رادار التجارب AI | ||
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حالة التجربة السريرية NCT07430930 (PROMPT-CKD) لـ أمراض الكلى المزمنة هي لم يبدأ القبول بعد. اطلعوا على جميع التفاصيل في عرض البطاقة الخاص برادار التجارب السريرية وأدوات اكتشاف الذكاء الاصطناعي. أو يمكنكم طرح أي سؤال هنا. | ||
تجربة واحدة تطابق معايير الفلتر
عرض البطاقة
العودة إلى البحث
جامعة ييلPragmatic Trial of Messaging to Providers About Treatment of Chronic Kidney Disease (PROMPT-CKD) ١٬٠٠٠ عشوائية
تفاصيل التجربة السريرية متاحة بشكل أساسي باللغة الإنجليزية. ومع ذلك، يمكن لـ رادار التجارب AI مساعدتك؛ ما عليك سوى النقر على «وصف الدراسة» لعرض ومناقشة معلومات التجربة باللغة التي اخترتها.
التجربة السريرية NCT07430930 (PROMPT-CKD) هي دراسة تدخُّلية لـأمراض الكلى المزمنة وهي لم يبدأ القبول بعد. من المقرر أن يبدأ التسجيل في ١٢ رمضان ١٤٤٧ هـ لتجنيد ١٬٠٠٠ مشاركًا. يقودها جامعة ييل، ومن المتوقع اكتمالها بحلول ٥ شوال ١٤٤٩ هـ. تم تحديث البيانات الأخيرة من ClinicalTrials.gov في ٧ رمضان ١٤٤٧ هـ.
الملخص
This study is a cluster-randomized clinical trial to evaluate whether a tailored, user-centered, clinical decision support (CDS) tool can positively influence prescriber behavior and increase prescription of guideline-directed medical therapy (GDMT) among patients with Chronic Kidney Disease (CKD) across a single healthcare center.
وصف مفصل
PROMPT-CKD is a single-system, cluster-randomized clinical trial to evaluate the effectiveness of a tailored, user-centered, clinical decision support (CDS) tool for the prescription of guideline-directed medical therapy (GDMT) in patients with Chronic Kidney Disease (CKD). Consented providers (physicians, DOs, PA, APRNs, and PharmDs within internal medicine, family medicine and nephrology departments) will be random...عرض المزيد
العنوان الرسمي
Pragmatic Trial of Messaging to Providers About Treatment of Chronic Kidney Disease
الحالات الطبية
أمراض الكلى المزمنةمعرّفات دراسة أخرى
- PROMPT-CKD
- 2000040989
NCT معرّف
تاريخ البدء (فعلي)
2026-03
آخر تحديث مُنشور
2026-02-24
تاريخ الاكتمال (المقدر)
2028-03
عدد المشاركين المخطط لهم
١٬٠٠٠
نوع الدراسة
تدخُّلية
المرحلة
غ/م
الحالة
لم يبدأ القبول بعد
الغرض الأساسي
العلاج
طريقة توزيع المشاركين
عشوائي
نموذج التدخل
التصميم المتوازي
التعمية
ثلاثي
مجموعات/التدخلات
| مجموعة المشاركين/الذراع | التدخل/العلاج |
|---|---|
تجريبيةExposure to clinical decision support tool Providers will see a best practice alert with an attached order set upon opening the order entry screen in an eligible patient's medical record. | Best practice alert and order set for CKD Providers are exposed to a best practice alert upon opening of the order entry screen in a patient's medical record. The alert informs the provider of the presence of CKD, details the patient's current relevant labs and medications, and provides a list of recommended indicated GDMT for CKD which the patient is currently not prescribed. The alert includes an order set with all indicated medications with additional pre...عرض المزيد |
بدون تدخلUsual Care Providers will not be exposed to the clinical decision support tool when in the medical record of an eligible patient. | غ/م |
النتيجة الرئيسية
النتيجة الثانوية
| مقياس النتيجة | وصف القياس | الإطار الزمني |
|---|---|---|
New GDMT prescription within 90 days | Proportion of patient subjects with one or more new eligible GDMT prescriptions within 90 days of randomization. | Up to 90 days of randomization |
| مقياس النتيجة | وصف القياس | الإطار الزمني |
|---|---|---|
Time to Major Adverse Kidney Events (MAKE) | Measure of the statistical difference between study arms in the time to develop any Major Adverse Kidney Events within one year-post randomization, to include:
1. Death OR
2. 40% reduction in eGFR as defined by 2 measurements at least 30 days apart OR
3. Development of end-stage kidney disease (ESKD) defined by ICD10 code n18.6 OR
4. Receipt of dialysis OR
5. Receipt of kidney transplant | Up to 365 days post-randomization |
