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

ISRCTN ISRCTN26610787
DOI https://doi.org/10.1186/ISRCTN26610787
Secondary identifying numbers N/A
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

Study designCluster randomized trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeQuality of life
Scientific title
Study objectivesA 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) studiedChronic kidney disease
InterventionThe 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 typeOther
Primary outcome measureUse 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.
Secondary outcome measures1. 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
Overall study start date01/04/2006
Completion date31/03/2008

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants46 Family Practices per group (92 total)
Key inclusion criteriaAll 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 criteriaThose patients not meeting the inclusion criteria.
Date of first enrolment01/04/2006
Date of final enrolment31/03/2008

Locations

Countries of recruitment

  • Canada

Study participating centre

1403-29th St NW
Alberta
T2N 2T9
Canada

Sponsor information

Alberta Heritage Foundation for Medical Research (Canada)
Research organisation

Suite 1500
10104-103 Avenue
Edmonton
T5J 4A7
Canada

Phone +1 780 423 5727
Email ahfmrinfo@ahfmr.ab.ca
Website http://www.ahfmr.ab.ca
ROR logo "ROR" https://ror.org/006b2g567

Funders

Funder type

Research organisation

Alberta Heritage Foundation for Medical Research (Canada)
Government organisation / Local government
Alternative name(s)
AHFMR
Location
Canada

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan