Back to resultsFamily Planning Counseling for Women With Chronic Medical Conditions in an Inpatient Setting
Primary Purpose
Chronic Disease
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Counseling
Flyer
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Disease focused on measuring Contraception, Access to Contraception, Health Inequities, Acute Care Setting, Inpatient
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
Sites / Locations
- Sutter Medical Center Sacramento
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Bedside Family Planning Counseling
Flyer
Routine care
Arm Description
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.
Patient is given a flyer that recommends they discuss pregnancy intention and contraception with their OB/GYN or primary care physician.
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.
Outcomes
Primary Outcome Measures
Contraception use - 3 months
Number of patients using contraception 3 months post discharge as ascertained by telephone interview.
Pregnancy - 3 months
Number of pregnancies 3 months post discharge as ascertained by telephone interview.
Contraception use - 12 months
Number of patient using contraception 12 months post discharge as ascertained by telephone interview.
Pregnancy - 12 months
Number of pregnancies 12 months post discharge as ascertained by telephone interview.
Secondary Outcome Measures
General contraception usage
Percent of study population using contraception at time of screening
EHR accuracy
Percentage of patients where the electronic medical record was inaccurate regarding patient's contraception usage
Contraception initiation
Number of patients in the counseling arm who initiated contraception immediately after study intervention
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05859087
Brief Title
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
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Terminated
Why Stopped
High attrition.
Study Start Date
February 26, 2018 (Actual)
Primary Completion Date
May 27, 2021 (Actual)
Study Completion Date
May 27, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sutter Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Disease
Keywords
Contraception, Access to Contraception, Health Inequities, Acute Care Setting, Inpatient
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
1:1:1 randomized controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
76 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bedside Family Planning Counseling
Arm Type
Experimental
Arm Description
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.
Arm Title
Flyer
Arm Type
Experimental
Arm Description
Patient is given a flyer that recommends they discuss pregnancy intention and contraception with their OB/GYN or primary care physician.
Arm Title
Routine care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Counseling
Intervention Description
Bedside pregnancy intention screening and family planning counseling with offer of bedside contraception initiation.
Intervention Type
Behavioral
Intervention Name(s)
Flyer
Intervention Description
Handing flyer to patient that discusses the importance of talking with their doctor about pregnancy intention and contraception use.
Primary Outcome Measure Information:
Title
Contraception use - 3 months
Description
Number of patients using contraception 3 months post discharge as ascertained by telephone interview.
Time Frame
3 months
Title
Pregnancy - 3 months
Description
Number of pregnancies 3 months post discharge as ascertained by telephone interview.
Time Frame
3 months
Title
Contraception use - 12 months
Description
Number of patient using contraception 12 months post discharge as ascertained by telephone interview.
Time Frame
12 months
Title
Pregnancy - 12 months
Description
Number of pregnancies 12 months post discharge as ascertained by telephone interview.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
General contraception usage
Description
Percent of study population using contraception at time of screening
Time Frame
up to 5 minutes
Title
EHR accuracy
Description
Percentage of patients where the electronic medical record was inaccurate regarding patient's contraception usage
Time Frame
up to 5 minutes
Title
Contraception initiation
Description
Number of patients in the counseling arm who initiated contraception immediately after study intervention
Time Frame
up to 1 hour
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ryan Spielvogel, MD
Organizational Affiliation
Sutter Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sutter Medical Center Sacramento
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
24314113
Citation
Curtin SC, Abma JC, Ventura SJ, Henshaw SK. Pregnancy rates for U.S. women continue to drop. NCHS Data Brief. 2013 Dec;(136):1-8.
Results Reference
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PubMed Identifier
19279299
Citation
Vahratian A, Barber JS, Lawrence JM, Kim C. Family-planning practices among women with diabetes and overweight and obese women in the 2002 National Survey For Family Growth. Diabetes Care. 2009 Jun;32(6):1026-31. doi: 10.2337/dc08-2105. Epub 2009 Mar 11.
Results Reference
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Citation
Kaemmerer M, Vigl M, Seifert-Klauss V, Nagdyman N, Bauer U, Schneider KT, Kaemmerer H. Counseling reproductive health issues in women with congenital heart disease. Clin Res Cardiol. 2012 Nov;101(11):901-7. doi: 10.1007/s00392-012-0474-9. Epub 2012 May 15.
Results Reference
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Citation
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Citation
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Citation
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PubMed Identifier
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Citation
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PubMed Identifier
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Citation
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Citation
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Citation
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Results Reference
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Family Planning Counseling for Women With Chronic Medical Conditions in an Inpatient Setting
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