The impact of a multidisciplinary, information technology supported program on blood pressure control in primary care

ISRCTN	ISRCTN75436659
DOI	https://doi.org/10.1186/ISRCTN75436659
ClinicalTrials.gov (NCT)	NCT00374829
Protocol serial number	DCT 67995
Sponsor	Canadian Institutes of Health Research (CIHR) (Canada)
Funders	Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: DCT 67995), Pfizer Canada Inc. (Canada)

Submission date: 29/06/2004
Registration date: 22/07/2004
Last edited: 01/02/2019

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

Dr Stéphane Rinfret
Scientific

University of Montreal
Cardiology and Outcomes Research
Centre Hospitalier de l'Université de Montréal (Notre-Dame Hospital)
1560 Sherbrooke East
Montréal, QC
H2L 4M1
Canada

Phone	+1 514 890 8232
Email	s.rinfret@umontreal.ca

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	The impact of a multidisciplinary information technology-supported program on blood pressure control in primary care.
Study objectives	It is hypothesised that blood pressure control will be improved in patients receiving the program by increasing compliance with pharmacotherapy, the use of higher doses of anti-hypertensive agents and the use of more anti-hypertensive agents when appropriate, without adversely impacting quality of life.
Ethics approval(s)	Approval received from the local ethics committee (Cité de la Santé de Laval Comité d'éthique et de la recherche) in November 2003.
Health condition(s) or problem(s) studied	Hypertension
Intervention	Intervention: We have developed an Information Technology (IT)-based system to help empower patients to be responsible for monitoring their Blood Pressure (BP) and compliance and to facilitate communication with healthcare providers. The IT-based system links with actual pharmacy prescription refill and renewal data. Using these data as well as responses to questions on compliance and BP control that patients provide, the system: a. offers patients counselling and telephone reminders b. generates prescription refill and renewal reminder calls c. monitors patient recorded BP The system generates monthly reports to the treating physician and pharmacist on compliance and blood pressure control, a retroaction that we expect will guide therapy. The system also links patients with a nurse if BP is inadequately controlled and/or if patients are non-compliant. These nurses can then provide appropriate counselling to patients and refer the patients to their physician or pharmacist as appropriate. Control: The control group will receive standard care with no access to the IT-based system and multidisciplinary approach.
Intervention type	Other
Primary outcome measure(s)	The primary objective of this study is to evaluate the impact of a multidisciplinary, information-technology supported hypertension management program on the mean change in 24-hour systolic and diastolic BP levels measured using Ambulatory Blood Pressure Monitoring (ABPM) compared to usual care.
Key secondary outcome measure(s)	1. To assess the likely mechanisms that account for the results for the primary objective by measuring refill compliance and the number and dosage of anti-hypertensive agents assessed through pharmacy prescription data records over the 12-month study period as well as the number and nature of interventions by pharmacists, nurses and physicians 2. To assess the effect of the program on mean daytime and nocturnal BP, office BP measured, the proportion of subjects who achieve target office BP 3. To assess the impact of the program on patients perceived health related quality of life 4. To assess the impact of the program on the incidence of adverse cardiovascular events, including hospitalisation for uncontrolled hypertension, new onset angina, myocardial infarction, hospitalisation for unstable angina, hospitalisation for congestive heart failure, hospitalisation for stroke, hospitalisation for other vascular event, and cardiovascular death 5. To evaluate the potential economic benefits of the intervention, from a third-party payers perspective
Completion date	01/02/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	500
Key inclusion criteria	1. Male and female uncontrolled hypertensive subjects 2. 18 years of age or more
Key exclusion criteria	1. Having a life-threatening disease 2. Chronic atrial fibrillation 3. Unable to use an ordinary telephone 4. Pregnant at the initial visit 5. Participating in another clinical trial 6. Living with another subject that is currently participating in the study
Date of first enrolment	01/05/2004
Date of final enrolment	01/02/2008

Locations

Countries of recruitment

Canada

Study participating centre

University of Montreal

Montréal, QC
H2L 4M1
Canada

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	01/05/2009	01/02/2019	Yes	No

Editorial Notes

01/02/2019: Publication reference added