An observational study in Contraception and Chronic Disease, sponsored by University of Michigan. Completed at 1 site in United States. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-23.
Sponsored by University of Michigan · Observational
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.
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.
990 studies on the registry are indexed under Chronic Disease; 178 are open to participants now.
This study's enrollment of 67 is below the median of 419 across 249 observational studies indexed under Chronic Disease.
Browse Chronic Disease studies →University of Michigan is the lead sponsor of 1,475 studies on the registry; 196 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 128 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Identification of primary care practices (5-10) that provide primary care services and provide prescriptions for birth control and/or provide insertion/removal of contraceptive devices (the intrauterine device or sub-dermal implant) within southeast Michigan. Primary care physicians (30) and medical staff (30) within the primary care practices identified for recruitment will be approached for interviews. Approximately 30 women will be approached about participation in the study after the approval of the primary care physician. A convenience sampling approach will be used.
Patients:
To be eligible for the study, the patient must meet all the following criteria:
Exclusion Criteria:
Patients who meet any of the following criteria will be excluded:
Practice Members Inclusion Criteria:
To be eligible for the study, the practice member must meet all the following criteria:
Primary Practices:
To be eligible for the study, primary care practices must meet all the following criteria:
Women with chronic medical conditions
Behavioral: Interview
Primary care providers can include doctors and advanced practice professionals, including midwives, nurse practitioners, and physician assistants. Medical staff can include social workers, nurses, medical assistants, and administrative staff
Behavioral: Interview
Primary care practices (family medicine, internal medicine, medicine-pediatric, or any combination of these) that at a practice-level already provide contraceptive counseling and services to reproductive-age women
Behavioral: Observation
1 hour semi-structured
Field Observation
Factors To Guide the Design of Contraceptive Design Application
A 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.
Time frame: 6 months
Plan to share: Undecided — Final sets of data may be shared for use via a signed Data Sharing Agreement. 1. The organizations in the project remain the full/joint owners of such data. 2. One of the following two conditions must be met: a. No personal health identifiers are included in the final data set; b. Appropriate patient consent and institutional review board waiver has been obtained for all identifiable data 3. All data transferred will be in an encrypted format and stored securely. 4. Both parties agree not to release information about specific identifiable subjects to anyone. 5. Both parties agree to the boundary conditions of the original proposal under which data sharing was initiated. 6. Both parties agree to support of the pertinent grant awards as part of published acknowledgments section for any document shared under this agreement. 7. All publications arising from this shared data set must be reviewed and approved by Principle Investigator of the study.
This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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University of Michigan