TransplantsNCT03610555
Creating a Patient-centered Report Card for Solid Organ Transplant Candidates
A study testing Intervention 1 - SRTR (age question 1st), Intervention 2 - SRTR (BMI question 1st) and Intervention 3 - TCST (age question 1st) in people with Transplants, run by Ajay Israni, MD at 1 site in United States.
Trial summary
Choosing a transplant center that will accept a particular candidate can be difficult and challenging for patients with end-stage organ failure. As transplant centers have varying levels of expertise, interests, and outcomes of solid organ transplant, patient health-related characteristics influence the variation in… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Transplants
- What is being tested?
- Intervention 1 - SRTR (age question 1st), Intervention 2 - SRTR (BMI question 1st) and Intervention 3 - TCST (age question 1st)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 268 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2016to 1 Apr 2023
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All adults seeking a kidney transplant are eligible for the RCT. We will focus on recruiting kidney waitlist candidates.
Who cannot join
- are inability to speak or understand English, visual impairment, and inability to give consent. All vulnerable populations except for those listed in the table titled vulnerable populations, will be excluded.
- .
- .
Trial locations and contacts
1 site in 1 country.
About this study
Choosing a transplant center that will accept a particular candidate can be difficult and challenging for patients with end-stage organ failure. As transplant centers have varying levels of expertise, interests, and outcomes of solid organ transplant, patient health-related characteristics influence the variation in candidates centers will accept. Most transplant candidates undergo waitlist work-ups as outpatients and many undergo transplant at centers not closest to their homes. Some are listed at more than one center. Several studies suggest that patients have a choice of centers. The PI, as Deputy Director of the Scientific Registry of Transplant Recipients (SRTR), provides comparative information to the public about each solid organ transplant center in the United States. The risk adjusted outcomes, in the report cards, account for the transplant recipient's health-related characteristics, donor characteristics and transplant related factors. Unfortunately, in their current format, the report cards are not designed for transplant candidates, many of whom may have low health literacy and numeracy.
The proposed work aims to develop and evaluate a patient-centered website and printouts of the SRTR report cards that will effectively communicate comparative information to transplant candidates about their alternatives when choosing transplant centers. We will develop a novel tool to allow candidates to tailor the report cards to their clinical profiles based on their health-related characteristics and to communicate information on alternative transplant centers that perform transplants in patients like them. Aim 1 will use focus groups to determine which transplant center characteristics to present to transplant candidates and how to present these characteristics clearly in a patient centered report card. Using this information, Aim 2 will develop a patient-centered website and printouts of the SRTR report card that effectively communicate comparative information about transplant centers to transplant candidates. Lastly, Aim 3 will conduct a randomized clinical trial to evaluate the effectiveness of the patient centered SRTR report card. We will determine transplant candidates' comprehension and the value of the comparative quality reports, and the effect on clinical decision making and status on the waiting list. After the RCT, a convenience sample of online visitors to the new website will be assessed for similar outcomes.
Read the detailed description
Before the intervention, the study design with use of hypothetical scenarios will be explained to the participant. The concept of randomization will be also be explained. The participants will be asked a few questions to assess their understanding of the study design, specifically the hypothetical nature of the scenarios. We will also assess whether they understand the concept of being randomized to see one website first and then the other. Only those participants that understand the study design will be invited to participate in the intervention and will be randomized. For subjects that are randomized, a survey will be administered verbally to collect demographic information and information about their kidney disease and comorbidities. The functional health literacy and numeracy assessment and health status questionnaire will be completed. Subjects will be stratified by the transplant center site and then block randomized. One group will be shown the existing SRTR website with its existing SRTR report cards and then the website with the new patient-centered AHRQ report cards for kidney transplants. The other group will be shown the two websites in opposite order. Each participant will have at most 30 minutes to view each of the websites. After viewing each website, responses to the intervention will be collected. Sessions where participants are reviewing the websites will be recorded using Zoom. Figure 2 shows the study design whereby subjects will be block randomized once to one of the four groups consisting of 18 subjects each. At the end of the study, the patients will have access to both the websites.
The study interventions can be administered in person on a laptop. During the COVID-19 pandemic, the intervention can be administered remotely via email and zoom. The link to the websites will be sent via encrypted email and the intervention will be recorded via zoom. The recordings for subjects at Hennepin Healthcare will be stored on computers at that site.
