Pregnancy at a Time That Is Happy and Healthy for You

NCT05216003 | Active Not Recruiting

• 1 other identifier: 1909180276
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 1

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. 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. 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. 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.

Conditions

Contraception Behavior

Outcome Measures

Primary Outcomes (7)

• Participant Satisfaction with Shared Decision Making

  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).

  Within 2-4 weeks of PATH4YOU service visit

• Participant Satisfaction with Same Day Contraception

  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.

  Within 2-4 weeks of PATH4YOU service visit

• Quality of family planning services

  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.

  Within 2-4 weeks of PATH4YOU service visit

• Participant reported Pregnancy Intention

  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.

  3 months, 6 months, and 12 months

• Receipt of Pre-Visit Birth Control Decision Aid

  Participants will be asked whether they received the decision aid and whether they used it prior to the visit.

  Within 2-4 weeks of PATH4YOU service visit

• Continuation of Contraceptive Method

  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.

  3 months, 6 months, and 12 months

• Unintended pregnancy rate

  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.

  3 months, 6 months, and 12 months

Secondary Outcomes (3)

• Number of women receiving PATH4YOU bundle

  3 years

• Impact of demographics and reproductive characteristics

  3 years

• Contraceptive choice

  3 years

Study Arms (2)

PATH4YOU County

EXPERIMENTAL

Behavioral: PATH4YOU

Matched-Pair Control County

NO INTERVENTION

Interventions

PATH4YOU BEHAVIORAL

PATH4YOU offers patient-center, comprehensive, contraceptive counseling; pregnancy planning; and same to next day access to birth control. This clinical care program will reduce obstacles to contraception in Indiana and enables access to healthy pregnancy planning conversations.

PATH4YOU County

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• history of hysterectomy or sterilization, or post-menopausal

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University Hospital

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Contraception Behavior

Condition Hierarchy (Ancestors)

Reproductive Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Obstetrics & Gynecology

Model Details: 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.

Study Record Dates

• First Submitted: January 19, 2022
• First Posted: January 31, 2022
• Study Start: September 2, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 8, 2026

Record last verified: 2026-04

Locations

US (1)