Family Planning Ahead

Study Overview
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Brief Summary
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Family Planning Ahead is a study that aims to improve decision-making about postpartum contraception. Family Planning Ahead will test two different strategies: a patient decision aid and a patient information leaflet.

Official Title
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Family Planning Ahead

Conditions
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Contraception, Pregnancy Related

Intervention / Treatment
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* Other: Birth Control After Pregnancy
* Other: Postpartum Birth Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Currently pregnant Between 28 and 38 weeks' gestation at the time of enrollment Estimated due date in March, April, May, or June 2018 15 years or older Can read and write English Live in the United States Share a valid email address for study purposes Exclusion Criteria Not currently pregnant Less than 28 weeks' or more than 38 weeks' gestation at the time of enrollment Estimated due date earlier than March 2018 or later than June 2018 Under 15 years Can not read and write English Do not live in the United States Do not share a valid email address for study purposes

Ages Eligible for Study
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Minimum Age: 15 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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patient Decision Aid<br>Birth Control After Pregnancy patient decision aid and supporting document | Other: Birth Control After Pregnancy<br>* A 27-page patient decision aid in portable document format (and an accompanying 3-page supporting document in portable document format) hosted online.<br>|
| Active Comparator: Patient Information Leaflet<br>Postpartum Birth Control patient information leaflet | Other: Postpartum Birth Control<br>* A 4-page patient information leaflet in portable document format and text format hosted online.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perceived support in decision-making | The extent to which the person feels they received adequate support and advice without pressure to make a decision about postpartum contraceptive methods, measured using adapted versions of the Support subscale of the Decisional Conflict Scale (O'Connor, 1993). | T2 (Approximately 7-11 weeks after self-reported estimated due date) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perceptions of being informed | The extent to which the person feels informed of available postpartum contraceptive methods and the benefits, risks, and side effects of each, measured using an adapted version of the Informed subscale of the Decisional Conflict Scale (O'Connor, 1993). | T0 (immediately following study enrollment); T1 (one week following study enrollment) | 
| Values clarity | The extent to which the person feels clear about personal values related to postpartum contraceptive method benefits, risks, and side effects, measured using an adapted version of the Values Clarity subscale of the Decisional Conflict Scale (O'Connor, 1993). | T0 (immediately following study enrollment); T1 (one week following study enrollment) | 
| Decisional uncertainty | The extent to which the person feels certain about which postpartum contraceptive method to choose, measured using an adapted version of the Uncertainty subscale of the Decisional Conflict Scale (O'Connor, 1993). | T0 (immediately following study enrollment); T1 (one week following study enrollment) | 
| Decision self-efficacy | The extent to which the person has self-confidence or belief in their ability to make decisions about postpartum contraceptive methods, measured using an adapted version of the Decision Self-Efficacy Scale (O'Connor, 1995). | T0 (immediately following study enrollment); T1 (one week following study enrollment) | 
| Intended contraceptive method(s): LARC vs. other | The proportion of people who intend to use a long-acting reversible contraceptive (LARC) method (i.e., hormonal intrauterine device, copper intrauterine device, or implant) 'in the first few months after giving birth', measured using a self-developed item. | T0 (immediately following study enrollment); T1 (one week following study enrollment) | 
| Intended contraceptive method(s): Most or moderately effective vs. other | The proportion of people who intend to use a most or moderately effective contraceptive method (i.e., female sterilization, hormonal intrauterine device, copper intrauterine device, implant, injection, combined pill, progestin-only pill, patch, ring, diaphragm) 'in the first few months after giving birth', measured using a self-developed item. | T0 (immediately following study enrollment); T1 (one week following study enrollment) | 
