Sickle Cell AnemiaENGAGE-HUNCT03442114
Shared-Decision Making for Hydroxyurea
A study testing Hydroxyurea SDM Toolkit and Clinician Pocket Guide in people with Sickle Cell Anemia and Children, Only, run by Children's Hospital Medical Center, Cincinnati at 11 sites in United States.
Trial summary
The goal of the study is to understand how best to help parents of young children with sickle cell disease and their clinicians have a shared discussion about hydroxyurea (one that takes into account medical evidence and parent values and preferences). Read more about this study
- Who is it for?
- Ages 1 month to 5 years
- Conditions the study is for
- Sickle Cell Anemia, Children, Only
- What is being tested?
- Hydroxyurea SDM Toolkit and Clinician Pocket Guide
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 11 sitesUnited States
- Study dates
- 12 Jul 2018to 28 Feb 2022
- 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 1 month to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis: sickle cell disease
- Age: birth-5 years, inclusive
- Eligible for hydroxyurea (genotype SS, Sβ0Thal or other genotype + clinical complications)
- Child's parent, legal guardian, or designated decision maker (caregiver) must participate in both study visits
- Child's parent, legal guardian, or designated decision maker (caregiver) must able to read, understand, and speak English
Who cannot join
- Parent/legal guardian has previously been approached OR made a decision about whether to initiate hydroxyurea.
- Any and all other diagnoses or conditions which, in the opinion of the site investigator or hematologist, would prevent the patient from being a suitable candidate for the study.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Boston Children's Hospital
Boston, Massachusetts, 02118
Ann & Robert H Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
Nationwide Children's Hospital
Columbus, Ohio, 43205
Baylor College of Medicine
Houston, Texas, 77030
Indiana Hemophilia & Thrombosis Center
Indianapolis, Indiana, 46260
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
UCSF Beinoff Children's Hospital and Research Center at Oakland
Oakland, California, 94609
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
The Washington University
St Louis, Missouri, 63110
Howard University
Washington D.C., District of Columbia, 20060
Nemours Children's Health
Wilmington, Delaware, 19803
About this study
Official title: Engaging Parents of Children With Sickle Cell Anemia and Their Providers in Shared-Decision Making for Hydroxyurea (ENGAGE HU)
The goal of the study is to understand how best to help parents of young children with sickle cell disease and their clinicians have a shared discussion about hydroxyurea (one that takes into account medical evidence and parent values and preferences). The study will compare two methods to help clinicians facilitate this-a clinician pocket guide and a clinician hydroxyurea shared decision making toolkit-in a group of parents of children ages 0-5 with sickle cell disease. The investigators hope that both methods lead to parents reaching a high-quality, well-informed decision. In addition, the team hopes to demonstrate that parents who experience a shared decision will have lower anxiety and decisional uncertainty. The researchers also expect these parents to be more likely to choose hydroxyurea and that their children will have less pain, fewer hospitalizations, better developmental outcomes, and higher quality of life. The project team hopes to show that the toolkit method is easy for clinicians to use and gives parents the support needed to make an informed decision.
Read the detailed description
Sickle cell disease (SCD) is a genetic blood disorder that places children at risk for serious medical complications, early morbidity and mortality, and high healthcare utilization. In the U.S., SCD primarily affects African-American and Latino children. Hydroxyurea is one of the only disease-modifying treatment for this devastating and life-threatening disease. National Evidence-Based Guidelines recommend the use of a shared decision making approach to offer hydroxyurea to all children with SCD as early as nine months of age. Hydroxyurea uptake remains low because parents lack information about hydroxyurea and have concerns about its safety and potential long-term side effects (e.g. cancer, infertility, birth defects). Clinicians do not have the training or tools to facilitate a shared discussion with parents that provides medical evidence and considers parent preferences and values. The current study compares two methods for disseminating hydroxyurea guidelines and facilitating shared decision-making: the American Society of Hematology's hydroxyurea clinician pocket guide (usual care method) and a clinician hydroxyurea shared decision-making toolkit (H-SDM toolkit). The specific aims of the study are to evaluate the effectiveness of the usual care dissemination method (clinician pocket guide) and the H-SDM clinician toolkit dissemination method on: parent report of decisional uncertainty (primary outcome chosen by parents of children with SCD), parent perception of experiencing shared decision-making, parent knowledge of hydroxyurea, the number of children offered hydroxyurea, hydroxyurea uptake (those with active prescriptions), and child health outcomes (pain, neurocognitive functioning, sickle cell related quality of life and healthcare utilization). Eligible children must be between the ages of 0 and 5 and a candidate for hydroxyurea to participate. The trial will use a stepped-wedge design (clinic is the unit of randomization). The long-term objective of the research team is to improve the quality of care for children with SCD. The investigators propose that suboptimal care for patients with SCD is preventable with the use of multicomponent dissemination methods if developed with key stakeholders and designed to address barriers to high quality care at multiple levels (patient, clinician, healthcare system, and community).
