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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
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The investigators have designed a tablet-based decision support tool to help women learn more about their birth control options and support them in choosing a method they are happy with. The investigators will test whether the decision support tool helps women choose a birth control method they can continue using successfully by having some women use the tool before their birth control-related visit to a health care provider, and some women not use the tool before their visit. The investigators will then follow up with all the women at four months and seven months after their visit to see if they are still using the birth control method they chose at the visit and how happy they are with the method.
Hypotheses:
The impacts of unintended pregnancy include adverse maternal and infant outcomes for women who continue their pregnancies, with higher rates of infant low birth weight, infant mortality, and maternal mortality and morbidity for these pregnancies as compared to planned pregnancies. In addition, children resulting from unplanned pregnancies have been found to be more likely to experience developmental delay.
Over the past several decades, the proportion of unintended pregnancy in the United States has remained stubbornly high at approximately 50%. Each year, one in 20 women of reproductive age experiences an unintended pregnancy, and it is estimated that over half of women will have an unintended pregnancy in their lifetime. This high rate of unintended pregnancy in the United States places a heavy burden on both women and the health care system. A disproportionate amount of this burden is experienced by minority women and women of lower socioeconomic status. Given the high rate of unintended pregnancies in this country, interventions designed to help women achieve their fertility goals could have a substantial impact on their health outcomes and life course. In addition, identifying strategies that are appropriate for use in high-risk, diverse populations could address disparities in women's ability to plan their pregnancies.
The investigators propose a cluster randomized trial to investigate the effect of an interactive, tablet-based contraceptive decision support tool that women will use immediately prior to their contraceptive counseling visits. The goal of the tool is to facilitate shared decision-making between the woman and her health care provider, with the ultimate goal of helping the woman to choose a contraceptive method that is consistent with her values and preferences, and is therefore best suited to helping her to avoid an unplanned pregnancy. The tool will be available in both English and Spanish.
The investigators will measure the tool's effect on women's contraceptive continuation, as well as on their experience of contraceptive counseling, measured both quantitatively and qualitatively. In addition, the investigators will collect quantitative and qualitative data to determine the impact of the implementation of this tool on the experiences of providers and the clinics in which they work.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Contraceptive Decision Support Tool | Experimental | Patients whose contraceptive counseling visits are scheduled with providers randomized to this arm will use the intervention immediately before their visit and bring the generated printout to their visit. Providers randomized to this arm will be free to integrate the tool and printout into their contraceptive counseling however they see fit. |
|
| Usual Care (Control) | No Intervention | Patients in this arm will receive usual family planning care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Contraceptive Decision Support Tool | Behavioral | The decision support tool:
|
| Measure | Description | Time Frame |
|---|---|---|
| Contraceptive Continuation | Whether or not a participant is still using the contraceptive method she selected at baseline. | 4 and 7 months post-enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Contraceptive Counseling Satisfaction | Patient-reported score on an 11-item factor analysis-validated measure created by the PI to assess patients' satisfaction with the contraceptive counseling experience. The measure consists of 5-point Likert scale items on which patients evaluate provider performance, with item response options ranging from 1 ("Poor") to 5 ("Excellent"). The score range for the total measure is11-55, with 11 as the worst possible score and 55 as the best possible score for provider performance. Analyzed dichotomously, top score (55) versus all lower scores. |
| Measure | Description | Time Frame |
|---|---|---|
| Choice of a Highly Effective Method of Contraception at Baseline | Patient report of whether or not patient chose highly effective method at baseline. Highly effective methods include implants, IUDs, and male and female sterilization. | Baseline (post-visit survey) |
| Use of a Highly Effective Method of Contraception at 4 and 7 Months Follow-up. |
Inclusion Criteria:
Patients
Providers
Clinic staff
Exclusion Criteria:
Patients
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| Name | Affiliation | Role |
|---|---|---|
| Christine Dehlendorf, MD, MAS | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Francisco City Clinic | San Francisco | California | 94103 | United States | ||
| Planned Parenthood San Francisco Health Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31537316 | Derived | Holt K, Kimport K, Kuppermann M, Fitzpatrick J, Steinauer J, Dehlendorf C. Patient-provider communication before and after implementation of the contraceptive decision support tool My Birth Control. Patient Educ Couns. 2020 Feb;103(2):315-320. doi: 10.1016/j.pec.2019.09.003. Epub 2019 Sep 4. | |
| 30763545 | Derived |
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A total of 2,458 patients were approached to participate in the study. Of these, 1,700 were excluded before assignment (1,642 due to ineligibility, 58 refusals), and 758 enrolled.
A total of 36 providers were approached to participate. Eight were excluded before assignment (7 due to ineligibility, 1 refusal), and 28 enrolled.
Female patients were approached to participate in the study before appointments at four San Francisco Bay Area clinics between December 2014 and March 2016.
Patients are grouped in cluster by provider. Providers of family planning care at the four clinics were approached to participate in the study in October to December 2014.
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| ID | Title | Description |
|---|---|---|
| FG000 | Contraceptive Decision Support Tool Patients | Patients whose contraceptive counseling visits are scheduled with providers randomized to this arm will use the intervention immediately before their visit and bring the generated printout to their visit. Providers randomized to this arm will be free to integrate the tool and printout into their contraceptive counseling however they see fit. Contraceptive Decision Support Tool: The decision support tool:
|
| FG001 | Usual Care (Control) Patients | Patients in this arm will receive usual family planning care. |
| FG002 | Contraceptive Decision Support Tool Providers | Family planning providers randomized to use the Contraceptive Decision Support tool with their patients in the study. |
| FG003 | Usual Care (Control) Providers | Family planning providers randomized to deliver usual care to their patient in the study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
758 patients enrolled in the study. Patients were excluded post-randomization if they were pregnant at baseline (n=8) or enrolled in the study twice (n=1), for a resultant baseline sample of 749 patients.
