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Effectiveness of a Patient Decision Aid in Immediate Postpartum Contraceptive Counseling (POCO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03088397
Recruitment Status : Completed
First Posted : March 23, 2017
Last Update Posted : March 23, 2018
Sponsor:
Information provided by (Responsible Party):
Erika Levi, Montefiore Medical Center

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.

Condition or disease Intervention/treatment Phase
Contraception Behavioral: Patient Decision Aid Behavioral: Website Behavioral: Shared- Decision Making Counseling Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Effectiveness of a Patient Decision Aid in Immediate Postpartum Contraceptive Counseling
Actual Study Start Date : January 2017
Actual Primary Completion Date : December 2017
Actual Study Completion Date : January 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Behavioral: Patient Decision Aid
One sheet of postpartum contraceptive information arranged in a grid.

Behavioral: Shared- Decision Making Counseling
Counseling using principles of shared-decision making

Active Comparator: Website information
Group receives directions on how to get to bedsider.org information pages regarding contraceptive choices. Group receives Shared Decision Making counseling afterwards.
Behavioral: Website
Patient directed to website with information on various contraceptive methods.

Behavioral: Shared- Decision Making Counseling
Counseling using principles of shared-decision making

Active Comparator: Standard of care
Group receives standard brochure on contraception in their postpartum packet. Group receives Shared Decision Making counseling afterwards.
Behavioral: Shared- Decision Making Counseling
Counseling using principles of shared-decision making




Primary Outcome Measures :
  1. Quality of decision making process [ Time Frame: 6 months ]
    Preparation for Decision Making scale


Secondary Outcome Measures :
  1. Choice in Contraceptive Method [ Time Frame: 6 months ]
    Data will be collected regarding which method of contraception each participant chooses to use



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Ages Eligible for Study:   14 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03088397


Locations
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United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10034
Sponsors and Collaborators
Montefiore Medical Center
Publications:

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Responsible Party: Erika Levi, Co-Principal Investigator, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT03088397    
Other Study ID Numbers: 2016-6978
First Posted: March 23, 2017    Key Record Dates
Last Update Posted: March 23, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No