Substance Use DisordersEMERALDNCT04627805
Evaluating MyPath to Enhance Reproductive Autonomy and Liberate Decision-making
A study testing MyPath tool in people with Substance Use Disorders and Reproductive Issues, run by University of Pittsburgh at 1 site in United States.
Trial summary
This is a pilot study to evaluate the acceptability and feasibility of incorporating a patient-facing reproductive decision support tool, MyPath, into existing clinical pathways in a SUD treatment program. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Substance Use Disorders, Reproductive Issues, Contraception
- What is being tested?
- MyPath tool
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Nov 2020to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female
- Aged 18-45 years
- Enrolled in a substance use treatment program
- English-speaking
- Interested in discussing their reproductive health with their substance use provider
- Willing and able to participate in a virtual study using video and/or phone
Who cannot join
- Currently pregnant
- History of female sterilization, hysterectomy, bilateral oophorectomy, or monogamous with a partner with vasectomy
- Previously enrolled in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Family Planning Research
Pittsburgh, Pennsylvania, 15201
About this study
Official title: Reproductive Decision Support Tool for Women With Substance Use Disorders: A Pilot Study
This is a pilot study to evaluate the acceptability and feasibility of incorporating a patient-facing reproductive decision support tool, MyPath, into existing clinical pathways in a SUD treatment program. This study will be conducted virtually in partnership with a single substance use treatment program within the University of Pittsburgh Medical Center (UPMC).
Aim 1: Assess the feasibility and acceptability of incorporating a patient-facing reproductive decision support tool (MyPath) into existing clinical pathways in a substance use treatment program.
Read more
Aim 2: Assess preliminary efficacy of MyPath on reproductive health knowledge, self-efficacy, and decisional conflict as compared to usual care, as well comparisons between receipt of reproductive health services during the usual care period versus after implementing the intervention.
The investigators hypothesize that the MyPath tool is acceptable and feasible for participants and their providers within a SUD treatment program. They also anticipate that preliminary efficacy data will show a positive correlation between the MyPath intervention and receipt of reproductive services, as well as increased knowledge and self-efficacy with decreased decision conflict. This pilot study will lay the groundwork for future larger trials in order to measure efficacy of this tool in substance use treatment settings.
Read the detailed description
The study will be completed in four phases.
Phase 1 (Preparation): First, a sample of women with SUDs (n=5) will be recruited through a separate MAT program in the UPMC system to pre-test the surveys for patient participants to ensure clarity and understandability of these assessments. A sample of substance use treatment providers (n=3) will also be recruited to pre-test the surveys for provider participants. To ensure that participants who want contraceptive services can receive them, the investigators will create a referral pathway that can be used to link participants interested in receiving reproductive health services to an appropriate provider. Through the electronic medical record system of UPMC, providers at NATP will be able to place referrals for reproductive health services for interested participants. Additionally, given the recent increase in use of telemedicine during the COVID-19 pandemic, participants will have the option of attending a telemedicine video visit with a family planning provider through UPMC Magee-Womens Hospital's Family Planning clinic. These various options will allow participants to choose the route that is easiest for them and therefore will further decrease barriers to care.
Phase 2 (Usual Care): Thirty three women with SUDs will be recruited from the NATP to evaluate baseline family planning discussions and referrals to women's health providers in SUD treatment settings. To establish usual care practice patterns, MyPath will not be administered to this group of participants. Participants will first complete a pre-visit survey. This will include demographics, substance use history, and current reproductive health goals, as well as questions about knowledge, self-efficacy, and decision conflict. The participants will then attend their scheduled visit with the substance use treatment provider, whether virtual or in-person. Following the provider visit, they will complete the post-visit survey, which will include the same knowledge, efficacy, and decision conflict survey questions as the pre-visit survey. Occurrence of reproductive health discussions, prescriptions or referrals, and satisfaction with reproductive health services will be measured following the visit as well. All surveys will be administered online through REDCap. Patient participants will be compensated for their time with a gift card after they complete the post-visit survey.