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| ID | Title | Description |
|---|---|---|
| BG000 | Contraceptive Decision Support Tool Patients | Patients whose contraceptive counseling visits are scheduled with providers randomized to this arm will use the intervention immediately before their visit and bring the generated printout to their visit. Providers randomized to this arm will be free to integrate the tool and printout into their contraceptive counseling however they see fit. Contraceptive Decision Support Tool: The decision support tool:
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Patients were excluded if they were pregnant at baseline (n=8) or enrolled in the study twice (n=1). |
| 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 Continuation | Whether or not a participant is still using the contraceptive method she selected at baseline. | Analysis was modified intention to treat. In accordance with the statistical analysis plan, patients were excluded from analysis if they were pregnant at baseline (n=8) or enrolled in the study twice (n=1, in which case information from their second enrollment was excluded). Outcome observed in patients only. | Posted | Count of Participants | Participants | 4 and 7 months post-enrollment |
|
7 months (from patient enrollment through study period)
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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 | Contraceptive Decision Support Tool Patients | Patients whose contraceptive counseling visits are scheduled with providers randomized to this arm will use the intervention immediately before their visit and bring the generated printout to their visit. Providers randomized to this arm will be free to integrate the tool and printout into their contraceptive counseling however they see fit. Contraceptive Decision Support Tool: The decision support tool:
|
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Limitations include potential for contamination between provider arms, our inability to blind patients or providers due to the nature of the intervention, and the potential for unobserved differences between patient arms due to cluster randomization.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Christine Dehlendorf, Principal Investigator | University of California, San Francisco | 415-206-8712 | christine.dehlendorf.@ucsf.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 22, 2016 | Jun 30, 2017 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 22, 2016 | Aug 14, 2017 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003268 | Contraception Behavior |
| ID | Term |
|---|---|
| D043762 | Reproductive Behavior |
| D001519 | Behavior |
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|
| Baseline, post-visit survey |
| Patient Satisfaction With Information Received About Side Effects During Counseling | Patient response to a 5-point Likert scale item about satisfaction with information that their provider gave them about side effects of their chosen methods during their baseline visit (1=completely unsatisfied, 5=completely satisfied). Analyzed dichotomously as top score of 5 versus <5. | Baseline (post-visit survey) |
| Overall Satisfaction With Visit | Patient report on 5-point Likert scale of satisfaction with baseline visit (1=completely unsatisfied, 5=completely satisfied). Analyzed dichotomously as top score of 5 versus <5. | Baseline (post-visit survey) |
| Shared Decision Making - Feelings About Provider Involvement | Patient report on 3-point scale of their feelings about provider involvement in contraceptive decision-making: I wish provider had been less involved, provider was involved the right amount, I wiss provider had been more involved. | Baseline (post-visit) and up to 24 months |
| Shared Decision Making - Provider Appropriately Expressed Preference | Patient report of attitude on 3-point scale on how provider expressed preference for contraceptive method choice: Right amount, wish less strongly, wish more strongly. | Baseline (post-visit survey) |
| Shared Decision Making - Satisfaction With How Provider Helped With Choice | Patient report of satisfaction on a 5-point Likert scale (from 1=completely unsatisfied to 5=completely satisfied) of how the provider helped contraceptive method choice. Analyzed dichotomously as top score of 5 versus <5. | Baseline (post-visit survey) |
| Shared Decision Making - Who Made the Decision? | Patient response to 5-point scale of who made decision on contraceptive method. The original 5 points were the provider by themselves, more provider, both equally, more patient, or provider by themselves. In analysis, these options were collapsed to three points: more provider, both equally, or more patient. | Baseline (post-visit) |
| Shared Decision Making - Provider Preference | Patient report of whether or not provider had preference for contraceptive method choice, reported on a 5-point scale: no preference, slight preference, moderate preference, strong preference, extremely strong preference. Analyzed dichotomously as any preference versus no preference. | Baseline (post-visit survey) |
| Patient Decisional Conflict in Contraceptive Choice | Patient Decisional Conflict was measured using the Decisional Conflict Scale (DCS), a validated measure to assess patients' decisional conflict in medical decision making. The DCS includes 16 items about experience of conflict, with 5-point Likert response options ranging from 0 ("Strongly disagree") to 4 ("Strongly agree"). Higher scores indicate less conflict. Top score on DCS (Range: 0-100, analyzed dichotomously as 100 versus <100). Top scores on subscales also analyzed (Informed decision, Uncertainty, Effective decision, Values clarity, Support, all ranging 0-100 and analyzed dichotomously as 100 versus <100). | Baseline (post-visit) |
| Patient Knowledge of Contraceptive Options and Features | Patient responses to items derived from National Survey of Reproductive Contraceptive Knowledge and previous studies of contraceptive knowledge and attitudes. All items analyzed as correct vs. incorrect. | Baseline (post-visit) |
| Patient Chosen Contraceptive Method Satisfaction | 5-point Likert scale item regarding patient satisfaction with contraceptive method chosen at baseline visit. The item is a statement of method satisfaction, and response options range from 1 ("Completely disagree") to 5 ("Completely agree"). A higher score indicates higher satisfaction. Analyzed dichotomously as top score (5) versus all lower scores. | Reported and analyzed at baseline (post-visit), 4 months and 7 months follow-up |
