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

Study Overview
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Brief Summary
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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.

Official Title
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The Feasibility of Providing Family Planning Counseling Services for Women With Chronic Medical Conditions in an Inpatient Setting

Conditions
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Chronic Disease

Intervention / Treatment
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* Behavioral: Counseling
* Behavioral: Flyer


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 1:1:1 randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bedside Family Planning Counseling<br>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. | Behavioral: Counseling<br>* Bedside pregnancy intention screening and family planning counseling with offer of bedside contraception initiation.<br>|
| Experimental: Flyer<br>Patient is given a flyer that recommends they discuss pregnancy intention and contraception with their OB/GYN or primary care physician. | Behavioral: Flyer<br>* Handing flyer to patient that discusses the importance of talking with their doctor about pregnancy intention and contraception use.<br>|
| No Intervention: Routine care<br>Patients receive a deception consent so as not to influence them by the consent process. Consent states that the purpose of the project is to study patterns of birth control usage of women admitted to the hospital. Patient is not given any further intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Contraception use - 3 months | Number of patients using contraception 3 months post discharge as ascertained by telephone interview. | 3 months | 
| Pregnancy - 3 months | Number of pregnancies 3 months post discharge as ascertained by telephone interview. | 3 months | 
| Contraception use - 12 months | Number of patient using contraception 12 months post discharge as ascertained by telephone interview. | 12 months | 
| Pregnancy - 12 months | Number of pregnancies 12 months post discharge as ascertained by telephone interview. | 12 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Contraception, Access to Contraception, Health Inequities, Acute Care Setting, Inpatient