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

Abstract

BackgroundThere 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/designThe 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.DiscussionThis 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 registrationISRCTN21333761. Registered on December 19, 2016

What is a prevention visit? A qualitative study of a structured approach to prevention and screening – the BETTER WISE project

“…The aim of BETTER WISE is to determine if patients aged 40 to 65, including patients with and without a cancer history (breast, colorectal, and/or prostate), randomized to receive an individualized prevention visit with a PP improve cancer surveillance and prevention and screening outcomes. The primary outcomes are measured at the patient level and determined by a composite index, as compared to standard care in a wait-list control group twelve months after the initial prevention visit (Manca et al, 2018). In the BETTER 2 implementation study, we found that physicians' opinions on the BETTER prevention visits deviated from the opinions of PPs and patients (Sopcak et al, 2016).…”

“…PPs were also trained and certi ed in Brief Action Planning (Gutnick et al, 2014;Reims et al, 2018), which "is grounded in the principles and practice of Motivational Interviewing and behaviour change theory and research, emphasizing compassion, acceptance, partnership and evocation" (Centre for Collaboration, Motivation & Innovation, 2019), in order to guide patients towards healthy lifestyle modi cation and behaviour change, and collaboratively set S.M.A.R.T. (speci c, measurable, attainable, realistic, time-based) lifestyle or screening-related goals (Manca et al, 2018).…”

“…At each of the 13 participating primary care clinic sites, a list of all eligible patients 40 to 65 years of age was generated. Detailed eligibility criteria and recruitment strategies for the BETTER WISE cRCT have been published elsewhere (Manca et al, 2018). For the qualitative sub-component, we invited all members of the 13 primary care clinics (including physicians, PPs, allied health professionals, administrators, and managers) to participate in focus groups or one-on-one interviews to share their perspectives on BETTER WISE.…”

“…This qualitative study is a sub-component of the BETTER WISE cRCT, described in detail elsewhere (Manca et al, 2018). The BETTER WISE team recruited 13 primary care clinics (urban, rural, and remote) in Alberta, Ontario, and Newfoundland & Labrador, Canada.…”

“…The BETTER WISE (Building on Existing Tools to Improve Cancer and Chronic Disease Prevention and Screening in Primary Care for Wellness of Cancer Survivors and Patients) project is a pragmatic, cluster randomized controlled trial (cRCT), embedded in a mixed method design with a qualitative evaluation and an economic assessment (Manca et al, 2018). BETTER WISE extends the focus of the BETTER approach, to include not only primary prevention and screening of chronic disease, but cancer surveillance and screening for poverty.…”