Contraceptive Pathway and Contraception Continuation Rates

Study Overview
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Brief Summary
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Women seeking contraception will be randomized to usual care or to a Contraceptive Pathway

Detailed Description
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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.

Official Title
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Impact of a Contraceptive Pathway on Contraception Continuation Rates

Conditions
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Contraceptive Usage

Intervention / Treatment
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* Other: COntraceptive pathway


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: usual care<br>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<br>Women who present for birth control to the gynecology office will be recognized by the front desk and offered a tablet which which will: collect relevant medical history provide educational material on birth control options provide a link to bedsider.com for further information 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. | Other: COntraceptive pathway<br>* alternative way of aiding patients in deciding contraception method<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Continued Use of Contraception at 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 | 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 | At each phone call, interval pregnancy rates will be collected and compared between subjects in the Contraceptive pathway vs usual care | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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contraceptive pathway, continuation