- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03153644
Improving Contraceptive Care for Women With Medical Conditions
Improving Contraceptive Care for Women With Chronic Conditions: A Novel, Web-Based Decision Aid in Primary Care
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Michigan
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Ann Arbor, Michigan, United States, 48104
- Department of Family Medicine
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients
Women with chronic medical conditions
|
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 |
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
|
Field Observation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Justine P WU, MD, University of Michigan
Publications and helpful links
General Publications
- Ornstein SM, Nietert PJ, Jenkins RG, Litvin CB. The prevalence of chronic diseases and multimorbidity in primary care practice: a PPRNet report. J Am Board Fam Med. 2013 Sep-Oct;26(5):518-24. doi: 10.3122/jabfm.2013.05.130012.
- Chor J, Rankin K, Harwood B, Handler A. Unintended pregnancy and postpartum contraceptive use in women with and without chronic medical disease who experienced a live birth. Contraception. 2011 Jul;84(1):57-63. doi: 10.1016/j.contraception.2010.11.018. Epub 2011 Jan 20.
- DeNoble AE, Hall KS, Xu X, Zochowski MK, Piehl K, Dalton VK. Receipt of prescription contraception by commercially insured women with chronic medical conditions. Obstet Gynecol. 2014 Jun;123(6):1213-1220. doi: 10.1097/AOG.0000000000000279.
- Akers AY, Gold MA, Borrero S, Santucci A, Schwarz EB. Providers' perspectives on challenges to contraceptive counseling in primary care settings. J Womens Health (Larchmt). 2010 Jun;19(6):1163-70. doi: 10.1089/jwh.2009.1735.
- Dehlendorf C, Levy K, Ruskin R, Steinauer J. Health care providers' knowledge about contraceptive evidence: a barrier to quality family planning care? Contraception. 2010 Apr;81(4):292-8. doi: 10.1016/j.contraception.2009.11.006. Epub 2009 Dec 11.
- Curtis KM, Tepper NK, Jamieson DJ, Marchbanks PA. Adaptation of the World Health Organization's Selected Practice Recommendations for Contraceptive Use for the United States. Contraception. 2013 May;87(5):513-6. doi: 10.1016/j.contraception.2012.08.024. Epub 2012 Oct 4.
- Lee JK, Parisi SM, Akers AY, Borrero S, Schwarz EB. The impact of contraceptive counseling in primary care on contraceptive use. J Gen Intern Med. 2011 Jul;26(7):731-6. doi: 10.1007/s11606-011-1647-3. Erratum In: J Gen Intern Med. 2011 Jul;26(7):822. Borrerro, Sonya [corrected to Borrero, Sonya].
- Dicicco-Bloom B, Crabtree BF. The qualitative research interview. Med Educ. 2006 Apr;40(4):314-21. doi: 10.1111/j.1365-2929.2006.02418.x.
- Crabtree BF, Miller WL. A qualitative approach to primary care research: the long interview. Fam Med. 1991 Feb;23(2):145-51.
- Wu JP, Damschroder LJ, Fetters MD, Zikmund-Fisher BJ, Crabtree BF, Hudson SV, Ruffin MT IV, Fucinari J, Kang M, Taichman LS, Creswell JW. A Web-Based Decision Tool to Improve Contraceptive Counseling for Women With Chronic Medical Conditions: Protocol For a Mixed Methods Implementation Study. JMIR Res Protoc. 2018 Apr 18;7(4):e107. doi: 10.2196/resprot.9249.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUM0012060
- 1K23HD084744-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Final sets of data may be shared for use via a signed Data Sharing Agreement.
- The organizations in the project remain the full/joint owners of such data.
- 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
- All data transferred will be in an encrypted format and stored securely.
- Both parties agree not to release information about specific identifiable subjects to anyone.
- Both parties agree to the boundary conditions of the original proposal under which data sharing was initiated.
- Both parties agree to support of the pertinent grant awards as part of published acknowledgments section for any document shared under this agreement.
- All publications arising from this shared data set must be reviewed and approved by Principle Investigator of the study.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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