If participant does not have your own electronic device or internet, the study will send the participant a study iPad with internet that participant can use for the intervention and then to send back to the study team. We will provide detailed instructions on how to use the iPad and Zoom application. The study will also pay for a FedEx pick up from the participants' home to return the iPad to the study team after the completion of the intervention.
- Conditions
- Transplants
- Being tested
- Intervention 1 - SRTR (age question 1st), Intervention 2 - SRTR (BMI question 1st), Intervention 3 - TCST (age question 1st), Intervention 4 - TCST (BMI question 1st)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention 1 - SRTR (age question 1st)Other
Participants first viewed the SRTR website to answer Question 1 (Which transplant program within a prespecified area had the most recipients over 70 years of age?). Subsequently, participants crossed over to view the TCST website to answer Question 2 (Which program within a prespecified area had the most recipients with BMI >40?)
Intervention 2 - SRTR (BMI question 1st)Other
Participants first viewed the SRTR website to answer Question 2. Subsequently, participants crossed over to view the TCST website to answer Question 1.
Intervention 3 - TCST (age question 1st)Other
Participants first viewed the TCST website to answer Question 1. Subsequently, participants crossed over to view the SRTR website to answer Question 2.
Intervention 4 - TCST (BMI question 1st)Other
Participants first viewed the TCST website to answer Question 2. Subsequently, participants crossed over to view the SRTR website to answer Question 1.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Other | Sequence 1: SRTR then TCST (Question 1 then Question 2) Receives: Other: Intervention 1 - SRTR (age question 1st) |
| Arm 2 | Other | Sequence 2: SRTR then TCST (Question 2 then Question 1) Receives: Other: Intervention 2 - SRTR (BMI question 1st) |
| Arm 3 | Other | Sequence 3: TCST then SRTR (Question 1 then Question 2) Receives: Other: Intervention 3 - TCST (age question 1st) |
| Arm 4 | Other | Sequence 4: TCST then SRTR (Question 2 then Question 1) Receives: Other: Intervention 4 - TCST (BMI question 1st) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Correct Response to Question 1 and 2
The primary outcome is the comprehension of the report card. To assess comprehension, the correct response to the following question will be assessed, "Which transplant program within a prespecified area had the most recipients over 70 years of age; and which programs had the most recipients with BMI >40"
Measured: 30 minutes
Secondary outcomes (2)
Perceived Value of Information
Perceived value of information will be determined via patient responses to the following question, "How useful is the information in the report card in helping you choose a transplant center for you or your family?" Response choices to the questions will be based on a 5-point Likert-type scale (1 = extremely useful to 5 = not useful at all; score 1 indicates the better outcome and score 5 indicates worse outcome).
Measured: 30 minutes
Measurement of Satisfaction With Decision Making
We measured satisfaction with decision-making and decisional conflict using the Ottawa Decisional Conflict Scale (DCS). Participants were asked to answer four items to assess satisfaction with decision making. These four items are: a) summed; b) divided by 4; and c) multiplied by 25. Scores ranges from 0 [great satisfaction] to 100 [lower satisfaction].
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2018
- Study start1 Nov 2016
- Primary completion1 Apr 2023
- Study completion1 Apr 2023
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 (7)Papers the sponsor has linked to this study.
- Other trials for TransplantsStudies 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
- Randomised
- Intervention model
- Crossover
- Model description
- Participants were stratified by transplant center site and block randomized to one of the four groups using permuted block randomization with blocks of size four. * Arm 1: SRTR website first, Question 1 first * Arm 2: SRTR website first, Question 2 first * Arm 3: TCST first, Question 1 first * Arm 4: TCST first, Question 2 first
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 268 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ajay Israni, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ajay Israni, MD, Hennepin Healthcare Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03610555
- Sponsor's protocol ID
- HSR#16-4130
- Status last verified
- Dec 2025
- First submitted
- 15 Jun 2018
- Last updated
- 16 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Israni AK, Schladt D, Bruin MJ, Chu S, Snyder JJ, Hertz M, Valapour M, Kasiske B, McKinney WT, Schaffhausen CR. Deconstructing Silos of Knowledge Around Lung Transplantation to Support Patients: A Patient-specific Search of Scientific Registry of Transplant Recipients Data. Transplantation. 2022 Aug 1;106(8):1517-1519. doi: 10.1097/TP.0000000000004051. Epub 2022 Feb 11. No abstract available.