| Patient Current Contraceptive Method Satisfaction | 5-point Likert scale question regarding patient satisfaction with the contraceptive method they are currently using. The item is a statement of method satisfaction, and response options range from 1 ("Completely disagree") to 5 ("Completely agree"). A higher score indicates higher satisfaction. Analyzed dichotomously as top score of 5 versus <5. | 7 months follow-up |
| Patient Attitude Towards Use of Contraceptive Options | Patient ratings of contraceptive methods on the 11-point Global Contraceptive Attitude scale, developed by the PI. To assess overall (or "global") attitude towards use of various methods, patients are asked to respond the following with regard to each method listed in the data table: "Overall, how would you rate each of the following as a birth control method for yourself, (even if you've never used it)?" Response options range from 0 ("Terrible method") to 10 ("Great method"). A higher score on an individual item indicates a more positive attitude towards a method. Analyzed as discrete items with responses of 0 to 10; item scores not combined into an overall scale score. | Baseline (post-visit survey) |
| Newly Heard About Methods During Visit | Percentage of patients who reported having heard about a method in the post-survey, but not the pre-survey. | Baseline (pre- and post-survey) |
| Patient Rating of Visit as "Much Better" Than Previous Family Planning Visit | Patient report on 5-point Likert scale question asking patient to compare this visit to last family planning visit (1=Today was much worse; 5=today was much better). Analyzed dichotomously as top score of 5 versus <5. | Baseline (post-visit survey) |
| Total Clinic Visit Time | Total amount of time a patient spends in a clinic for a family planning visit, from check-in to check-out. | Baseline visit |
| Time Spent With Contraceptive Counseling Provider | Total amount of time spent with the provider that is providing contraceptive counseling. | Baseline visit |
| Maslach Burnout Inventory | Provider participants were asked to respond to the Maslach Burnout Inventory on workplace burnout among human services workers. The scale includes 22 items with response options on a Likert scale of 0-6. Individual scores were calculated at both baseline and follow-up for three subscales: emotional exhaustion (Range: 0-54, with higher score representing higher emotional exhaustion), depersonalization (Range: 0-30, with a higher score representing higher depersonalization), and personal accomplishment (Range: 0-48, with a higher score representing more personal accomplishment in the workplace). | Change between baseline and end of study (up to 24 months post-enrollment). In multivariate analysis, follow-up score analyzed controlling for site and score at baseline (Analyses 1-3). |
Whether patient is using a highly effective contraceptive method at 4 and 7 month follow-up survey. Highly effective methods include implant, IUDs, and male and female sterilization. |
| 4 and 7 months post-enrollment |
| Use of Any Moderately or Highly Effective Method of Contraception at 4 and 7 Months Follow-up | Patient report of whether or not patient is using a highly or moderately effective contraceptive method at 4 and 7 month follow-up survey. As defined by the Centers for Disease Control, moderately effective methods include injectables, pills, patch, vaginal ring, and diaphragm; typical failure rates range from 6-12%. Highly effective methods include implants, IUDs, and male and female sterilization; failure rates are less than 1%. | 4 and 7 months post-enrollment |
| Unplanned Pregnancy | Incidence of unplanned pregnancy among study participants, as determined by responses of patients who experienced a pregnancy to the 6-item London Measure of Unplanned Pregnancy. The London Measure includes items on attitude towards an experienced pregnancy and behaviors before pregnancy to determine the intendedness of pregnancy. The score range of the London Measure is 0-12, with a score of <10 indicating unplanned pregnancy and a score of 10 or higher indicating planned pregnancy. We report the percentage of patients who report a pregnancy and report a score of <10 on the London Measure. | 4 months and 7 months from enrollment |
| San Francisco |
| California |
| 94110 |
| United States |
| San Francisco General Hospital Family Planning Clinic | San Francisco | California | 94110 | United States |
| City College of San Francisco Student Health Services | San Francisco | California | 94112 | United States |
| Dehlendorf C, Fitzpatrick J, Fox E, Holt K, Vittinghoff E, Reed R, Campora MP, Sokoloff A, Kuppermann M. Cluster randomized trial of a patient-centered contraceptive decision support tool, My Birth Control. Am J Obstet Gynecol. 2019 Jun;220(6):565.e1-565.e12. doi: 10.1016/j.ajog.2019.02.015. Epub 2019 Feb 11. |
| Pregnant at baseline |
|
| Enrolled twice |
|
| BG001 | Usual Care (Control) Patients | Patients in this arm will receive usual family planning care. |
| BG002 | Contraception Decision Support Tool Providers | Family planning providers randomized to use the Contraceptive Decision Support tool with their patients. Providers were the unit of randomization in this cluster trial |
| BG003 | Usual Care (Control) Providers | Family planning providers randomized to practice usual care with their patients. Providers were the unit of randomization in this cluster trial |
| BG004 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Patients were excluded from analysis if they were pregnant at baseline (n=8) or enrolled in the study twice (n=1). | Count of Participants | Participants |
|
| Language spoken during study participation | Patients were excluded from analysis if they were pregnant at baseline (n=8) or enrolled in the study twice (n=1). | Count of Participants | Participants |
|
| Parental education | Patients were excluded from analysis if they were pregnant at baseline (n=8) or enrolled in the study twice (n=1). These data were not collected from the provider sample. | Count of Participants | Participants |
|
| % Federal Poverty Line | Patients were excluded from analysis if they were pregnant at baseline (n=8) or enrolled in the study twice (n=1). These data were not collected from the provider sample. | Count of Participants | Participants |
