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Helping People With Health Conditions Make Birth Control Decisions

Improving Contraceptive Care for Individuals With Chronic Conditions

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03153644
Enrollment
67
Registered
2017-05-15
Start date
2017-09-07
Completion date
2020-06-30
Last updated
2025-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Disease, Contraception

Keywords

Qualitative Research, Medical conditions, Birth control methods, Intrauterine Devices, Physicians, Primary Care, Long-acting reversible contraceptives (LARC)

Brief summary

The purpose of this project is to describe how contraceptive services are currently being delivered to women with medical conditions who seek care in community-based primary care settings, such as family medicine and internal medicine clinical offices.

Detailed description

This pilot study seeks to: 1\. To understand women's beliefs, attitudes, and experiences with contraception in context of their medical conditions, drug therapy, personal preferences, and current experiences in primary care. b. To describe provider- To describe provider- and practice-level factors that impact the delivery of contraceptive services in primary care. To seek the perspectives of multiple stakeholders: 1) women aged 18-50 with one or more medical conditions; and 2) practice members who consist of primary care providers (PCPs) and office staff (e.g. nurses, medical assistants, and administrative staff members). The specific objective of this formative, qualitative study is to identify key patient-, provider-, and practice-level factors that are critical to the delivery of contraceptive counseling and services to women with medical conditions. To accomplish these aims, qualitative data will be collected in clinical settings that currently provide primary care and family planning for reproductive-aged women with medical conditions. Data collected will be: 1) in-depth interviews with women with medical conditions and practice members; and 2) semi-structured observations of office activities and processes (e.g. patient check in, patient scheduling). Using rigorous qualitative mixed methods to collect and analyze data, a deeper understanding will be gained of factors that should be considered in the design and implementation of future interventions to improve contraceptive care for women with medical conditions in primary care.

Interventions

BEHAVIORALInterview

1 hour semi-structured

BEHAVIORALObservation

Field Observation

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
CollaboratorNIH
University of Michigan
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

Patients: To be eligible for the study, the patient must meet all the following criteria: * Able to speak English * Able to give informed consent * Have at least one significant medical condition (defined as any condition that requires medication management and/or active monitoring, like hypertension, diabetes) that would pose greater than average risk to the woman during pregnancy, including the use of medications that could be associated with potential fetal harm in the event of unplanned pregnancy (defined as medications that are Pregnancy Category C, D, or X).

Exclusion criteria

Patients who meet any of the following criteria will be excluded: * surgically or medically sterile or whose current male partner(s) are surgically or medically sterile * females under 18 years are excluded because prior literature has shown that their healthcare and pregnancy-related experiences differ substantially enough from those of adult women. Practice Members Inclusion Criteria: To be eligible for the study, the practice member must meet all the following criteria: * Age 18 or older * Able to speak English * Able to give informed consent * Indirectly or directly involved with patient care Primary Practices: To be eligible for the study, primary care practices must meet all the following criteria: * currently provide primary care services to reproductive-aged women aged 18-45 * currently provide prescriptions for birth control and/or provide insertion/removal of contraceptive devices (the intrauterine device or sub-dermal implant) on site OR refer patients to another site.

Design outcomes

Primary

MeasureTime frameDescription
Factors To Guide the Design of Contraceptive Design Application6 monthsA semi-structured interview will be used to identify patient-, provider- and practice-level factors that are relevant to the design and implementation of a contraceptive decision aid.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026