| Intended contraceptive method(s): Method vs. no method or unsure | The proportion of people who intend to use one or more contraceptive methods (i.e., female sterilization, hormonal intrauterine device, copper intrauterine device, implant, injection, combined pill, progestin-only pill, patch, ring, diaphragm, male condom, internal (female) condom, spermicide, sponge, cervical cap, lactational amenorrhea method, withdrawal, fertility awareness, male sterilization, and/or emergency contraceptive pill) 'in the first few months after giving birth', measured using a self-developed item. | T0 (immediately following study enrollment); T1 (one week following study enrollment) | 
| Intended timing of contraceptive method(s) initiation: Not unsure vs. unsure | The proportion of people who are not unsure about how soon after giving birth they will (first) start using a contraceptive method (i.e., intend to start using a contraceptive method 'in the first 10 minutes', 'in the first few days', 'in the first few weeks', 'around 6 weeks', 'in the first few months' or 'other'), measured using a self-developed item. | T0 (immediately following study enrollment); T1 (one week following study enrollment) | 
| Values concordance of intended contraceptive method(s) | The proportion of people who perceive optimal values concordance of their intended postpartum contraceptive method(s) (or intention to use no contraceptive methods), measured using the Measure of Alignment of Choices (Thompson et al., 2017). | T0 (immediately following study enrollment); T1 (one week following study enrollment) | 
| Trust in health professional(s) | The extent to which the person feels trust in the health professional(s) they talk to about postpartum contraception during and/or after pregnancy, measured using an adapted version of the Patient Trust in a Physician Scale (Dugan et al., 2005). | T2 (Approximately 7-11 weeks after self-reported estimated due date) | 
| Interpersonal quality of family planning care | The proportion of people who report high interpersonal quality of family planning care during and/or after pregnancy, measured using an adapted version of the four-item Interpersonal Quality of Family Planning Care (IQFP-R) scale (Dehlendorf et al. 2016). | T2 (Approximately 7-11 weeks after self-reported estimated due date) | 
| Shared decision-making | The extent to which which the person feels they experienced shared decision-making about postpartum contraceptive methods during and/or after pregnancy, measured using the CollaboRATE measure (Barr et al., 2014). | T2 (Approximately 7-11 weeks after self-reported estimated due date) | 
| Concordance between preferred and actual decision-making involvement (self): Concordant vs. discordant | The proportion of people who report concordance between their actual and preferred involvement in the decision to use their postpartum contraceptive method(s), measured using two self-developed items. | T2 (Approximately 7-11 weeks after self-reported estimated due date) | 
| Concordance between preferred and actual decision-making involvement (partner): Concordant vs. discordant | The proportion of people who report concordance between the actual involvement of their partner and their preferences pertaining to partner involvement in the decision to use their postpartum contraceptive method(s), measured using two self-developed items. | T2 (Approximately 7-11 weeks after self-reported estimated due date) | 
| Concordance between preferred and actual decision-making involvement (health professional(s)): Concordant vs. discordant | The proportion of people who report concordance between the actual involvement of their health professional(s) and their preferences pertaining to health professional involvement in the decision to use their postpartum contraceptive method(s), measured using two self-developed items. | T2 (Approximately 7-11 weeks after self-reported estimated due date) | 
| Time pressure in decision-making | The extent to which the person feels they had (or have) enough time to make a decision about postpartum contraceptive methods, measured using a self-developed item. | T2 (Approximately 7-11 weeks after self-reported estimated due date) | 
| Pressure to use a certain contraceptive method | The extent to which the person felt (or feels) pushed to use a certain postpartum contraceptive method, measured using a self-developed item. | T2 (Approximately 7-11 weeks after self-reported estimated due date) | 
| Values concordance of contraceptive method(s) used | The proportion of people who perceive optimal values concordance of the postpartum contraceptive method(s) they have used, measured using the Measure of Alignment of Choices (Thompson et al., 2017). | T2 (Approximately 7-11 weeks after self-reported estimated due date) | 