- Conditions
- Sickle Cell Anemia, Children, Only
- Being tested
- Hydroxyurea SDM Toolkit, Clinician Pocket Guide
- Keywords
- shared decision making, parent-provider communication, hydroxyurea, sickle cell disease
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydroxyurea SDM ToolkitBehavioural
Implementation tools and visit decision aids
Clinician Pocket GuideBehavioural
current hydroxyurea protocol and ASH pocket guide
| Study group | Role | What they receive |
|---|---|---|
| Hydroxyurea SDM Toolkit (H-SDM) | Experimental | During the H-SDM toolkit condition, sites will develop methods for identifying Eligible Patients \& Monitoring Progress, have the opportunity to use Implementation Tools, and will use the Visit Decision Aids. The H-SDM toolkit has four visit decision aids to support parents in their decision about hydroxyurea: pre-visit brochure, in-visit issue card, after-visit booklet and video narratives {videos of parents telling their story about how they made a decision about hydroxyurea). Receives: Behavioral: Hydroxyurea SDM Toolkit |
| Clinician Pocket Guide | Active comparator | In this condition, sites will provide current guidelines for offering hydroxyurea and use the American Society of Hematology (ASH) pocket guide as a reference. ASH developed 'The Hydroxyurea and Transfusion Therapy for the Treatment of Sickle Cell Disease' clinician pocket guide based on the National Heart, Lung, and Blood Institute's Evidence Based Management of Sickle Cell Disease: Expert Panel Report, 2014.' Receives: Behavioral: Clinician Pocket Guide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decisional Conflict
Decisional Conflict Scale (DCS) is a 16-item parent-completed survey that measures uncertainty experienced when feeling uninformed about options, unclear about personal values, or unsupported in making a choice. Parents report their level of agreement with each item using a 5 point likert scale (0=strongly agree to 4=strongly disagree). For the total score, items are summed, divided by 16, and multiplied by 25. All subscores consist of 3 items except the Effective Decisions subcore (4 items) that are summed, divided by the number of items (3 or4) and multiplied by 25.
Scores range from 0 (feels extremely certain about best choice) to 100 (feels extremely uncertain about best choice) on the total score and all subscores. Thus, a higher score indicates a high decisional conflict.
Measured: Baseline - after shared discussion with clinician
Dyadic OPTION
Dyadic OPTION describes clinician behaviors to involve a patient/parent in decision-making. A total score is calculated which ranges from 0 (no involvement) to 100 (maximal involvement). Dyadic OPTION scores correlate well with OPTION scale (Melbourne et al., 2011); 1 item "My doctor and I made the decision together"(Légaré et al., 2010). Higher scores indicate that the patient/parent has higher shared decision making competencies.
Measured: Baseline visit - after shared discussion with clinician
Secondary outcomes (5)
Hydroxyurea Offered
1 of 3 responses - completed by the research coordinator based on review of electronic medical record (EMR) data: hydroxyurea was not offered, offered, or previously prescribed.
Measured: From date of randomization until the date of first documented offering or prescription, whichever came first, assessed up to 7 months
Satisfaction With Decision-Making
Eight-item survey adapted from the Satisfaction With Decision scale 41 (4 items) and the Agency for Healthcare Research and Quality's Consumer Assessment of Healthcare Providers and Systems survey related to patient experience of care (4 items). 42 Items are summed to obtain a total score ranging from 0 to 28, with higher scores indicating higher satisfaction.
Measured: Baseline after the shared discussion
Ages & Stages Questionnaire - Gross Motor Subscale
This questionnaire is a reliable, accurate developmental and social-emotional screener for children between birth and 6 years of age, with a Cronbach α = .60 to .85. Scores range from 0 to 60, with higher scores indicating that the child's development is on schedule.
