Clinical trial NCT03153644: Improving Contraceptive Care for Women With Medical Conditions
Official title: Improving Contraceptive Care for Women With Chronic Conditions: A Novel, Web-Based Decision Aid in Primary Care
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Contraception
Chronic Disease
Keywords: Qualitative Research
Medical conditions
Birth control methods
Intrauterine Devices
Physicians, Primary Care
Long-acting reversible contraceptives (LARC)
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2017-05-15
Enrollment: 67
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.

Eligibility 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.

Primary outcomes:
measure: Factors To Guide the Design of Contraceptive Design Application
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: Department of Family Medicine
state: Michigan
Study officials:
affiliation: University of Michigan
name: Justine P WU, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Crabtree BF, Miller WL. A qualitative approach to primary care research: the long interview. Fam Med. 1991 Feb;23(2):145-51.
citation: 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.