Clinical trial NCT05216003: Pregnancy at a Time That Is Happy and Healthy for You
Official title: Pregnancy at a Time That Is Happy and Healthy for You
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Contraception Behavior
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2022-01-31
Enrollment: 100000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study will evaluate matched-pair counties in a step-wedge design. As the intervention is implemented within a particular Indiana county, researchers will identify a matching Indiana county based on infant mortality rate. At the end of each year post-implementation, data will be compared between the intervention county and the match-paired county.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: Inclusion Criteria for Clinic Level Analysis:

* women age 18-49
* presenting for care at PATH4YOU clinic site

Exclusion Criteria:

* history of hysterectomy or sterilization, or post-menopausal

Primary outcomes:
measure: Participant Satisfaction with Shared Decision Making
timeFrame: Within 2-4 weeks of PATH4YOU service visit
measure: Participant Satisfaction with Same Day Contraception
timeFrame: Within 2-4 weeks of PATH4YOU service visit
measure: Quality of family planning services
timeFrame: Within 2-4 weeks of PATH4YOU service visit
measure: Participant reported Pregnancy Intention
timeFrame: 3 months, 6 months, and 12 months
measure: Receipt of Pre-Visit Birth Control Decision Aid
timeFrame: Within 2-4 weeks of PATH4YOU service visit
measure: Continuation of Contraceptive Method
timeFrame: 3 months, 6 months, and 12 months
measure: Unintended pregnancy rate
timeFrame: 3 months, 6 months, and 12 months
Secondary outcomes:
measure: Number of women receiving PATH4YOU bundle
timeFrame: 3 years
measure: Impact of demographics and reproductive characteristics
timeFrame: 3 years
measure: Contraceptive choice
timeFrame: 3 years
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Hospital
state: Indiana
Study officials:
References: