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
Secondary identifying numbers	CTGPC1

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

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

Study design	Cluster randomised controlled trial
Primary study design	Interventional
Secondary study design	Cluster randomised trial
Study setting(s)	GP practice
Study type	Other
Participant information sheet	Not available in web format, please use the contact details to request a patient 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 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(s)	Ethics Committee for Clinical Research, Euskadi (Comité Etico de Investigación Clínica de Euskadi) (CEIC-C), 25/07/2008
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.
Intervention type	Other
Primary outcome measure	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 study start date	01/01/2009
Overall study end date	30/06/2010

Eligibility

Participant type(s)	Patient
Age group	Other
Sex	Both
Target number of participants	43 health units, 400 family physicians, 380 nurses
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 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

Study participating centre

Osakidetza-Servicio Vasco de Salud (Basque Health Service)

Hernani
20120
Spain

Sponsor information

Ministry of Health (Spain)
Government

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

Phone	+34 (0)915961599
Email	privero@msc.es
Website	http://www.msc.es

Health Technology Assessment Service (Servicio de Evaluación de Tecnologías Sanitarias [OSTEBA])
Other

c/o José Asua Asurmendi
C/ Donostia-San Sebastian, 1
Vitoria-Gasteiz
01010
Spain

Phone	+34 (0)945 019250
Email	osteba-san@ej-gv.es
Website	http://www.osanet.euskadi.net/osteba/es

Ministry of Health
Government

Website	http://www.msssi.gob.es/
"ROR"	https://ror.org/00y6q9n79

Funders

Funder type

Government

Ministry of Health (Spain)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

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

Editorial Notes

13/02/2018: Publication reference added.