WomenNCT06582160
Enhancing Uptake of Preconception Care Services in Family Practice Clinics Using a Patient Centered Screening Tool
A study testing Risk-Based Pre-conception Screening and Patient-centered Pre-conception Screening in people with Women and Reproductive Age, run by University of Nebraska at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Women, Reproductive Age
- What is being tested?
- Risk-Based Pre-conception Screening and Patient-centered Pre-conception Screening
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 286 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Sep 2023to 26 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Biologically female
- Child-bearing age
- Visiting the clinic for a routine or preventative appointment during the study period
Who cannot join
- Under 19 or over 49 years of age
- Not biologically female
Trial locations and contacts
1 site in 1 country.
United States1 site
Nebraska Medicine - Fontenelle Clinic
Omaha, Nebraska, 68104
About this study
Official title: Enhancing Uptake of Preconception Care Services in Family Practice Clinics Using a Patient Centered Screening Tool: A Pilot Study
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.
Read the 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
- Being tested
- Risk-Based Pre-conception Screening, Patient-centered Pre-conception Screening
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risk-Based Pre-conception ScreeningOther
A long form questionnaire screening questionnaire administered via tablet in health clinic waiting room. Offered to participants when checking-in for appointment.
Patient-centered Pre-conception ScreeningOther
A short form, 2 question screening administered via tablet in health clinic waiting room. Offered to participants when checking-in for appointment.
| Study group | Role | What they receive |
|---|---|---|
| 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" Receives: 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 Receives: 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?" |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 18 month duration of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2024
- Study start23 Sep 2023
- Primary completion26 Aug 2025
- Study completion26 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WomenStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned to one of three conditions upon enrollment: 1) Long form screening; 2) Short form screening; 3) control
- Masking
- None (open label)
- Enrolment
- 286 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shannon I Maloney, PhD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06582160
- Sponsor's protocol ID
- 0422-22-EP
- Status last verified
- Dec 2025
- First submitted
- 26 Aug 2024
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Uptake of Preconception Care Services in Family Practice Clinics Using a Patient Centered Screening Tool: A Pilot Study
- ClinicalTrials.gov ID
- NCT06582160
- Acronym / sponsor ID
- 0422-22-EP
- Conditions
- Women, Reproductive Age
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 286 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 23 Sep 2023 (actual)
- Primary completion
- 26 Aug 2025 (actual)
- Study completion
- 26 Aug 2025 (actual)
- First posted
- 3 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants are assigned to one of three conditions upon enrollment: 1) Long form screening; 2) Short form screening; 3) control
| Arm | Type | Receives |
|---|---|---|
| Patient-centered Pre-conception Screening | Experimental | Other: Patient-centered Pre-conception ScreeningA 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" |
| Risk-based Pre-conception Screening | Active comparator | Other: Risk-Based Pre-conception ScreeningA 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 |
| 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?" |
Who may qualify
- Ages
- 19 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Biologically female
- Child-bearing age
- Visiting the clinic for a routine or preventative appointment during the study period
Key exclusion criteria (2 listed)
- Under 19 or over 49 years of age
- Not biologically female
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Risk-Based Pre-conception ScreeningA long form questionnaire screening questionnaire administered via tablet in health clinic waiting room. Offered to participants when checking-in for appointment. | Other | Risk-based Pre-conception Screening |
| Patient-centered Pre-conception ScreeningA short form, 2 question screening administered via tablet in health clinic waiting room. Offered to participants when checking-in for appointment. | Other | Patient-centered Pre-conception Screening |
Primary outcome
Risk Detection Rate
Time frame: 18 month duration of study
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.
Screening Tool Completion Rate
Time frame: 18 month duration of study
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).
Health Care Relationship Trust Scale - Revised
Time frame: 18 month duration of the study
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.
Preconception Health Behavior Intentions
Time frame: 18 month duration of the study
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.
Preconception Knowledge
Time frame: 18 month duration of the study
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shannon I Maloney, PhD principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Risk-Based Pre-conception Screening and Patient-centered Pre-conception Screening in people with Women and Reproductive Age, run by University of Nebraska at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risk Detection Rate (time frame: 18 month duration of study). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025.