Time to all-cause mortality | Measure of the statistical difference between study arms in the time to death from any cause within one year-post randomization. | Up to 365 days post-randomization |
Time to reduction in estimated glomerular filtration rate (eGFR) | Measure of the statistical difference between study arms in the time to achieve reduction of eGFR by greater than 40% within one year-post randomization. | Up to 365 days post-randomization |
Time to end-stage kidney disease (ESKD) | Measure of the statistical difference between study arms in the time to develop ESKD within one year-post randomization. | Up to 365 days post-randomization |
Time to all-cause hospitalization | Measure of the statistical difference between study arms in the time to hospitalization from any cause within one year-post randomization. | Up to 365 days post-randomization |
Time to CKD progression | Measure of the statistical difference between study arms in the time to worsening of CKD stage, either by eGFR criteria, or by albuminuria criteria within one year-post randomization:
* eGFR criteria (with a higher stage indicating worsening disease): Stage 1: eGFR of 90 or higher Stage 2: eGFR of 60-89 Stage 3: eGFR of 30-59 Stage 4: eGFR of 15-29 Stage 5: eGFR of less than 15
* Albuminuria criteria (based on urine protein levels), with higher stages indicating worsening disease: A1: \<30 mg/g or \<3mg/mmol; A2: 30-300 mg/g or 3-30 mg/mmol; A3: \>300 mg/g or \>30 mg/mmol. | Up to 365 days post-randomization |
Time to new GDMT prescription | Measure of the statistical difference between study arms in the time to at least one new GDMT prescription for CKD within 90 days post-randomization. | Up to 90 days post-randomization |
مساعد المشاركة
معايير الأهلية
الأعمار المؤهلة للدراسة
بالغ, كبار السن
العمر الأدنى للدراسة
18 Years
الجنس المؤهل
الكل
- Male or female, aged ≥18 years
- Diagnosed with CKD defined by an eGFR ≤60 mL/min/1.732 on two occasions at least ≥3 months apart with most recent being ≤60 or eGFR 60-90 mL/min/1.73m2 with an uACR ≥30 mg/g or eGFR >90 mL/min/1.73m2 with an uACR ≥30 mg/g.
- Eligible to receive at least 1 of the following CKD GDMT: ACEi/ARB, SGLT2i, MRA or GLP-1 RA based on the following criteria.
- To receive an ACEi/ARB: eGFR ≥15 ml/min/1.732 and have diagnosis of hypertension based on ICD10 code or proteinuria (uACR ≥30 mg/g).
- To receive an SGLT2i: have heart failure (defined by ICD10 code); or T2D; or uACR ≥200 mg/g; or eGFR ≥20 ml/min/1.732.
- To receive an MRA: ns-MRA: have an eGFR ≥25 ml/min/1.732, diagnosis of T2D, normal serum potassium (≤4.8 mmol/L) and albuminuria (>30 mg/g). s-MRA: have an eGFR ≥45 ml/min/1.732 and heart failure, hyperaldosteronism, or refractory hypertension.
- To receive a GLP-1 RA: have T2D.
- Ability to take oral medication.
- Allergy to the GDMT for which the patient is eligible
- End-stage kidney disease
- CKD stage 5 (eGFR <15 ml/min/1.73m2)
- Glomerulonephritis (by ICD-10 code)
- Polycystic kidney disease (by ICD-10 code)
- History of kidney transplant
- End-stage heart failure
- Eligible to receive ACEi/ARB but having blood pressure <110/70 mmHg or have known renal artery stenosis
- Eligible to receive SGLT2i but pregnant or breastfeeding, type 1 DM, history of euglycemic diabetic ketoacidosis or Fournier's gangrene based on ICD10 code.
- Eligible to receive MRA but serum potassium ≥5 mmol/L, have office SBP <100 mmHg, adrenal insufficiency based on ICD10 code or concomitant treatment with CYP3A4 inhibitors (Strong: grapefruit, grapefruit juice, itraconazole. Moderate: erythromycin. Weak: amiodarone).
- Eligible to receive GLP-1 RA but pregnant; or found to have personal history of pancreatitis; or personal or family history of medullary thyroid cancer or MEN type 2 based on ICD10 code or gastroparesis based on ICD10 code.
- Opted out of EHR-based research.
جامعة ييلجهة اتصال مركزية للدراسة
جهة اتصال: Francis P Wilson, MD MSCE, 203-737-1704, [email protected]
1 مواقع الدراسة في 1 بلدان
Connecticut
Yale New Haven Health, New Haven, Connecticut, 06520, United States