Pregnancy at a Time That Is Happy and Healthy for You

Contraception Behavior Clinical Trial

— PATH4YOU  

Official title:

Pregnancy at a Time That Is Happy and Healthy for You

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05216003
• Other study ID #: 1909180276
• Status: Enrolling by invitation
• Phase: N/A
• Start date: September 2, 2021
• Est. completion date: December 2025

Study information

• Verified date: April 2024
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100000
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Contraception Behavior

Intervention

Behavioral:
• PATH4YOU
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.

Locations

Country	Name	City	State
United States	Indiana University Hospital	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Number of women receiving PATH4YOU bundle	The number of participants in each county will be totaled.	3 years
Secondary	Impact of demographics and reproductive characteristics	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.	3 years
Secondary	Contraceptive choice	Of the women not desiring pregnancy, the percentage of women choosing each contraceptive method will be evaluated.	3 years