PubMed 35152256Chu S, Bruin MJ, McKinney WT, Israni AK, Schaffhausen CR. Design of a patient-centered decision support tool when selecting an organ transplant center. PLoS One. 2021 May 17;16(5):e0251102. doi: 10.1371/journal.pone.0251102. eCollection 2021.
PubMed 33999964McKinney WT, Schaffhausen CR, Schladt D, Bruin MJ, Chu S, Snyder JJ, Martin C, Alexy T, Kasiske B, Israni AK. Designing a patient-specific search of transplant program performance and outcomes: Feedback from heart transplant candidates and recipients. Clin Transplant. 2021 Feb;35(2):e14183. doi: 10.1111/ctr.14183. Epub 2020 Dec 19.
PubMed 33617066McKinney WT, Schaffhausen CR, Bruin MJ, Chu S, Schladt D, Matas A, Snyder J, Kasiske B, Israni AK. Development of a Patient-specific Search of Transplant Program Outcomes and Characteristics: Feedback From Kidney Transplant Patients. Transplant Direct. 2020 Jul 17;6(8):e585. doi: 10.1097/TXD.0000000000001036. eCollection 2020 Aug.
PubMed 32766433Schaffhausen CR, Bruin MJ, McKinney WT, Snyder JJ, Matas AJ, Kasiske BL, Israni AK. How patients choose kidney transplant centers: A qualitative study of patient experiences. Clin Transplant. 2019 May;33(5):e13523. doi: 10.1111/ctr.13523. Epub 2019 Apr 21.
PubMed 30861199Schaffhausen CR, Bruin MJ, Chu S, Wey A, McKinney WT, Snyder JJ, Lake JR, Matas AJ, Kasiske BL, Israni AK. Comparing Pretransplant and Posttransplant Outcomes When Choosing a Transplant Center: Focus Groups and a Randomized Survey. Transplantation. 2020 Jan;104(1):201-210. doi: 10.1097/TP.0000000000002809.
PubMed 31283676McKinney WT, Israni K, Schaffhausen CR, Schladt DP, Lyden GR, Matas A, Wolf J, Japuntich S, Israni AK. Randomized Controlled Trial to Evaluate a New Tool to Support Patient Decision-making on Transplant Centers. Clin Transplant. 2024 Dec;38(12):e70043. doi: 10.1111/ctr.70043.
PubMed 39620865
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Creating a Patient-centered Report Card for Solid Organ Transplant Candidates
- ClinicalTrials.gov ID
- NCT03610555
- Acronym / sponsor ID
- HSR#16-4130
- Conditions
- Transplants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 268 participants (actual)
- Lead sponsor
- Ajay Israni, MDUniversity, hospital or other
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 1 Apr 2023 (actual)
- First posted
- 1 Aug 2018 (actual)
- Results
- Posted 16 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Choosing a transplant center that will accept a particular candidate can be difficult and challenging for patients with end-stage organ failure. As transplant centers have varying levels of expertise, interests, and outcomes of solid organ transplant, patient health-related characteristics influence the variation in candidates centers will accept. Most transplant candidates undergo waitlist work-ups as outpatients and many undergo transplant at centers not closest to their homes. Some are listed at more than one center. Several studies suggest that patients have a choice of centers. The PI, as Deputy Director of the Scientific Registry of Transplant Recipients (SRTR), provides comparative information to the public about each solid organ transplant center in the United States. The risk adjusted outcomes, in the report cards, account for the transplant recipient's health-related characteristics, donor characteristics and transplant related factors. Unfortunately, in their current format, the report cards are not designed for transplant candidates, many of whom may have low health literacy and numeracy.
The proposed work aims to develop and evaluate a patient-centered website and printouts of the SRTR report cards that will effectively communicate comparative information to transplant candidates about their alternatives when choosing transplant centers. We will develop a novel tool to allow candidates to tailor the report cards to their clinical profiles based on their health-related characteristics and to communicate information on alternative transplant centers that perform transplants in patients like them. Aim 1 will use focus groups to determine which transplant center characteristics to present to transplant candidates and how to present these characteristics clearly in a patient centered report card. Using this information, Aim 2 will develop a patient-centered website and printouts of the SRTR report card that effectively communicate comparative information about transplant centers to transplant candidates. Lastly, Aim 3 will conduct a randomized clinical trial to evaluate the effectiveness of the patient centered SRTR report card. We will determine transplant candidates' comprehension and the value of the comparative quality reports, and the effect on clinical decision making and status on the waiting list. After the RCT, a convenience sample of online visitors to the new website will be assessed for similar outcomes.
