Family Planning Counseling for Women With Chronic Medical Conditions in an Inpatient Setting

Not Applicable

Terminated

• Conditions: Chronic Disease
• Interventions: Behavioral: Counseling; Behavioral: Flyer

• Registration Number: NCT05859087
• Lead Sponsor: Sutter Health

Brief Summary

Women with chronic medical conditions have been found in multiple studies to use birth control less often compared to women without chronic medical conditions. The investigators hypothesized that approaching women with chronic medical conditions who were admitted to the hospital and having a bedside conversation about pregnancy intention and counseling regarding birth control usage along with offering to start birth control before discharge would increase the use of birth control in this population. As a separate intervention, the investigators hypothesized that having a brief conversation with the participants and then giving them a flyer that recommended talking with their doctor about birth control could also increase the use of birth control in this population.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-26
• Primary Completion: 2021-05-27
• Study Completion: 2021-05-27
• Study First Submitted: 2023-04-24
• Status Verified: 2023-05
• Study First Submitted QC: 2023-05-11
• Last Update Submitted: 2023-05-11
• Study First Posted: 2023-05-15
• Last Update Posted: 2023-05-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 76

Inclusion Criteria

• Currently admitted to the hospital
• Has one or more qualifying chronic medication conditions listed in their chart (hypertension, obesity with BMI>35, diabetes, current or history of breast cancer, rheumatoid arthritis, sickle cell disease, or lupus)

Exclusion Criteria

• Currently pregnant
• Using surgical or non-surgical contraception
• Immediately post-partum or admitted to the gynecology service
• Non-English speaking
• Non-verbal or too ill to consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bedside Family Planning Counseling	Counseling	Patient is screened for pregnancy intention and then has a bedside family planning counseling session with the investigator taking into account pregnancy intention, medical conditions, medications, and previous contraception used. At the end of the conversation, if patient is desiring contraception, the patient is offered three contraception options (as appropriate for their medical conditions and paid for as part of the study) to be initiated prior to discharge: Etonogestrel implant, medroxyprogesterone 150 mg IM injection, or a year's supply of oral contraception pills.
Flyer	Flyer	Patient is given a flyer that recommends they discuss pregnancy intention and contraception with their OB/GYN or primary care physician.

Primary Outcome Measures

Name	Time	Method
Pregnancy - 3 months	3 months	Number of pregnancies 3 months post discharge as ascertained by telephone interview.
Contraception use - 12 months	12 months	Number of patient using contraception 12 months post discharge as ascertained by telephone interview.
Pregnancy - 12 months	12 months	Number of pregnancies 12 months post discharge as ascertained by telephone interview.
Contraception use - 3 months	3 months	Number of patients using contraception 3 months post discharge as ascertained by telephone interview.

Secondary Outcome Measures

Name	Time	Method
EHR accuracy	up to 5 minutes	Percentage of patients where the electronic medical record was inaccurate regarding patient's contraception usage
General contraception usage	up to 5 minutes	Percent of study population using contraception at time of screening
Contraception initiation	up to 1 hour	Number of patients in the counseling arm who initiated contraception immediately after study intervention

Trial Locations

Locations (1)

Sutter Medical Center Sacramento; 🇺🇸 Sacramento, California, United States