Phase 3 (MyPath Pilot): Following completion of the usual care arm, a second group of 33 women with SUDs will be recruited from the NATP to participate in the MyPath intervention arm. Participants will complete the same pre-visit survey as the usual care group. In addition, they will be provided a website link to navigate through the online MyPath tool. Following completion of MyPath, participants will receive a summary page (see Appendix A for a sample summary) that they will be encouraged to share with their substance use treatment provider at their next scheduled visit, whether virtual or in-person. After the visit, they will complete the post-visit survey. In addition to satisfaction with reproductive health services, the intervention group will be asked specific questions about their perception of the MyPath tool. All surveys will be administered online through REDCap. Patient participants will be compensated for their time with a gift card after they complete the post-visit survey.
Phase 4 (Provider Assessment): Following study completion for patient participants, provider participants will be asked to complete an exit survey to assess feasibility of incorporating MyPath into their clinical work flow and their comfort with reproductive counseling and referring. This will be an anonymous survey administered online and will be sent to all providers identified as engaging with at least one patient participant during the MyPath intervention.
Phase 5 (Follow-up): Three months following study completion, a chart review will be performed for each patient participant through UPMC's electronic medical record. This will allow for the collection of information for completion of placed referrals and receipt of desired reproductive services.
- Conditions
- Substance Use Disorders, Reproductive Issues, Contraception
- Being tested
- MyPath tool
- Keywords
- Reproductive decisions, Pregnancy planning, Contraceptive counseling
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyPath toolBehavioural
MyPath is a reproductive decision support tool that utilizes a patient-centered approach to help women frame their reproductive decisions in the context of their goals, preferences, and health needs. This tool was developed by Dr. Lisa Callegari with funding from the Veterans Administration (VA) Health Services Research \& Development to be used in primary care settings with women veterans. It is conceptually grounded in Self-Determination Theory, which postulates that health care that meets patients' psychological needs in three key domains - autonomy, competence, and relatedness - will result in improved health behaviors and health outcomes. This is particularly relevant in reproductive health care, given the highly individualized and personal nature of these decisions, and the importance of centering a woman's aspirations and goals in her health care decision making.
| Study group | Role | What they receive |
|---|---|---|
| Phase 2: Usual Care | No intervention | The investigators will enroll 33 women with SUDs to evaluate baseline family planning discussions and referrals to women's health providers in SUD treatment settings. To establish usual care practice patterns, MyPath will not be administered to this group of participants. Participants will be asked to complete a pre-visit survey, including substance use history and current reproductive health goals, as well as questions about reproductive health knowledge, self-efficacy, and decision conflict. The participants will then attend their scheduled therapy visit with the substance use treatment provider. Following the therapy visit, they will complete the post-visit survey, which will include the same knowledge, efficacy, and decision conflict survey questions as the pre-visit survey. Occurrence of reproductive health discussions, prescriptions or referrals, and satisfaction with reproductive health services will be measured following the visit as well. |
| Phase 3: MyPath Pilot | Experimental | Following completion of the usual care arm, the investogators will enroll a second group of 33 women with SUDs to participate in the MyPath intervention arm. Participants will complete the same pre-visit survey as the usual care group. In addition, they will be provided a website link to navigate through the online MyPath tool. Following completion of MyPath, participants will receive a summary page that they will be encouraged to use as a guide when discussing their reproductive health with their substance use treatment provider at their next scheduled therapy visit. After the visit, they will complete the post-visit survey. In addition to satisfaction with reproductive health services, the intervention group will be asked specific questions about their perception of the MyPath tool. Receives: Behavioral: MyPath tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants reporting satisfaction with reproductive discussions assessed by 5-point Likert scale
Number of participants that report they are somewhat satisfied or very satisfied with reproductive discussions as assessed on a Likert scale from 1 (very dissatisfied) to 5 (very satisfied)
Measured: Approximately 2 weeks
Number of providers reporting comfort with reproductive discussions assessed by 5-point Likert scale
Number of providers that report they are comfortable or very comfortable with reproductive discussions as assessed on a Likert scale from 1 (very uncomfortable) to 5 (very comfortable)
Measured: Approximately one month
Number of participants reporting satisfaction with MyPath assessed by 5-point Likert scale
Number of participants that report they agree or strongly agree with satisfaction statements about MyPath as assessed on a Likert scale from 1 (strongly disagree) to 5 (strongly agree)
Measured: Approximately 2 weeks
Number of providers reporting satisfaction with MyPath assessed by 5-point Likert scale
