Effectiveness of an eHealth Tool for Older Adults With Multimorbidity ("KeepWell"): Protocol for a Hybrid Effectiveness-implementation, Pragmatic Randomized Controlled Trial

Methods

Design We will evaluate the effectiveness and uptake of the KeepWell solution in a 6-month, pragmatic, hybrid effectiveness-implementation RCT for optimizing and sustaining the self-management of older adults with multimorbidity. We will use the type 2 design, which facilitates the simultaneously investigation of the effectiveness of an intervention while rigorously testing the implementation strategy. The implementation evaluation will be guided by the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework.

Theoretical basis of our work We used the Knowledge-to-Action (KTA) model to guide our methods. Our team has experience applying the KTA framework in creating technology-based interventions [refs]. We have also adapted an integrated KT (IKT) strategy whereby all our stakeholder team members who helped us to create KeepWell and prepare this protocol are going to continue to steer the execution of our study. This team helped to develop the objectives, project plan and timelines; discussed potential barriers and mitigating strategies, and monitored progress.

Population and recruitment Older adults will be identified with support from: (i) the University of Toronto Primary Care Research Network (UTOPIAN); (ii) the Retired Teachers of Ontario (RTO); and (iii) our clinician (geriatricians and family physicians) partnering sites: North York General Hospital, St. Michael's hospital of Unity Health, Sunnybrook healthcentre, and St. Peter's hospital. All these recruitment sources have a roster of older adults with multiple chronic conditions via their affiliated primary care and geriatric clinics. We have created a recruitment poster that will be administered at each site according to a procedure most feasible and practical for their practice flow and resources. For example, the poster may be administered directly to older adults by family physicians and geriatricians during a visit or through their clinic staff upon registering for a visit or posted on walls. In addition, the poster will be distributed via an email listserv from our patient partner organization, the RTO with a membership of more than 70,000 older adults. Study eligibility criteria are: (i) age 65 years; (ii) have one or more of the following chronic conditions: diabetes, heart failure, cardiovascular disease, dementia, chronic kidney disease, osteoporosis, osteoarthritis, rheumatoid arthritis, Chronic Obstructive Pulmonary Disease (COPD), depression, urinary incontinence, stroke; (iii) English speaking; (iv) access to a computer or tablet device; (v) have an email address; and (vi) able to consent. Consent-giving capacity will be assessed using the validated "MacCAT-CR" tool.

The recruitment poster includes a phone number and email address dedicated to this research project. Potential participants will self-refer after reviewing the poster, by contacting the research coordinator using one of two strategies: (1) if their mode of reply is by phone, the research coordinator will review the study information sheet and consent process document with potential participants and answer any questions. Study eligibility will also be assessed. Participants will have the option to consent over the phone or via an online survey (SurveyMonkey). Non-consenting respondents will be asked to provide a reason for their decision; (2) if the mode of reply is email, an automated, email response system will be initiated. The email will include the same study and consent process information as described for the phone option and a link to a survey (via SurveyMonkey) that will include questions to assess their eligibility and to obtain conent. Regardless of participants' mode of reply, they will be enrolled and assigned a unique identification number and randomization sequence as soon as the research coordinator receives confirmation of eligibility and consent. Once they do, participants will receive an email with a link to KeepWell and their unique login details (intervention condition) or to a link to an online survey to complete a risk assessment questionnaire (usual care control condition).