Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06582160
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-26
Brief Title:
Enhancing Uptake of Preconception Care Services in Family Practice Clinics Using a Patient Centered Screening Tool
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Enhancing Uptake of Preconception Care Services in Family Practice Clinics Using a Patient Centered Screening Tool A Pilot Study
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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 preconception 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 pre-determined health-related questions to identify health risks Pre-selected tools identify health information needs for the patient based on the patients response to the risk assessment This study proposes a patient-selected screening tool whereby the patient selects from a list of pre-conception 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 patients who receive patient-selected and preselected 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 preselected preconception screening 2 patient-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 projects results can demonstrate the relevance of utilizing a quicker and potentially more effective preconception screening tool for improving maternal and child health
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None