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Clinical Trials/NCT05216003
NCT05216003
Active, Not Recruiting
N/A

Pregnancy at a Time That Is Happy and Healthy for You

Indiana University2 sites in 1 country1,200 target enrollmentSeptember 2, 2021
InterventionsPATH4YOU

Overview

Phase
N/A
Intervention
PATH4YOU
Conditions
Contraception Behavior
Sponsor
Indiana University
Enrollment
1200
Locations
2
Primary Endpoint
Participant Satisfaction with Shared Decision Making
Status
Active, Not Recruiting
Last Updated
24 days ago

Overview

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.
Registry
clinicaltrials.gov
Start Date
September 2, 2021
End Date
December 1, 2026
Last Updated
24 days ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Tracey Wilkinson

Associate Professor, Department of Obstetrics & Gynecology

Indiana University

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

Arms & Interventions

PATH4YOU County

Intervention: PATH4YOU

Matched-Pair Control County

Outcomes

Primary Outcomes

Participant Satisfaction with Shared Decision Making

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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 Outcomes

  • Number of women receiving PATH4YOU bundle(3 years)
  • Impact of demographics and reproductive characteristics(3 years)
  • Contraceptive choice(3 years)

Study Sites (2)

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