Improving Contraceptive Care for Women With Medical Conditions

Sponsor

University of Michigan (Other)

Overall Status

Completed

CT.gov ID

NCT03153644

Collaborator

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

Enrollment

Location

33.7

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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	Phase
Contraception Chronic Disease	Behavioral: Interview Behavioral: Observation

Detailed Description

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.

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 Design

Study Type:

Observational

Actual Enrollment :

67 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 :

Sep 7, 2017

Actual Primary Completion Date :

Jun 30, 2020

Actual Study Completion Date :

Jun 30, 2020

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Factors To Guide the Design of Contraceptive Design Application [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.