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Patient-Centered Support for Contraceptive Decision-Making

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02078713
Recruitment Status : Completed
First Posted : March 5, 2014
Results First Posted : November 19, 2018
Last Update Posted : November 19, 2018
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
University of California, San Francisco

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.

Condition or disease Intervention/treatment Phase
Contraception Contraceptive Behavior Behavioral: Contraceptive Decision Support Tool Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 786 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Patient-Centered Support for Contraceptive Decision-Making: A Cluster Randomized Controlled Trial of a Contraceptive Decision Support Tool
Study Start Date : October 2014
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control

Arm Intervention/treatment
Experimental: Contraceptive Decision Support Tool
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

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

No Intervention: Usual Care (Control)
Patients in this arm will receive usual family planning care.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Patient Contraceptive Counseling Satisfaction [ Time Frame: Baseline, post-visit survey ]
    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.

  2. Patient Satisfaction With Information Received About Side Effects During Counseling [ Time Frame: Baseline (post-visit survey) ]
    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.

  3. Overall Satisfaction With Visit [ Time Frame: Baseline (post-visit survey) ]
    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.

  4. Shared Decision Making - Feelings About Provider Involvement [ Time Frame: Baseline (post-visit) and up to 24 months ]
    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.

  5. Shared Decision Making - Provider Appropriately Expressed Preference [ Time Frame: Baseline (post-visit survey) ]
    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.

  6. Shared Decision Making - Satisfaction With How Provider Helped With Choice [ Time Frame: Baseline (post-visit survey) ]
    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.

  7. Shared Decision Making - Who Made the Decision? [ Time Frame: Baseline (post-visit) ]
    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.

  8. Shared Decision Making - Provider Preference [ Time Frame: Baseline (post-visit survey) ]
    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.

  9. Patient Decisional Conflict in Contraceptive Choice [ Time Frame: Baseline (post-visit) ]
    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).

  10. Patient Knowledge of Contraceptive Options and Features [ Time Frame: Baseline (post-visit) ]
    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.

  11. Patient Chosen Contraceptive Method Satisfaction [ Time Frame: Reported and analyzed at baseline (post-visit), 4 months and 7 months follow-up ]
    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.

  12. Patient Current Contraceptive Method Satisfaction [ Time Frame: 7 months follow-up ]
    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.

  13. Patient Attitude Towards Use of Contraceptive Options [ Time Frame: Baseline (post-visit survey) ]
    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.

  14. Newly Heard About Methods During Visit [ Time Frame: Baseline (pre- and post-survey) ]
    Percentage of patients who reported having heard about a method in the post-survey, but not the pre-survey.

  15. Patient Rating of Visit as "Much Better" Than Previous Family Planning Visit [ Time Frame: Baseline (post-visit 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.

  16. Total Clinic Visit Time [ Time Frame: Baseline visit ]
    Total amount of time a patient spends in a clinic for a family planning visit, from check-in to check-out.

  17. Time Spent With Contraceptive Counseling Provider [ Time Frame: Baseline visit ]
    Total amount of time spent with the provider that is providing contraceptive counseling.

  18. 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). ]
    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).


Other Outcome Measures:
  1. Choice of a Highly Effective Method of Contraception at Baseline [ Time Frame: Baseline (post-visit survey) ]
    Patient report of whether or not patient chose highly effective method at baseline. Highly effective methods include implants, IUDs, and male and female sterilization.

  2. Use of a Highly Effective Method of Contraception at 4 and 7 Months Follow-up. [ Time Frame: 4 and 7 months post-enrollment ]
    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.

  3. Use of Any Moderately or Highly Effective Method of Contraception at 4 and 7 Months Follow-up [ Time Frame: 4 and 7 months post-enrollment ]
    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%.

  4. Unplanned Pregnancy [ Time Frame: 4 months and 7 months from enrollment ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   15 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02078713


Locations
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United States, California
San Francisco City Clinic
San Francisco, California, United States, 94103
Planned Parenthood San Francisco Health Center
San Francisco, California, United States, 94110
San Francisco General Hospital Family Planning Clinic
San Francisco, California, United States, 94110
City College of San Francisco Student Health Services
San Francisco, California, United States, 94112
Sponsors and Collaborators
University of California, San Francisco
Patient-Centered Outcomes Research Institute
Investigators
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Principal Investigator: Christine Dehlendorf, MD, MAS University of California, San Francisco
  Study Documents (Full-Text)

Documents provided by University of California, San Francisco:
Study Protocol  [PDF] November 22, 2016
Statistical Analysis Plan  [PDF] November 22, 2016

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02078713    
Other Study ID Numbers: CE-1304-6874
First Posted: March 5, 2014    Key Record Dates
Results First Posted: November 19, 2018
Last Update Posted: November 19, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by University of California, San Francisco:
contraception
patient decision support
patient decision aid
shared decision making
Decision Making, Shared
Patient-Centered Outcomes Research
Additional relevant MeSH terms:
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Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs