Contraceptive Pathway and Contraception Continuation Rates
Impact of a Contraceptive Pathway on Contraception Continuation Rates
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Patients who present to the gynecology clinic for an annual, postpartum or contraceptive visit will be asked if they are interested in obtaining contraception by the front desk staff. If they respond yes, they will be seen in a triage or exam room by study personnel/medical assistant (MA) who will ask them if they would like to participate in the study, review the study and then randomize them to either the contraceptive pathway or usual care. The randomization will be done by opening sequentially numbered envelopes once they consent and while in the triage/exam room.
Patients triaged to the pathway will be handed an electronic tablet questionnaire while they are waiting to see the physician/(Advanced practice nurse (APN). The tablet contains a link to bedside.org, a public website which reviews contraceptive options. Vital signs will be collected as per usual care and recorded on both the questionnaire and in the electronic medical record(EMR). Study personnel will be available to offer the patient additional information on their choice of contraception or assist them with the link for information. The completed survey will be printed and placed in the subject room for review by the physician/APN. A copy will be kept in the subject binder and another will be scanned into the EMR.
Patients triaged to usual care will wait for their physician without the pathway questionnaire and will be asked the usual questions by the MA which will be recorded in the EMR. Vital signs will be collected and recorded in the EMR.
The physician/APN will see the subject as usual, review either the questionnaire or the EMR, review contraception options and initiate the contraception.
At completion of the visit, all woman will be asked if she would complete a satisfaction survey for her visit. She will be called at 2 weeks, 3, 6 and 12 months to discuss contraception initiation and continuation.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New Jersey
-
New Brunswick, New Jersey, United States, 08901
- Clinical Academic Building. 125 Paterson Street
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria
- Women at risk for pregnancy
- Women able to read and write in English
Exclusion Criteria
- Women who have undergone permanent sterilization
- Women not sexually active with a male partner
- Women who intend to become pregnant in the next 12 months
Study Plan
How is the study designed?
Design Details
- Primary Purpose: HEALTH_SERVICES_RESEARCH
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
NO_INTERVENTION: usual care
women who present for birth control to the gynecology office will see their physician in the usual fashion for review, counseling and contraception decision/initiation. Follow up phone call will be done at 2 weeks, 3, 6 and 12 months to discuss contraception initiation and continuation. |
|
|
EXPERIMENTAL: Contraceptive pathway
Women who present for birth control to the gynecology office will be recognized by the front desk and offered a tablet which which will:
They will then discuss the tablet information/history with the medical assistant, who will answer any remaining questions. They will then see the physician/APN. Follow up phone call will be done at 2 weeks, 3, 6 and 12 months to discuss contraception initiation and continuation. |
alternative way of aiding patients in deciding contraception method
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Continued Use of Contraception at 1 year
Time Frame: 1 year
|
The difference in contraception continuation rates will be compared between the Contraceptive Pathway group and the Usual care group, based on follow up phone calls at 3 weeks, 6 months and 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Subject satisfaction with contraceptive counseling
Time Frame: at initial office visit/immediate
|
Subjects will complete a Likert scale 1 - 5 with 1 being most and 5 being least satisfied with the contraceptive counseling.
Responses will be compared between the Contraceptive Pathway and Usual care group
|
at initial office visit/immediate
|
|
Pregnancy rates
Time Frame: 1 year
|
At each phone call, interval pregnancy rates will be collected and compared between subjects in the Contraceptive pathway vs usual care
|
1 year
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Adrian C Balica, MD, Rutgers Robert Wood Johnson Medical School
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro2018002901
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.