Measured: After discussion with clinician
Pediatric Quality of Life Inventory - Sickle Cell Disease Module (Peds QL - SCD Module) - Total Score
Parent report of sickle cell disease (SCD)-specific quality of life (QOL) and pain, as measured by the Pediatric Quality of Life (PedsQL) SCD Module, which assesses several domains of health-related quality of life (HRQOL), including pain impact, fatigue, pain management, emotions, communication, and treatment adherence. Scores range from 0 to 100, with higher scores indicating higher HRQOL or higher functioning.
Measured: After shared discussion with clinician
Hydroxyurea Knowledge
Eight-item survey developed based on the existing literature, the Ottawa Knowledge User Manual, and parent and clinician stakeholders and used in our pilot work. Items are summed to obtain a total score ranging from 0 to 9, with higher scores indicating more knowledge.
Measured: After shared discussion with clinician
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study start12 Jul 2018
- Primary completion28 Feb 2022
- Study completion28 Feb 2022
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 (3)Papers the sponsor has linked to this study.
- Other trials for Sickle Cell AnemiaStudies of the same condition, open and under way.
- 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
- Stepped Wedge Randomized Clinical Trial
- Masking
- None (open label)
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lori E Crosby, PsyD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03442114
- Sponsor's protocol ID
- CDR_1609_36055
- Acronym
- ENGAGE-HU
- Status last verified
- Jun 2025
- First submitted
- 9 Feb 2018
- Last updated
- 13 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This study will comply with the Patient Centered Outcomes Research Institute (PCORI) Public Access Policy, which ensures that the public has access to the published results of PCORI funded research.
Publications
Williford DN, McTate EA, Hood AM, Reader SK, Hildenbrand AK, Smith-Whitley K, Creary SE, Thompson AA, Hackworth R, Raphael JL, Crosby LE. Psychologists as leaders in equitable science: Applications of antiracism and community participatory strategies in a pediatric behavioral medicine clinical trial. Am Psychol. 2023 Feb-Mar;78(2):107-118. doi: 10.1037/amp0001086.
PubMed 37011163Strong H, Hood AM, Johnson Y, Hackworth R, Reed-Shackelford M, Ramaswamy R, Varughese T, Quinn CT, Crosby LE. Using the consolidated framework for implementation research to identify recruitment barriers and targeted strategies for a shared decision-making randomized clinical trial in pediatric sickle cell disease. Clin Trials. 2023 Jun;20(3):211-222. doi: 10.1177/17407745231154199. Epub 2023 Feb 16.
PubMed 36794731Hood AM, Strong H, Nwankwo C, Johnson Y, Peugh J, Mara CA, Shook LM, Brinkman WB, Real FJ, Klein MD, Hackworth R, Badawy SM, Thompson AA, Raphael JL, Yates AM, Smith-Whitley K, King AA, Calhoun C, Creary SE, Piccone CM, Hildenbrand AK, Reader SK, Neumayr L, Meier ER, Sobota AE, Rana S, Britto M, Saving KL, Treadwell M, Quinn CT, Ware RE, Crosby LE. Engaging Caregivers and Providers of Children With Sickle Cell Anemia in Shared Decision Making for Hydroxyurea: Protocol for a Multicenter Randomized Controlled Trial. JMIR Res Protoc. 2021 May 21;10(5):e27650. doi: 10.2196/27650.
PubMed 34018965
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Engaging Parents of Children With Sickle Cell Anemia and Their Providers in Shared-Decision Making for Hydroxyurea (ENGAGE HU)
- ClinicalTrials.gov ID
- NCT03442114
- Acronym / sponsor ID
- ENGAGE-HU / CDR_1609_36055
- Conditions
- Sickle Cell Anemia, Children, Only
- Keywords
- shared decision making, parent-provider communication, hydroxyurea, sickle cell disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- 12 Jul 2018 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 22 Feb 2018 (actual)
- Results
- Posted 25 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of the study is to understand how best to help parents of young children with sickle cell disease and their clinicians have a shared discussion about hydroxyurea (one that takes into account medical evidence and parent values and preferences). The study will compare two methods to help clinicians facilitate this-a clinician pocket guide and a clinician hydroxyurea shared decision making toolkit-in a group of parents of children ages 0-5 with sickle cell disease. The investigators hope that both methods lead to parents reaching a high-quality, well-informed decision. In addition, the team hopes to demonstrate that parents who experience a shared decision will have lower anxiety and decisional uncertainty. The researchers also expect these parents to be more likely to choose hydroxyurea and that their children will have less pain, fewer hospitalizations, better developmental outcomes, and higher quality of life. The project team hopes to show that the toolkit method is easy for clinicians to use and gives parents the support needed to make an informed decision.
