Kidney DisordersASCENTNCT02879812
Disparities in National Kidney Allocation Policy
A study testing Performance Feedback Reports, Educational Video for Staff and Educational Video for Patients in people with Kidney Disorders, run by Emory University at 3 sites in United States.
Trial summary
The purpose of the current study is to test a systems-level approach to disseminate a multicomponent, multilevel intervention consisting of educational materials about transplantation and the new kidney allocation system targeting dialysis facility medical directors, staff, and patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Disorders
- What is being tested?
- Performance Feedback Reports, Educational Video for Staff and Educational Video for Patients
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56,332 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2016to 2 Aug 2019
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Dialysis facilities with at least 25 patients composed of at least 10% African American and 10% Caucasian
Who cannot join
- Dialysis facilities with wait listing rates above the national tertile
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Emory Clinic
Atlanta, Georgia, 30322
Emory University Hospital
Atlanta, Georgia, 30322
Emory University
Atlanta, Georgia, 30322
About this study
Official title: Allocation System for Changes in Equity in kidNey Transplantation (ASCENT) Study
The purpose of the current study is to test a systems-level approach to disseminate a multicomponent, multilevel intervention consisting of educational materials about transplantation and the new kidney allocation system targeting dialysis facility medical directors, staff, and patients. Roughly 750 dialysis facilities in up to 18 End Stage Renal Disease Network regions across the United States will be randomized to receive intervention materials. The overall goal of the study is to extend the influence of the national allocation policy in reducing disparities in early steps in kidney transplant access.
Read the detailed description
The purpose of the Allocation System for Changes in Equity in kidNey Transplantation (ASCENT) study is to test a systems-level approach to disseminate a multi-component intervention consisting of in the era of the new national kidney allocation policy and educational materials targeting dialysis facility medical directors, staff, and patients. The investigators will randomize ~750 dialysis facilities in up to 18 End Stage Renal Disease Network regions across the United States, where approximately half of facilities will receive the intervention materials and half will receive an informational brochure. This pragmatic, clinical effectiveness-implementation study will test the effectiveness of the multicomponent, multilevel interventions consisting of a tailored, facility-specific transplant and disparity performance report, educational videos for staff and dialysis patients, and an educational webinar for dialysis facility medical directors and staff.
- Conditions
- Kidney Disorders
- Being tested
- Performance Feedback Reports, Educational Video for Staff, Educational Video for Patients, Educational Webinar, Standard Care
- Keywords
- Transplantation Surgery, Nephrology, Organ and Tissue Transplantation, End stage renal disease (ESRD)
- Medical subject headings
- Kidney Diseases, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Performance Feedback ReportsOther
Also called Audit and Feedback Report
Medical directors will be provided performance feedback reports that are a summary of clinical performance of transplant and racial disparity performance over a period of time aimed at providing information to allow them to assess and adjust their transplant performance. The report will emphasize tailored facility-specific information on the mean time on dialysis for patients in that facility and transplant access performance measures, such as wait listing and transplantation, including the magnitude of racial disparity, detailing when a facility is performing below the national or regional average.
Educational Video for StaffOther
Dialysis facility staff will watch a ~10 minute educational video that describes the role of dialysis staff in improving transplant access, the new kidney allocation policy, and how the new policy impacts minority patients and those on dialysis for a substantial period of time.
Educational Video for PatientsOther
Dialysis facilities will receive a ~10 minute educational video targeted to dialysis patients to explain the transplant process and allocation policy.
Educational WebinarOther
Education for medical directors and facility staff about the kidney allocation policy will be discussed in a webinar and information will be hosted on a website for participants to access. The seminar will be roughly 45 minutes, and continuing medical education (CME) credits will be offered.
Standard CareOther
Dialysis facilities will conduct standard or usual care and education regarding transplantation.
United Network for Organ Sharing (UNOS) PamphletOther
Dialysis facility staff will be provided an educational pamphlet detailing the changes in the new kidney allocation policy .
| Study group | Role | What they receive |
|---|---|---|
| Multi-Component Intervention | Experimental | End Stage Renal Disease (ESRD) facilities will receive feedback reports containing facility specific data, an educational webinar for dialysis facility medical directors and staff, and an educational video for patients and staff. Receives: Other: Performance Feedback Reports; Other: Educational Video for Staff; Other: Educational Video for Patients; Other: Educational Webinar; Other: United Network for Organ Sharing (UNOS) Pamphlet |
| Standard Care + Pamphlet | Active comparator | End Stage Renal Disease (ESRD) facilities will conduct usual care and receive United Network for Organ Sharing (UNOS) educational pamphlets for staff. Receives: Other: Standard Care; Other: United Network for Organ Sharing (UNOS) Pamphlet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Incident Patients Waitlisted
The adjusted mean proportions of incident (new) patients waitlisted for kidney transplantation at study dialysis facilities, at the baseline and post-intervention time periods, were calculated. Incident patients are those who initiated dialysis treatment at study facilities during one of the study time periods. Mean proportions were adjusted for time and facility-level random effects.
