Pregnancy at a Time That Is Happy and Healthy for You

Not Applicable

• Conditions: Contraception Behavior
• Interventions: Behavioral: PATH4YOU

• Registration Number: NCT05216003
• Lead Sponsor: Indiana University

Brief Summary

In an effort reduce maternal and infant mortality and health disparities overall, PATH4YOU (Pregnancy At a Time that's Healthy and Happy for You) will be implemented starting in Marion County, and will ultimately be a statewide comprehensive contraceptive access program that ensures that patient-centered counseling and same-day access to no (or low) cost contraception are delivered to women across the state. The goal of this project is to partner with community stakeholders to tailor and implement a patient-centered, comprehensive contraceptive access intervention, the PATH4YOU Bundle.

The health center level intervention will consist of three key principles:

1. Pregnancy Intention Screening: Provide training for health care providers and assist in health center implementation of a patient-centered pregnancy intention screening strategy within clinical settings

2. Contraception and Reproductive Health Counseling: Implement the use of a pre-visit patient-centered decision-aid for all patients presenting to a health center for reproductive health care.

3. Same-Day Access to Contraception: Provide training for health care providers and logistical assistance to health centers to implement care consistent with providing patients with their chosen method of contraception the day of patient contact.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-02
• Study First Submitted: 2022-01-19
• Study First Submitted QC: 2022-01-19
• Study First Posted: 2022-01-31
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-29
• Last Update Posted: 2024-05-02
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Female
• Target Recruitment: 100000

Inclusion Criteria

Not provided

Exclusion Criteria

• history of hysterectomy or sterilization, or post-menopausal

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PATH4YOU County	PATH4YOU	-

Primary Outcome Measures

Name	Time	Method
Participant Satisfaction with Shared Decision Making	Within 2-4 weeks of PATH4YOU service visit	Participant satisfaction is measured by the validated CollaboRATE scale, which is a 3 question survey. Each question is rated on a 5 point Likert scale with a response range of "every effort was made" (1) to "no effort was made" (5).
Unintended pregnancy rate	3 months, 6 months, and 12 months	The number of unintended pregnancies within 1 year of enrollment will be assessed. Participants will be surveyed at 3 months, 6 months and 12 months after the PATH4YOU service visit.
Quality of family planning services	Within 2-4 weeks of PATH4YOU service visit	Quality of family planning services will be evaluated through the validated Patient Centered Contraceptive Counseling (PCCC) Measure. The PCCC is a 4 question survey. Each question is rated on a 5 point Likert scale with responses ranging from poor (1) to excellent (5). Individual participant scores may range from 4 to 20 (with higher scores reflecting higher quality of care). A proportion of patient responses (80%) is used to determine overall quality of services. Participants will be asked to complete the PCCC one time, within 2-4 weeks after they have received care through the PATH4YOU program. Total responses will then be aggregated to determine overall quality of services upon final participant completion, approximately 3 years after project initiation.
Participant reported Pregnancy Intention	3 months, 6 months, and 12 months	Participants will complete the Parenting Attitudes Timing and How important (PATH) validated scale on pregnancy intention. The scale askes participants to express an opinion about having children (yes/no), to rate the importance of pregnancy on a 5 point Likert scale (from very important as a 1 to not at all important as a 5), and to estimate the timeframe in which intend to be pregnant (ranging from within 6 months to more than 5 years from now). Participants will be surveyed at 3 months, 6 months and 12 months after the PATH4YOU service visit.
Participant Satisfaction with Same Day Contraception	Within 2-4 weeks of PATH4YOU service visit	Participants will be asked to respond to a single question of whether they received their desired contraception on the day of the visit. Responses will be either yes or no.
Receipt of Pre-Visit Birth Control Decision Aid	Within 2-4 weeks of PATH4YOU service visit	Participants will be asked whether they received the decision aid and whether they used it prior to the visit.
Continuation of Contraceptive Method	3 months, 6 months, and 12 months	Participants will be asked whether they are satisfied with, and continuation of, contraceptive method. Participants will be surveyed at 3 months, 6 months and 12 months after the PATH4YOU service visit.

Secondary Outcome Measures

Name	Time	Method
Number of women receiving PATH4YOU bundle	3 years	The number of participants in each county will be totaled.
Impact of demographics and reproductive characteristics	3 years	The sociodemographic and reproductive characteristics of participants, including participant self-reported age, race, ethnicity, gender, orientation, type of insurance, and zip code, will be evaluated to determine potential correlation with contraceptive method choice.
Contraceptive choice	3 years	Of the women not desiring pregnancy, the percentage of women choosing each contraceptive method will be evaluated.

Trial Locations

Locations (1)

Indiana University Hospital; 🇺🇸 Indianapolis, Indiana, United States