Condition category
Circulatory System
Date applied
29/05/2008
Date assigned
29/05/2008
Last edited
18/08/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims.
The potential benefits of new drug treatments and increased medication use have not been fully realized, even though the proportion of health costs due to drug costs continues to rise on a yearly basis. This has created a need to investigate new methods to maximize the benefits of existing and new drug treatments while minimizing costs. This research will build on North American initiatives to implement electronic prescribing and integrated drug management systems to improve safety. The study will assess whether access to detailed comparative information on patient out-of-pocket cost for drugs of equivalent effectiveness at the time of prescribing will reduce the overall cost of medication prescribed for elderly patients. The intervention will target medications commonly used to treat cardiovascular disease, high cholesterol, acid-peptic disease, and common chronic respiratory problems. It will also determine the impact on patient adherence with the targeted prescription medications. The results of this research will help to assess the degree to which evidence-based decision-support systems for chronic disease management can be integrated into drug management systems and produce improvements in quality and outcome of care by primary care physicians.

Who can participate?
Physicians are eligible for inclusion if they are primary care practitioners who treat elderly patients and are participating in part or full-time practices in Quebec City, Montreal, or Boston in the electronic prescribing and integrated electronic medical record projects (MOXXI in Quebec and the Partners Healthcare Longitudinal Medical Record with RxHub in Boston).
Patients will be eligible for inclusion in the study if they are 65 years of age or older, and make one or more visits to an enrolled study physician during follow-up. Only patients who have been prescribed or dispensed one or more of the target medications (i.e. antihypertensives, lipid-lowering drugs, anti-ulcer drugs, and drugs for asthma and COPD) during follow-up will be eligible.

What does the study involve?
A study with 12 months of follow-up will be conducted in 100 primary care clinics, representing 300 physicians and 52,852 of their elderly patients. Clinics, sorted by city, size, and baseline drug costs for elderly patients, will be randomly allocated to receive a) comparative expected patient out-of-pocket expenditure information or b) the integrated drug management/electronic record system alone. Comparative expected patient out-of-pocket expenditure information will be provided for elderly patients receiving drug treatment for cardiovascular disease, hyperlipidemia, acid-peptic disease, and common chronic respiratory problems as drug treatment for these conditions is responsible for 65% of the drug budget and is the fastest growing sector of expenditure.

What are the possible benefits and risks of participating?
This study involves minimal to no risk.

Where is the study run from?
The study is run from Quebec City and Montreal, Quebec, Canada and Boston, MA, USA

When is study starting and how long is it expected to run for?
The study started on January 1st, 2009 and is expected to run until January 1st, 2014

Who is funding the study?
Canadian Institutes of Health Research (CIHR)

Who is the main contact?
Dr. Robyn Tamblyn
robyn.tamblyn@mcgill.ca

Trial website

http://www.moxxi.mcgill.ca

Contact information

Type

Scientific

Primary contact

Dr Robyn M. Tamblyn

ORCID ID

Contact details

Université McGill
1140
av des Pins ouest
Montreal
Quebec
H3A 1A3
Canada
+1 514 934 1934 ext. 32999
robyn.tamblyn@mcgill.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

MCT-82331

Study information

Scientific title

Providing comparative out-of-pocket cost information for prescription drugs through an integrated physician electronic prescribing system: a proof of concept with anti-hypertensive drugs

Acronym

Study hypothesis

The primary objective is to determine if provision of comparative information on expected out-of-pocket expenditures for anti-hypertensive drugs to physicians at the time of prescribing for uncomplicated hypertension therapy will increase the proportion of patients receiving more cost-effective treatment. The secondary objective is to determine if primary and secondary adherence with anti-hypertensive medication is improved by providing physicians with information needed to reduce out-of-pocket expenditures for anti-hypertensive treatment.

As of 14/06/2012, the following changes have been made on the trial record:
1. Anticipated start date has been amended from 01/07/2007 to 26/01/2009.
2. Anticipated end date has been amended from 01/07/2009 to 31/10/2013.

Please note that as of 30/04/2013, the following changes have been made to the trial record:
1. The anticipated start date of this trial has been updated from 26/01/2009 to 01/01/2009
2. The anticipated end date of this trial has been updated from 31/10/2013 to 01/01/2014

Ethics approval

Institutional Review Board of McGill University/Université McGill approved on the 20th September 2006 (ref: A07-B27-06b)

Study design

Cluster randomised single blind (study participant, caregiver, outcome assessor, data analyst), single centre, interventional trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

Uncomplicated hypertension

Intervention

1. Control: basic integrated prescribing and medical record system
2. Experimental: control and comparative information on out-ot-pocket expenditures at time of prescribing

Contact for public queries:
Patricia Plouffe
Tel: +1 514 934 1934 ext 32999
Fax: +1 514 843 1551
Email: patricia.plouffe@mcgill.ca

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Monthly cost of prescription(s) for uncomplicated hypertension at last date of prescribed or dispensed anti-hypertensive medication in the 12-month follow up period.

Secondary outcome measures

Primary and secondary adherence to anti-hypertensive medication during last six months of follow up.

Overall trial start date

01/01/2009

Overall trial end date

31/12/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Male or female subjects, 18 years of age or older
2. Make one or more visits to an enrolled study physician during follow-up
3. Have a diagnosis of uncomplicated hypertension (i.e. hypertension recorded by the study physician in the therapeutic indication field that must be completed with each prescription)
4. No documented diabetes, congestive heart failure, established atherosclerotic disease, peripheral arterial disease, ischaemic heart disease (angina or prior myocardial infarction), past cerebrovascular accident or transient ischaemic attack (TIA), renal disease, asthma, chronic obstructive pulmonary disease (COPD) or left ventricular hypertrophy

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

8733 patients, 97 primary care physicians

Participant exclusion criteria

1. Documented diabetes
2. Congestive heart failure
3. Established atherosclerotic disease
4. Peripheral arterial disease
5. Ischaemic heart disease (angina or prior myocardial infarction)

Recruitment start date

31/05/2011

Recruitment end date

30/09/2016

Locations

Countries of recruitment

Canada

Trial participating centre

Université McGill
Montreal, Quebec
H3A 1A3
Canada

Sponsor information

Organisation

McGill University (Université McGill) (Canada)

Sponsor details

845 Sherbrooke Street West
James Administration Bldg.
Suite 429
Montreal
Quebec
H3A 2T5
Canada

Sponsor type

University/education

Website

http://www.mcgill.ca/

Funders

Funder type

Research organisation

Funder name

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-82331)

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

Publication citations

Additional files

Editorial Notes

18/08/2016: Overall study end date changed from 01/01/2014 to 31/12/2016. Recruitment start date change from 01/01/2009 to 31/05/2011. Recruitment end date changed from 01/01/2014 to 30/09/2016.