Detailed description
Before the intervention, the study design with use of hypothetical scenarios will be explained to the participant. The concept of randomization will be also be explained. The participants will be asked a few questions to assess their understanding of the study design, specifically the hypothetical nature of the scenarios. We will also assess whether they understand the concept of being randomized to see one website first and then the other. Only those participants that understand the study design will be invited to participate in the intervention and will be randomized. For subjects that are randomized, a survey will be administered verbally to collect demographic information and information about their kidney disease and comorbidities. The functional health literacy and numeracy assessment and health status questionnaire will be completed. Subjects will be stratified by the transplant center site and then block randomized. One group will be shown the existing SRTR website with its existing SRTR report cards and then the website with the new patient-centered AHRQ report cards for kidney transplants. The other group will be shown the two websites in opposite order. Each participant will have at most 30 minutes to view each of the websites. After viewing each website, responses to the intervention will be collected. Sessions where participants are reviewing the websites will be recorded using Zoom. Figure 2 shows the study design whereby subjects will be block randomized once to one of the four groups consisting of 18 subjects each. At the end of the study, the patients will have access to both the websites.
The study interventions can be administered in person on a laptop. During the COVID-19 pandemic, the intervention can be administered remotely via email and zoom. The link to the websites will be sent via encrypted email and the intervention will be recorded via zoom. The recordings for subjects at Hennepin Healthcare will be stored on computers at that site.
If participant does not have your own electronic device or internet, the study will send the participant a study iPad with internet that participant can use for the intervention and then to send back to the study team. We will provide detailed instructions on how to use the iPad and Zoom application. The study will also pay for a FedEx pick up from the participants' home to return the iPad to the study team after the completion of the intervention.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- Participants were stratified by transplant center site and block randomized to one of the four groups using permuted block randomization with blocks of size four. * Arm 1: SRTR website first, Question 1 first * Arm 2: SRTR website first, Question 2 first * Arm 3: TCST first, Question 1 first * Arm 4: TCST first, Question 2 first
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Other | Other: Intervention 1 - SRTR (age question 1st)Sequence 1: SRTR then TCST (Question 1 then Question 2) |
| Arm 2 | Other | Other: Intervention 2 - SRTR (BMI question 1st)Sequence 2: SRTR then TCST (Question 2 then Question 1) |
| Arm 3 | Other | Other: Intervention 3 - TCST (age question 1st)Sequence 3: TCST then SRTR (Question 1 then Question 2) |
| Arm 4 | Other | Other: Intervention 4 - TCST (BMI question 1st)Sequence 4: TCST then SRTR (Question 2 then Question 1) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All adults seeking a kidney transplant are eligible for the RCT. We will focus on recruiting kidney waitlist candidates.
Key exclusion criteria (3 listed)
- are inability to speak or understand English, visual impairment, and inability to give consent. All vulnerable populations except for those listed in the table titled vulnerable populations, will be excluded.
- .
- .
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 |
|---|---|---|
| Intervention 1 - SRTR (age question 1st)Participants first viewed the SRTR website to answer Question 1 (Which transplant program within a prespecified area had the most recipients over 70 years of age?). Subsequently, participants crossed over to view the TCST website to answer Question 2 (Which program within a prespecified area had the most recipients with BMI >40?) | Other | Arm 1 |
| Intervention 2 - SRTR (BMI question 1st)Participants first viewed the SRTR website to answer Question 2. Subsequently, participants crossed over to view the TCST website to answer Question 1. | Other | Arm 2 |
| Intervention 3 - TCST (age question 1st)Participants first viewed the TCST website to answer Question 1. Subsequently, participants crossed over to view the SRTR website to answer Question 2. | Other | Arm 3 |
| Intervention 4 - TCST (BMI question 1st)Participants first viewed the TCST website to answer Question 2. Subsequently, participants crossed over to view the SRTR website to answer Question 1. | Other | Arm 4 |
Primary outcome
Number of Participants With Correct Response to Question 1 and 2
Time frame: 30 minutes
The primary outcome is the comprehension of the report card. To assess comprehension, the correct response to the following question will be assessed, "Which transplant program within a prespecified area had the most recipients over 70 years of age; and which programs had the most recipients with BMI >40"
2 secondary outcomes
Perceived Value of Information
Time frame: 30 minutes
Measurement of Satisfaction With Decision Making
Time frame: 30 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 35152256Israni AK, Schladt D, Bruin MJ, Chu S, Snyder JJ, Hertz M, Valapour M, Kasiske B, McKinney WT, Schaffhausen CR. Deconstructing Silos of Knowledge Around Lung Transplantation to Support Patients: A Patient-specific Search of Scientific Registry of Transplant Recipients Data. Transplantation. 2022 Aug 1;106(8):1517-1519. doi: 10.1097/TP.0000000000004051. Epub 2022 Feb 11. No abstract available.
