Effectiveness of a Patient Decision Aid in Immediate Postpartum Contraceptive Counseling

NCT03088397 | Completed

• 1 other identifier: 2016-6978
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

Effective physician-patient communication in postpartum contraceptive counseling is essential for patients to meet their contraceptive needs and reduce the risk of rapid repeat pregnancies. This project will utilize a patient decision aid to facilitate shared decision making in the immediate postpartum setting, assess the effectiveness of such aid in "decision quality" and "decision-making process quality", and observe its effects on contraceptive choice mix at the time of discharge.

Conditions

Contraception

Outcome Measures

Primary Outcomes (1)

• Quality of decision making process

  Preparation for Decision Making scale

  6 months

Secondary Outcomes (1)

• Choice in Contraceptive Method

  6 months

Study Arms (3)

Patient decision aid

EXPERIMENTAL

Group receives the patient decision aid, POCO (POstpartum Contraceptive Options), a grid with various contraceptive options across the columns and characteristics of each option in rows. Group receives Shared Decision Making counseling afterwards.

Behavioral: Patient Decision Aid; Behavioral: Shared- Decision Making Counseling

Website information

ACTIVE COMPARATOR

Group receives directions on how to get to bedsider.org information pages regarding contraceptive choices. Group receives Shared Decision Making counseling afterwards.

Behavioral: Website; Behavioral: Shared- Decision Making Counseling

Standard of care

ACTIVE COMPARATOR

Group receives standard brochure on contraception in their postpartum packet. Group receives Shared Decision Making counseling afterwards.

Behavioral: Shared- Decision Making Counseling

Interventions

Patient Decision Aid BEHAVIORAL

One sheet of postpartum contraceptive information arranged in a grid.

Patient decision aid

Website BEHAVIORAL

Patient directed to website with information on various contraceptive methods.

Website information

Shared- Decision Making Counseling BEHAVIORAL

Counseling using principles of shared-decision making

Patient decision aid; Standard of care; Website information

Eligibility Criteria

• Age: 14 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Fluent English or Spanish speaking
• Delivered during current admission to hospital
• Postpartum day 1 or post-op day 1 or 2

You may not qualify if:

• Females less than 14 years of age
• Status post sterilization or hysterectomy
• Received an intrauterine device immediately after delivery (postplacental)
• Does not have a smartphone capable of browsing the internet

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10034, United States

Location

Related Publications (8)

• Finer LB, Zolna MR. Shifts in intended and unintended pregnancies in the United States, 2001-2008. Am J Public Health. 2014 Feb;104 Suppl 1(Suppl 1):S43-8. doi: 10.2105/AJPH.2013.301416. Epub 2013 Dec 19.

  PMID: 24354819 BACKGROUND

• Frost JJ, Darroch JE, Remez L. Improving contraceptive use in the United States. Issues Brief (Alan Guttmacher Inst). 2008;(1):1-8.

  PMID: 18561392 BACKGROUND

• Donnelly KZ, Foster TC, Thompson R. What matters most? The content and concordance of patients' and providers' information priorities for contraceptive decision making. Contraception. 2014 Sep;90(3):280-7. doi: 10.1016/j.contraception.2014.04.012. Epub 2014 Apr 30.

  PMID: 24863169 BACKGROUND

• Dehlendorf C, Levy K, Kelley A, Grumbach K, Steinauer J. Women's preferences for contraceptive counseling and decision making. Contraception. 2013 Aug;88(2):250-6. doi: 10.1016/j.contraception.2012.10.012. Epub 2012 Nov 21.

  PMID: 23177265 BACKGROUND

• Elwyn G, Frosch D, Thomson R, Joseph-Williams N, Lloyd A, Kinnersley P, Cording E, Tomson D, Dodd C, Rollnick S, Edwards A, Barry M. Shared decision making: a model for clinical practice. J Gen Intern Med. 2012 Oct;27(10):1361-7. doi: 10.1007/s11606-012-2077-6. Epub 2012 May 23.

  PMID: 22618581 BACKGROUND

• Stacey D, Bennett CL, Barry MJ, Col NF, Eden KB, Holmes-Rovner M, Llewellyn-Thomas H, Lyddiatt A, Legare F, Thomson R. Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev. 2011 Oct 5;(10):CD001431. doi: 10.1002/14651858.CD001431.pub3.

  PMID: 21975733 BACKGROUND

• Lopez LM, Grey TW, Chen M, Hiller JE. Strategies for improving postpartum contraceptive use: evidence from non-randomized studies. Cochrane Database Syst Rev. 2014 Nov 27;2014(11):CD011298. doi: 10.1002/14651858.CD011298.pub2.

  PMID: 25429714 BACKGROUND

• Sepucha KR, Borkhoff CM, Lally J, Levin CA, Matlock DD, Ng CJ, Ropka ME, Stacey D, Joseph-Williams N, Wills CE, Thomson R. Establishing the effectiveness of patient decision aids: key constructs and measurement instruments. BMC Med Inform Decis Mak. 2013;13 Suppl 2(Suppl 2):S12. doi: 10.1186/1472-6947-13-S2-S12. Epub 2013 Nov 29.

  PMID: 24625035 BACKGROUND

Study Design

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

Study Record Dates

• First Submitted: September 7, 2016
• First Posted: March 23, 2017
• Study Start: January 1, 2017
• Primary Completion: December 1, 2017
• Study Completion: January 1, 2018
• Last Updated: March 23, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)