Measured: Baseline (the twelve month period prior to the intervention), Post-intervention (the twelve month period after the intervention)
Proportion of Black and White Incident Patients Waitlisted
The adjusted mean proportions of Black versus White incident patients waitlisted for kidney transplantation at study dialysis facilities, at the baseline and post-intervention follow-up assessments, were calculated. Mean proportions were adjusted for time and facility-level random effects.
Measured: Baseline (the twelve month period prior to the intervention), Post-intervention (the twelve month period after the intervention)
Proportion of Prevalent Patients Waitlisted During the Baseline Period
The adjusted mean proportions of prevalent patients waitlisted for kidney transplantation at study dialysis facilities during the baseline time period were calculated. Mean proportions were adjusted for time and facility-level random effects.
Measured: Baseline (the twelve month period prior to the intervention)
Proportion of Prevalent Patients Waitlisted During the Post-Intervention Time Period
The adjusted mean proportions of prevalent patients waitlisted for kidney transplantation at study dialysis facilities during the post-intervention period were calculated. Mean proportions were adjusted for time and facility-level random effects.
Measured: Post-intervention (the twelve month period after the intervention)
Proportion of Black and White Prevalent Patients Waitlisted During the Baseline Period
Waitlisting disparity is assessed as the adjusted mean proportion of Black versus White prevalent patients waitlisted for kidney transplantation at study dialysis facilities during the baseline time period. Mean proportions were adjusted for time and facility-level random effects.
Measured: Baseline (the twelve month period prior to the intervention)
Proportion of Black and White Prevalent Patients Waitlisted During the Post-Intervention Time Period
Waitlisting disparity is assessed as the adjusted mean proportion of Black versus White prevalent patients waitlisted for kidney transplantation at study dialysis facilities during the post-intervention period. Mean proportions were adjusted for time and facility-level random effects.
Measured: Post-intervention (the twelve month period after the intervention)
Secondary outcomes (4)
Knowledge About the Kidney Allocation System
Knowledge about the kidney allocation system was assessed using a survey among dialysis facility medical directors or nurse managers. The survey measured provider knowledge of Kidney Allocation System (KAS) and transplantation using a cumulative knowledge score ranging from 0 to 5, where 0 = least knowledge and 5 = highest level of knowledge (higher scores are preferable, indicating greater knowledge).
Measured: Baseline, Immediately Post-intervention (3 months after the start of the intervention)
Percentage of Facilities With Increases or No Change/Decreases in Staff Training
Staff training about kidney transplant and the allocation system was assessed among dialysis facility medical directors or nurse managers by asking "what proportion of staff have you trained regarding the new kidney allocations system?" The staff training score was based on facility-level average percent and used a scale of 0 = 0% of staff trained, 1 = 1-20% of staff trained, 2 = 21-40% of staff trained, 3 = 41-60% of staff trained, 4 = 61-80% of staff trained, and 5 = 81-100% of staff trained. Facilities were grouped as either having an increase in the percentage of staff who were trained about KAS, or had no change or a decrease in the percentage of staff trained between the baseline and post-intervention follow-up at 3 months.
Measured: Baseline, Immediately Post-intervention (3 months after the start of the intervention)
Percentage of Facilities With Increases or No Change/Decreases in Patient Education
Patient education about kidney transplant and the allocation system was assessed among dialysis facility medical directors or nurse managers by asking "what proportion of patients in this specific facility have you or your staff educated about kidney transplantation?" The patient education score was based on facility-level average percent and recorded as ordinal responses scored on a scale of 0 = 0% of patients educated, 1 = 1-20% of patients educated, 2 = 21-40% of patients educated, 3 = 41-60% of patients educated, 4 = 61-80% of patients educated, and 5 = 81-100% of patients educated. Facilities were grouped as either having an increase in the percentage of patients educated about KAS, or had no change or a decrease in the percentage of patients educated between the baseline and post-intervention follow-up at 3 months.
