a1 Alberta Bone and Joint Health Institute and Curtin University of Technology
a2 Alberta Bone and Joint Health Institute
a3 Alberta Health Services
a4 Alberta Bone and Joint Health Institute
a5 University of Michigan
a6 Capital Health/Alberta Health Services
a7 Alberta Health Services
a8 Alberta Bone and Joint Health Institute
Background: The Alberta Hip and Knee Replacement Project developed a new evidence-based clinical pathway (NCP) for total hip (THR) and knee (TKR) replacement. The aim was to facilitate the delivery of services in a timely and cost-effective manner while achieving the highest quality of care for the patient across the full continuum of care from patient referral to an orthopedic surgeon through surgery, recovery, and rehabilitation. The purpose of this article is to provide an overview of the study design, rationale, and execution of this project as a model for health technology assessment based on comparative effectiveness of alternative clinical pathways.
Methods: A pragmatic randomized controlled trial study design was used to evaluate the NCP compared with the standard of care (SOC) for these procedures. The pragmatic study design was selected as a rigorous approach to produce high quality evidence suitable for informing decisions between relevant interventions in real clinical practice. The NCP was evaluated in three of the nine regional health authorities (RHAs) in Alberta with dedicated central intake clinics offering multidisciplinary care teams, constituting 80 percent of THR and TKR surgeries performed annually in Alberta. Patients were identified in the offices of twenty orthopedic surgeons who routinely performed THR or TKR surgeries. Evaluation outcome measures were based on the six dimensions of the Alberta Quality Matrix for Health (AQMH): acceptability, accessibility, appropriateness, effectiveness, efficiency and safety. Data were collected prospectively through patient self-completed questionnaires at baseline and 3 and 12 months after surgery, ambulatory and inpatient chart reviews, and electronic administrative data.
Results: The trial design was successful in establishing similar groups for rigorous evaluation. Of the 4,985 patients invited to participate, 69 percent of patients consented. A total of 3,434 patients were randomized: 1,712 to SOC and 1,722 to the NCP. The baseline characteristics of patients in the two study arms, including demographics, comorbidity as measured by CDS and exposure to pain medications, and health-related quality of life, as measured by Western Ontario and McMaster Universities Osteoarthritis Index and Short Form-36, were similar.
Conclusions: The Alberta Hip and Knee Replacement Project demonstrates the feasibility and advantages of applying a pragmatic randomized controlled trial to ascertain comparative effectiveness. This is a model for health technology assessment that incorporates how clinical pathways can be effectively evaluated.
The study's investigators thank the McCaig Institute for Bone & Joint Health, Alberta Health and Wellness, Max Bell Foundation and Norlien Foundation for the grant funding to support the evaluation of the Alberta Hip and Knee Replacement Project. The considerable effort and the degree of collaboration by the project partners, including the Calgary Health Region, the Capital Health Authority, the David Thompson Health Region, the Alberta Orthopaedic Society, and Alberta Health and Wellness were essential to the evaluation's success. We gratefully thank the participating orthopaedic surgeons: Drs Greg Abelseth, Lance Bredo, Brian Burkart, John Cinats, Kelly deSouza, Hugh Dougall, Thomas Greidanus, Kenneth James, Donald Johnston, Guy Lavoie, James Mackenzie, Ed Masson, James McMillan, Stephen Miller, Gregory O'Connor, Timothy Pearce, Rod Reikie, Lowell Van Zuiden, Donald Weber, and Jason Werle. We acknowledge the efforts of the Alberta Bone and Joint Scientific Committee. (Please see supplementary list, which can be viewed online at www.journals.cambridge.org/thc, for all acknowledgements.) We thank Kelly Novak for project support. The lead author thanks her PhD supervisors Profs. Colin Binns, Kay Sauer, and Ron Zernicke. We especially thank the patients for their time and contributions to this study.