Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
7395/4843 (HF)
Study information
Scientific title
Acronym
QI CKD
Study hypothesis
This cluster randomised trial (CRT) will compare two well-established quality improvement interventions with usual practice. The two intervention arms are:
1. Provision of clinical practice guidelines with prompts
2. Audit-based education
Ethics approval
Ethics approval received from the Oxford Research Ethics Committee (Committee C) on the 31st October 2006 (ref: 07/H0606/141).
Study design
A two-year three-armed cluster randomised trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Quality of life
Patient information sheet
Condition
Chronic kidney disease
Intervention
The three interventions are:
1. Usual practice: a minimum of contacts will be made of these practices other than for data collection (n = 35 practices)
2. Distribution of clinical practice guidelines with prompts: this is an established, low cost method. It will provide a benchmark with which the effectiveness of other quality improvement interventions can be compared. We will develop a consensus between the study team, our expert advisory group and external peer reviewers', and produce appropriate guidance for the management of CKD in primary care. We will use the "Appraisal of Guidelines Research and Evaluation" (AGREE) instrument do to this. AGREE is a validated guideline development tool. This guidance will be distributed to practices with quarterly updates/reminders (n = 35 practices). In addition practices will have access to a supportive website with information about CKD, frequently asked questions (FAQs) and tools to improve CKD management.
3. Audit-based education: in addition to clinical practice guidelines, practices will receive six-monthly detailed comparative feedback about their quality of CKD management (n = 35 practices)
The total duration of the intervention is two years.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
The reduction of systolic blood pressure in hypertensive people with stage 3 to 5 chronic kidney disease according to the agreed target.
The measure of primary and secondary outcome measures will take place at t = 0 (baseline), t = 1 year and t = 2 years.
Secondary outcome measures
Clinical and laboratory markers:
1. Recording and management of key co-morbidities:
1.1. Diabetes and its complications
1.2. Ischaemic heart disease
1.3. Heart failure
1.4. Obstruction/lower urinary tract symptoms
2. Recording and management of other cardiovascular risk factors:
2.1. Smoking status
2.2. Lipid management
2.3. Proteinuria
2.4. Anaemia
2.5. Glycated haemoglobin and microalbuminuria in people with diabetes mellitus
3. Serial measures of serum creatinine concentration and estimated glomerular filtration rate (GFR)
4. Avoiding harm. We wish to collect data to monitor whether blood pressure reduction is associated with an increased number of falls particularly in older people. Most people with CKD are elderly and at potential risk of falls. Notwithstanding the results of recent systematic reviews which failed to show an association between falls and anti-hypertensive medication, this possibility remains a genuine concern to some practitioners, and one that we propose to examine. A falls dataset will be devised and integrated into the renal dataset. We will investigate the relationship with use of angiotensin converting enzymes (ACE) inhibitors and angiotensin II receptor blockers and systolic blood pressure below 120 in CKD.
5. Practitioner confidence to be measured at t = 0, t = 1 year, and at end of project
6. Medicines management:
6.1. Use of drugs/therapy which affect renal function (for example non-steroidal anti-inflammatory drugs)
6.2. Use of angiotensin converting enzyme inhibitors and angiotensin II receptor blockers to control hypertension
6.3. Recording of medicines possession ratio based on days prescribed therapy as an index of concordance with anti-hypertensive therapy
The measure of primary and secondary outcome measures will take place at t = 0 (baseline), t = 1 year and t = 2 years.
Overall trial start date
01/04/2007
Overall trial end date
01/04/2010
Reason abandoned
Eligibility
Participant inclusion criteria
The primary research participants are general practitioners involved in the study who will receive the various quality improvement interventions listed below. The interventions will be implemented at the practice (cluster) rather than the individual level. The study subjects (who may be regarded as secondary participants) will be all individuals with chronic kidney disease within the study practices.
Inclusion criteria:
1. Practices who provide written consent to participate
2. Locality specialist who will support the participation of the practice and the implementation of standard guidelines across the participating practices (appropriate to the arm of the study they are involved in)
3. Primary Care Trust (PCT) commissioners' engagement with the project and willingness to consider learning from its findings
4. Practice has had the same computer system for the last five years and has no plans to change it, or will allow access to check data quality
5. Practice has electronic laboratory links for the last three years
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
105 GP practices
Participant exclusion criteria
1. Practices in whom the computing system has changed over the last five years
2. Practices lacking an appropriate computer system from which data can be extracted
3. Practices in which referral data (from primary care to secondary care) is not available
Recruitment start date
01/04/2007
Recruitment end date
01/04/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department in Health Care
Guildford
GU2 7XH
United Kingdom
Sponsor information
Organisation
St George's University of London (UK)
Sponsor details
Research and Development Office
Cranmer Terrace
London
SW17 0RE
United Kingdom
+44 (0)20 8725 5661
slusigna@sgul.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
The Health Foundation (UK) (ref: 7395/4843 (HF))
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Kidney Research (UK) (ref: CDK/2007)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23351270
2013 cross-sectional analysis in http://www.ncbi.nlm.nih.gov/pubmed/23442335
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24040373
Publication citations
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Results
Dmitrieva O, de Lusignan S, Macdougall IC, Gallagher H, Tomson C, Harris K, Desombre T, Goldsmith D, Association of anaemia in primary care patients with chronic kidney disease: cross sectional study of quality improvement in chronic kidney disease (QICKD) trial data., BMC Nephrol, 2013, 14, 24, doi: 10.1186/1471-2369-14-24.
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Results
McGovern AP, de Lusignan S, van Vlymen J, Liyanage H, Tomson CR, Gallagher H, Rafiq M, Jones S, Serum phosphate as a risk factor for cardiovascular events in people with and without chronic kidney disease: a large community based cohort study., PLoS ONE, 2013, 8, 9, e74996, doi: 10.1371/journal.pone.0074996.
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Kearns B, Gallagher H, de Lusignan S, Predicting the prevalence of chronic kidney disease in the English population: a cross-sectional study., BMC Nephrol, 2013, 14, 49, doi: 10.1186/1471-2369-14-49.