Detailed description
Sickle cell disease (SCD) is a genetic blood disorder that places children at risk for serious medical complications, early morbidity and mortality, and high healthcare utilization. In the U.S., SCD primarily affects African-American and Latino children. Hydroxyurea is one of the only disease-modifying treatment for this devastating and life-threatening disease. National Evidence-Based Guidelines recommend the use of a shared decision making approach to offer hydroxyurea to all children with SCD as early as nine months of age. Hydroxyurea uptake remains low because parents lack information about hydroxyurea and have concerns about its safety and potential long-term side effects (e.g. cancer, infertility, birth defects). Clinicians do not have the training or tools to facilitate a shared discussion with parents that provides medical evidence and considers parent preferences and values. The current study compares two methods for disseminating hydroxyurea guidelines and facilitating shared decision-making: the American Society of Hematology's hydroxyurea clinician pocket guide (usual care method) and a clinician hydroxyurea shared decision-making toolkit (H-SDM toolkit). The specific aims of the study are to evaluate the effectiveness of the usual care dissemination method (clinician pocket guide) and the H-SDM clinician toolkit dissemination method on: parent report of decisional uncertainty (primary outcome chosen by parents of children with SCD), parent perception of experiencing shared decision-making, parent knowledge of hydroxyurea, the number of children offered hydroxyurea, hydroxyurea uptake (those with active prescriptions), and child health outcomes (pain, neurocognitive functioning, sickle cell related quality of life and healthcare utilization). Eligible children must be between the ages of 0 and 5 and a candidate for hydroxyurea to participate. The trial will use a stepped-wedge design (clinic is the unit of randomization). The long-term objective of the research team is to improve the quality of care for children with SCD. The investigators propose that suboptimal care for patients with SCD is preventable with the use of multicomponent dissemination methods if developed with key stakeholders and designed to address barriers to high quality care at multiple levels (patient, clinician, healthcare system, and community).
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Stepped Wedge Randomized Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| Hydroxyurea SDM Toolkit (H-SDM) | Experimental | Behavioral: Hydroxyurea SDM ToolkitDuring the H-SDM toolkit condition, sites will develop methods for identifying Eligible Patients \& Monitoring Progress, have the opportunity to use Implementation Tools, and will use the Visit Decision Aids. The H-SDM toolkit has four visit decision aids to support parents in their decision about hydroxyurea: pre-visit brochure, in-visit issue card, after-visit booklet and video narratives {videos of parents telling their story about how they made a decision about hydroxyurea). |
| Clinician Pocket Guide | Active comparator | Behavioral: Clinician Pocket GuideIn this condition, sites will provide current guidelines for offering hydroxyurea and use the American Society of Hematology (ASH) pocket guide as a reference. ASH developed 'The Hydroxyurea and Transfusion Therapy for the Treatment of Sickle Cell Disease' clinician pocket guide based on the National Heart, Lung, and Blood Institute's Evidence Based Management of Sickle Cell Disease: Expert Panel Report, 2014.' |
Who may qualify
- Ages
- 1 month to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Diagnosis: sickle cell disease
- Age: birth-5 years, inclusive
- Eligible for hydroxyurea (genotype SS, Sβ0Thal or other genotype + clinical complications)
- Child's parent, legal guardian, or designated decision maker (caregiver) must participate in both study visits
- Child's parent, legal guardian, or designated decision maker (caregiver) must able to read, understand, and speak English
Key exclusion criteria (2 listed)
- Parent/legal guardian has previously been approached OR made a decision about whether to initiate hydroxyurea.