Number of providers that report they agree or strongly agree with satisfaction statements about MyPath as assessed on a Likert scale from 1 (strongly disagree) to 5 (strongly agree)
Measured: Approximately one month
Secondary outcomes (6)
Number of providers reporting ease of incorporating MyPath into clinical workflow assessed by 5-point Likert scale
Likert scale Number of providers that report they agree or strongly agree with ease of incorporation statements about MyPath as assessed on a Likert scale from 1 (strongly disagree) to 5 (strongly agree)
Measured: Approximately one month
Number of participants who complete all study procedures
Number of participants who enroll and complete all study procedures, including enrollment visit, pre- and post-surveys, and MyPath tool
Measured: Approximately six months
Mean change in reproductive health knowledge
Mean change in reproductive health knowledge defined as the difference in the number of correct responses to a set of reproductive health knowledge questions from surveys administered before and after the study visit
Measured: Approximately one month
Mean change in self-efficacy
Mean change in self-efficacy, as assessed on a 5-point Likert scale from 1 (not confident at all) to 5 (very confident) by a set of self-efficacy statements from surveys administered before and after the study visit
Measured: Approximately one month
Mean change in decisional conflict
Mean change in decisional conflict, as assessed on a 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree) by a set of decision statements from surveys administered before and after the study visit
Measured: Approximately one month
Number of participants who received reproductive health services
Number of participants who received reproductive health services as assessed by medical chart review at three month follow-up
Measured: Approximately four months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2020
- Study start20 Nov 2020
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Why it stopped: Recruitment hindered by COVID-19 pandemic, unable to recruit participants virtually
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Substance Use DisordersStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- The investigators will enroll the first 33 participants to the usual care group, to evaluate the baseline occurrence of family planning discussions and referrals. Following the completion of the usual care group, the investigators will then enroll 33 participants to the MyPath intervention. This allocation scheme was chosen so as to not contaminate the baseline group by rolling out the intervention simultaneously. Providers will be recruited at the conclusion of the study to complete an exit survey if they interacted with at least one Phase 3 participant.
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Society of Family Planning
- Responsible party
- Principal investigator, Beatrice Chen, University of Pittsburgh
- Investigators
- Beatrice A Chen, MD MPH, Principal investigator, University of PittsburghSamantha J Deans, MD MPH, Study director, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04627805
- Sponsor's protocol ID
- STUDY20010128
- Acronym
- EMERALD
- Status last verified
- Jul 2022
- First submitted
- 8 Nov 2020
- Last updated
- 14 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Teal S, Haider S, Harris L, Hubacher D, Raine-Bennett T. Scientific abstracts: Featured research at the 2019 Society of Family Planning Annual Meeting. Contraception. 2019 Jul 23:303-304. doi: 10.1016/j.contraception.2019.07.007. Online ahead of print. No abstract available.
PubMed 31472941
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reproductive Decision Support Tool for Women With Substance Use Disorders: A Pilot Study
- ClinicalTrials.gov ID
- NCT04627805
- Acronym / sponsor ID
- EMERALD / STUDY20010128
- Conditions
- Substance Use Disorders, Reproductive Issues, Contraception
- Keywords
- Reproductive decisions, Pregnancy planning, Contraceptive counseling
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment hindered by COVID-19 pandemic, unable to recruit participants virtually
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Society of Family Planning
- Study start
- 20 Nov 2020 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 13 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a pilot study to evaluate the acceptability and feasibility of incorporating a patient-facing reproductive decision support tool, MyPath, into existing clinical pathways in a SUD treatment program. This study will be conducted virtually in partnership with a single substance use treatment program within the University of Pittsburgh Medical Center (UPMC).
Aim 1: Assess the feasibility and acceptability of incorporating a patient-facing reproductive decision support tool (MyPath) into existing clinical pathways in a substance use treatment program.
Aim 2: Assess preliminary efficacy of MyPath on reproductive health knowledge, self-efficacy, and decisional conflict as compared to usual care, as well comparisons between receipt of reproductive health services during the usual care period versus after implementing the intervention.
The investigators hypothesize that the MyPath tool is acceptable and feasible for participants and their providers within a SUD treatment program. They also anticipate that preliminary efficacy data will show a positive correlation between the MyPath intervention and receipt of reproductive services, as well as increased knowledge and self-efficacy with decreased decision conflict. This pilot study will lay the groundwork for future larger trials in order to measure efficacy of this tool in substance use treatment settings.
Detailed description
The study will be completed in four phases.