|
| Parity | Patients were excluded from analysis if they were pregnant at baseline (n=8) or enrolled in the study twice (n=1). These data were not collected from the provider sample. | Count of Participants | Participants |
|
| OG001 | Usual Care (Control) | Patients in this arm will receive usual family planning care. |
|
|
|
| Secondary | Patient Contraceptive Counseling Satisfaction | Patient-reported score on an 11-item factor analysis-validated measure created by the PI to assess patients' satisfaction with the contraceptive counseling experience. The measure consists of 5-point Likert scale items on which patients evaluate provider performance, with item response options ranging from 1 ("Poor") to 5 ("Excellent"). The score range for the total measure is11-55, with 11 as the worst possible score and 55 as the best possible score for provider performance. Analyzed dichotomously, top score (55) versus all lower scores. | Observed in patients only | Posted | Count of Participants | Participants | Baseline, post-visit survey |
|
|
|
|
| Secondary | Patient Satisfaction With Information Received About Side Effects During Counseling | Patient response to a 5-point Likert scale item about satisfaction with information that their provider gave them about side effects of their chosen methods during their baseline visit (1=completely unsatisfied, 5=completely satisfied). Analyzed dichotomously as top score of 5 versus <5. | Observed in patients only | Posted | Count of Participants | Participants | Baseline (post-visit survey) |
|
|
|
|
| Secondary | Overall Satisfaction With Visit | Patient report on 5-point Likert scale of satisfaction with baseline visit (1=completely unsatisfied, 5=completely satisfied). Analyzed dichotomously as top score of 5 versus <5. | Observed in patients only | Posted | Count of Participants | Participants | Baseline (post-visit survey) |
|
|
|
|
| Secondary | Shared Decision Making - Feelings About Provider Involvement | Patient report on 3-point scale of their feelings about provider involvement in contraceptive decision-making: I wish provider had been less involved, provider was involved the right amount, I wiss provider had been more involved. | Observed in patients only | Posted | Count of Participants | Participants | Baseline (post-visit) and up to 24 months |
|
|
|
|
| Secondary | Shared Decision Making - Provider Appropriately Expressed Preference | Patient report of attitude on 3-point scale on how provider expressed preference for contraceptive method choice: Right amount, wish less strongly, wish more strongly. | Observed in patients only | Posted | Count of Participants | Participants | Baseline (post-visit survey) |
|
|
|
|
| Secondary | Shared Decision Making - Satisfaction With How Provider Helped With Choice | Patient report of satisfaction on a 5-point Likert scale (from 1=completely unsatisfied to 5=completely satisfied) of how the provider helped contraceptive method choice. Analyzed dichotomously as top score of 5 versus <5. | Observed in patients only | Posted | Count of Participants | Participants | Baseline (post-visit survey) |
|
|
|
|
| Secondary | Shared Decision Making - Who Made the Decision? | Patient response to 5-point scale of who made decision on contraceptive method. The original 5 points were the provider by themselves, more provider, both equally, more patient, or provider by themselves. In analysis, these options were collapsed to three points: more provider, both equally, or more patient. | Observed in patients only | Posted | Count of Participants | Participants | Baseline (post-visit) |
|
|
|
|
| Secondary | Shared Decision Making - Provider Preference | Patient report of whether or not provider had preference for contraceptive method choice, reported on a 5-point scale: no preference, slight preference, moderate preference, strong preference, extremely strong preference. Analyzed dichotomously as any preference versus no preference. | Observed in patients only | Posted | Count of Participants | Participants | Baseline (post-visit survey) |
|
|
|
|
| Secondary | Patient Decisional Conflict in Contraceptive Choice | Patient Decisional Conflict was measured using the Decisional Conflict Scale (DCS), a validated measure to assess patients' decisional conflict in medical decision making. The DCS includes 16 items about experience of conflict, with 5-point Likert response options ranging from 0 ("Strongly disagree") to 4 ("Strongly agree"). Higher scores indicate less conflict. Top score on DCS (Range: 0-100, analyzed dichotomously as 100 versus <100). Top scores on subscales also analyzed (Informed decision, Uncertainty, Effective decision, Values clarity, Support, all ranging 0-100 and analyzed dichotomously as 100 versus <100). | Observed in patients only | Posted | Count of Participants | Participants | Baseline (post-visit) |
|
|
|
|
| Secondary | Patient Knowledge of Contraceptive Options and Features | Patient responses to items derived from National Survey of Reproductive Contraceptive Knowledge and previous studies of contraceptive knowledge and attitudes. All items analyzed as correct vs. incorrect. | Observed in patients only | Posted | Count of Participants | Participants | Baseline (post-visit) |
|
|
|
|
| Secondary | Patient Chosen Contraceptive Method Satisfaction | 5-point Likert scale item regarding patient satisfaction with contraceptive method chosen at baseline visit. The item is a statement of method satisfaction, and response options range from 1 ("Completely disagree") to 5 ("Completely agree"). A higher score indicates higher satisfaction. Analyzed dichotomously as top score (5) versus all lower scores. | Posted | Count of Participants | Participants | Reported and analyzed at baseline (post-visit), 4 months and 7 months follow-up |
|
|
|
|
| Secondary | Patient Current Contraceptive Method Satisfaction | 5-point Likert scale question regarding patient satisfaction with the contraceptive method they are currently using. The item is a statement of method satisfaction, and response options range from 1 ("Completely disagree") to 5 ("Completely agree"). A higher score indicates higher satisfaction. Analyzed dichotomously as top score of 5 versus <5. | Observed in patients only | Posted | Count of Participants | Participants | 7 months follow-up |
