Effectiveness of a Patient Decision Aid in Immediate Postpartum Contraceptive Counseling

NCT ID: NCT03088397

Last Updated: 2018-03-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2018-01-31

Brief Summary

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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.

Detailed Description

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More than 51% of pregnancies in the US are unintentional. Of the unintended pregnancies, 43% are attributable to incorrect or inconsistent use of contraceptive methods. Gaps in contraceptive use can arise from a misalignment of the patient's needs or preferences and her chosen method. This is particularly salient in the postpartum setting; nearly two-thirds of women in their first year of postpartum have unmet need for family planning, and adolescents in particular are at high risk for repeat pregnancies within a year.

Effective physician-patient communication in postpartum contraceptive counseling is essential for patients to meet their contraceptive needs. Previously, there has been an emphasis on "informed choice" model for counseling, in which the clinician's role is to provide information to the patient in order to facilitate her choice of a contraceptive method. The provider does not actively participate in the process of selecting the method, in the spirit of respecting patient autonomy. Dehlendorf et al. has shown that while women do value autonomy in making a decision about their contraceptive method, they prefer more provider involvement in the decision making process than the "informed choice" model allows. This has given room for a rise in interest in Shared Decision Making (SDM) model of counseling for contraceptive care. In the SDM model, the clinical plays a supportive role in patient decision making, by not only providing information but also guiding the patient through her deliberation. While the final decision is left in the hands of the patient, they are given support to identify their preferences and needs, and to align them with an option that best matches her preferences and needs.

Various decision making tools have been developed to facilitate SDM. One method is to display all available options in one axis, and frequently-asked questions regarding each option in the other axis. Patients are asked to select frequently-asked questions that address their concerns, thereby sorting through the most pertinent information regarding their options in one view. Research has shown that such patient decision aids (PtDA) help patients understand their options, feel more informed, participate in decision making, and have more accurate expectations of possible outcomes.

The goal of this project is to utilize a PtDA to facilitate SDM in the immediate postpartum setting, assess the effectiveness of such PtDA on decision quality and decision-making process quality (as defined and measured by previously validated survey tools), and to observe its effects on patients' contraceptive choice at the time of discharge.

Conditions

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Contraception

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Patient decision aid

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.

Group Type EXPERIMENTAL

Patient Decision Aid

Intervention Type BEHAVIORAL

One sheet of postpartum contraceptive information arranged in a grid.

Shared- Decision Making Counseling

Intervention Type BEHAVIORAL

Counseling using principles of shared-decision making

Website information

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

Group Type ACTIVE_COMPARATOR

Website

Intervention Type BEHAVIORAL

Patient directed to website with information on various contraceptive methods.

Shared- Decision Making Counseling

Intervention Type BEHAVIORAL

Counseling using principles of shared-decision making

Standard of care

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

Group Type ACTIVE_COMPARATOR

Shared- Decision Making Counseling

Intervention Type BEHAVIORAL

Counseling using principles of shared-decision making

Interventions

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Patient Decision Aid

One sheet of postpartum contraceptive information arranged in a grid.

Intervention Type BEHAVIORAL

Website

Patient directed to website with information on various contraceptive methods.

Intervention Type BEHAVIORAL

Shared- Decision Making Counseling

Counseling using principles of shared-decision making

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

14 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Montefiore Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Erika Levi

Co-Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Montefiore Medical Center

The Bronx, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 24354819 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 18561392 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24863169 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23177265 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22618581 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21975733 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25429714 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24625035 (View on PubMed)

Other Identifiers

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2016-6978

Identifier Type: -

Identifier Source: org_study_id

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