Phase 1 (Preparation): First, a sample of women with SUDs (n=5) will be recruited through a separate MAT program in the UPMC system to pre-test the surveys for patient participants to ensure clarity and understandability of these assessments. A sample of substance use treatment providers (n=3) will also be recruited to pre-test the surveys for provider participants. To ensure that participants who want contraceptive services can receive them, the investigators will create a referral pathway that can be used to link participants interested in receiving reproductive health services to an appropriate provider. Through the electronic medical record system of UPMC, providers at NATP will be able to place referrals for reproductive health services for interested participants. Additionally, given the recent increase in use of telemedicine during the COVID-19 pandemic, participants will have the option of attending a telemedicine video visit with a family planning provider through UPMC Magee-Womens Hospital's Family Planning clinic. These various options will allow participants to choose the route that is easiest for them and therefore will further decrease barriers to care.
Phase 2 (Usual Care): Thirty three women with SUDs will be recruited from the NATP to evaluate baseline family planning discussions and referrals to women's health providers in SUD treatment settings. To establish usual care practice patterns, MyPath will not be administered to this group of participants. Participants will first complete a pre-visit survey. This will include demographics, substance use history, and current reproductive health goals, as well as questions about knowledge, self-efficacy, and decision conflict. The participants will then attend their scheduled visit with the substance use treatment provider, whether virtual or in-person. Following the provider visit, they will complete the post-visit survey, which will include the same knowledge, efficacy, and decision conflict survey questions as the pre-visit survey. Occurrence of reproductive health discussions, prescriptions or referrals, and satisfaction with reproductive health services will be measured following the visit as well. All surveys will be administered online through REDCap. Patient participants will be compensated for their time with a gift card after they complete the post-visit survey.
Phase 3 (MyPath Pilot): Following completion of the usual care arm, a second group of 33 women with SUDs will be recruited from the NATP to participate in the MyPath intervention arm. Participants will complete the same pre-visit survey as the usual care group. In addition, they will be provided a website link to navigate through the online MyPath tool. Following completion of MyPath, participants will receive a summary page (see Appendix A for a sample summary) that they will be encouraged to share with their substance use treatment provider at their next scheduled visit, whether virtual or in-person. After the visit, they will complete the post-visit survey. In addition to satisfaction with reproductive health services, the intervention group will be asked specific questions about their perception of the MyPath tool. All surveys will be administered online through REDCap. Patient participants will be compensated for their time with a gift card after they complete the post-visit survey.
Phase 4 (Provider Assessment): Following study completion for patient participants, provider participants will be asked to complete an exit survey to assess feasibility of incorporating MyPath into their clinical work flow and their comfort with reproductive counseling and referring. This will be an anonymous survey administered online and will be sent to all providers identified as engaging with at least one patient participant during the MyPath intervention.
Phase 5 (Follow-up): Three months following study completion, a chart review will be performed for each patient participant through UPMC's electronic medical record. This will allow for the collection of information for completion of placed referrals and receipt of desired reproductive services.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The investigators will enroll the first 33 participants to the usual care group, to evaluate the baseline occurrence of family planning discussions and referrals. Following the completion of the usual care group, the investigators will then enroll 33 participants to the MyPath intervention. This allocation scheme was chosen so as to not contaminate the baseline group by rolling out the intervention simultaneously. Providers will be recruited at the conclusion of the study to complete an exit survey if they interacted with at least one Phase 3 participant.
