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Completed

NCT Number: NCT03088397

Effectiveness of a Patient Decision Aid in Immediate Postpartum Contraceptive Counseling

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.

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Key information

Conditions

Age range

14 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Montefiore Medical Center

The Bronx, New York, 10034, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Patient Decision Aid

Behavioral

One sheet of postpartum contraceptive information arranged in a grid.

Website

Behavioral

Patient directed to website with information on various contraceptive methods.

Shared- Decision Making Counseling

Behavioral

Counseling using principles of shared-decision making

Primary outcomes

  1. Quality of decision making process

    Time frame: 6 months

    Preparation for Decision Making scale

Secondary outcomes

  1. Choice in Contraceptive Method

    Time frame: 6 months

    Data will be collected regarding which method of contraception each participant chooses to use

Sponsors and collaborators

Lead sponsor

Montefiore Medical Center

Other

Registry information

Acronym: POCO

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Mar 23, 2017
Registry last updated
Mar 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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