Condition category
Circulatory System
Date applied
13/01/2009
Date assigned
30/04/2009
Last edited
29/10/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Ms Arritxu Etxeberria

ORCID ID

Contact details

Osakidetza-Servicio Vasco de Salud (Basque Health Service).
Centro de Salud de Hernani
C.S. Hernani
Aristizabal 1
Hernani
20120
Spain
+34 943 006655
arritxu.etxeberriaagirre@osakidetza.net

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CTGPC1

Study information

Scientific title

Evaluation of a multifaceted implementation strategy of three Clinical Practice Guidelines on cardiovascular risks in primary health care in the Basque Country: a cluster randomised trial

Acronym

CLUES

Study hypothesis

An implementation strategy that includes interactive presentations, a web platform and workshops with reminders is more effective than the usual strategy in the Basque Health Service.

Ethics approval

Ethics Committee for Clinical Research, Euskadi (Comité Etico de Investigación Clínica de Euskadi) (CEIC-C), approved on 25/07/2008

Study design

Cluster randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Cardiovascular risk, hypertension, diabetes, dyslipemia

Intervention

Control group (usual intervention): guidelines sent by post, electronic dissemination, presentations in health centres, limited number of workshops.

Experimental group (multifaceted intervention): usual intervention plus Clinical Practice Guidelines (CPG) website, feedback on performance data, specific workshops and reminders.

Intervention will last for 12 weeks, with reminders at 6 and 12 months from the beginning of the intervention. Total duration of follow up is 18 months from the beginning of the intervention.

Details of Joint Sponsor:
Health Technology Assessment Service (Servicio de Evaluación de Tecnologías Sanitarias [OSTEBA])
c/o José Asua Asurmendi
C/ Donostia-San Sebastian, 1
Vitoria-Gasteiz
01010
Spain
Tel: +34 945 019250
Fax: +34 945 019280
Email: osteba-san@ej-gv.es
Website: http://www.osanet.euskadi.net/osteba/es

Details of Principal Investigator:
Ms Iciar Pérez Irazusta
Unidad Docente de Medicina Familiar y Comunitaria
Hospital Donostia
Buzón 60
Paseo Begiristain s/n
San Sebastian
20014
Spain
Tel: 0034 943007629
Email: iciar.perezirazusta@osakidetza.net

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Hypertension:
1.1. Percentage of patients monitored over the study period (blood pressure and blood analysis registered)
2. Dyslipemia:
2.1. Percentage of patients (women >44 of age and men >39) whose coronary risk has been calculated during the study period
2.2. Percentage of patients with new statin prescription whose coronary risk was calculated during the previous year
3. Diabetes:
3.1. Percentage of patients with HbA1c determination during the study period

All primary and secondary outcome measures will be assessed at the end of the study period, i.e., 18 months after initiation of intervention.

Secondary outcome measures

1. Hypertension:
1.1. Systolic blood pressure (SBP), diastolic blood pressure (DBP)
1.2. Percentage of patients with good blood pressure control (<140 mmHg/90 mmHg)
1.3. Percentage of patients with high blood pressure (>140/90 mmHg) being treated with only one drug
1.4. Percentage of patients treated with an angiotensin II receptor blocker (ARB-II)
2. Dyslipemia:
2.1. Patients with coronary heart disease treated with statins

All primary and secondary outcome measures will be assessed at the end of the study period, i.e., 18 months after initiation of intervention.

Overall trial start date

01/01/2009

Overall trial end date

30/06/2010

Reason abandoned

Eligibility

Participant inclusion criteria

Primary care units from two health districts (family physicians and nurses). Data will be taken from the computerised clinical records of all diabetics, hypertensive patients and general patients, who have attended the health centre over the last year for whatever reason.

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

43 heath units, 400 family physicians, 380 nurses

Participant exclusion criteria

Units, physicians and nurses who refuse to take part in the study

Recruitment start date

01/01/2009

Recruitment end date

30/06/2010

Locations

Countries of recruitment

Spain

Trial participating centre

Osakidetza-Servicio Vasco de Salud (Basque Health Service).
Hernani
20120
Spain

Sponsor information

Organisation

Ministry of Health (Spain)

Sponsor details

c/o Pablo Rivero
Agencia de Calidad del Sistema Nacional de Salud
Ministerio de Sanidad y Consumo
C/Paseo del Prado
18-20
Madrid
28071
Spain
+34 915961599
privero@msc.es

Sponsor type

Government

Website

http://www.msc.es

Funders

Funder type

Government

Funder name

Ministry of Health (Spain)

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 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24156549

Publication citations

  1. Protocol

    Etxeberria A, Pérez I, Alcorta I, Emparanza JI, Ruiz de Velasco E, Iglesias MT, Orozco-Beltrán D, Rotaeche R, The CLUES study: a cluster randomized clinical trial for the evaluation of cardiovascular guideline implementation in primary care., BMC Health Serv Res, 2013, 13, 438, doi: 10.1186/1472-6963-13-438.

Additional files

Editorial Notes