Clinical trial NCT02078713: Patient-Centered Support for Contraceptive Decision-Making
Official title: Patient-Centered Support for Contraceptive Decision-Making: A Cluster Randomized Controlled Trial of a Contraceptive Decision Support Tool
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contraception
Contraceptive Behavior
Keywords: contraception
patient decision support
patient decision aid
shared decision making
Decision Making, Shared
Patient-Centered Outcomes Research
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2014-03-05
Enrollment: 786
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Detailed description: 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.

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.)

Primary outcomes:
measure: Contraceptive Continuation
timeFrame: 4 and 7 months post-enrollment
Secondary outcomes:
measure: Patient Contraceptive Counseling Satisfaction
timeFrame: Baseline, post-visit survey
measure: Patient Satisfaction With Information Received About Side Effects During Counseling
timeFrame: Baseline (post-visit survey)
measure: Overall Satisfaction With Visit
timeFrame: Baseline (post-visit survey)
measure: Shared Decision Making - Feelings About Provider Involvement
timeFrame: Baseline (post-visit) and up to 24 months
measure: Shared Decision Making - Provider Appropriately Expressed Preference
timeFrame: Baseline (post-visit survey)
measure: Shared Decision Making - Satisfaction With How Provider Helped With Choice
timeFrame: Baseline (post-visit survey)
measure: Shared Decision Making - Who Made the Decision?
timeFrame: Baseline (post-visit)
measure: Shared Decision Making - Provider Preference
timeFrame: Baseline (post-visit survey)
measure: Patient Decisional Conflict in Contraceptive Choice
timeFrame: Baseline (post-visit)
measure: Patient Knowledge of Contraceptive Options and Features
timeFrame: Baseline (post-visit)
measure: Patient Chosen Contraceptive Method Satisfaction
timeFrame: Reported and analyzed at baseline (post-visit), 4 months and 7 months follow-up
measure: Patient Current Contraceptive Method Satisfaction
timeFrame: 7 months follow-up
measure: Patient Attitude Towards Use of Contraceptive Options
timeFrame: Baseline (post-visit survey)
measure: Newly Heard About Methods During Visit
timeFrame: Baseline (pre- and post-survey)
measure: Patient Rating of Visit as "Much Better" Than Previous Family Planning Visit
timeFrame: Baseline (post-visit survey)
measure: Total Clinic Visit Time
timeFrame: Baseline visit
measure: Time Spent With Contraceptive Counseling Provider
timeFrame: Baseline visit
measure: Maslach Burnout Inventory
timeFrame: 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 outcomes:
measure: Choice of a Highly Effective Method of Contraception at Baseline
timeFrame: Baseline (post-visit survey)
measure: Use of a Highly Effective Method of Contraception at 4 and 7 Months Follow-up.
timeFrame: 4 and 7 months post-enrollment
measure: Use of Any Moderately or Highly Effective Method of Contraception at 4 and 7 Months Follow-up
timeFrame: 4 and 7 months post-enrollment
measure: Unplanned Pregnancy
timeFrame: 4 months and 7 months from enrollment
Locations:
city: San Francisco
country: United States
facility: San Francisco City Clinic
state: California
city: San Francisco
country: United States
facility: Planned Parenthood San Francisco Health Center
state: California
city: San Francisco
country: United States
facility: San Francisco General Hospital Family Planning Clinic
state: California
city: San Francisco
country: United States
facility: City College of San Francisco Student Health Services
state: California
Study officials:
affiliation: University of California, San Francisco
name: Christine Dehlendorf, MD, MAS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.