| Effective decision | The extent to which the person feels they made an effective decision about postpartum contraceptive methods, measured using an adapted version of the Effective Decision subscale of the Decisional Conflict Scale (O'Connor, 1993). | T2 (Approximately 7-11 weeks after self-reported estimated due date) | 
| Contraceptive method(s) prescribed in first 60 days: LARC vs. other | The proportion of people who report being given or prescribed a long-acting reversible contraceptive (LARC) method (i.e., hormonal intrauterine device, copper intrauterine device, or implant) in the first 60 days after giving birth, measured using a self-developed item. | T2 (Approximately 7-11 weeks after self-reported estimated due date) | 
| Contraceptive method(s) prescribed in first 60 days: Most or moderately effective vs. other | The proportion of people who report being given or prescribed a most or moderately effective contraceptive method (i.e., female sterilization, hormonal intrauterine device, copper intrauterine device, implant, injection, combined pill, progestin-only pill, patch, ring, diaphragm) in the first 60 days after giving birth, measured using a self-developed item. | T2 (Approximately 7-11 weeks after self-reported estimated due date) | 
| Contraceptive method(s) prescribed in first 3 days: LARC vs. other | The proportion of people who report being given or prescribed a long-acting reversible contraceptive (LARC) method (i.e., hormonal intrauterine device, copper intrauterine device, or implant) in the first 3 days after giving birth, measured using a self-developed item. | T2 (Approximately 7-11 weeks after self-reported estimated due date) | 
| Contraceptive method(s) prescribed in first 3 days: Most or moderately effective vs. other | The proportion of people who report being given or prescribed a most or moderately effective contraceptive method (i.e., female sterilization, hormonal intrauterine device, copper intrauterine device, implant, injection, combined pill, progestin-only pill, patch, ring, diaphragm) in the first 3 days after giving birth, measured using a self-developed item. | T2 (Approximately 7-11 weeks after self-reported estimated due date) | 
| Contraceptive method(s) used: LARC vs. other | The proportion of people who, at the time of survey completion, report having used a long-acting reversible contraceptive (LARC) method (i.e., hormonal intrauterine device, copper intrauterine device, or implant) since giving birth, measured using a self-developed item. | T2 (Approximately 7-11 weeks after self-reported estimated due date) | 
| Contraceptive method(s) used: Most or moderately effective vs. other | The proportion of people who, at the time of survey completion, report having used a most or moderately effective contraceptive method (i.e., female sterilization, hormonal intrauterine device, copper intrauterine device, implant, injection, combined pill, progestin-only pill, patch, ring, diaphragm) since giving birth, measured using a self-developed item. | T2 (Approximately 7-11 weeks after self-reported estimated due date) | 
| Contraceptive method(s) used: Method vs. no method | The proportion of people who, at the time of survey completion, report having used one or more contraceptive methods (i.e., female sterilization, hormonal intrauterine device, copper intrauterine device, implant, injection, combined pill, progestin-only pill, patch, ring, diaphragm, male condom, internal (female) condom, spermicide, sponge, cervical cap, lactational amenorrhea method, withdrawal, fertility awareness, male sterilization, and/or emergency contraceptive pill) since giving birth, measured using a self-developed item. | T2 (Approximately 7-11 weeks after self-reported estimated due date) | 
| Timing of decision about contraceptive method(s): During pregnancy vs. since giving birth | The proportion of people who report deciding to use their postpartum contraceptive method(s) during pregnancy, measured using a self-developed item. | T2 (Approximately 7-11 weeks after self-reported estimated due date) | 
| Likelihood of recommending the intervention to a friend | The proportion of people who report that they are extremely likely to recommend the intervention to a friend, measured using a self-developed item. | T1 (one week following study enrollment) | 
| Likelihood of reviewing the intervention in the future | The proportion of people who report that they are extremely likely to review the intervention in the future, measured using a self-developed item. | T1 (one week following study enrollment) | 
| Perceived utility of the intervention | The extent to which the person perceives that the intervention was useful in preparing them to communicate with their health professional and make a decision, measured using an adapted version of the Preparation for Decision Making Scale (Graham & O'Connor, 2010). | T1 (one week following study enrollment) |