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| ID | Type | Description | Link |
|---|---|---|---|
| CD-1304-6117 | Other Grant/Funding Number | PCORI |
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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
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The purpose of this web-based study is to determine whether reproductive life planning (RLP), with or without contraceptive action planning (RLP+), will result in reduced risk of unintended pregnancy when compared to an information-only control group.
Most US families want 2 children, resulting in the average woman spending 3 decades of her life trying to avoid pregnancy. However, most women have at least one unintended pregnancy, resulting in 1.5 million abortions and 1.7 million unintended births annually. Women and couples try to avoid unintended pregnancy for a range of personal, social, and economic reasons, but also due to the increased physical and mental health effects for children that result from unintended pregnancy. Healthcare reform now requires that private health insurance companies cover all FDA-approved contraceptive methods with no copays or deductibles to the patient, creating a great opportunity for women with health insurance to get contraceptive methods they previously could not afford. In this study, women with health insurance will be randomly assigned to one of three groups: (1) Reproductive Life Planning (RLP)-women will complete a reproductive life plan that guides them to think about if and when they would want any future pregnancies, and to determine what contraceptive method(s) are best suited to them; (2) Reproductive Life Planning Plus (RLP+) which additionally includes "if-then planning," where women determine what they will do when they encounter difficult situations that make it difficult to use their contraceptive method perfectly; or (3) an information-only control group. The online format of the study allows for the potential of wide dissemination. The RLP and RLP+ interventions are expected to result in greater likelihood of contraceptive use, continuity of contraceptive use, and contraceptive adherence, and thus reduce overall risk of unintended pregnancy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reproductive Life Planning (RLP) | Experimental | RLP is an online adaptation of the Centers for Disease Control and Prevention (CDC) reproductive life planning toll that guides women to identify their reproductive goals and individual requirements for contraception. |
|
| Reproductive Life Planning Plus (RLP+) | Experimental | RLP+ additionally includes contraceptive action planning, aimed at helping women select solutions for potential problems they may encounter with contraceptive adherence. |
|
| Information-only control | Active Comparator | The information-only control will deliver on-line information about their contraceptive benefits coverage and information about all FDA-approved contraceptive methods. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reproductive Life Planning (RLP) | Behavioral |
| ||
| Measure | Description | Time Frame |
|---|---|---|
| Contraceptive Use | Percentage of surveys with any contraceptive use | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness of Contraceptive Method | Percentage of surveys where most effective contraceptive method used | 24 months |
| Contraceptive Method Satisfaction | percentage of surveys where very satisfied with contraceptive method |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cynthia H Chuang, MD, MSc | Penn State College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penn State College of Medicine | Hershey | Pennsylvania | 17033 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36126298 | Derived | Zheng A, Nelson HN, McCall-Hosenfeld JS, Lehman EB, Chuang CH. Recent Intimate Partner Violence and Oral Contraceptive Pill Adherence in a Cohort of Reproductive-Aged Women. J Womens Health (Larchmt). 2022 Dec;31(12):1703-1709. doi: 10.1089/jwh.2021.0622. Epub 2022 Sep 20. | |
| 27059507 | Derived | Lauring JR, Lehman EB, Deimling TA, Legro RS, Chuang CH. Combined hormonal contraception use in reproductive-age women with contraindications to estrogen use. Am J Obstet Gynecol. 2016 Sep;215(3):330.e1-7. doi: 10.1016/j.ajog.2016.03.047. Epub 2016 Apr 5. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Reproductive Life Planning (RLP) | RLP is an online adaptation of the Centers for Disease Control and Prevention (CDC) reproductive life planning toll that guides women to identify their reproductive goals and individual requirements for contraception. Reproductive Life Planning (RLP) Contraception information |
| FG001 | Reproductive Life Planning Plus (RLP+) | RLP+ additionally includes contraceptive action planning, aimed at helping women select solutions for potential problems they may encounter with contraceptive adherence. Reproductive Life Planning (RLP) Contraceptive Action Planning Contraception information |
