Randomized Controlled Trial of Adjunctive Social Media for More Effective Contraceptive Counseling

November 19, 2013 updated by: Jason Kofinas MD, New York Presbyterian Hospital
The scope of this project was to provide evidence that better contraceptive choices are made with more effective counseling as well as improvement in patients' contraceptive knowledge. Specifically we wanted to evaluate the use of social media as a means for effective patient counseling.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study was performed at an urban obstetrics/gynecology clinic at New York-Presbyterian Hospital-Weill Cornell Medical Center. Institutional review board approval for this trial was obtained from the Weill Cornell Medical Center.

A total of 180 subjects, ages 18-45, were approached for enrollment into this study. Patients were eligible if they were scheduled for a new gynecologic visit, follow-up gynecologic visit, preconception counseling or post-partum visit. Patients who did not speak English or declined participation were ineligible as well as currently pregnant patients; 32 subjects were thus excluded. There were no exclusion criteria outside of age, language, currently pregnant status and willingness to participate. 148 patients met inclusion criteria and were randomized. 4 patients were excluded after randomization: 1 for not disclosing age, 3 for not completing the study (Figure 1). All patients provided written informed consent prior to randomization. Subjects in our population are a well-educated population. In a previous study conducted in the same clinic, 60% of women had some college education and another 29% had high school diploma or GED (unpublished data).

Randomization was achieved through an opaque envelope system. Equal numbers of opaque envelopes contained slips of paper with the number 1 or 2, signifying to the investigators the randomization group of each subject. Subjects were randomized to either standard counseling + pamphlet education (n= 74) or standard counseling + Facebook education (n=70). After randomization and prior to any intervention, a validated contraceptive knowledge survey (Contraceptive Knowledge Inventory, CKI)10 was administered to the subjects. The survey contained 25 questions specifically addressing general contraceptive knowledge and risks/benefits associated with different contraceptive methods. The subjects had unlimited time to complete the pre-intervention survey. Patients were also questioned about demographic information, including gravidity, marital status, age, and race/ethnicity, and their currently used contraceptive, including no contraceptive. A single provider then provided standardized counseling for all subjects involved in the study, which was conducted one-on-one. Standard counseling included discussion of barrier, hormonal, surgical and implantable/intrauterine devices. 15 minutes was allocated per patient for standard counseling in both groups. The goal of the standard counseling was to simulate a 15-minute in-office consultation specifically addressing contraception. Only American Congress of Obstetricians and Gynecologists (ACOG) derived facts were used, and a transcript was followed by the single provider, who was an M.D., to guarantee uniformity. The ACOG pamphlets were chosen for content pertaining to the CKI. Once the pamphlets were chosen, the Facebook page was constructed to be identical in content to the ACOG pamphlets.

Depending on the randomization group, patients were given 30 minutes to review ACOG patient education pamphlets specifically addressing contraception, or to interact with a Facebook page created by the investigators using identical content but in video, diagram and game format. The pamphlets were accessed on the ACOG website under patient education (www.acog.org). Following the intervention phase of the project, the subjects were administered the CKI again to assess post-intervention knowledge. At the completion of the post-intervention CKI, subjects were questioned regarding their preference for contraception and satisfaction with their counseling method. Subject satisfaction was measured in a similar fashion as clinical pain control. A 1-10 scale was used with 5 being neutral (i.e. the subject did not feel the method improves or negatively effects their counseling). A score of less than 5 was dissatisfaction with the counseling method and a score of greater than 5 signified satisfaction. 10 was a perfect score and meant the subject felt the intervention provided a significant improvement in counseling method.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
144

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10021
        • Women's Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 18-45 years of age
  • English speaking

Exclusion Criteria:

  • <18 or >45 years old
  • Non-English speaking

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Standard + Pamphlet
Subjects receiving standard counseling + ACOG pamphlets
Behavioral: Pamphlet
Contraceptive knowledge pamphlets
Active Comparator: Group 2: standard + facebook
Subjects receiving standard counseling + facebook education Intervention is 30 mins of use of facebook page
Behavioral: Facebook
Facebook page with contraception information used for counseling

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Contraceptive knowledge score
Time Frame: 1 year
Subjects will be tested using the contraceptive knowledge inventory survey, which is a validated 25 question survey of contraceptive knowledge. Pre scores will be obtained. Intervention will then be completed and the survey will be administered again with post scores recorded. The improvement and overall scores will be numerically measured (both raw score out of 25 points and percentage correct)
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Contraceptive Choice
Time Frame: 1 year
This is a outcome based on subject preference for contraception. Pre intervention contraceptive use will be recorded. Typically no contraception, barrier methods, hormonal, long acting reversible contraception and sterilization/abstinence are the choices. Subjects post intervention will also be asked their contraceptive choice/preference and analysis will be run to see if our intervention influenced the contraceptive choice by subjects
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
New York Presbyterian Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Bayer

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Tirsit Asfaw, MD, Weill Medical College of Cornell University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 7, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 19, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 25, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 25, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 19, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 5327714500
  • ACOG/Bayer Healthcare (Other Grant/Funding Number: ACOG/Bayer Health Care Pharmaceuticals)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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