic
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Shannon I Maloney, PhD
role: PRINCIPAL_INVESTIGATOR
References: