Multiple Intervention and AUdit in Renal Diseases to Optimize Care (MAURO)

January 27, 2012 updated by: Carmine Zoccali, Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy

Multiple Intervention and AUdit in Renal Diseases to Optimize Care: the MAURO Study.

Test whether the intensive intervention improves renal and cardiovascular outcomes in patients with chronic renal insufficiency.

Test whether a multi-method intensive intervention including clinical Audit improves adherence to a series of quality indicators relevant to hypertension control, proteinuria, treatment of dyslipidemia, anemia, calcium and phosphate alterations in patients with chronic renal insufficiency.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background:

Guidelines are currently promoted as a means for linking evidence based medicine to clinical practice and for reducing variation in clinical practice (1). However, there is ample evidence that implementation of evidence-based recommendations for prevention and management of renal disease progression and associated cardiovascular complications remain largely unsatisfactory (2). Deficiencies exist in the treatment of dyslipidemia and hypertension, inadequate use of angiotensin-converting enzyme inhibitors or angiotensin receptor blockers as well as in the treatment of anemia and of alterations in calcium and phosphate metabolism (2). Furthermore patients with diabetes mellitus infrequently receive recommended treatment for elevated glycosylated haemoglobin levels, hypertension, and dyslipidemia.

The importance of interventions to increase adherence to practice guidelines and to improve disease control is now widely perceived. However, little is known about the relative effectiveness of different implementation strategies. Fresh research is required to develop and validate practical strategies for improving the provision of evidence-based medicine in nephrology clinics. In particular, studies addressing multiple common, chronic conditions which simultaneously affect the population of patients with chronic renal insufficiency are now felt as of primary importance. The study was approved by Ethical Committees of all Nephrology Units participating into the MAURO study.

Specific hypotheses:

This study is designed as a clinical trial aimed at assessing whether a quality improvement intervention is more effective than standard care for improving adherence to a series of quality indicators relevant to the prevention of renal disease progression and associated cardiovascular complications. The multi-method quality improvement intervention (intensive intervention) adds telephone and e-mail contacts (for quality improvement facilitation) and audits to the approach of periodic guideline dissemination used in standard care.

Objective(s):

Test whether the intensive intervention improves renal and cardiovascular outcomes in patients with chronic renal insufficiency.

Test whether the intensive intervention improves adherence to a series of quality indicators relevant to hypertension control, proteinuria, treatment of dyslipidemia, anemia and calcium and phosphate alterations.

Endpoints:

The primary end point is a composite renal and cardiovascular end point, i.e. >30% decrease in the GFR, dialysis, transplantation, death or cardiovascular event [ECG documented angina or myocardial infarction, heart failure, arrhythmia (atrial fibrillation), cerebro-vascular event (stroke or transient ischemic attacks) or peripheral vascular diseases].

The renal unit-level outcome is the percentage of performance targets achieved. The patient level outcome is the percentage of patients for whom the recommended process measures occurs.

Key Inclusion Criteria:

  • Average of at least 2 measurements of creatinine >1.5-4.0 mg/dL (males) and >1.3-3.5 mg/dL (females) during the six months run-in period or albuminuria> 30 mg/24h in at least two consecutive visits
  • Previous diagnosis of specific nephropathy
  • Non acute or rapidly evolving renal diseases
  • Age range :18 - 75 years.
  • Non-transplanted.
  • Non-pregnant.
  • Not affected by cancer or diseases in the terminal phase.

Study Design and procedures:

Randomized, controlled clinical trial, with the renal clinic as the unit of randomization.The two study arms (multi-intervention including AUDIT vs standard care) will be informed on the general aim of the study but will be kept blinded to the type of intervention made [(PRospective Blinded Intervention Design (PROBID)].

Drug Dosage, schedule and Route of Administration:

Drugs for the treatment of blood pressure, dyslipidemia, anemia and alterations in calcium phosphate metabolism will be administered according to doses recommended by the guidelines promoted by the Italian society of Nephrology and by the KDOQI guidelines.