- Background: PubMed 33999964Chu S, Bruin MJ, McKinney WT, Israni AK, Schaffhausen CR. Design of a patient-centered decision support tool when selecting an organ transplant center. PLoS One. 2021 May 17;16(5):e0251102. doi: 10.1371/journal.pone.0251102. eCollection 2021.
- Background: PubMed 33617066McKinney WT, Schaffhausen CR, Schladt D, Bruin MJ, Chu S, Snyder JJ, Martin C, Alexy T, Kasiske B, Israni AK. Designing a patient-specific search of transplant program performance and outcomes: Feedback from heart transplant candidates and recipients. Clin Transplant. 2021 Feb;35(2):e14183. doi: 10.1111/ctr.14183. Epub 2020 Dec 19.
- Background: PubMed 32766433McKinney WT, Schaffhausen CR, Bruin MJ, Chu S, Schladt D, Matas A, Snyder J, Kasiske B, Israni AK. Development of a Patient-specific Search of Transplant Program Outcomes and Characteristics: Feedback From Kidney Transplant Patients. Transplant Direct. 2020 Jul 17;6(8):e585. doi: 10.1097/TXD.0000000000001036. eCollection 2020 Aug.
- Background: PubMed 30861199Schaffhausen CR, Bruin MJ, McKinney WT, Snyder JJ, Matas AJ, Kasiske BL, Israni AK. How patients choose kidney transplant centers: A qualitative study of patient experiences. Clin Transplant. 2019 May;33(5):e13523. doi: 10.1111/ctr.13523. Epub 2019 Apr 21.
- Background: PubMed 31283676Schaffhausen CR, Bruin MJ, Chu S, Wey A, McKinney WT, Snyder JJ, Lake JR, Matas AJ, Kasiske BL, Israni AK. Comparing Pretransplant and Posttransplant Outcomes When Choosing a Transplant Center: Focus Groups and a Randomized Survey. Transplantation. 2020 Jan;104(1):201-210. doi: 10.1097/TP.0000000000002809.
- Results publication: PubMed 39620865McKinney WT, Israni K, Schaffhausen CR, Schladt DP, Lyden GR, Matas A, Wolf J, Japuntich S, Israni AK. Randomized Controlled Trial to Evaluate a New Tool to Support Patient Decision-making on Transplant Centers. Clin Transplant. 2024 Dec;38(12):e70043. doi: 10.1111/ctr.70043.
- This website is the finalized version of the intervention study site.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Transplants
RecruitingPhase 2
High vs.Standard Dose Influenza Vaccine in Pediatric Solid Organ Transplant (SOT) Recipients
Immunization; Infection, Transplantation Infection
RecruitingPhase 2
COVID-19 Booster and IIV Schedule in Immunocompromised Hosts
COVID 19, Influenza
Active, not recruitingPhase 3
Pandemic Influenza Vaccine in Organ Transplantation (PIVOT Trial)
Influenza (Pandemic), Avian Influenza
RecruitingPhase 2
A Study to Learn About the Effects of Felzartamab Infusions in Adults With Kidney Transplants Who Have Late Isolated Microvascular Inflammation
Microvascular Inflammation
Active, not recruitingPhase 2
Viral Specific T-cells for Treatment of Viral Infections After Solid Organ Transplant
Solid Organ Transplant, Viral Infection
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention 1 - SRTR (age question 1st), Intervention 2 - SRTR (BMI question 1st) and Intervention 3 - TCST (age question 1st) in people with Transplants, run by Ajay Israni, MD 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 1 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: finished, as of the sponsor's last update on 16 Dec 2025. 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?
Yes. Results are posted in the registry (first posted 16 Dec 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?
Number of Participants With Correct Response to Question 1 and 2 (time frame: 30 minutes). 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 NCT03610555, which also lists 7 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 16 Dec 2025.