NCT02078713

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. 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. 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. 3.The contraceptive decision support tool will decrease decision conflict, compared to usual care.
  4. 4.The contraceptive decision support tool will increase patient satisfaction with the clinic visit and with their method, compared to usual care.
  5. 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. 6.The contraceptive decision support tool will increase shared patient-provider decision making in contraceptive counseling visits, compared to usual care.
  7. 7.The contraceptive decision support tool will decrease provider frustration when providing contraceptive counseling and increase provider job satisfaction.
  8. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
786

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2014

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 5, 2014

Completed
7 months until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

November 19, 2018

Completed
Last Updated

November 19, 2018

Status Verified

April 1, 2018

Enrollment Period

2 years

First QC Date

February 25, 2014

Results QC Date

July 7, 2017

Last Update Submit

April 30, 2018

Conditions

ContraceptionContraceptive Behavior

Keywords

contraceptionpatient decision supportpatient decision aidshared decision makingDecision Making, SharedPatient-Centered Outcomes Research

Outcome Measures

Primary Outcomes (1)

  • Contraceptive Continuation

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

    4 and 7 months post-enrollment

Secondary Outcomes (18)

  • Patient Contraceptive Counseling Satisfaction

    Baseline, post-visit survey

  • Patient Satisfaction With Information Received About Side Effects During Counseling

    Baseline (post-visit survey)

  • Overall Satisfaction With Visit

    Baseline (post-visit survey)

  • Shared Decision Making - Feelings About Provider Involvement

    Baseline (post-visit) and up to 24 months

  • Shared Decision Making - Provider Appropriately Expressed Preference

    Baseline (post-visit survey)

  • +13 more secondary outcomes

Other Outcomes (4)

  • Choice of a Highly Effective Method of Contraception at Baseline

    Baseline (post-visit survey)

  • Use of a Highly Effective Method of Contraception at 4 and 7 Months Follow-up.

    4 and 7 months post-enrollment

  • Use of Any Moderately or Highly Effective Method of Contraception at 4 and 7 Months Follow-up

    4 and 7 months post-enrollment

  • +1 more other outcomes

Study Arms (2)

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.

Behavioral: Contraceptive Decision Support Tool

Usual Care (Control)

NO INTERVENTION

Patients in this arm will receive usual family planning care.

Interventions

Contraceptive Decision Support ToolBEHAVIORAL

The decision support tool: * Provides an educational session about different aspects of contraception * Elicits patient preferences about different aspects of contraception * Identifies potential contraindications to certain contraceptive methods * Allows the patient to view details about and compare available contraceptive methods * Suggests methods most appropriate based on the patient's preferences * Collects questions the patient may have for her provider * Generates a printout the patient can bring to her contraceptive counseling visit

Contraceptive Decision Support Tool

Eligibility Criteria

Age15 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

San Francisco City Clinic

San Francisco, California, 94103, United States

Location

Planned Parenthood San Francisco Health Center

San Francisco, California, 94110, United States

Location

San Francisco General Hospital Family Planning Clinic

San Francisco, California, 94110, United States

Location

City College of San Francisco Student Health Services

San Francisco, California, 94112, United States

Location

Related Publications (2)

  • 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.

    PMID: 31537316DERIVED

  • 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.

    PMID: 30763545DERIVED

MeSH Terms

Conditions

Contraception Behavior

Condition Hierarchy (Ancestors)

Reproductive BehaviorBehavior

Limitations and Caveats

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.

Results Point of Contact

Title
Dr. Christine Dehlendorf, Principal Investigator
Organization
University of California, San Francisco
christine.dehlendorf.@ucsf.edu
415-206-8712

Study Officials

  • Christine Dehlendorf, MD, MAS

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2014

First Posted

March 5, 2014

Study Start

October 1, 2014

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

November 19, 2018

Results First Posted

November 19, 2018

Record last verified: 2018-04

Locations

US(4)