|
|
|
|
| Secondary | Patient Attitude Towards Use of Contraceptive Options | Patient ratings of contraceptive methods on the 11-point Global Contraceptive Attitude scale, developed by the PI. To assess overall (or "global") attitude towards use of various methods, patients are asked to respond the following with regard to each method listed in the data table: "Overall, how would you rate each of the following as a birth control method for yourself, (even if you've never used it)?" Response options range from 0 ("Terrible method") to 10 ("Great method"). A higher score on an individual item indicates a more positive attitude towards a method. Analyzed as discrete items with responses of 0 to 10; item scores not combined into an overall scale score. | Observed in patients only. | Posted | Mean | Standard Error | Units on a scale | Baseline (post-visit survey) |
|
|
|
|
| Secondary | Newly Heard About Methods During Visit | Percentage of patients who reported having heard about a method in the post-survey, but not the pre-survey. | Only calculated for those patients who reported not having heard of method in pre-survey, and then completed post-survey. All other patients missing for this item and excluded from analysis. | Posted | Count of Participants | Participants | Baseline (pre- and post-survey) |
|
|
|
|
| Secondary | Patient Rating of Visit as "Much Better" Than Previous Family Planning Visit | Patient report on 5-point Likert scale question asking patient to compare this visit to last family planning visit (1=Today was much worse; 5=today was much better). Analyzed dichotomously as top score of 5 versus <5. | Observed in patients only. Only calculated among those participants who reported ever having had a family planning visit. All others missing. | Posted | Count of Participants | Participants | Baseline (post-visit survey) |
|
|
|
|
| Secondary | Total Clinic Visit Time | Total amount of time a patient spends in a clinic for a family planning visit, from check-in to check-out. | Observed in patients only | Posted | Mean | Standard Deviation | minutes | Baseline visit |
|
|
|
|
| Secondary | Time Spent With Contraceptive Counseling Provider | Total amount of time spent with the provider that is providing contraceptive counseling. | Observed in patients | Posted | Mean | Standard Deviation | minutes | Baseline visit |
|
|
|
|
| Secondary | Maslach Burnout Inventory | Provider participants were asked to respond to the Maslach Burnout Inventory on workplace burnout among human services workers. The scale includes 22 items with response options on a Likert scale of 0-6. Individual scores were calculated at both baseline and follow-up for three subscales: emotional exhaustion (Range: 0-54, with higher score representing higher emotional exhaustion), depersonalization (Range: 0-30, with a higher score representing higher depersonalization), and personal accomplishment (Range: 0-48, with a higher score representing more personal accomplishment in the workplace). | Observed in providers only | Posted | Mean | Standard Deviation | Units on a scale | Change between baseline and end of study (up to 24 months post-enrollment). In multivariate analysis, follow-up score analyzed controlling for site and score at baseline (Analyses 1-3). |
|
|
|
|
| Other Pre-specified | Choice of a Highly Effective Method of Contraception at Baseline | Patient report of whether or not patient chose highly effective method at baseline. Highly effective methods include implants, IUDs, and male and female sterilization. | Observed in patients only | Posted | Count of Participants | Participants | Baseline (post-visit survey) |
|
|
|
|
| Other Pre-specified | Use of a Highly Effective Method of Contraception at 4 and 7 Months Follow-up. | Whether patient is using a highly effective contraceptive method at 4 and 7 month follow-up survey. Highly effective methods include implant, IUDs, and male and female sterilization. | Observed in patients only | Posted | Count of Participants | Participants | 4 and 7 months post-enrollment |
|
|
|
|
| Other Pre-specified | Use of Any Moderately or Highly Effective Method of Contraception at 4 and 7 Months Follow-up | Patient report of whether or not patient is using a highly or moderately effective contraceptive method at 4 and 7 month follow-up survey. As defined by the Centers for Disease Control, moderately effective methods include injectables, pills, patch, vaginal ring, and diaphragm; typical failure rates range from 6-12%. Highly effective methods include implants, IUDs, and male and female sterilization; failure rates are less than 1%. | Posted | Count of Participants | Participants | 4 and 7 months post-enrollment |
|
|
|
|
| Other Pre-specified | Unplanned Pregnancy | Incidence of unplanned pregnancy among study participants, as determined by responses of patients who experienced a pregnancy to the 6-item London Measure of Unplanned Pregnancy. The London Measure includes items on attitude towards an experienced pregnancy and behaviors before pregnancy to determine the intendedness of pregnancy. The score range of the London Measure is 0-12, with a score of <10 indicating unplanned pregnancy and a score of 10 or higher indicating planned pregnancy. We report the percentage of patients who report a pregnancy and report a score of <10 on the London Measure. | Observed in patients only | Posted | Count of Participants | Participants | 4 months and 7 months from enrollment |
|
|
|
|
| 0 |
| 407 |
| 0 |
| 407 |
| 0 |
| 407 |
| EG001 | Usual Care (Control) Patients | Patients in this arm will receive usual family planning care. | 0 | 351 | 0 | 351 | 0 | 351 |
| EG002 | Contraceptive Decision Support Tool Providers | Providers randomized to use the tool with their study patients. | 0 | 15 | 0 | 15 | 0 | 15 |
| EG003 | Usual Care (Control) Providers | Providers randomized to deliver usual care to their study patients. | 0 | 13 | 0 | 13 | 0 | 13 |
Not provided
Not provided
| 20-24 |
|
| 25-29 |
|
| 30-34 |
|
| 35-39 |
|
| 40-45 |
|
| Over 45 |
|
| Missing |
|
| Male |
|
| Asian or Pacific Islander |
|
| Hispanic/Latina |
|
| White |
|
| Other |
|
| Missing |
|
| Spanish |
|
| Some high school, but did not graduate |
|
| High school graduate or GED |
|
| Some college or 2-year degree |
|
| 4-year college graduate or more |
|
| Missing |
|
| 101-200% |
|
| >200% |
|
| Missing |
|
| Parous |
|
| Missing |
|
| Missing |
|
