Open Access Study protocol

The QICKD study protocol: a cluster randomised trial to compare quality improvement interventions to lower systolic BP in chronic kidney disease (CKD) in primary care

Simon de Lusignan1*, Hugh Gallagher12, Tom Chan1, Nicki Thomas3, Jeremy van Vlymen1, Michael Nation4, Neerja Jain4, Aumran Tahir1, Elizabeth du Bois5, Iain Crinson1, Nigel Hague1, Fiona Reid1 and Kevin Harris6

Author Affiliations

1 Division of Community Health Sciences, St George's – University of London, London, SW17 0RE, UK

2 SW Thames Institute for Renal Research, St Helier Hospital, Carshalton, Surrey, SM5 1AA, UK

3 Department of Public Health Primary Care and Food Policy, City Community and Health Sciences, City University, 20, Bartholomew Close, London, EC1A 7QN, UK

4 Kidney Research UK, Kings Chambers, Priestgate, Peterborough, PE1 1FG, UK

5 Public Health Department, Wandsworth PCT, Wimbledon Bridge House (3rd Floor), 1, Hartfield Road, London, SW19 3RU, UK

6 University Hospitals of Leicester, John Walls Renal Unit, Leicester General Hospital, Leicester, LE5 4PW, UK

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Implementation Science 2009, 4:39  doi:10.1186/1748-5908-4-39

Published: 14 July 2009

Abstract

Background

Chronic kidney disease (CKD) is a relatively newly recognised but common long-term condition affecting 5 to 10% of the population. Effective management of CKD, with emphasis on strict blood pressure (BP) control, reduces cardiovascular risk and slows the progression of CKD. There is currently an unprecedented rise in referral to specialist renal services, which are often located in tertiary centres, inconvenient for patients, and wasteful of resources. National and international CKD guidelines include quality targets for primary care. However, there have been no rigorous evaluations of strategies to implement these guidelines. This study aims to test whether quality improvement interventions improve primary care management of elevated BP in CKD, reduce cardiovascular risk, and slow renal disease progression

Design

Cluster randomised controlled trial (CRT)

Methods

This three-armed CRT compares two well-established quality improvement interventions with usual practice. The two interventions comprise: provision of clinical practice guidelines with prompts and audit-based education.

The study population will be all individuals with CKD from general practices in eight localities across England. Randomisation will take place at the level of the general practices. The intended sample (three arms of 25 practices) powers the study to detect a 3 mmHg difference in systolic BP between the different quality improvement interventions. An additional 10 practices per arm will receive a questionnaire to measure any change in confidence in managing CKD. Follow up will take place over two years. Outcomes will be measured using anonymised routinely collected data extracted from practice computer systems. Our primary outcome measure will be reduction of systolic BP in people with CKD and hypertension at two years. Secondary outcomes will include biomedical outcomes and markers of quality, including practitioner confidence in managing CKD.

A small group of practices (n = 4) will take part in an in-depth process evaluation. We will use time series data to examine the natural history of CKD in the community. Finally, we will conduct an economic evaluation based on a comparison of the cost effectiveness of each intervention.

Clinical Trials Registration

ISRCTN56023731. ClinicalTrials.gov identifier.