PREPARE Trial: A Parallel Arm Randomized Trial of Fraility-Focused Preoperative Exercise to Decrease Postoperative Disability ScoREs
Quality Improvement & Outcomes
Daniel I McIsaac
613-204-3096
Affiliation
TOH – The Ottawa Hospital Academic Medical Organization
University of Ottawa, Department of Anesthesiology & Pain Medicine
Ottawa Hospital Research Institute, Clinical Epidemiology Program
Highlights
The aim of the multi-center PREPARE Trial is to improve recovery for older Canadians with frailty having surgery. To do this, we are testing whether a home-based exercise and nutrition intervention (called ‘prehab’) compared to standard care can improve patient-reported disability scores, reduce complication rates and improve system-level outcomes. There are 11 hospitals across Canada actively recruiting patients into the trial, 8 of which are in Ontario. Our prehab intervention was improved following feedback from patients who participated in our pilot trial (i.e., tailored exercises, user-friendly instructional booklets, seated cardio videos, etc.,). Our prehab coaches at The Ottawa Hospital call intervention patients weekly to encourage, offer support, and to suggest exercise modifications and ways to increase protein intake through diet. Patients in the trial are completing their exercises more consistently than in our pilot trial and often communicate that they feel stronger and better prepared for surgery.
Abstract
Older adults with frailty are at an increased risk of worsened disability and complications after surgery, which affects their ability to live independently at home and causes increased costs to the healthcare system. We must develop and test new ways to improve their care and outcomes. Therefore, we are conducting the PREAPRE Trial, a multi-center randomized controlled trial testing whether home-based exercise and nutrition (‘prehab’) compared to standard care can improve patient-reported disability scores and decrease complication rates among older adults with frailty having surgery. System-level outcomes including healthcare utilization and cost will also be evaluated.
Our project is innovative because we refined our prehab intervention following interviews with older adults with frailty who participated in the pilot PREHAB study (https://doi.org/10.1016/j.bja.2022.04.006) and through engagement of patient partners. Further, our intervention in centralized through The Ottawa Hospital. This means that our prehab coaches at The Ottawa Hospital phone patients across the country to provide an orientation to the intervention, review their paper-based materials and provide prescription of exercise and nutrition through collaborative goal-setting. The prehab coaches also phone patients weekly to encourage adherence, provide exercise and nutrition modifications and to provide supportive counselling during the preoperative period.
There are 11 hospitals across Canada actively recruiting patients into the trial, 8 of which are in Ontario. As of August 2023, we have enrolled 704/850 (82%) of our study sample size. Our patient-centered prehab intervention is proving to be feasible for older adults with frailty and easily implemented across hospitals, which has the potential to transform preoperative care in Ontario. This is a program that patients want to participate in, with 85% of eligible patients choosing to consent to the trial.
We anticipate reaching our sample size of 850 patients by February 2024, followed by one-year follow-up data collection. Our next step is to evaluate the feasibility of a virtually-supported prehab intervention through a web-based platform for adults >18 years preparing for major surgery (The STRIVE Before Surgery Trial). We have received CIHR funding ($260,100.00) and TOHAMO funding ($95,800.00).
Publications
McIsaac DI, Fergusson DA, Khadaroo R, Meliambro A, Muscedere J, Gillis C, Hladkowicz E, Taljaard M; Group Authorship the Prepare Investigators. (2022). PREPARE trial: a protocol for a multicentre randomised trial of frailty-focused preoperative exercise to decrease postoperative complication rates and disability scores. BMJ Open. 12(8): e064165.
http://dx.doi.org/10.1136/bmjopen-2022-064165