| Missing |
|
| Missing |
|
| Missing |
|
| Wish provider had been more involved |
|
| Missing |
|
| Comparison of patients who reported they wished their providers had been more involved, compared to right amount (ref) | Regression, Logistic | We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen. | 0.24 | P-value calculated in multiply imputed dataset. | Relative risk ratio | 1.6 | 2-Sided | 95 | 0.73 | 3.50 | The estimation value represents the relative risk of the outcome in the intervention group, compared to relative risk in the control group. | Superiority |
| No, I wish more |
|
| Missing |
|
| Comparison of patients who reported they wished provider had expressed preference more strongly, compared to right amount (ref). | Regression, Logistic | We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen. | 0.16 | P-value calculated in multiply imputed dataset. | Relative risk ratio | 0.69 | 2-Sided | 95 | 0.41 | 1.16 | The estimation value represents the relative risk of the outcome in the intervention group, compared to relative risk in the control group. | Superiority |
| Missing |
|
| Both |
|
| Missing |
|
| Comparison of provider decision to both (ref) | Regression, Logistic | We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen. | 0.09 | P-value calculated in multiply imputed dataset. | Relative risk ratio | 2.14 | 2-Sided | 95 | 0.89 | 5.15 | The estimation value represents the relative risk of the outcome in the intervention group, compared to relative risk in the control group. | Superiority |
| Missing |
|
| Missing |
|
| Informed decision subscale |
|
| Uncertainty subscale |
|
| Effective decision subscale |
|
| Values clarity subscale |
|
| Support subscale |
|
| Comparison of informed decision subscale | Regression, Logistic | We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen. | 0.0496 | Odds Ratio (OR) | 1.34 | 2-Sided | 95 | 1.00 | 1.80 | The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator. | Superiority |
| Comparison of uncertainty subscale of DCS | Regression, Logistic | We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen. | 0.03 | P-value calculated in multiply imputed dataset. | Odds Ratio (OR) | 1.45 | 2-Sided | 95 | 1.03 | 2.05 | The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator. | Superiority |
| Comparison of effective decision subscale | Regression, Logistic | We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen. | 0.5 | P-value calculated in multiply imputed dataset. | Odds Ratio (OR) | 1.13 | 2-Sided | 95 | 0.80 | 1.59 | The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator. | Superiority |
| Comparison of values clarity subscale | Regression, Logistic | We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen. | 0.31 | P-value calculated in multiply imputed dataset. | Odds Ratio (OR) | 1.17 | 2-Sided | 95 | 0.86 | 1.59 | The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator. | Superiority |
| Comparison of support subscale | Regression, Logistic | We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen. | 0.73 | P-value calculated in multiply imputed dataset. | Odds Ratio (OR) | 1.06 | 2-Sided | 95 | 0.76 | 1.49 | The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator. | Superiority |
| Missing |
|
| IUDs are more effective than pills |
|
| Depo is more effective than condoms |
|
| IUDs are an option for nulliparous young women |
|
| Methods causing periods to stop are safe |
|
| LARC can be removed early |
|
| Copper IUDs can act as EC |
|
| After sex, something to prevent pregnancy |
|
| EC can prevent pregnancy after sex |
|
| Pill does not affect fertility |
|
| Patch does not affect fertility |
|
| Ring does not affect fertility |
|
| Depo does affect fertility |
|
| Hormonal IUD does not affect fertility |
|
| Non-hormonal IUD does not affect fertility |
|
| Implant does not affect fertility |
|
| Composite IUD knowledge |
|
| Comparison of correct knowledge - IUDs are more effective than pills | Regression, Logistic | We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen. | <0.0001 | P-value calculated in multiply imputed dataset. | Odds Ratio (OR) | 2.65 | 2-Sided | 95 | 1.94 | 3.62 | The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator. | Superiority |
| Comparison of correct knowledge - depo is more effective than condoms | Regression, Logistic | We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen. | 0.0004 | P-value calculated in multiply imputed dataset. | Odds Ratio (OR) | 1.77 | 2-Sided | 95 | 1.29 | 2.44 | The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator. | Superiority |
| Comparison of correct knowledge - IUDs are an option for nulliparous young women | Regression, Logistic | We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen. | 0.0002 | P-value calculated in multiply imputed dataset. | Odds Ratio (OR) | 1.92 | 2-Sided | 95 | 1.36 | 2.71 | The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator. | Superiority |
| Comparison of correct knowledge - Methods causing periods to stop are safe. | Regression, Logistic | We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen. | 0.001 | P-value calculated in multiply imputed dataset. | Odds Ratio (OR) | 1.86 | 2-Sided | 95 | 1.28 | 2.71 | The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator. | Superiority |
| Comparison of correct knowledge - LARC can be removed early | Regression, Logistic | We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen. | 0.36 | P-value calculated in multiply imputed dataset. | Odds Ratio (OR) | 1.15 | 2-Sided | 95 | 0.85 | 1.57 | The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator. | Superiority |
| Comparison of knowledge - Copper IUD can act as EC | Regression, Logistic | We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen. | <0.0001 | P-value calculated in multiply imputed dataset. | Odds Ratio (OR) | 2.76 | 2-Sided | 95 | 1.72 | 4.41 | The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator. | Superiority |
| Comparison of knowledge - After sex, there is something you can do to prevent pregnancy | Regression, Logistic | We ran a regression model in a multiply imputed dataset. This outcome was not adjusted for site due to model being unable to run with imputed data. | 0.49 | P-value calculated in multiply imputed dataset. | Odds Ratio (OR) | 0.77 | 2-Sided | 95 | 0.36 | 1.63 | The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator. | Superiority |
