ContraceptionNCT02078713
Patient-Centered Support for Contraceptive Decision-Making
A study testing Contraceptive Decision Support Tool in people with Contraception and Contraceptive Behavior, run by University of California, San Francisco at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception, Contraceptive Behavior
- What is being tested?
- Contraceptive Decision Support Tool
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 786 participants
- Where
- 4 sitesUnited States
- Study dates
- Oct 2014to Oct 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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.)
Trial locations and contacts
4 sites in 1 country.
United States4 sites
San Francisco City Clinic
San Francisco, California, 94103
Planned Parenthood San Francisco Health Center
San Francisco, California, 94110
San Francisco General Hospital Family Planning Clinic
San Francisco, California, 94110
City College of San Francisco Student Health Services
San Francisco, California, 94112
About this study
Official title: Patient-Centered Support for Contraceptive Decision-Making: A Cluster Randomized Controlled Trial of a Contraceptive Decision Support Tool
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:
- 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.
- The contraceptive decision support tool will increase women's knowledge, choice of, and use of highly effective reversible contraception, compared to usual care.
- The contraceptive decision support tool will decrease decision conflict, compared to usual care.
- The contraceptive decision support tool will increase patient satisfaction with the clinic visit and with their method, compared to usual care.
- 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.
- The contraceptive decision support tool will increase shared patient-provider decision making in contraceptive counseling visits, compared to usual care.
- The contraceptive decision support tool will decrease provider frustration when providing contraceptive counseling and increase provider job satisfaction.
- 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.
Read the 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.
- Conditions
- Contraception, Contraceptive Behavior
- Being tested
- Contraceptive Decision Support Tool
- Keywords
- contraception, patient decision support, patient decision aid, shared decision making, Decision Making, Shared, Patient-Centered Outcomes Research
- Medical subject headings
- Contraception Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contraceptive Decision Support ToolBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Contraceptive Decision Support Tool |
| Usual Care (Control) | No intervention | Patients in this arm will receive usual family planning care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contraceptive Continuation
Whether or not a participant is still using the contraceptive method she selected at baseline.
Measured: 4 and 7 months post-enrollment
Secondary outcomes (18)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline visit
Time Spent With Contraceptive Counseling Provider
Total amount of time spent with the provider that is providing contraceptive counseling.
Measured: 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).
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2014 (estimated)
- Study startOct 2014
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 786 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
- Investigators
- Christine Dehlendorf, MD, MAS, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02078713
- Sponsor's protocol ID
- CE-1304-6874
- Status last verified
- Apr 2018
- First submitted
- 25 Feb 2014
- Last updated
- 19 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 31537316Dehlendorf 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.
PubMed 30763545
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-Centered Support for Contraceptive Decision-Making: A Cluster Randomized Controlled Trial of a Contraceptive Decision Support Tool
- ClinicalTrials.gov ID
- NCT02078713
- Acronym / sponsor ID
- CE-1304-6874
- Conditions
- Contraception, Contraceptive Behavior
- Keywords
- contraception, patient decision support, patient decision aid, shared decision making, Decision Making, Shared, Patient-Centered Outcomes Research
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 786 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- Oct 2014
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 5 Mar 2014 (estimated)
- Results
- Posted 19 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- The contraceptive decision support tool will increase women's knowledge, choice of, and use of highly effective reversible contraception, compared to usual care.
- The contraceptive decision support tool will decrease decision conflict, compared to usual care.
- The contraceptive decision support tool will increase patient satisfaction with the clinic visit and with their method, compared to usual care.
- 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.
- The contraceptive decision support tool will increase shared patient-provider decision making in contraceptive counseling visits, compared to usual care.
- The contraceptive decision support tool will decrease provider frustration when providing contraceptive counseling and increase provider job satisfaction.
- 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Contraceptive Decision Support Tool | Experimental | Behavioral: Contraceptive Decision Support ToolPatients 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. |
Who may qualify
- Ages
- 15 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Contraceptive Decision Support ToolThe 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 | Behavioural | Contraceptive Decision Support Tool |
Primary outcome
Contraceptive Continuation
Time frame: 4 and 7 months post-enrollment
Whether or not a participant is still using the contraceptive method she selected at baseline.
18 secondary outcomes
Patient Contraceptive Counseling Satisfaction
Time frame: Baseline, post-visit survey
Patient Satisfaction With Information Received About Side Effects During Counseling
Time frame: Baseline (post-visit survey)
Overall Satisfaction With Visit
Time frame: Baseline (post-visit survey)
Shared Decision Making - Feelings About Provider Involvement
Time frame: Baseline (post-visit) and up to 24 months
Shared Decision Making - Provider Appropriately Expressed Preference
Time frame: Baseline (post-visit survey)
Shared Decision Making - Satisfaction With How Provider Helped With Choice
Time frame: Baseline (post-visit survey)
Shared Decision Making - Who Made the Decision?
Time frame: Baseline (post-visit)
Shared Decision Making - Provider Preference
Time frame: Baseline (post-visit survey)
Patient Decisional Conflict in Contraceptive Choice
Time frame: Baseline (post-visit)
Patient Knowledge of Contraceptive Options and Features
Time frame: Baseline (post-visit)
Patient Chosen Contraceptive Method Satisfaction
Time frame: Reported and analyzed at baseline (post-visit), 4 months and 7 months follow-up
Patient Current Contraceptive Method Satisfaction
Time frame: 7 months follow-up
Patient Attitude Towards Use of Contraceptive Options
Time frame: Baseline (post-visit survey)
Newly Heard About Methods During Visit
Time frame: Baseline (pre- and post-survey)
Patient Rating of Visit as "Much Better" Than Previous Family Planning Visit
Time frame: Baseline (post-visit survey)
Total Clinic Visit Time
Time frame: Baseline visit
Time Spent With Contraceptive Counseling Provider
Time frame: Baseline visit
Maslach Burnout Inventory
Time frame: 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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31537316Holt 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.
- Derived from this study: PubMed 30763545Dehlendorf 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine Dehlendorf, MD, MAS principal investigator
University of California, San Francisco
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contraceptive Decision Support Tool in people with Contraception and Contraceptive Behavior, run by University of California, San Francisco at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Contraceptive Continuation (time frame: 4 and 7 months post-enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02078713, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2018.