Study duration:

Three years.

Sample Size for the primary end-point:

The sample size was calculated with the underlying assumption that the intracluster correlation coefficient (ICC)(estimated in a pilot study) be 0.016. The expected annual rate of the primary end point (at least 36% in 3 years) was derived from a previous study (3). With this background in mind, we found that allocating 330 patients in the active arm and 330 in the control arm, the study will have a 80% power for capturing as statistically significant (P <0.05, two tailed) a 1/3 risk reduction in three years (36% vs 24%) in the intensive intervention group.

Corollary information:

During the study a sera and DNA data-bank will be created to allow testing a series of open questions on renal disease progression and associated cardiovascular complications.

Ethical considerations:

The protocol is in conformity with the declaration of Helsinki and informed consent will be asked for to all participants.

Nephrology Units participating into the MAURO study:

Reggio Calabria, Melito(RC), Locri(RC), Palmi(RC), Taurianova(RC), Catanzaro(2 Units), Soverato(CZ), Lamezia(CZ), Cosenza, Lungro(CS), Rossano(CS), S.Giovanni in Fiore(CS), Paola(CS), Amantea-Praia a Mare(CS), Vibo Valentia-Tropea-Soriano(VV), Crotone, Messina, Catania, Acireale(CT), Sassari, Francavilla(TA).

References:

  1. Hayward RS. Clinical practice guidelines on trial. CMAJ 1997; 156:1725-1727.
  2. De Nicola L, Minutolo R, Chiodini P, Zoccali C, Castellino P, Donadio C, Strippoli M, Casino F, Giannattasio M, Petrarulo F, Virgilio M, Laraia E, Di Iorio BR, Savica V, Conte G; TArget Blood Pressure LEvels in Chronic Kidney Disease (TABLE in CKD) Study Group. Global approach to cardiovascular risk in chronic kidney disease: reality and opportunities for intervention. Kidney Int 2006;69:538-545.
  3. Sarnak MJ, Greene T, Wang X, Beck G, Kusek JW, Collins AJ, Levey AS.The effect of a lower target blood pressure on the progression of kidney disease: long-term follow-up of the modification of diet in renal disease study.1: Ann Intern Med 2005; 142: 342-351.

Study Type

Interventional

Enrollment (Actual)

788

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Calabrian, Sicily, Puglia and Sardenia Regions, Italy
        • Nephrology Units participating to the MAURO study in the

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Creatinine >1.5 -4.0 mg/dL (males) and >1.3-3.5 mg/dL (females).
  • Age range :18 - 75 years

Exclusion Criteria:

  • Transplanted
  • Pregnant
  • Affected by cancer or diseases in the terminal phase
  • Non acute or rapidly evolving renal diseases.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Behavioral: Audit-driven intervention
Patients included in this arm will undergo to the multi-method quality improvement intervention (intensive intervention) that adds practice visits, telephone and e-mail contacts (for quality improvement facilitation) and audits to the approach of periodic guideline dissemination and feedback on demand used in the less intensive intervention.
No Intervention: 2
Patients in this arm (arm 2) will undergo to standard care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
A composite renal and cardiovascular (CV) end point, i.e. >30% decrease in the GFR, dialysis, transplantation, death or CV event.
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
The primary renal unit-level outcome is the percentage of performance targets achieved. The primary patient-level outcome is the percentage of patients for whom the recommended process measures occurs.
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy

Investigators

  • Study Director: Carmine Zoccali, Prof., CNR-IBIM & Nephrology Unit of Reggio Calabria

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

November 29, 2007

First Submitted That Met QC Criteria

November 29, 2007

First Posted (Estimate)

November 30, 2007

Study Record Updates

Last Update Posted (Estimate)

January 31, 2012

Last Update Submitted That Met QC Criteria

January 27, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MAURO-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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