| Comparison of knowledge - EC can prevent pregnancy after sex | Regression, Logistic | We ran a regression model in a multiply imputed dataset. This outcome was not adjusted for site due to model being unable to run with imputed data. | 0.31 | P-value calculated in multiply imputed dataset. | Odds Ratio (OR) | 0.73 | 2-Sided | 95 | 0.39 | 1.34 | The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator. | Superiority |
| Comparison of correct knowledge - pill does not affect fertility | Regression, Logistic | We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen. | 0.08 | P-value calculated in multiply imputed dataset. | Odds Ratio (OR) | 1.33 | 2-Sided | 95 | 0.96 | 1.84 | The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator. | Superiority |
| Comparison of correct knowledge - patch does not affect fertility | Regression, Logistic | We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen. | 0.002 | P-value calculated in multiply imputed dataset. | Odds Ratio (OR) | 1.65 | 2-Sided | 95 | 1.2 | 2.26 | Superiority | The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator. |
| Comparison of correct knowledge - ring does not affect fertility | Regression, Logistic | We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen. | 0.002 | P-value calculated in multiply imputed dataset. | Odds Ratio (OR) | 1.7 | 2-Sided | 95 | 1.23 | 2.35 | The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator. | Superiority |
| Comparison of correct knowledge - Depo does affect fertility | Regression, Logistic | We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen. | 0.77 | P-value calculated in multiply imputed dataset. | Odds Ratio (OR) | 0.94 | 2-Sided | 95 | 0.62 | 1.43 | The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator. | Superiority |
| Comparison of correct knowledge - Hormonal IUD does not affect fertility | Regression, Logistic | We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen. | 0.002 | P-value calculated in multiply imputed dataset. | Odds Ratio (OR) | 1.61 | 2-Sided | 95 | 1.19 | 2.17 | The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator. | Superiority |
| Comparison of correct knowledge - Non-hormonal IUD does not affect fertility | Regression, Logistic | We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen. | 0.004 | P-value calculated in multiply imputed dataset. | Odds Ratio (OR) | 1.56 | 2-Sided | 95 | 1.15 | 2.1 | The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator. | Superiority |
| Comparison of correct knowledge - Implant does not affect fertility | Regression, Logistic | We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen. | 0.005 | P-value calculated in multiply imputed dataset. | Odds Ratio (OR) | 1.54 | 2-Sided | 95 | 1.14 | 2.07 | The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator. | Superiority |
| Comparison of correct knowledge - composite IUD knowledge item (all correct responses on items related to IUD knowledge, versus any incorrect) | Regression, Logistic | <0.0001 | P-value calculated in multiply imputed dataset. | Odds Ratio (OR) | 2.47 | 2-Sided | 95 | 1.75 | 3.49 | OR calculated in multiply imputed dataset. Intervention patients had 2.47 times the odds of control patients to give correct answer. | Superiority |
| Missing |
|
| 4 months post-enrollment |
|
| 7 months post-enrollment |
|
| Comparison of percentage of patients giving top score at 4 months post-enrollment | Regression, Logistic | We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen. | 0.5 | P-value calculated in multiply imputed dataset. | Odds Ratio (OR) | 0.9 | 2-Sided | 95 | 0.66 | 1.22 | The odds ratio represents the odds of the intervention groups in the numerator over the odds of the control group in the denominator. | Superiority |
| Comparison of percentage of patients giving a top score on the 5-point Likert scale at 7 months post-enrollment. | Regression, Logistic | We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen. | 0.23 | P-value calculated in multiply imputed dataset. | Odds Ratio (OR) | 0.83 | 2-Sided | 95 | 0.60 | 1.13 | The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator. | Superiority |
| Missing |
|
| Ring |
|
| Shot |
|
| Hormonal IUD |
|
| Non-hormonal IUD |
|
| Implant |
|
| Condoms |
|
| Withdrawal |
|
| Female sterilization |
|
| Male sterilization |
|
| Comparison of rating on non-hormonal IUD. Patients were excluded from this analysis if they reported not having heard of the non-hormonal IUD in the post-visit survey. | Regression, Logistic | We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen. | 0.92 | P-value calculated in multiply imputed dataset. | Odds Ratio (OR) | 0.99 | 2-Sided | 95 | 0.75 | 1.3 | The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator. | Superiority |
| Comparison of rating of implant | Regression, Logistic | We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen. | 0.17 | P-value calculated in multiply imputed dataset | Odds Ratio (OR) | 0.85 | 2-Sided | 95 | 0.67 | 1.07 | The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator. | Superiority |
| Comparison of rating on condoms. Patients were excluded from this analysis if they reported not having heard of condoms in the post-visit survey. | Regression, Logistic | We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen. | 0.009 | P-value calculated in multiply imputed dataset. | Odds Ratio (OR) | 0.71 | 2-Sided | 95 | 0.54 | 0.92 | The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator. | Superiority |
| Comparison of rating on the shot (Depo Provera). Patients were excluded from this analysis if they reported not having heard of the the shot (Depo Provera) in the post-visit survey. | Regression, Logistic | We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen. | 0.26 | P-value calculated in multiply imputed dataset. | Odds Ratio (OR) | 0.86 | 2-Sided | 95 | 0.65 | 1.12 | The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator. | Superiority |
| Comparison of rating on the pill. Patients were excluded from this analysis if they reported not having heard of the pill in the post-visit survey. | Regression, Logistic | We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen. | 0.23 | P-value calculated in multiply imputed dataset. | Odds Ratio (OR) | 0.85 | 2-Sided | 95 | 0.64 | 1.11 | The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator. | Superiority |