Measured: Baseline, Immediately Post-intervention (3 months after the start of the intervention)
Percentage of Facilities With Increases or No Change/Decreases in Intent to Refer Patients for Kidney Transplantation
Change in referral practices were measured by asking dialysis facility medical directors or nurse managers about the estimated number of patients where were referred for kidney transplantation in that facility. The medical director or nurse manager was asked "since the beginning of the ASCENT quality improvement project (about 3 months ago), have you been referring more or fewer patients?" Possible responses were: more, same, fewer, or unsure. Facilities were grouped as either having an increase in the number of patients referred for transplant, or had no change or a decrease in the proportion of patients referred for transplant.
Measured: Immediately Post-intervention (3 months after the start of the intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2016 (estimated)
- Study startSep 2016
- Primary completion2 Aug 2019
- Study completion2 Aug 2019
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 (4)Papers the sponsor has linked to this study.
- Other trials for Kidney DisordersStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56,332 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Rachel Patzer, Emory University
- Investigators
- Rachel Patzer, PhD, MPH, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02879812
- Sponsor's protocol ID
- IRB00081580
- Other IDs
- 1R01MD010290-01
- Acronym
- ASCENT
- Status last verified
- Sep 2025
- First submitted
- 23 Aug 2016
- Last updated
- 7 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Urbanski M, Lee YH, Escoffery C, Buford J, Plantinga L, Pastan SO, Hamoda R, Blythe E, Patzer RE. Implementation of the ASCENT Trial to Improve Transplant Waitlisting Access. Kidney Int Rep. 2023 Nov 2;9(2):225-238. doi: 10.1016/j.ekir.2023.10.028. eCollection 2024 Feb.
PubMed 38344743Patzer RE, Smith K, Basu M, Gander J, Mohan S, Escoffery C, Plantinga L, Melanson T, Kalloo S, Green G, Berlin A, Renville G, Browne T, Turgeon N, Caponi S, Zhang R, Pastan S. The ASCENT (Allocation System Changes for Equity in Kidney Transplantation) Study: a Randomized Effectiveness-Implementation Study to Improve Kidney Transplant Waitlisting and Reduce Racial Disparity. Kidney Int Rep. 2017 May;2(3):433-441. doi: 10.1016/j.ekir.2017.02.002. Epub 2017 Feb 9.
PubMed 28845470Patzer RE, Zhang R, Buford J, McPherson L, Lee YH, Urbanski M, Li D, Wilk A, Paul S, Plantinga L, Escoffery C, Pastan SO. The ASCENT Intervention to Improve Access and Reduce Racial Inequalities in Kidney Waitlisting: A Randomized, Effectiveness-Implementation Trial. Clin J Am Soc Nephrol. 2023 Mar 1;18(3):374-382. doi: 10.2215/CJN.0000000000000071. Epub 2023 Feb 8.
PubMed 36764664Magua W, Basu M, Pastan SO, Kim JJ, Smith K, Gander J, Mohan S, Escoffery C, Plantinga LC, Melanson T, Garber MD, Patzer RE. Effect of the ASCENT Intervention to Increase Knowledge of Kidney Allocation Policy Changes Among Dialysis Providers. Kidney Int Rep. 2020 Jul 2;5(9):1422-1431. doi: 10.1016/j.ekir.2020.06.027. eCollection 2020 Sep.
PubMed 32954067
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Allocation System for Changes in Equity in kidNey Transplantation (ASCENT) Study
- ClinicalTrials.gov ID
- NCT02879812
- Acronym / sponsor ID
- ASCENT / IRB00081580
- Conditions
- Kidney Disorders
- Keywords
- Transplantation Surgery, Nephrology, Organ and Tissue Transplantation, End stage renal disease (ESRD)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56,332 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- Sep 2016 (actual)
- Primary completion
- 2 Aug 2019 (actual)
- Study completion
- 2 Aug 2019 (actual)
- First posted
- 26 Aug 2016 (estimated)
- Results
- Posted 3 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the current study is to test a systems-level approach to disseminate a multicomponent, multilevel intervention consisting of educational materials about transplantation and the new kidney allocation system targeting dialysis facility medical directors, staff, and patients. Roughly 750 dialysis facilities in up to 18 End Stage Renal Disease Network regions across the United States will be randomized to receive intervention materials. The overall goal of the study is to extend the influence of the national allocation policy in reducing disparities in early steps in kidney transplant access.
