Browsing by Author "Sopcak, Nicolette"
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Item Open Access Results from the BETTER WISE trial: a pragmatic cluster two arm parallel randomized controlled trial for primary prevention and screening in primary care during the COVID-19 pandemic(2023-09-28) Manca, Donna P.; Fernandes, Carolina; Lofters, Aisha; Aubrey-Bassler, Kris; Shea-Budgell, Melissa; Campbell-Scherer, Denise; Sopcak, Nicolette; Meaney, Christopher; Moineddin, Rahim; McBrien, Kerry; Krueger, Paul; Wong, Tracy; Grunfeld, EvaAbstract Background Cancer and chronic diseases are a major cost to the healthcare system and multidisciplinary models with access to prevention and screening resources have demonstrated improvements in chronic disease management and prevention. Research demonstrated that a trained Prevention Practitioner (PP) in multidisciplinary team settings can improve achievement of patient level prevention and screening actions seven months after the intervention. Methods We tested the effectiveness of the PP intervention in a pragmatic two-arm cluster randomized controlled trial. Patients aged 40–65 were randomized at the physician level to an intervention group or to a wait-list control group. The intervention consisted of a patient visit with a PP. The PP received training in prevention and screening and use of the BETTER WISE tool kit. The effectiveness of the intervention was assessed using a composite outcome of the proportion of the eligible prevention and screening actions achieved between intervention and control groups at 12-months. Results Fifty-nine physicians were recruited in Alberta, Ontario, and Newfoundland and Labrador. Of the 1,005 patients enrolled, 733 (72.9%) completed the 12-month analysis. The COVID-19 pandemic occurred during the study time frame at which time nonessential prevention and screening services were not available and in-person visits with the PP were not allowed. Many patients and sites did not receive the intervention as planned. The mean composite score was not significantly higher in patients receiving the PP intervention as compared to the control group. To understand the impact of COVID on the project, we also considered a subset of patients who had received the intervention and who attended the 12-month follow-up visit before COVID-19. This assessment demonstrated the effectiveness of the BETTER visits, similar to the findings in previous BETTER studies. Conclusions We did not observe an improvement in cancer and chronic disease prevention and screening (CCDPS) outcomes at 12 months after a BETTER WISE prevention visit: due to the COVID-19 pandemic, the study was not implemented as planned. Though benefits were described in those who received the intervention before COVID-19, the sample size was too small to make conclusions. This study may be a harbinger of a substantial decrease and delay in CCDPS activities under COVID restrictions. Trial registration ISRCTN21333761. Registered on 19/12/2016. http://www.isrctn.com/ISRCTN21333761 .Item Open Access The BETTER WISE protocol: building on existing tools to improve cancer and chronic disease prevention and screening in primary care for wellness of cancer survivors and patients – a cluster randomized controlled trial embedded in a mixed methods design(2018-09-26) Manca, Donna P; Fernandes, Carolina; Grunfeld, Eva; Aubrey-Bassler, Kris; Shea-Budgell, Melissa; Lofters, Aisha; Campbell-Scherer, Denise; Sopcak, Nicolette; O’Brien, Mary A; Meaney, Christopher; Moineddin, Rahim; McBrien, Kerry; Salvalaggio, Ginetta; Krueger, PaulAbstract Background There is a pressing need to reduce the burden of chronic disease and improve healthcare system sustainability through improved cancer and chronic disease prevention and screening (CCDPS) in primary care. We aim to create an integrated approach that addresses the needs of the general population and the special concerns of cancer survivors. Building on previous research, we will develop, implement, and test the effectiveness of an approach that proactively targets patients to attend an individualized CCDPS intervention delivered by a Prevention Practitioner (PP). The objective is to determine if patients randomized to receive an individualized PP visit (vs standard care) have improved cancer surveillance and CCDPS outcomes. Implementation frameworks will help identify and address facilitators and barriers to the approach and inform future dissemination and uptake. Methods/design The BETTER WISE project is a pragmatic two-arm cluster randomized controlled trial embedded in a mixed methods design, including a qualitative evaluation and an economic assessment. The intervention, informed by the expanded chronic care model and previous research, will be refined by engaging researchers, practitioners, policy makers, and patients. The BETTER WISE tool kit includes blended care pathways for cancer survivors (breast, colorectal, prostate) and CCDPS including lifestyle risk factors and screening for poverty. Patients aged 40–65, including both cancer survivors and general population patients, will be randomized at the physician level to an intervention group or to a wait-list control group. Once the intervention is completed, patients randomized to wait-list control will be invited to receive a prevention visit. The main outcome, calculated at 12-months follow-up, will be an individual patient-level summary composite index, defined as the proportion of CCDPS actions achieved relative to those for which the patient was eligible at baseline. A qualitative evaluation will capture information related to program outcome, implementation (facilitators and barriers), and sustainability. An economic assessment will examine the projected cost-benefit impact of investing in the BETTER WISE approach. Discussion This project builds on existing work and engages end users throughout the process to develop, implement, and determine the effectiveness of a multi-faceted intervention that addresses CCDPS and cancer survivorship in primary care settings. Trial registration ISRCTN21333761 . Registered on December 19, 2016