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 number NCT00374829
Secondary identifying numbers DCT 67995
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

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleThe impact of a multidisciplinary information technology-supported program on blood pressure control in primary care.
Study objectivesIt 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) studiedHypertension
InterventionIntervention:
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 typeOther
Primary outcome measureThe 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.
Secondary outcome measures1. 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 patient’s 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 payer’s perspective
Overall study start date01/05/2004
Completion date01/02/2008

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants500
Key inclusion criteria1. Male and female uncontrolled hypertensive subjects
2. 18 years of age or more
Key exclusion criteria1. 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 enrolment01/05/2004
Date of final enrolment01/02/2008

Locations

Countries of recruitment

  • Canada

Study participating centre

University of Montreal
Montréal, QC
H2L 4M1
Canada

Sponsor information

Canadian Institutes of Health Research (CIHR) (Canada)
Research organisation

Room 97
160 Elgin Street
Address locator: 4809A
Ottawa, ON
K1A OW9
Canada

Phone +1 888 603 4178
Email info@cihr-irsc.gc.ca
Website http://www.cihr-irsc.gc.ca
ROR logo "ROR" https://ror.org/01gavpb45

Funders

Funder type

Research organisation

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: DCT 67995)

No information available

Pfizer Canada Inc. (Canada)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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