Detailed description
The purpose of the Allocation System for Changes in Equity in kidNey Transplantation (ASCENT) study is to test a systems-level approach to disseminate a multi-component intervention consisting of in the era of the new national kidney allocation policy and educational materials targeting dialysis facility medical directors, staff, and patients. The investigators will randomize ~750 dialysis facilities in up to 18 End Stage Renal Disease Network regions across the United States, where approximately half of facilities will receive the intervention materials and half will receive an informational brochure. This pragmatic, clinical effectiveness-implementation study will test the effectiveness of the multicomponent, multilevel interventions consisting of a tailored, facility-specific transplant and disparity performance report, educational videos for staff and dialysis patients, and an educational webinar for dialysis facility medical directors and staff.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multi-Component Intervention | Experimental | Other: Performance Feedback Reports, Other: Educational Video for Staff, Other: Educational Video for Patients, Other: Educational Webinar, Other: United Network for Organ Sharing (UNOS) PamphletEnd Stage Renal Disease (ESRD) facilities will receive feedback reports containing facility specific data, an educational webinar for dialysis facility medical directors and staff, and an educational video for patients and staff. |
| Standard Care + Pamphlet | Active comparator | Other: Standard Care, Other: United Network for Organ Sharing (UNOS) PamphletEnd Stage Renal Disease (ESRD) facilities will conduct usual care and receive United Network for Organ Sharing (UNOS) educational pamphlets for staff. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Dialysis facilities with at least 25 patients composed of at least 10% African American and 10% Caucasian
Key exclusion criteria (1 listed)
- Dialysis facilities with wait listing rates above the national tertile
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 |
|---|---|---|
| Performance Feedback ReportsAlso: Audit and Feedback ReportMedical directors will be provided performance feedback reports that are a summary of clinical performance of transplant and racial disparity performance over a period of time aimed at providing information to allow them to assess and adjust their transplant performance. The report will emphasize tailored facility-specific information on the mean time on dialysis for patients in that facility and transplant access performance measures, such as wait listing and transplantation, including the magnitude of racial disparity, detailing when a facility is performing below the national or regional average. | Other | Multi-Component Intervention |
| Educational Video for StaffDialysis facility staff will watch a ~10 minute educational video that describes the role of dialysis staff in improving transplant access, the new kidney allocation policy, and how the new policy impacts minority patients and those on dialysis for a substantial period of time. | Other | Multi-Component Intervention |
| Educational Video for PatientsDialysis facilities will receive a ~10 minute educational video targeted to dialysis patients to explain the transplant process and allocation policy. | Other | Multi-Component Intervention |
| Educational WebinarEducation for medical directors and facility staff about the kidney allocation policy will be discussed in a webinar and information will be hosted on a website for participants to access. The seminar will be roughly 45 minutes, and continuing medical education (CME) credits will be offered. | Other | Multi-Component Intervention |
| Standard CareDialysis facilities will conduct standard or usual care and education regarding transplantation. | Other | Standard Care + Pamphlet |
| United Network for Organ Sharing (UNOS) PamphletDialysis facility staff will be provided an educational pamphlet detailing the changes in the new kidney allocation policy . | Other | Multi-Component Intervention, Standard Care + Pamphlet |
Primary outcome
Proportion of Incident Patients Waitlisted
Time frame: Baseline (the twelve month period prior to the intervention), Post-intervention (the twelve month period after the intervention)
The adjusted mean proportions of incident (new) patients waitlisted for kidney transplantation at study dialysis facilities, at the baseline and post-intervention time periods, were calculated. Incident patients are those who initiated dialysis treatment at study facilities during one of the study time periods. Mean proportions were adjusted for time and facility-level random effects.
Proportion of Black and White Incident Patients Waitlisted
Time frame: Baseline (the twelve month period prior to the intervention), Post-intervention (the twelve month period after the intervention)
The adjusted mean proportions of Black versus White incident patients waitlisted for kidney transplantation at study dialysis facilities, at the baseline and post-intervention follow-up assessments, were calculated. Mean proportions were adjusted for time and facility-level random effects.
Proportion of Prevalent Patients Waitlisted During the Baseline Period
Time frame: Baseline (the twelve month period prior to the intervention)
The adjusted mean proportions of prevalent patients waitlisted for kidney transplantation at study dialysis facilities during the baseline time period were calculated. Mean proportions were adjusted for time and facility-level random effects.
