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

NCT05859087 | Terminated

• 1 other identifier: Family14_SIMR_Spielvogel
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Disease

Keywords

Contraception; Access to Contraception; Health Inequities; Acute Care Setting; Inpatient

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• General contraception usage

  up to 5 minutes

• EHR accuracy

  up to 5 minutes

• Contraception initiation

  up to 1 hour

Study Arms (3)

Bedside Family Planning Counseling

EXPERIMENTAL

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

Flyer

EXPERIMENTAL

Patient is given a flyer that recommends they discuss pregnancy intention and contraception with their OB/GYN or primary care physician.

Behavioral: Flyer

Routine care

NO INTERVENTION

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.

Interventions

Counseling BEHAVIORAL

Bedside pregnancy intention screening and family planning counseling with offer of bedside contraception initiation.

Bedside Family Planning Counseling

Flyer BEHAVIORAL

Handing flyer to patient that discusses the importance of talking with their doctor about pregnancy intention and contraception use.

Flyer

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Sutter Health: lead

Study Sites (1)

Sutter Medical Center Sacramento

Sacramento, California, 95816, United States

Location

Related Publications (14)

• 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.

  PMID: 24314113 BACKGROUND

• 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.

  PMID: 19279299 BACKGROUND

• 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.

  PMID: 22584383 BACKGROUND

• Han SN, Van Peer S, Peccatori F, Gziri MM, Amant F; International Network on Cancer, Infertility and Pregnancy. Contraception is as important as fertility preservation in young women with cancer. Lancet. 2015 Feb 7;385(9967):508. doi: 10.1016/S0140-6736(15)60201-X. No abstract available.

  PMID: 25705843 BACKGROUND

• Dominick SA, McLean MR, Whitcomb BW, Gorman JR, Mersereau JE, Bouknight JM, Su HI. Contraceptive Practices Among Female Cancer Survivors of Reproductive Age. Obstet Gynecol. 2015 Sep;126(3):498-507. doi: 10.1097/AOG.0000000000000963.

  PMID: 26181090 BACKGROUND

• Kendrick J, Sharma S, Holmen J, Palit S, Nuccio E, Chonchol M. Kidney disease and maternal and fetal outcomes in pregnancy. Am J Kidney Dis. 2015 Jul;66(1):55-9. doi: 10.1053/j.ajkd.2014.11.019. Epub 2015 Jan 16.

  PMID: 25600490 BACKGROUND

• Hink E, Bolte AC. Pregnancy outcomes in women with heart disease: Experience of a tertiary center in the Netherlands. Pregnancy Hypertens. 2015 Apr;5(2):165-70. doi: 10.1016/j.preghy.2014.12.001. Epub 2015 Jan 5.

  PMID: 25943639 BACKGROUND

• Ghaffari N, Srinivas SK, Durnwald CP. The multidisciplinary approach to the care of the obese parturient. Am J Obstet Gynecol. 2015 Sep;213(3):318-25. doi: 10.1016/j.ajog.2015.03.001. Epub 2015 Mar 4.

  PMID: 25747546 BACKGROUND

• Chuang CH, Chase GA, Bensyl DM, Weisman CS. Contraceptive use by diabetic and obese women. Womens Health Issues. 2005 Jul-Aug;15(4):167-73. doi: 10.1016/j.whi.2005.04.002.

  PMID: 16051107 BACKGROUND

• 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.

  PMID: 21237338 BACKGROUND

• 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.

  PMID: 24971372 BACKGROUND

• DeNoble AE, Hall KS, Xu X, Zochowski MK, Piehl K, Dalton VK. Receipt of prescription contraception by commercially insured women with chronic medical conditions. Obstet Gynecol. 2014 Jun;123(6):1213-1220. doi: 10.1097/AOG.0000000000000279.

  PMID: 24807345 BACKGROUND

• 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.

  PMID: 27227578 BACKGROUND

• Spielvogel R, Stephens RB, Clark R, Guillen M, Hankins A, Parise C. Providing family planning counseling services for women with chronic medical conditions in an inpatient setting: A randomized feasibility trial. Contraception. 2023 Dec;128:110133. doi: 10.1016/j.contraception.2023.110133. Epub 2023 Aug 6.

  PMID: 37549724 DERIVED

MeSH Terms

Conditions

Chronic Disease

Interventions

Counseling

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Ryan Spielvogel, MD

  Sutter Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 1:1:1 randomized controlled trial

Study Record Dates

• First Submitted: April 24, 2023
• First Posted: May 15, 2023
• Study Start: February 26, 2018
• Primary Completion: May 27, 2021
• Study Completion: May 27, 2021
• Last Updated: May 15, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)