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

Contraception Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01994005
• Other study ID #: 5327714500
• Secondary ID: ACOG/Bayer Healt
• Status: Completed
• Phase: N/A
• First received: November 7, 2013
• Last updated: November 19, 2013
• Start date: October 2012
• Est. completion date: February 2013

Study information

• Verified date: November 2013
• Source: New York Presbyterian Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Data and Safety Monitoring Board
• Study type: Interventional

Clinical Trial Summary

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.

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conducted in the same clinic, 60% of women had some college education and another 29% had high school diploma or GED (unpublished data).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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• 18-45 years of age

• English speaking

Exclusion Criteria:

• <18 or >45 years old

• Non-English speaking

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Contraception

Intervention

Behavioral:
• Facebook
Facebook page with contraception information used for counseling
• Pamphlet
Contraceptive knowledge pamphlets

Locations

Country	Name	City	State
United States	Women's Health Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York Presbyterian Hospital	Bayer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Contraceptive knowledge score	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	No
Secondary	Contraceptive Choice	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	No