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| Name | Class |
|---|---|
| Society of Family Planning | OTHER |
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The purpose of this study is to conduct a randomized clinical trial of a web-based contraceptive decision aid compared to routine contraceptive counseling to evaluate the effect of the contraceptive decision aid on the contraceptive method selected by the participant.
The investigators primary hypothesis is that women utilizing a computerized Contraceptive Decision Aid (CDA) will be more likely to choose highly effective contraception than women who undergo standard clinical contraceptive counseling.
Our primary specific aim is to test the CDA by conducting a randomized clinical trial comparing the CDA to routine contraceptive counseling. Our primary outcome of interest will be selection of highly effective contraception including the intrauterine device (IUD), the implant, and injectable contraception compared to all other reversible contraceptive methods.
We will also complete the following secondary specific aims:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CDM Tool | Experimental | participants will be randomized to completing the CDM tool |
|
| Control | No Intervention | Participants will fill out a computer survey similar to CDM tool without the decisive factors and computer print out |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CDM Tool | Other | Participants will be required to complete the CDM tool and receive a tailored print out of their contraceptive options based on survey answers |
|
| Measure | Description | Time Frame |
|---|---|---|
| Decisional Conflict Scale Score | Pre-Visit, Post-Visit and change in Decisional Conflict Scale (DCS) Score between Post-Visit (immediately following visit) and Pre-Visit (immediately prior to visit). The Decisional Conflict Scale scores range from 0 to 100; 0 represents no decisional conflict and 100 represents high decisional conflict. | Pre-Visit and Post-Visit (same day) |
| Measure | Description | Time Frame |
|---|---|---|
| Contraceptive Method Chosen | Contraceptive method chosen at end of visit with healthcare provider as reported on the post-visit survey | Post-visit (immediately after visit) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tessa E Madden, MD, MPH | Washington University School of Medicine | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | CDM Tool | participants will be randomized to completing the CDM tool CDM Tool: Participants will be required to complete the CDM tool and receive a tailored print out of their contraceptive options based on survey answers |
| FG001 | Control | Participants will fill out a computer survey similar to CDM tool without the decisive factors and computer print out |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | CDM Tool | participants will be randomized to completing the CDM tool CDM Tool: Participants will be required to complete the CDM tool and receive a tailored print out of their contraceptive options based on survey answers |
| BG001 | Control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Decisional Conflict Scale Score | Pre-Visit, Post-Visit and change in Decisional Conflict Scale (DCS) Score between Post-Visit (immediately following visit) and Pre-Visit (immediately prior to visit). The Decisional Conflict Scale scores range from 0 to 100; 0 represents no decisional conflict and 100 represents high decisional conflict. | 8 subjects did not complete the post-visit survey, so a post-visit DCS score and change in DCS score could not be calculated | Posted | Median | Full Range | score on a scale | Pre-Visit and Post-Visit (same day) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CDM Tool | participants will be randomized to completing the CDM tool CDM Tool: Participants will be required to complete the CDM tool and receive a tailored print out of their contraceptive options based on survey answers |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Tessa Madden, MD, MPH | Washington University in St. Louis | 314-747-6495 | maddent@wudosis.wustl.edu |
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| ID | Term |
|---|---|
| D010549 | Personal Satisfaction |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| No post-visit survey |
|
Participants will fill out a computer survey similar to CDM tool without the decisive factors and computer print out |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Control |
Participants will fill out a computer survey similar to CDM tool without the decisive factors and computer print out |
|
|
| Secondary | Contraceptive Method Chosen | Contraceptive method chosen at end of visit with healthcare provider as reported on the post-visit survey | Posted | Count of Participants | Participants | Post-visit (immediately after visit) |
|
|
|
| 0 |
| 167 |
| 0 |
| 167 |
| 0 |
| 167 |
| EG001 | Control | Participants will fill out a computer survey similar to CDM tool without the decisive factors and computer print out | 0 | 86 | 0 | 86 | 0 | 86 |
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| Implant |
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| DMPA |
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| Pills |
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| Contraceptive patch |
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| Vaginal ring |
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| Sterilization |
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| Condoms |
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| Other |
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| No method/undecided |
|