Justification:
Low back pain (LBP) is a global problem creating more disability than cardiovascular
disease and cancer.
In Canada, many people with LBP seek care from general practitioners (GPs) whose services
are fully funded by public health programs. Although "free" to Canadians, most approaches
used by physicians to address LBP are of low-value - they are often ineffective and
potentially dangerous. While research shows that effective LBP interventions are
currently available including education, therapeutic exercise, reassurance, manual
therapy and non-opioid medications, most LBP patients don't receive these more effective
approaches because of their cost (they are not fully funded by public health care) and
their GPs are not trained to deliver them. As a result, most LBP patients receive
ineffective care that creates 1) unnecessary pain, ongoing disability and potential
painkiller addiction, 2) misuse of limited health resources and 3) systemic
de-integration of community clinicians who provide evidence-based care for LBP, but are
not funded by the current health care system (e.g. Chiropractors and Physical
Therapists). To overcome the increasing provision of low-value care for LBP in Canada,
the Alberta Back Care pathway has been created (ABCp). The ABCp incorporates GLA:D Back
programming (Good Life with Osteoarthritis: Denmark) the elements of which include
patient education, structured exercise and data collection. This new program provides
evidence-based care at no cost to the patient through innovative decision-making tools
that de-medicalize LBP care.
Objectives:
The primary objective is to evaluate the cost-saving performance measures, described by
three economic indicators known to be influenced by evidence-based care for LBP. These
include 1) the number of LBP visits to family physicians, 2) the number of family
physician referrals of LBP patients to specialists and 3) the number of LBP imaging
requests from family physicians.
The second objective is to evaluate Quality-Adjusted Life Years (QALY) derived from
patient-reported quality of life.
Hypotheses:
the primary outcome will be decreased healthcare resource utilization with secondary
improvements in quality of life and opioid consumption. The healthcare resource
utilization costs, at both sites, will decrease (a minimal 30% reduction in revisits,
imaging and referrals). Overall, the savings realized through ABCp will create a
self-sustaining, scalable solution for LBP care in Alberta.
Background:
LBP is a global problem responsible for more years lived with disability than any other
condition. As a result, health, societal, and economic burdens associated with LBP
approach those of cardiovascular disease, cancer, mental illness, and autoimmune
diseases.
While current evidence-based guidelines consistently recommend education, therapeutic
exercise and non-opioid medications, these recommendations are infrequently delivered by
GPs for many reasons including a lack of incentives and lack of effective implementation
strategies. In addition, patients often have preferences for imaging, procedures and
referrals and GPs or other clinicians may be complicit in providing ineffective
recommendations to appease their patients. Even when first-line treatments are available,
they typically require out-of-pocket payment or a health benefit plan thereby severely
limiting access for many Canadians. Together, these factors have conspired globally to
significantly increase chronic LBP while also increasing use of narcotics, imaging, and
specialist referrals.
The ~700,000 annual healthcare visits in Alberta related to LBP illustrate the above
problems clearly. Guideline-discordant LBP care accounts for much of the ~$54,000,000
spent on Emergency Departments (ED), Primary Care Networks (PCN) and specialist visits.
Guideline-discordant LBP care is not only low value but is potentially harmful. Up to 22%
of persons with LBP in Alberta manage their condition with opioids, creating significant
risk for opioid use disorder. Potential harms also arise from care delays. Up to 90% of
LBP surgical referrals in Alberta never go to surgery which creates consultation wait
times of up to 2 years as well as chronicity or additional disability for LBP patients
who could benefit from non-invasive interventions. Further, up to 50% of spine imaging is
unnecessary which can create nocebo messaging that can initiate or perpetuate
care-seeking behavior.
The cost-saving performance measures are described by three economic indicators known to
be influenced by evidence-based care for LBP. These include 1) the number of LBP visits
to family physicians, 2) the number of family physician referrals of LBP patients to
specialists and 3) the number of LBP imaging requests from family physicians.
The second performance measure is Quality-Adjusted Life Years (QALY) derived from
patient-reported quality of life using the EQ-5D-5L.
the third performance measure is opioid safety measured by the number of opioid
prescriptions dispensed for family physician patients having a diagnosis of LBP. These
data will be obtained from the Alberta Pharmaceutical Information Network (PIN) or the
College of Physicians and Surgeons of Alberta (CPSA). We will also track dose exposure
and duration of use but these will not be tied to costs.
Study design:
A full-scale feasibility trial utilizing a cluster-randomized design in a primary care
setting (EWPCN) as well as a secondary care setting (CPC).
METHODS
ABCp methodology Low back pain patients will be assessed by the clinic's physicians using
the ABCp. This begins with a 10-minute exam to place LBP patients into Acute, SubAcute,
Chronic, Chronic Non-Responsive or Radiculopathy categories.
Each diagnostic category is derived from existing international guidelines and has its
own specific prognosis, evidence-based pharmaceutical and non-pharmaceutical
interventions and a list of procedures that should be avoided. For patients whose
diagnosis category is Sub-Acute, Chronic or stable Radiculopathy, GLA:D Back programs
will be funded by the grant at no cost to patients. Overall, two control populations will
be used in our design: pre-implementation controls from the 12-months prior to patient
enrollment and concurrent controls using clinics who will wait to implement ABCp in
Milestone 3.
Overall timeline and setting:
The first 1-6 months (interim stage) will consist of project staging and
pre-implementation activities. A project charter consisting of terms of reference for
team expectations, accountability and conflict resolution will be completed and ratified
by the leadership team and patient advocates. Project infrastructure will be established
including approved ethics protocols, operational approvals, REDCap design and testing,
creation of a web presence and designing infographics. Following the interim period,
clinician training will commence for EWPCN GPs and CPC GLA:D Back clinicians. Training
materials will be presented in a form that best suits the team structure and may consist
of educational sessions, team seminars, video vignettes, and one-on-one meetings.
Frontline staff training will consist of a web-based video that can be accessed at the
staff's convenience.
With the completion of pre-implementation activities, full project implementation will
begin. The commencement date of enrollment will be flexible to accommodate COVID-19
delays if present. GLA:D Back ban now be provided on a telehealth platform if needed.
Enrollment will occur for a period of one year. Once enrollment ends, a one-year follow
up period will begin. At completion of enrollment health resource utilization data from
the AHS Enterprise Data Warehouse will be obtained for each participant during the
9-month period before they enrolled in the study. Both secondary outcomes (health
resource utilization and PROMs) will be compared to traditional concurrent controls
(usual care). In total, the duration of the project will be 2.5 years or 30 months (1-6
months pre-implementation activities, 12 months of enrollment, 12 months follow up).
Recruitment:
The EWPCN leadership will identify interested clinics in their jurisdiction and
interested clinicians from those clinics will enroll in the study to a maximum of 50% of
all clinicians in the PCN.
The CPC leadership will be responsible for enrolling low back pain referrals into ABCp.
Those not enrolled will serve as controls.