Trial Outcomes & Findings for Patient-Centered Support for Contraceptive Decision-Making (NCT NCT02078713)

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.

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.

Patients were excluded if they were pregnant at baseline (n=8) or enrolled in the study twice (n=1).

Whether or not a participant is still using the contraceptive method she selected at baseline.

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.

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.

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.

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.

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.

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.

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.

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.

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).

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.

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.

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.

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.

Percentage of patients who reported having heard about a method in the post-survey, but not the pre-survey.

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.

Total amount of time a patient spends in a clinic for a family planning visit, from check-in to check-out.

Total amount of time spent with the provider that is providing contraceptive counseling.

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).

Patient report of whether or not patient chose highly effective method at baseline. Highly effective methods include implants, IUDs, and male and female sterilization.

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.

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%.

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.