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| ID | Type | Description | Link |
|---|---|---|---|
| U01AI169477 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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Patients receiving dialysis are one of the highest risk groups for serious illness with SARS-CoV-2 infection. In addition to the inherent risks of travel to and dialysis within indoor facilities, patients receiving dialysis are more likely to be older, non-white, from disadvantaged backgrounds, and have impaired immune responses to viral infections and vaccinations. Universal testing offered at hemodialysis facilities could shield this vulnerable population from exposure, enable early identification and treatment for those affected, and reduce transmission to other patients and family members. In this pragmatic cluster randomized controlled trial as part of NIH RADx-UP Consortium, we will randomize 62 US Renal Care facilities with an estimated 2480 patients to static versus dynamic universal screening testing strategies. Static universal screening will involve offering patients SARS-CoV-2 screening tests every two weeks; the dynamic universal screening strategy will vary the frequency of testing from once every week to once every four weeks, depending on community COVID-19 case rates. We hypothesize that patients dialyzing at facilities randomized to a dynamic testing frequency responsive to community case rates will have higher test acceptability (primary outcome), experience lower rates of COVID-19 death and hospitalization, and report better experience-of-care metrics.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Static frequency | Active Comparator | Test based screening for SARS-CoV-2 every two weeks |
|
| Dynamic frequency | Active Comparator | Test based screening for SARS-CoV-2 ranging from once a week to once every four weeks anchored to county COVID-19 case rates |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Offering SARS-CoV-2 test | Behavioral | A pragmatic cluster (facility-level) randomized clinical trial, comparing test-based screening performed at a static (every two weeks) frequency versus a dynamic frequency (ranging from once a week to once every four weeks) anchored to county COVID-19 case rates |
| Measure | Description | Time Frame |
|---|---|---|
| Number and Percentage of Total SARS-CoV-2 Tests Accepted Out of Total Tests Offered | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Deaths | 4 months | |
| Hospitalizations | 4 months | |
| Change in Facility Scores on In-Center Hemodialysis Consumer Assessment of Healthcare Providers and Systems (ICH CAHPS) Survey |
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Inclusion Criteria:
Facility
Exclusion Criteria:
Patient
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| Name | Affiliation | Role |
|---|---|---|
| Shuchi Anand, MD | Stanford University | Principal Investigator |
| Julie Parsonnet, MD | Stanford University | Principal Investigator |
| Glenn Chertow, MD | Stanford University | Principal Investigator |
| Geoff Block, MD | US Renal Care | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| US Renal Care | Plano | Texas | 75024 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39298171 | Derived | Montez-Rath M, Varkila M, Yu X, Brillhart S, Morgan C, Leppink A, Block MS, Mehta S, Hunsader P, Fountaine A, Subramanian N, Dittrich M, Owens DK, Chertow GM, Parsonnet J, Anand S, Block GA. Acceptance of SARS-CoV-2 Surveillance Testing Among Patients Receiving Dialysis: A Cluster Randomized Trial. JAMA Netw Open. 2024 Sep 3;7(9):e2434159. doi: 10.1001/jamanetworkopen.2024.34159. | |
| 36976655 | Derived | Anand S, Montez-Rath M, Varkila M, Yu X, Block M, Brillhart S, Leppink A, Hunsader P, Owens DK, Chertow GM, Parsonnet J, Block GA. Feasibility and Acceptability of SARS-CoV-2 Screening among Patients Receiving Hemodialysis: A Pilot Study. Clin J Am Soc Nephrol. 2023 Jul 1;18(7):930-932. doi: 10.2215/CJN.0000000000000137. Epub 2023 Apr 24. No abstract available. |
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Anonymized data will be shared with NIH Radx-UP data repository.
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Patients were offered tests over a period of 3 months then entered a 1-month follow-up period.
| ID | Title | Description |
|---|---|---|
| FG000 | Static Frequency | Test based screening for SARS-CoV-2 every two weeks |
| FG001 | Dynamic Frequency | Test based screening for SARS-CoV-2 ranging from once a week to once every four weeks anchored to county COVID-19 case rates |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Static Frequency | Test based screening for SARS-CoV-2 every two weeks |
| BG001 | Dynamic Frequency | Test based screening for SARS-CoV-2 ranging from once a week to once every four weeks anchored to county COVID-19 case rates |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number and Percentage of Total SARS-CoV-2 Tests Accepted Out of Total Tests Offered | All participants who started in the Participant Flow | Posted | Count of Units | Tests | 3 months | Tests | Tests |
|
|
4 months
Incidence of deaths and hospitalizations were collected; however, no adverse event data were collected in this study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Static Frequency | Test based screening for SARS-CoV-2 every two weeks | 31 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Shuchi Anand, MD, MS | Stanford University | 650-725-2207 | sanand2@stanford.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 26, 2023 | Jul 17, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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|
this survey is administered annually at each dialysis facility dialysis facility (based on Centers for Medicare Services regulation) |
| 4 months |
| BG002 | Total | Total of all reporting groups |
| Facilities |
|
| years |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants | Participants |
|
| Diabetes | Count of Participants | Participants | Participants |
|
| Facility Region | Count of Units | Facilities | Facilities |
|
| Counts |
|---|
| Participants |
|
| Tests |
|
|
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| Secondary | Deaths | Posted | Count of Participants | Participants | 4 months |
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|
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| Secondary | Hospitalizations | Posted | Count of Participants | Participants | 4 months |
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|
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| Secondary | Change in Facility Scores on In-Center Hemodialysis Consumer Assessment of Healthcare Providers and Systems (ICH CAHPS) Survey | this survey is administered annually at each dialysis facility dialysis facility (based on Centers for Medicare Services regulation) | Data were not collected for this outcome measure | Posted | 4 months |
|
|
| 1,069 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Dynamic Frequency | Test based screening for SARS-CoV-2 ranging from once a week to once every four weeks anchored to county COVID-19 case rates | 41 | 1,320 | 0 | 0 | 0 | 0 |
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| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |