The Impact of Laboratory-based Prompts on the Management of Patients with Chronic Kidney Disease

ISRCTN	ISRCTN26610787
DOI	https://doi.org/10.1186/ISRCTN26610787
Protocol serial number	N/A
Sponsor	Alberta Heritage Foundation for Medical Research (Canada)
Funder	Alberta Heritage Foundation for Medical Research (Canada)

Submission date: 10/02/2006
Registration date: 10/07/2006
Last edited: 14/02/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Bruce Culleton
Scientific

1403-29th St NW
Calgary
Alberta
T2N 2T9
Canada

Phone	+1403 944 8166
Email	bruce.culleton@calgaryhealthregion.ca

Study information

Primary study design	Interventional
Study design	Cluster randomized trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	A laboratory prompt, which identifies a patient with chronic kidney disease (CKD) as being at high risk for cardiovascular disease and progression to kidney failure, improves the management of cardiovascular disease risk factors and kidney disease by physicians.
Ethics approval(s)	Approved by Bioethics Committess at the University of Calgary and the University of Alberta, 2005, reference number: 18050
Health condition(s) or problem(s) studied	Chronic kidney disease
Intervention	The following prompt will be added to laboratory reports for patients who meet the inclusion criteria and are seen by a physician practice randomized to receive the prompt: This patient has reduced kidney function and is at risk for cardiovascular events and progression to kidney failure. The National Kidney Foundation recommends: 1. Measure random urine albumin to creatinine (Alb:Cr) ratio 2. Institute an angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB) in patients with diabetes, or those with an Alb:Cr >35 mg/mmol 3. Referral to a nephrologist if GFR <30 ml/min/1.73 m^2 4. Assess and treat modifiable risk factors for cardiovascular (CV) and renal disease: a. Target blood pressure (BP) less than 130/80 mmHg b. Target low-density lipoprotein cholesterol(LDL-C) <2.5 mmol/l c. If diabetic, target hemoglobin A1C (HbA1C) <7.0% The above recommendations are general in nature and may not apply to all patients. Further information is available at http://www.akdn.info The control group will receive usual care.
Intervention type	Other
Primary outcome measure(s)	Use of ACEi or ARB in patients >65 years of age with CKD who have a clear indication for ACEi or ARB use as defined by the presence of diabetes or significant albuminuria.
Key secondary outcome measure(s)	1. Use of an ACEi or ARB in patients >65 years of age with CKD 2. Subsequent measurement of lipids, hemoglobin A1C (in patients with diabetes, if not done in previous six months), urine protein or urine albumin, and subsequent frequency of measurement of serum creatinine 3. Referral to a specialist 4. Addition of cholesterol-lowering drugs in patients >65 years of age 5. Addition of new blood pressure medication(s) in patients >65 years of age 6. Health care costs
Completion date	31/03/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	92
Key inclusion criteria	All patients >18 years of age who are registered with one of the participating general practices and have a GFR measured at <60 ml/min during the one-year study period will be included. All participating general practices will be geographically separated (not located in the same office building), and staffed by >1 full time practitioners who do not see outpatients in another general practice unit (to reduce the risk of contamination).
Key exclusion criteria	Those patients not meeting the inclusion criteria.
Date of first enrolment	01/04/2006
Date of final enrolment	31/03/2008

Locations

Countries of recruitment

Canada

Study participating centre

1403-29th St NW

Alberta
T2N 2T9
Canada

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan