N/A
N=786
Patient-Centered Support for Contraceptive Decision-Making
Contraception · Contraceptive Behavior
Bottom Line
View on ClinicalTrials.gov: NCT02078713 ↗Enrolled (actual)
786
Serious AEs
0.0%
Results posted
Nov 2018
Primary outcome: Primary: Contraceptive Continuation — 201; 174; 154; 118 Participants — p=0.46
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Contraceptive Decision Support Tool (Behavioral)
- Age
- Pediatric, Adult · 15+ yrs
- Sex
- Female
- Sponsor
- University of California, San Francisco
- Primary completion
- Oct 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Contraceptive Continuation |
201; 174; 154; 118; 49; 53 | 0.46 |
| SECONDARY Patient Contraceptive Counseling Satisfaction |
261; 194; 133; 143; 10; 8 | 0.03 sig |
| SECONDARY Patient Satisfaction With Information Received About Side Effects During Counseling |
325; 253; 64; 81; 15; 11 | 0.01 sig |
| SECONDARY Overall Satisfaction With Visit |
338; 282; 56; 54; 10; 9 | 0.62 |
| SECONDARY Shared Decision Making - Feelings About Provider Involvement |
370; 305; 8; 10; 16; 21 | 0.85 |
| SECONDARY Shared Decision Making - Provider Appropriately Expressed Preference |
16; 13; 357; 297; 21; 26 | 0.997 |
| SECONDARY Shared Decision Making - Satisfaction With How Provider Helped With Choice |
303; 240; 91; 96; 10; 9 | 0.13 |
| SECONDARY Shared Decision Making - Who Made the Decision? |
286; 244; 20; 9; 88; 83 | 0.50 |
| SECONDARY Shared Decision Making - Provider Preference |
194; 143; 200; 193; 10; 9 | 0.12 |
| SECONDARY Patient Decisional Conflict in Contraceptive Choice |
100; 76; 294; 260; 10; 9 | 0.41 |
| SECONDARY Patient Knowledge of Contraceptive Options and Features |
220; 170; 174; 166; 10; 9 | 0.12 |
| SECONDARY Patient Chosen Contraceptive Method Satisfaction |
249; 199; 145; 137; 10; 9 | 0.25 |
| SECONDARY Patient Current Contraceptive Method Satisfaction |
209; 177; 147; 113; 48; 55 | 0.55 |
| SECONDARY Patient Attitude Towards Use of Contraceptive Options |
6.26; 6.55; 5.22; 5.4; 5.07; 5.49 | 0.13 |
| SECONDARY Newly Heard About Methods During Visit |
79; 46; 21; 18; 304; 281 | 0.27 |
| SECONDARY Patient Rating of Visit as "Much Better" Than Previous Family Planning Visit |
142; 104; 144; 140; 118; 101 | 0.18 |
| SECONDARY Total Clinic Visit Time |
98.40; 86.94 | <0.001 sig |
| SECONDARY Time Spent With Contraceptive Counseling Provider |
44.0; 44.4 | 0.63 |
| SECONDARY Maslach Burnout Inventory |
-2.27; 1.07; -0.87; 0.46; -0.80; 2.38 | 0.24 |
Summary
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:
1. Women who use the contraceptive decision support tool will be more likely to continue using their chosen method at 4 and 7 months follow-up, compared to women who receive usual care.
2. The contraceptive decision support tool will increase women's knowledge, choice of, and use of highly effective reversible contraception, compared to usual care.
3. The contraceptive decision support tool will decrease decision conflict, compared to usual care.
4. The contraceptive decision support tool will increase patient satisfaction with the clinic visit and with their method, compared to usual care.
5. Women who use the contraceptive decision support tool will have fewer unintended pregnancies during the follow-up period, compared to women who received usual care.
6. The contraceptive decision support tool will increase shared patient-provider decision making in contraceptive counseling visits, compared to usual care.
7. The contraceptive decision support tool will decrease provider frustration when providing contraceptive counseling and increase provider job satisfaction.
8. Women using the tool will be more likely to report use of any moderately or highly effective method of contraception at 4 and 7 months follow-up, compared to women not using the tool.
Eligibility Criteria
Inclusion Criteria
Patients
- Women of reproductive age (15-45)
- Wish to discuss starting or changing a contraceptive method during their visit
- Speak, read, and understand English or Spanish (Note: for the pre- and post-intervention audio recording phases, only patients who can speak, read, and understand English easily will be enrolled.)
- History of sexual activity with men
Providers
- Provide contraceptive counseling in one of the participating clinics
- Plan to remain in job role for at least six months
Clinic staff
- Work at one of the participating clinics
- Had a job that included patient contact, but did not solely consist of family planning counseling at the time of the implementation of the intervention
Exclusion Criteria
Patients
- Previously enrolled in the study
- Previously used the decision support tool at the Women's Community Clinic in San Francisco
- Are unable to get pregnant
- Appointment reason is for insertion of IUD or contraceptive implant
- Currently pregnant
- Desire pregnancy currently or in the next seven months (Note: The last criterion is designed to ensure we will have limited numbers of women that will discontinue their contraceptive methods during the study due to planning a pregnancy.)
Data sourced from ClinicalTrials.gov (NCT02078713). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.