| FG002 | Information-only Control | The information-only control will deliver on-line information about their contraceptive benefits coverage and information about all FDA-approved contraceptive methods. Contraception information |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Reproductive Life Planning (RLP) | RLP is an online adaptation of the Centers for Disease Control and Prevention (CDC) reproductive life planning toll that guides women to identify their reproductive goals and individual requirements for contraception. Reproductive Life Planning (RLP) Contraception information |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Contraceptive Use | Percentage of surveys with any contraceptive use | Posted | Mean | Standard Deviation | percentage of surveys | 24 months |
|
1 year, 5 months
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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 | Reproductive Life Planning (RLP) | RLP is an online adaptation of the Centers for Disease Control and Prevention (CDC) reproductive life planning toll that guides women to identify their reproductive goals and individual requirements for contraception. Reproductive Life Planning (RLP) Contraception information |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Cynthia Chuang | Penn State College of Medicine | 7175318161 | CChuang@psu.edu |
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| Contraceptive Action Planning |
| Behavioral |
|
| Contraception information | Behavioral |
|
| 24 months |
| Contraceptive Adherence | Percentage of surveys where contraceptive adherence was high | 24 months |
| 26307564 | Derived | Chuang CH, Velott DL, Weisman CS, Sciamanna CN, Legro RS, Chinchilli VM, Moos MK, Francis EB, Confer LN, Lehman EB, Armitage CJ. Reducing Unintended Pregnancies Through Web-Based Reproductive Life Planning and Contraceptive Action Planning among Privately Insured Women: Study Protocol for the MyNewOptions Randomized, Controlled Trial. Womens Health Issues. 2015 Nov-Dec;25(6):641-8. doi: 10.1016/j.whi.2015.06.010. Epub 2015 Aug 22. |
| 26002807 | Derived | Weisman CS, Lehman EB, Legro RS, Velott DL, Chuang CH. How do pregnancy intentions affect contraceptive choices when cost is not a factor? A study of privately insured women. Contraception. 2015 Nov;92(5):501-7. doi: 10.1016/j.contraception.2015.05.007. Epub 2015 May 19. |
| Reproductive Life Planning Plus (RLP+) |
RLP+ additionally includes contraceptive action planning, aimed at helping women select solutions for potential problems they may encounter with contraceptive adherence. Reproductive Life Planning (RLP) Contraceptive Action Planning Contraception information |
| BG002 | Information-only Control | The information-only control will deliver on-line information about their contraceptive benefits coverage and information about all FDA-approved contraceptive methods. Contraception information |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Information-only Control | The information-only control will deliver on-line information about their contraceptive benefits coverage and information about all FDA-approved contraceptive methods. Contraception information |
|
|
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| Secondary | Effectiveness of Contraceptive Method | Percentage of surveys where most effective contraceptive method used | Posted | Mean | Standard Deviation | percentage of surveys | 24 months |
|
|
|
|
| Secondary | Contraceptive Method Satisfaction | percentage of surveys where very satisfied with contraceptive method | Posted | Mean | Standard Deviation | percentage of surveys | 24 months |
|
|
|
|
| Secondary | Contraceptive Adherence | Percentage of surveys where contraceptive adherence was high | Posted | Mean | Standard Deviation | percentage of surveys | 24 months |
|
|
|
|
| 0 |
| 329 |
| 0 |
| 329 |
| 0 |
| 329 |
| EG001 | Reproductive Life Planning Plus (RLP+) | RLP+ additionally includes contraceptive action planning, aimed at helping women select solutions for potential problems they may encounter with contraceptive adherence. Reproductive Life Planning (RLP) Contraceptive Action Planning Contraception information | 0 | 329 | 0 | 329 | 0 | 329 |
| EG002 | Information-only Control | The information-only control will deliver on-line information about their contraceptive benefits coverage and information about all FDA-approved contraceptive methods. Contraception information | 0 | 326 | 0 | 326 | 0 | 326 |
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| Odds Ratio (OR) |
| 1.08 |
| 2-Sided |
| 95 |
| 0.87 |
| 1.35 |
| Superiority |
| Regression, Logistic | 0.07 | Odds Ratio (OR) | 1.23 | 2-Sided | 95 | 0.99 | 1.53 | Superiority |
| Odds Ratio (OR) |
| 1.02 |
| 2-Sided |
| 95 |
| 0.82 |
| 1.26 |
| Superiority |
| Regression, Logistic | 1.0 | Odds Ratio (OR) | 0.98 | 2-Sided | 95 | 0.79 | 1.22 | Superiority |
| Odds Ratio (OR) |
| 1.04 |
| 2-Sided |
| 95 |
| 0.81 |
| 1.33 |
| Superiority |
| Regression, Logistic | 1.0 | Odds Ratio (OR) | 0.97 | 2-Sided | 95 | 0.75 | 1.25 | Superiority |