Randomized Controlled Trial of Adjunctive Social Media for More Effective Contraceptive Counseling
NCT ID: NCT01994005
Last Updated: 2013-11-25
Study Results
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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COMPLETED
NA
144 participants
INTERVENTIONAL
2012-10-31
2013-02-28
Brief Summary
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Detailed Description
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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conducted in the same clinic, 60% of women had some college education and another 29% had high school diploma or GED (unpublished data).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.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
SINGLE
Study Groups
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Standard + Pamphlet
Subjects receiving standard counseling + ACOG pamphlets
Pamphlet
Contraceptive knowledge pamphlets
Group 2: standard + facebook
Subjects receiving standard counseling + facebook education Intervention is 30 mins of use of facebook page
Facebook page with contraception information used for counseling
Interventions
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Facebook page with contraception information used for counseling
Pamphlet
Contraceptive knowledge pamphlets
Eligibility Criteria
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Inclusion Criteria
* English speaking
Exclusion Criteria
* Non-English speaking
18 Years
45 Years
FEMALE
No
Sponsors
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Bayer
INDUSTRY
New York Presbyterian Hospital
OTHER
Responsible Party
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Jason Kofinas MD
Physician
Principal Investigators
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Tirsit Asfaw, MD
Role: PRINCIPAL_INVESTIGATOR
Weill Medical College of Cornell University
Locations
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Women's Health Center
New York, New York, United States
Countries
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References
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Kofinas JD, Varrey A, Sapra KJ, Kanj RV, Chervenak FA, Asfaw T. Adjunctive social media for more effective contraceptive counseling: a randomized controlled trial. Obstet Gynecol. 2014 Apr;123(4):763-70. doi: 10.1097/AOG.0000000000000172.
Other Identifiers
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ACOG/Bayer Healthcare
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
5327714500
Identifier Type: -
Identifier Source: org_study_id