| Comparison of rating on the patch. Patients were excluded from this analysis if they reported not having heard of the patch in the post-visit survey. | Regression, Logistic | We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen. | 0.55 | P-value calculated in multiply imputed dataset. | Odds Ratio (OR) | 0.92 | 2-Sided | 95 | 0.69 | 1.22 | The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator. | Superiority |
| Comparison of rating on the pull-out method. Patients were excluded from this analysis if they reported not having heard of the pull-out method in the post-visit survey. | Regression, Logistic | We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen. | 0.84 | P-value calculated in multiply imputed dataset. | Odds Ratio (OR) | 0.97 | 2-Sided | 95 | 0.76 | 1.25 | The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator. | Superiority |
| Comparison of rating on the ring. Patients were excluded from this analysis if they reported not having heard of the ring in the post-visit survey. | Regression, Logistic | We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen. | 0.07 | P-value calculated in multiply imputed dataset. | Odds Ratio (OR) | 0.81 | 2-Sided | 95 | 0.64 | 1.02 | The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator. | Superiority |
| Comparison of rating on female sterilization/tubal ligation. Patients were excluded from this analysis if they reported not having heard of female sterilization/tubal ligation in the post-visit survey. | Regression, Logistic | We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen. | 0.002 | P-value calculated in multiply imputed dataset. | Odds Ratio (OR) | 0.59 | 2-Sided | 95 | 0.42 | 0.82 | The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator. | Superiority |
| Comparison of rating on male sterilization/vasectomy. Patients were excluded from this analysis if they reported not having heard of male sterilization/vasectomy in the post-visit survey. | Regression, Logistic | We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen. | 0.005 | P-value calculated in multiply imputed dataset. | Odds Ratio (OR) | 0.58 | 2-Sided | 95 | 0.4 | 0.85 | The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator. | Superiority |
| Missing |
|
| Newly heard of non-hormonal IUD |
|
| Newly heard of implant |
|
| Newly heard of patch |
|
| Newly heard of ring |
|
| Newly heard of male sterilization |
|
| Newly heard of female sterilization |
|
| Comparison of patients who newly heard of non-hormonal IUD | Regression, Logistic | We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen. | 0.18 | P-value calculated in multiply imputed dataset | Odds Ratio (OR) | 1.65 | 2-Sided | 95 | 0.80 | 3.40 | The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator. | Superiority |
| Comparison of patients who newly heard of implant | Regression, Logistic | We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen. | 0.5 | P-value calculated in multiply imputed dataset. | Odds Ratio (OR) | 1.29 | 2-Sided | 95 | 0.62 | 2.69 | The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator. | Superiority |
| Comparison of patients who newly heard of the patch | Regression, Logistic | We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen. | 0.32 | P-value calculated in multiply imputed dataset. | Odds Ratio (OR) | 1.7 | 2-Sided | 95 | 0.59 | 4.89 | The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator. | Superiority |
| Comparison of patients who newly heard of ring | Regression, Logistic | We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen. | 0.37 | P-value calculated in multiply imputed dataset. | Odds Ratio (OR) | 1.38 | 2-Sided | 95 | 0.68 | 2.81 | The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator. | Superiority |
| Comparison of patients who newly heard of male sterilization (vasectomy) | Regression, Logistic | We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen. | 0.39 | P-value calculated in multiply imputed dataset. | Odds Ratio (OR) | 1.49 | 2-Sided | 95 | 0.60 | 3.73 | The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator. | Superiority |
| Comparison of patients who newly heard of female sterilization | Regression, Logistic | We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen. | 0.39 | P-value calculated in multiply imputed dataset. | Odds Ratio (OR) | 1.49 | 2-Sided | 95 | 0.6 | 3.73 | The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator. | Superiority |
| Missing |
|
| Superiority |
| Change in personal accomplishment |
|
Linear regression of follow-up score for depersonalization subscale of Maslach Burnout Inventory, controlling for baseline score and site. |
| Regression, Linear |
| 0.36 |
| Observed coefficient |
| -1.52 |
| Standard Error of the Mean |
| 1.91 |
| 2-Sided |
| 95 |
| -4.76 |
| 1.72 |
Tool group is compared to control group (ref). Bootstrapping used for standard error |
| Superiority |
| Linear regression of follow-up score for personal accomplishment subscale of Maslach Burnout Inventory, controlling for site and baseline score. | Regression, Linear | 0.28 | Slope | -1.64 | Standard Error of the Mean | 1.34 | 2-Sided | 95 | -4.61 | 1.34 | Tool group compared to control group (ref). Bootstrapping used for standard error. | Superiority |
| Missing |
|
| Missing |
|
| At 7 months |
|
| Comparison at 7 months post-enrollment | Regression, Logistic | We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen. | 0.71 | P-value calculated in multiply imputed dataset. | Odds Ratio (OR) | 1.07 | 2-Sided | 95 | 0.75 | 1.53 | The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator. | Superiority |
| Missing |
|
| At 7 months post-enrollment |
|
| Comparison at 7 months post-enrollment | Regression, Logistic | We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen. | 0.37 | P-value calculated in multiply imputed dataset | Odds Ratio (OR) | 1.17 | 2-Sided | 95 | 0.83 | 1.64 | The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator. | Superiority |
| Missing |
|
| At 7 months post-enrollment |
|
| Comparison at 7 months post-enrollment | Regression, Logistic | We ran a mixed effect regression model in a multiply imputed dataset, using fixed effects for study site and random effects for provider seen. | 0.11 | P-value calculated in multiply imputed dataset | Odds Ratio (OR) | 1.83 | 2-Sided | 95 | 0.88 | 3.80 | The odds ratio represents the odds of the intervention group in the numerator over the odds of the control group in the denominator. | Superiority |