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OpenTrials
Completed

NCT Number: NCT03153644

Helping People With Health Conditions Make Birth Control Decisions

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.

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Department of Family Medicine

Ann Arbor, Michigan, 48104, United States

About this study

This pilot study seeks to:

  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Interview

Behavioral

1 hour semi-structured

observation

Behavioral

Field Observation

Primary outcomes

  1. Factors To Guide the Design of Contraceptive Design Application

    Time frame: 6 months

    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.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

Improving Contraceptive Care for Individuals With Chronic Conditions

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
May 15, 2017
Registry last updated
Jul 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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