Clinical trial NCT05859087: Family Planning Counseling for Women With Chronic Medical Conditions in an Inpatient Setting
Official title: The Feasibility of Providing Family Planning Counseling Services for Women With Chronic Medical Conditions in an Inpatient Setting
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Chronic Disease
Keywords: Contraception
Access to Contraception
Health Inequities
Acute Care Setting
Inpatient
Lead sponsor: Sutter Health
Sponsor class: OTHER
First posted: 2023-05-15
Enrollment: 76
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:1:1 randomized controlled trial
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Contraception use - 3 months
timeFrame: 3 months
measure: Pregnancy - 3 months
timeFrame: 3 months
measure: Contraception use - 12 months
timeFrame: 12 months
measure: Pregnancy - 12 months
timeFrame: 12 months
Secondary outcomes:
measure: General contraception usage
timeFrame: up to 5 minutes
measure: EHR accuracy
timeFrame: up to 5 minutes
measure: Contraception initiation
timeFrame: up to 1 hour
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Sutter Medical Center Sacramento
state: California
Study officials:
affiliation: Sutter Health
name: Ryan Spielvogel, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: O'Brien SH, Klima J, Reed S, Chisolm D, Schwarz EB, Kelleher KJ. Hormonal contraception use and pregnancy in adolescents with sickle cell disease: analysis of Michigan Medicaid claims. Contraception. 2011 Feb;83(2):134-7. doi: 10.1016/j.contraception.2010.06.017.
citation: Lee JK, Parisi SM, Schwarz EB. Contraceptive Counseling and Use among Women with Poorer Health. J Womens Health Issues Care. 2013;2(1):103. doi: 10.4172/2325-9795.1000103.
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citation: Guth U, Huang DJ, Bitzer J, Moffat R. Unintended pregnancy during the first year after breast cancer diagnosis. Eur J Contracept Reprod Health Care. 2016 Aug;21(4):290-4. doi: 10.1080/13625187.2016.1180678. Epub 2016 May 26.