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Improving Contraceptive Care for Women With Medical Conditions

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ClinicalTrials.gov Identifier: NCT03153644
Recruitment Status : Recruiting
First Posted : May 15, 2017
Last Update Posted : June 27, 2018
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Justine Wu, University of Michigan

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.

Condition or disease Intervention/treatment
Contraception Chronic Disease Behavioral: Interview Behavioral: Observation

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 18-45 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.


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Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Improving Contraceptive Care for Women With Chronic Conditions: A Novel, Web-Based Decision Aid in Primary Care
Actual Study Start Date : September 7, 2017
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : June 30, 2020

Group/Cohort Intervention/treatment
Patients
Women with chronic medical conditions
Behavioral: Interview
1 hour semi-structured

Primary Care Providers and Medical Staff

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
1 hour semi-structured

Primary Practice
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
Field Observation




Primary Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03153644


Contacts
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Contact: Linda S Taichman, PhD 734-998-7120 ext 311 hipolite@umich.edu
Contact: Erin Sargent 734-936-3348 esargent@med.umich.edu

Locations
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United States, Michigan
Department of Family Medicine Recruiting
Ann Arbor, Michigan, United States, 48104
Contact: Susan Taichman, PhD    734-998-7120 ext 311    hipolite@umich.edu   
Principal Investigator: Justine P Wu, MD         
Sponsors and Collaborators
University of Michigan
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Principal Investigator: Justine P WU, MD University of Michigan

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Justine Wu, Assistant Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT03153644     History of Changes
Other Study ID Numbers: HUM0012060
1K23HD084744-01A1 ( U.S. NIH Grant/Contract )
First Posted: May 15, 2017    Key Record Dates
Last Update Posted: June 27, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Justine Wu, University of Michigan:
Qualitative Research
Medical conditions
Birth control methods
Intrauterine Devices
Physicians, Primary Care
Long-acting reversible contraceptives (LARC)

Additional relevant MeSH terms:
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Chronic Disease
Disease Attributes
Pathologic Processes
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs