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

ISRCTN	ISRCTN88876909
DOI	https://doi.org/10.1186/ISRCTN88876909
Protocol serial number	CTGPC1
Sponsors	Ministry of Health (Spain), Health Technology Assessment Service (Servicio de Evaluación de Tecnologías Sanitarias [OSTEBA]), Ministry of Health
Funder	Ministry of Health (Spain)

Submission date: 13/01/2009
Registration date: 30/04/2009
Last edited: 13/02/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Ms Arritxu Etxeberria
Scientific

Osakidetza-Servicio Vasco de Salud (Basque Health Service).
Centro de Salud de Hernani
C.S. Hernani
Aristizabal 1
Hernani
20120
Spain

Phone	+34 (0)943 006655
Email	arritxu.etxeberriaagirre@osakidetza.net

Ms Iciar Pérez Irazusta
Scientific

Unidad Docente de Medicina Familiar y Comunitaria
Hospital Donostia
Buzón 60
Paseo Begiristain s/n
San Sebastian
20014
Spain

Phone	+34 (0)943007629
Email	iciar.perezirazusta@osakidetza.net

Study information

Primary study design	Interventional
Study design	Cluster randomised controlled trial
Secondary study design	Cluster randomised trial
Study type	Participant information sheet
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
Study acronym	CLUES
Study objectives	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(s)	Ethics Committee for Clinical Research, Euskadi (Comité Etico de Investigación Clínica de Euskadi) (CEIC-C), 25/07/2008
Health condition(s) or problem(s) studied	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.
Intervention type	Other
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	30/06/2010

Eligibility

Participant type(s)	Patient
Age group	Other
Sex	All
Target sample size at registration	780
Key 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.
Key exclusion criteria	Units, physicians and nurses who refuse to take part in the study
Date of first enrolment	01/01/2009
Date of final enrolment	30/06/2010

Locations

Countries of recruitment

Spain

Study participating centre

Osakidetza-Servicio Vasco de Salud (Basque Health Service)

Hernani
20120
Spain

Results and Publications

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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	08/02/2018		Yes	No
Protocol article	protocol	24/10/2013		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

13/02/2018: Publication reference added.