Proportion of Prevalent Patients Waitlisted During the Post-Intervention Time Period
Time frame: Post-intervention (the twelve month period after the intervention)
The adjusted mean proportions of prevalent patients waitlisted for kidney transplantation at study dialysis facilities during the post-intervention period were calculated. Mean proportions were adjusted for time and facility-level random effects.
Proportion of Black and White Prevalent Patients Waitlisted During the Baseline Period
Time frame: Baseline (the twelve month period prior to the intervention)
Waitlisting disparity is assessed as the adjusted mean proportion of Black versus White prevalent patients waitlisted for kidney transplantation at study dialysis facilities during the baseline time period. Mean proportions were adjusted for time and facility-level random effects.
Proportion of Black and White Prevalent Patients Waitlisted During the Post-Intervention Time Period
Time frame: Post-intervention (the twelve month period after the intervention)
Waitlisting disparity is assessed as the adjusted mean proportion of Black versus White prevalent patients waitlisted for kidney transplantation at study dialysis facilities during the post-intervention period. Mean proportions were adjusted for time and facility-level random effects.
4 secondary outcomes
Knowledge About the Kidney Allocation System
Time frame: Baseline, Immediately Post-intervention (3 months after the start of the intervention)
Percentage of Facilities With Increases or No Change/Decreases in Staff Training
Time frame: Baseline, Immediately Post-intervention (3 months after the start of the intervention)
Percentage of Facilities With Increases or No Change/Decreases in Patient Education
Time frame: Baseline, Immediately Post-intervention (3 months after the start of the intervention)
Percentage of Facilities With Increases or No Change/Decreases in Intent to Refer Patients for Kidney Transplantation
Time frame: Immediately Post-intervention (3 months after the start of the intervention)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 38344743Urbanski M, Lee YH, Escoffery C, Buford J, Plantinga L, Pastan SO, Hamoda R, Blythe E, Patzer RE. Implementation of the ASCENT Trial to Improve Transplant Waitlisting Access. Kidney Int Rep. 2023 Nov 2;9(2):225-238. doi: 10.1016/j.ekir.2023.10.028. eCollection 2024 Feb.
- Background: PubMed 28845470Patzer RE, Smith K, Basu M, Gander J, Mohan S, Escoffery C, Plantinga L, Melanson T, Kalloo S, Green G, Berlin A, Renville G, Browne T, Turgeon N, Caponi S, Zhang R, Pastan S. The ASCENT (Allocation System Changes for Equity in Kidney Transplantation) Study: a Randomized Effectiveness-Implementation Study to Improve Kidney Transplant Waitlisting and Reduce Racial Disparity. Kidney Int Rep. 2017 May;2(3):433-441. doi: 10.1016/j.ekir.2017.02.002. Epub 2017 Feb 9.
- Results publication: PubMed 36764664Patzer RE, Zhang R, Buford J, McPherson L, Lee YH, Urbanski M, Li D, Wilk A, Paul S, Plantinga L, Escoffery C, Pastan SO. The ASCENT Intervention to Improve Access and Reduce Racial Inequalities in Kidney Waitlisting: A Randomized, Effectiveness-Implementation Trial. Clin J Am Soc Nephrol. 2023 Mar 1;18(3):374-382. doi: 10.2215/CJN.0000000000000071. Epub 2023 Feb 8.
- Results publication: PubMed 32954067Magua W, Basu M, Pastan SO, Kim JJ, Smith K, Gander J, Mohan S, Escoffery C, Plantinga LC, Melanson T, Garber MD, Patzer RE. Effect of the ASCENT Intervention to Increase Knowledge of Kidney Allocation Policy Changes Among Dialysis Providers. Kidney Int Rep. 2020 Jul 2;5(9):1422-1431. doi: 10.1016/j.ekir.2020.06.027. eCollection 2020 Sep.
- 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.
Rachel Patzer, PhD, MPH principal investigator
Emory University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Performance Feedback Reports, Educational Video for Staff and Educational Video for Patients in people with Kidney Disorders, run by Emory University at 3 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 1 inclusion and 1 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 7 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 3 Sep 2020). 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?
Proportion of Incident Patients Waitlisted (time frame: Baseline (the twelve month period prior to the intervention), Post-intervention (the twelve month period after the intervention)). The study lists 6 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 NCT02879812, which also lists 4 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 7 Oct 2025.