Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00688285
Other study ID # PRO07110299
Secondary ID
Status Completed
Phase N/A
First received May 28, 2008
Last updated March 24, 2011
Start date December 2008
Est. completion date December 2009

Study information

Verified date March 2011
Source University of Pittsburgh
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

To determine whether the use of educational sessions and computerized clinical reminders can improve primary care doctors' delivery of care to CKD patients compared to educational sessions alone. Hypothesis: Clinical reminders will improve the care delivered to CKD patients


Description:

Literature supports that most chronic kidney disease (CKD) patients are cared for by primary care physicians (PCP) without the help of a kidney specialist. Many of these patients fail to achieve targeted outcomes and late referral to a nephrologist has been associated with an increased risk of death. Automated computerized clinical reminders have been shown to improve physician compliance with recommended guidelines in other settings.

Aims: To determine if clinical reminders can help PCPs decrease the rate of late referrals, improve urine albumin checks in CKD patients

Design: prospective randomized controlled, single-blinded study with additional historical control

Methods: Two 20-minute teaching sessions aimed at all GIM PCPs in the UPMC clinic followed by randomization of the eligible GIM providers to receive automated clinical reminders (CR) for their CKD stage 3b-5 patients versus routine care.

Outcomes: Using a database search, individuals with an eGFR<45ml/min/1.73m2 (not seen by a nephrologist) will have data collected on: PCP referral to a nephrologist, urinary albumin (or protein) quantification in the past year, PCP recognition of patients with eGFR<45ml/min, ACE/ARB usage.


Recruitment information / eligibility

Status Completed
Enrollment 248
Est. completion date December 2009
Est. primary completion date December 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- For PCPs: all GIM attending physicians with a weekly continuity clinic.

- For patients: >= 18 years-old with an eGFR<45ml/min/1.73m2 being seen in the UPMC GIM clinic by a faculty member during the 10-month intervention period

Exclusion Criteria:

- for PCPs: imminent plans to leave the department

- patients with a renal transplant, on any form of dialysis, or with a previous nephrology evaluation.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research


Intervention

Other:
automated clinical alerts
automated clinical alerts in the electronic medical record
provider education
PCP education session on CKD

Locations

Country Name City State
United States University of Pittsburgh Pittsburgh Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary referral to a nephrologist Referral to a nephrologist within the 12 months following decision support system activation. 12 months No
Secondary Use of ACE/ARB Active use of ACE/ARB at the end of the 12 month period following decision support system activation. 12 months No
Secondary Annual ACR or PCR check ACR or PCR within 12months of the decision support system activation 12 months No
See also
  Status Clinical Trial Phase
Completed NCT05491642 - A Study in Male and Female Participants (After Menopause) With Mild to Moderate High Blood Pressure to Learn How Safe the Study Treatment BAY3283142 is, How it Affects the Body and How it Moves Into, Through and Out of the Body After Taking Single and Multiple Doses Phase 1
Recruiting NCT06363097 - Urinary Uromodulin, Dietary Sodium Intake and Ambulatory Blood Pressure in Patients With Chronic Kidney Disease
Terminated NCT04043026 - The Effects of Renal Function and Atrial Fibrillation on Lipoproteins and Clot Structure/Function
Completed NCT05318014 - Low-protein Formula Supplements in Chronic Kidney Disease N/A
Active, not recruiting NCT06071065 - Clinical Pharmacist Intervention on Medication Adherence and Clinical Outcomes in Chronic Kidney Disease Patients N/A
Completed NCT02878317 - Skin Autofluorescence as a Risk Marker in People Receiving Dialysis.
Not yet recruiting NCT06039254 - Safety and Pharmacokinetics of HRS-1780 in Healthy Subjects and Subjects With Impaired Renal Function Phase 1
Recruiting NCT03160326 - The QUALITY Vets Project: Muscle Quality and Kidney Disease
Completed NCT02888171 - Impact of Ferric Citrate vs Ferrous Sulfate on Iron Parameters and Hemoglobin in Individuals With CKD and Iron Deficiency N/A
Withdrawn NCT02885545 - The Strategy to Prevent Hemorrhage Associated With Anticoagulation in Renal Disease Management (STOP HARM) Trial Phase 4
Completed NCT02836574 - A Study of Renal Autologous Cell Therapy (REACT) in Type 2 Diabetics With Chronic Kidney Disease Phase 2
Completed NCT02896309 - The Effect of Correction of Metabolic Acidosis in CKD on Intrarenal RAS Activity N/A
Completed NCT02875886 - DD-study: Diet or Diuretics for Salt-sensitivity in Chronic Kidney Disease Phase 4
Completed NCT02756520 - Observational Study on CKD Treatment With a Ketosteril Supplemented Protein-restricted Diet (Keto-024-CNI)
Active, not recruiting NCT02483039 - Nephrologist Follow-up Versus Usual Care After an Acute Kidney Injury Hospitalization N/A
Completed NCT02992548 - Effect of Pravastatin on Erythrocyte Membrane Fatty Acid Contents in Patients With Chronic Kidney Disease Phase 4
Terminated NCT02543177 - Optimised Procedure in Patients With NSTEMI and CKD N/A
Completed NCT02369549 - Micro-Particle Curcumin for the Treatment of Chronic Kidney Disease Phase 3
Recruiting NCT02205944 - Impact of Presurgical Exercise on Hemodialysis Fistula Outcomes N/A
Active, not recruiting NCT02231138 - Efficacy and Safety of Abelmoschus Manihot for Chronic Kidney Disease Phase 4