- Any and all other diagnoses or conditions which, in the opinion of the site investigator or hematologist, would prevent the patient from being a suitable candidate for 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 |
|---|---|---|
| Hydroxyurea SDM ToolkitImplementation tools and visit decision aids | Behavioural | Hydroxyurea SDM Toolkit (H-SDM) |
| Clinician Pocket Guidecurrent hydroxyurea protocol and ASH pocket guide | Behavioural | Clinician Pocket Guide |
Primary outcome
Decisional Conflict
Time frame: Baseline - after shared discussion with clinician
Decisional Conflict Scale (DCS) is a 16-item parent-completed survey that measures uncertainty experienced when feeling uninformed about options, unclear about personal values, or unsupported in making a choice. Parents report their level of agreement with each item using a 5 point likert scale (0=strongly agree to 4=strongly disagree). For the total score, items are summed, divided by 16, and multiplied by 25. All subscores consist of 3 items except the Effective Decisions subcore (4 items) that are summed, divided by the number of items (3 or4) and multiplied by 25. Scores range from 0 (feels extremely certain about best choice) to 100 (feels extremely uncertain about best choice) on the total score and all subscores. Thus, a higher score indicates a high decisional conflict.
Dyadic OPTION
Time frame: Baseline visit - after shared discussion with clinician
Dyadic OPTION describes clinician behaviors to involve a patient/parent in decision-making. A total score is calculated which ranges from 0 (no involvement) to 100 (maximal involvement). Dyadic OPTION scores correlate well with OPTION scale (Melbourne et al., 2011); 1 item "My doctor and I made the decision together"(Légaré et al., 2010). Higher scores indicate that the patient/parent has higher shared decision making competencies.
5 secondary outcomes
Hydroxyurea Offered
Time frame: From date of randomization until the date of first documented offering or prescription, whichever came first, assessed up to 7 months
Satisfaction With Decision-Making
Time frame: Baseline after the shared discussion
Ages & Stages Questionnaire - Gross Motor Subscale
Time frame: After discussion with clinician
Pediatric Quality of Life Inventory - Sickle Cell Disease Module (Peds QL - SCD Module) - Total Score
Time frame: After shared discussion with clinician
Hydroxyurea Knowledge
Time frame: After shared discussion with clinician
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37011163Williford DN, McTate EA, Hood AM, Reader SK, Hildenbrand AK, Smith-Whitley K, Creary SE, Thompson AA, Hackworth R, Raphael JL, Crosby LE. Psychologists as leaders in equitable science: Applications of antiracism and community participatory strategies in a pediatric behavioral medicine clinical trial. Am Psychol. 2023 Feb-Mar;78(2):107-118. doi: 10.1037/amp0001086.
- Derived from this study: PubMed 36794731Strong H, Hood AM, Johnson Y, Hackworth R, Reed-Shackelford M, Ramaswamy R, Varughese T, Quinn CT, Crosby LE. Using the consolidated framework for implementation research to identify recruitment barriers and targeted strategies for a shared decision-making randomized clinical trial in pediatric sickle cell disease. Clin Trials. 2023 Jun;20(3):211-222. doi: 10.1177/17407745231154199. Epub 2023 Feb 16.
- Derived from this study: PubMed 34018965Hood AM, Strong H, Nwankwo C, Johnson Y, Peugh J, Mara CA, Shook LM, Brinkman WB, Real FJ, Klein MD, Hackworth R, Badawy SM, Thompson AA, Raphael JL, Yates AM, Smith-Whitley K, King AA, Calhoun C, Creary SE, Piccone CM, Hildenbrand AK, Reader SK, Neumayr L, Meier ER, Sobota AE, Rana S, Britto M, Saving KL, Treadwell M, Quinn CT, Ware RE, Crosby LE. Engaging Caregivers and Providers of Children With Sickle Cell Anemia in Shared Decision Making for Hydroxyurea: Protocol for a Multicenter Randomized Controlled Trial. JMIR Res Protoc. 2021 May 21;10(5):e27650. doi: 10.2196/27650.
- Individual participant dataSharing planned: No. This study will comply with the Patient Centered Outcomes Research Institute (PCORI) Public Access Policy, which ensures that the public has access to the published results of PCORI funded research.
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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.
Lori E Crosby, PsyD principal investigator
Children's Hospital Medical Center, Cincinnati
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydroxyurea SDM Toolkit and Clinician Pocket Guide in people with Sickle Cell Anemia and Children, Only, run by Children's Hospital Medical Center, Cincinnati at 11 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 5 inclusion and 2 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 13 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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 25 May 2025). 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?
Decisional Conflict (time frame: Baseline - after shared discussion with clinician). The study lists 2 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 NCT03442114, which also lists 3 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 13 Jun 2025.