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

Sponsor
Sutter Health (Other)
Overall Status
Terminated
CT.gov ID
NCT05859087
Collaborator
(none)
76
Enrollment
1
Location
3
Arms
39
Actual Duration (Months)
2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Counseling
  • Behavioral: Flyer
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
76 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
1:1:1 randomized controlled trial1:1:1 randomized controlled trial
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Feasibility of Providing Family Planning Counseling Services for Women With Chronic Medical Conditions in an Inpatient Setting
Actual Study Start Date :
Feb 26, 2018
Actual Primary Completion Date :
May 27, 2021
Actual Study Completion Date :
May 27, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Contraception use - 3 months [3 months]

    Number of patients using contraception 3 months post discharge as ascertained by telephone interview.

  2. Pregnancy - 3 months [3 months]

    Number of pregnancies 3 months post discharge as ascertained by telephone interview.

  3. Contraception use - 12 months [12 months]

    Number of patient using contraception 12 months post discharge as ascertained by telephone interview.

  4. Pregnancy - 12 months [12 months]

    Number of pregnancies 12 months post discharge as ascertained by telephone interview.

Secondary Outcome Measures

  1. General contraception usage [up to 5 minutes]

    Percent of study population using contraception at time of screening

  2. EHR accuracy [up to 5 minutes]

    Percentage of patients where the electronic medical record was inaccurate regarding patient's contraception usage

  3. Contraception initiation [up to 1 hour]

    Number of patients in the counseling arm who initiated contraception immediately after study intervention

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sutter Medical Center Sacramento Sacramento California United States 95816

Sponsors and Collaborators

  • Sutter Health

Investigators

  • Principal Investigator: Ryan Spielvogel, MD, Sutter Health

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Ryan Spielvogel, Principal Investigator, Sutter Health
ClinicalTrials.gov Identifier:
NCT05859087
Other Study ID Numbers:
  • Family14_SIMR_Spielvogel
First Posted:
May 15, 2023
Last Update Posted:
May 15, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ryan Spielvogel, Principal Investigator, Sutter Health
Contraception
Access to Contraception
Health Inequities
Acute Care Setting
Inpatient
Additional relevant MeSH terms:
Chronic Disease

Study Results

No Results Posted as of May 15, 2023