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

May 11, 2023 updated by: Ryan Spielvogel, Sutter Health

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

76

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Sacramento, California, United States, 95816
        • Sutter Medical Center Sacramento

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bedside Family Planning 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.
Behavioral: Counseling
Bedside pregnancy intention screening and family planning counseling with offer of bedside contraception initiation.
Experimental: Flyer
Patient is given a flyer that recommends they discuss pregnancy intention and contraception with their OB/GYN or primary care physician.
Behavioral: Flyer
Handing flyer to patient that discusses the importance of talking with their doctor about pregnancy intention and contraception use.
No Intervention: Routine care
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?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Contraception use - 3 months
Time Frame: 3 months
Number of patients using contraception 3 months post discharge as ascertained by telephone interview.
3 months
Pregnancy - 3 months
Time Frame: 3 months
Number of pregnancies 3 months post discharge as ascertained by telephone interview.
3 months
Contraception use - 12 months
Time Frame: 12 months
Number of patient using contraception 12 months post discharge as ascertained by telephone interview.
12 months
Pregnancy - 12 months
Time Frame: 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
Time Frame: up to 5 minutes
Percent of study population using contraception at time of screening
up to 5 minutes
EHR accuracy
Time Frame: up to 5 minutes
Percentage of patients where the electronic medical record was inaccurate regarding patient's contraception usage
up to 5 minutes
Contraception initiation
Time Frame: up to 1 hour
Number of patients in the counseling arm who initiated contraception immediately after study intervention
up to 1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sutter Health

Investigators

  • Principal Investigator: Ryan Spielvogel, MD, Sutter Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 26, 2018

Primary Completion (Actual)

May 27, 2021

Study Completion (Actual)

May 27, 2021

Study Registration Dates

First Submitted

April 24, 2023

First Submitted That Met QC Criteria

May 11, 2023

First Posted (Actual)

May 15, 2023

Study Record Updates

Last Update Posted (Actual)

May 15, 2023

Last Update Submitted That Met QC Criteria

May 11, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Family14_SIMR_Spielvogel

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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