| Arm | Type | Receives |
|---|---|---|
| Phase 2: Usual Care | No intervention | –The investigators will enroll 33 women with SUDs to evaluate baseline family planning discussions and referrals to women's health providers in SUD treatment settings. To establish usual care practice patterns, MyPath will not be administered to this group of participants. Participants will be asked to complete a pre-visit survey, including substance use history and current reproductive health goals, as well as questions about reproductive health knowledge, self-efficacy, and decision conflict. The participants will then attend their scheduled therapy visit with the substance use treatment provider. Following the therapy visit, they will complete the post-visit survey, which will include the same knowledge, efficacy, and decision conflict survey questions as the pre-visit survey. Occurrence of reproductive health discussions, prescriptions or referrals, and satisfaction with reproductive health services will be measured following the visit as well. |
| Phase 3: MyPath Pilot | Experimental | Behavioral: MyPath toolFollowing completion of the usual care arm, the investogators will enroll a second group of 33 women with SUDs to participate in the MyPath intervention arm. Participants will complete the same pre-visit survey as the usual care group. In addition, they will be provided a website link to navigate through the online MyPath tool. Following completion of MyPath, participants will receive a summary page that they will be encouraged to use as a guide when discussing their reproductive health with their substance use treatment provider at their next scheduled therapy visit. After the visit, they will complete the post-visit survey. In addition to satisfaction with reproductive health services, the intervention group will be asked specific questions about their perception of the MyPath tool. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Female
- Aged 18-45 years
- Enrolled in a substance use treatment program
- English-speaking
- Interested in discussing their reproductive health with their substance use provider
Key exclusion criteria (3 listed)
- Currently pregnant
- History of female sterilization, hysterectomy, bilateral oophorectomy, or monogamous with a partner with vasectomy
- Previously enrolled in the study
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 |
|---|---|---|
| MyPath toolMyPath is a reproductive decision support tool that utilizes a patient-centered approach to help women frame their reproductive decisions in the context of their goals, preferences, and health needs. This tool was developed by Dr. Lisa Callegari with funding from the Veterans Administration (VA) Health Services Research \& Development to be used in primary care settings with women veterans. It is conceptually grounded in Self-Determination Theory, which postulates that health care that meets patients' psychological needs in three key domains - autonomy, competence, and relatedness - will result in improved health behaviors and health outcomes. This is particularly relevant in reproductive health care, given the highly individualized and personal nature of these decisions, and the importance of centering a woman's aspirations and goals in her health care decision making. | Behavioural | Phase 3: MyPath Pilot |
Primary outcome
Number of participants reporting satisfaction with reproductive discussions assessed by 5-point Likert scale
Time frame: Approximately 2 weeks
Number of participants that report they are somewhat satisfied or very satisfied with reproductive discussions as assessed on a Likert scale from 1 (very dissatisfied) to 5 (very satisfied)
Number of providers reporting comfort with reproductive discussions assessed by 5-point Likert scale
Time frame: Approximately one month
Number of providers that report they are comfortable or very comfortable with reproductive discussions as assessed on a Likert scale from 1 (very uncomfortable) to 5 (very comfortable)
Number of participants reporting satisfaction with MyPath assessed by 5-point Likert scale
Time frame: Approximately 2 weeks
Number of participants that report they agree or strongly agree with satisfaction statements about MyPath as assessed on a Likert scale from 1 (strongly disagree) to 5 (strongly agree)
Number of providers reporting satisfaction with MyPath assessed by 5-point Likert scale
Time frame: Approximately one month
Number of providers that report they agree or strongly agree with satisfaction statements about MyPath as assessed on a Likert scale from 1 (strongly disagree) to 5 (strongly agree)
6 secondary outcomes
Number of providers reporting ease of incorporating MyPath into clinical workflow assessed by 5-point Likert scale
Time frame: Approximately one month
Number of participants who complete all study procedures
Time frame: Approximately six months
Mean change in reproductive health knowledge
Time frame: Approximately one month
Mean change in self-efficacy
Time frame: Approximately one month
Mean change in decisional conflict
Time frame: Approximately one month
Number of participants who received reproductive health services
Time frame: Approximately four months
Results and safety
The study was stopped early (reason given: Recruitment hindered by COVID-19 pandemic, unable to recruit participants virtually). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2022.
- Background: PubMed 31472941Teal S, Haider S, Harris L, Hubacher D, Raine-Bennett T. Scientific abstracts: Featured research at the 2019 Society of Family Planning Annual Meeting. Contraception. 2019 Jul 23:303-304. doi: 10.1016/j.contraception.2019.07.007. Online ahead of print. No abstract available.
- MyPath web-based decision support toolLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Beatrice A Chen, MD MPH principal investigator
University of Pittsburgh
Samantha J Deans, MD MPH study director
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MyPath tool in people with Substance Use Disorders and Reproductive Issues, run by University of Pittsburgh at 1 site 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 6 inclusion and 3 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: stopped early, as of the sponsor's last update on 14 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study was stopped early (reason given: Recruitment hindered by COVID-19 pandemic, unable to recruit participants virtually). Results are not available in the source record.
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?
Number of participants reporting satisfaction with reproductive discussions assessed by 5-point Likert scale (time frame: Approximately 2 weeks). The study lists 4 primary outcomes in all. 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 NCT04627805, which also lists 1 linked publication.
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 14 Jul 2022.