Implementeringsprogram för att förbättra screening och hantering för CKD i diabetes (IRIS-CKD) (program 2) (IRIS-CKD)
Implementeringsprogram för att förbättra screening och hantering för CKD i diabetes (program 2) (IRIS-CKD)
IRIS-CKD is a two-program implementation study to improve guideline-recommended screening and treatment of chronic kidney disease (CKD) in individuals with type 2 diabetes (T2D) in the United States.
Studieöversikt
Status
Intervention / Behandling
Detaljerad beskrivning
IRIS-CKD Management Program: will compare prescriptions for guideline-directed medical therapies (GDMT) during the study period. To account for variable GDMT requirements, we will use opportunity scores to compare intervention arms. Patients will be screened, identified and undergo consent by the study site. Patients will receive educational materials related to CKD screening in T2D and details regarding the testing intervention study as per site specific recruitment requirements. The primary objective is to determine whether implementing a guided management program versus education alone will improve prescription of GDMT for people with CKD and T2D. Patients will complete approximately 6 months of follow-up.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Gretchen Sanders, MSN
- Telefonnummer: 919 6687829
- E-post: gretchen.sanders@duke.edu
Studera Kontakt Backup
- Namn: lisa monk, MSN
- E-post: lisa.monk@duke.edu
Studieorter
-
-
Alabama
-
Birmingham, Alabama, Förenta staterna, 35233
- Rekrytering
- University of Alabama
-
Huvudutredare:
- Clare Lyas, MD
-
Kontakt:
- Sarah Machado
- Telefonnummer: 205-934-7649
- E-post: smachado@uabmc.edu
-
-
Florida
-
St. Petersburg, Florida, Förenta staterna, 33701
- Rekrytering
- Orlando Health
-
Huvudutredare:
- Timothy Marsh, DO
-
-
Michigan
-
Ann Arbor, Michigan, Förenta staterna, 48109
- Rekrytering
- University of Michigan
-
Kontakt:
- Angie Westover
- Telefonnummer: 734-936-6467
- E-post: funke@med.umich.edu
-
Huvudutredare:
- Ilka Decker, MD
-
-
Minnesota
-
Duluth, Minnesota, Förenta staterna, 55805
- Rekrytering
- Essentia Institute of Rural Health
-
Huvudutredare:
- Sreedhar Devathi, MD
-
Kontakt:
- Haley Messenger
- Telefonnummer: 218.786.2077
- E-post: haley.messenger@essentiahealth.org
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-
North Carolina
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Durham, North Carolina, Förenta staterna, 27707
- Rekrytering
- Duke University
-
Huvudutredare:
- John Middleton, MD
-
Kontakt:
- Kim Cicio
- E-post: kimberly.cicio@duke.edu
-
-
Texas
-
Houston, Texas, Förenta staterna, 77030
- Rekrytering
- Houston Methodist
-
Huvudutredare:
- Peter Nguyen
-
Kontakt:
- Daphne Medina
- Telefonnummer: 713-744-2016
- E-post: damedina2@houstonmethodist.org
-
Kontakt:
- Steven Puckett
- E-post: srpuckitt@houstonmethodist.org
-
Temple, Texas, Förenta staterna, 76508
- Rekrytering
- Baylor Scott & White
-
Huvudutredare:
- Tariq Tariq, MD
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
-
(CKD Management)
-
Adults with type 2 diabetes (T2D)
-
Receiving primary care within the healthcare system, visit within 24 months (any PCP provider, including APP)
-
Evidence of CKD based on laboratory testing within the past 2 years (must be confirmed during screening if not checked within 3 months of enrollment):
- UACR >300 mg/g or
- eGFR <45 ml/min/1.73 m2 or
- UACR ≥30 mg/g with eGFR <60 ml/min/1.73 m2
-
Receiving <100% GDMT at baseline. For patients with UACR <30 mg/g, GDMT includes sodium-glucose cotransporter-2 inhibitors (SGLT2i) therapy. For all other eligible patients, GDMT includes ACEi/ARB, SGLT2i, and Finerenone, unless contraindications for any of these therapies exist (e.g., hyperkalemia, diabetic ketoacidosis, etc.).
-
Exclusion Criteria:
-
(CKD Management)
- Type 1 diabetes
- Most recent eGFR <20 ml/min/1.73 m2
- Prior kidney transplant
- Autosomal dominant polycystic kidney disease (ADPKD)
- Active pregnancy or plans for conception within 1 year
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: (IRIS-CKD Management Program): Education
Education: Participants will receive targeted educational materials related to their stage of CKD, including recommendations for potential GDMT to discuss with their primary care provider. |
Patients randomized to the education arm will receive targeted education materials regarding their severity of CKD, including the potential for additional GDMT to slow CKD progression to discuss with their Primary Care Provider (PCP). At 6 months, the study pharmacist (or APP) will order repeat eGFR and UACR after 6 months to standardize CKD follow up during the study period. |
|
Aktiv komparator: (IRIS-CKD Management Program): GDMT
Management: Participants will receive targeted educational materials, along with GDMT prescription, dose titration, and laboratory monitoring by a pharmacist/APP, as necessary, with guidance from a centralized algorithm and oversight from a nephrologist site PI. |
Patients randomized to the education arm will receive targeted education materials regarding their severity of CKD, including the potential for additional GDMT to slow CKD progression to discuss with their Primary Care Provider (PCP). At 6 months, the study pharmacist (or APP) will order repeat eGFR and UACR after 6 months to standardize CKD follow up during the study period. Patients randomized to the education arm will receive targeted education materials regarding their severity of CKD, including the potential for additional GDMT to slow CKD progression to discuss with their PCP. At 6 months, the study pharmacist (or APP) will order repeat eGFR and UACR after 6 months to standardize CKD follow up during the study period. Plus, receive guided care by APP. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
CKD GDMT Opportunity Score at 6 months
Tidsram: 6 months
|
Opportunity score of GDMT prescriptions at 6 months that were missing at baseline. The score will include prescriptions for GDMT that are active at month 6 or the loss of an indication for the GDMT. |
6 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
CKD GDMT Opportunity Score at 6 months weighted by dose
Tidsram: 6 months
|
Change in opportunity score from baseline to 6 months weighted by prescribed dose of GDMT. |
6 months
|
|
CKD GDMT Opportunity Score at 3 months
Tidsram: 3 months
|
Opportunity score of GDMT prescriptions at 3 months that were missing at baseline. The score will include prescriptions for GDMT that are active at month 3 or the loss of an indication for the GDMT. |
3 months
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
UACR change
Tidsram: 6 months
|
Change in UACR after 6 months |
6 months
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Neha Pagidipati, MD, Duke University
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Urogenitala sjukdomar
- Sjukdomar i det endokrina systemet
- Patologiska processer
- Manliga urogenitala sjukdomar
- Njursjukdomar
- Urologiska sjukdomar
- Kvinnliga urogenitala sjukdomar
- Kvinnliga urogenitala sjukdomar och graviditetskomplikationer
- Kronisk sjukdom
- Sjukdomsegenskaper
- Metaboliska sjukdomar
- Störningar i glukosmetabolism
- Diabetes mellitus
- Njurinsufficiens
- Patologiska tillstånd, tecken och symtom
- Närings- och metabola sjukdomar
- Diabetes mellitus, typ 2
- Njurinsufficiens, kronisk
Andra studie-ID-nummer
- Pro00116493_1
Plan för individuella deltagardata (IPD)
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