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
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
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