BedMed High Blood Pressure Study Reaches Milestone, Expands to Help More Canadians

Involvement from community physicians and patients helps build momentum for Canada’s largest primary care Randomized Control Trial

Danica Erickson - 26 February 2021

It’s often said that it’s best to avoid something that seems too good to be true.  For one researcher in the Department of Family Medicine, hearing about a study with results that seemed too good to be true was an opportunity to investigate further. The result of this investigation has become the largest non-industry supported primary care randomized control trial (RTC) ever conducted in Canada: BedMed, the High Blood Pressure Study.

It all started in 2010, when family physician and primary care researcher Scott Garrison was listening to a popular evidence-based medicine podcast called Best Science Medicine.The podcast hosts referred to a study, conducted by a Spanish research team, published earlier that year. The study, called MAPEC, reported a 61% reduction in a composite of death, stroke, heart attack and other cardiovascular outcomes if blood pressure pills were taken at bedtime rather than in the morning. These results were outstanding; this simple change in timing made a bigger difference than anything else that had been done to treat high blood pressure. However, the results didn’t change medication practice, which Garrison attributes to the obscurity of the publishing journal and results seeming too good to be true. He believed the results warranted further investigation.

By the time he heard the podcast that mentioned MAPEC, Garrison had spent nearly 20 years as a practicing family physician in British Columbia. Over the course of his practice, he had developed a significant interest in primary care research, and built a strong track record of organizing physicians to be involved in studies. Lee Green, chair of the Department of Family Medicine, heard about Garrison<s work through the Best Science Medicine podcast host Dr. Mike Allan, and contacted him about his research interests. Following their conversation, Green suggested Garrison consider applying for a faculty position being created in the Department of Family Medicine.       

When Garrison joined the Department of Family Medicine at the University of Alberta, he brought his research project with him. In October of 2016, he was awarded an Alberta Innovates PRIUS 3 Grant for the study, and was able to start enrolling the first patients in Alberta in early spring 2017. Using the PRIUS grant as matching funding, the team was then able to secure a Canadian Institutes of Health Research (CIHR) Strategy for Patient Oriented Research (SPOR) Innovative clinical trial grant. That grant allowed the study to be expanded into BC and Manitoba. Eventually they had opportunities to also expand into Saskatchewan and Ontario and physicians and patients from five provinces are now currently involved in BedMed.

There are now 359 family physicians involved in the study, most of whom are participating in research for the first time, which is an unprecedented level of engagement from Canadian family physicians which means unique new research capacity is being developed. “We’re creating new and unique research capacity." explains Garrison. "Doctors that are participating with us are generally participating in research for the first time and are generally remote from academic centres. If you were to look at a map of where all these people are, they’re spread across the map; they’re not just in major centres. So it really is community research.” Garrison believes the high rate of involvement is because the study is primary care-led; it’s research for primary care by primary care and the physicians involved know they are working together to answer a big question that matters, because high blood pressure is a medical condition that affects 1 in 5 Canadians.

Within two years of starting, BedMed reached a significant milestone; the patient participation rate surpassed the number of patients enrolled in the study it was modelled after. The MAPEC study enrolled 2,165 in total, and BedMed has enrolled 2,631 patients as of August 4, 2020. Since then, an additional 10 physicians have agreed to participate, and Garrison predicts 3,200 - 3,500 patients will be randomized by the time enrollment stops in summer 2021. A well-planned social media campaign also helped to reach that milestone. The research team created a website, used Google and Facebook ads, and ran the same ads on closed-circuit TVs in Alberta Health Service waiting rooms. The campaign resulted in roughly 300 additional participants being recruited. 

BedMed, with a 10-member patient working group helping to guide the trial, is a demonstration project for the Alberta Supports for People and Patient-oriented Research (SPOR) Patient Engagement Platform. It is also breaking ground for the SPOR Canadian Data Platform, a new initiative from the CIHR which provides access to health and social data from a variety of sources across Canada. Garrison has been asked to be part of the platform’s advisory committee.

As the study proceeded, the team launched a second randomized trial, BedMed-Frail, which employs the same intervention in 18 nursing homes in Alberta. The Alberta Health Services Data Steward is supporting both trials. "For BedMed-Frail, the data steward identifies eligible patients, randomizes them, communicates the allocation to caregivers, and accesses and analyses all study outcomes and baseline characteristics. This is a completely new relationship for researchers and government that facilitates robust and inexpensive comparative effectiveness evaluations. AHS plays a much bigger role in our trials than I think they've ever done. I don’t know of any other study that's been done this way." says Garrison.

Garrison anticipates enrolling 1,200 long term care residents and observing them over the period of a few years. BedMed Frail is important because people who are frail and elderly are normally excluded from randomized trials and the risks and benefits could be very different for them. "That's why it's important to do this study; no one else is ever going to study this if we don’t." he emphasizes. "If BedMed results are published, and people start believing it should go one way or the other, nobody is going to go back and look separately at this frail group; they'll typically just apply the results from a younger, healthier group to frail elders. So we thought it was important because we have the opportunity. There is one other group trying to validate the MAPEC trial findings, but we are the only ones looking at a frail population."

Click here to find out how you or someone you know can participate in BedMed: the HIgh Blood Pressure Study.