Eligibility criteria
Inclusion criteria include: (a) age greater than 65 years with Alberta government-sponsored seniors drug insurance (30 % copayment), (b) high cardiovascular risk based on a history of any one of: heart disease, stroke, chronic kidney disease, heart failure, or any two of: current smoking, diabetes, hypertension, or high cholesterol; and (c) household income <$50,000.
Exclusion criteria include: (a) coverage by a secondary insurance plan (in addition to Blue Cross), resulting in patient-borne copayment of <30 %, or (b) inability to participate in self-management modules due to cognitive impairment or a lack of an English-speaking family member or close friend.
Goals of interventions
The overarching purposes of the interventions in the ACCESS study will be to:
(1)
Increase initiation and adherence to medications that have been proven to reduce the risk of cardiovascular events in this population of high risk patients, including HMG-CoA reductase inhibitors (Statins) [
25] and renin-angiotensin-aldosterone system inhibitors (ACE inhibitors [ACEi] and angiotensin receptor blockers [ARBs]) [
26].
(2)
Encourage participants to make positive health behavior changes, including healthy dietary choices, engagement in physical activity, cessation of tobacco use, and increased adherence to all preventive medications.
Intervention 1 will be enrolment in a new drug formulary (operationalized through their existing government drug insurance) that will eliminate copayments for high value preventive medications (those which prevent myocardial infarction, strokes, hospitalizations and delay progression of kidney and other vascular disease): statins, beta blockers, ACE-i, ARBs, calcium channel blockers, diuretics, anti-platelet agents, anti-arrhythmic drugs, anticoagulants, oral anti-diabetes agents, insulins, and smoking cessation aids (Additional file
1: Appendix 1).
Intervention 2 will be a tailored, adaptive, and interactive self-management support system that attempts to address determinants of intention and self-efficacy with regards to improving health habits and medication taking behavior. The second component of this intervention is comprised of facilitated relay of participants’ current use of recommended medications to their regular healthcare providers to facilitate prescription changes as needed, with the goal of overcoming clinical inertia.
The system was designed by behavioral and implementation scientists, clinical experts, health services researchers, in partnership with a health marketing firm (Emergence, New York, NY) and a health technology firm (Locus Health, Charlottesville, VA) to incorporate principles of design-thinking and brand-engagement, informed by a process of patient engagement, as described below. Details, including the final design and implementation plan, are presented in the Box.
Box: Intervention 2 design and implementation
Step 1—defining the objective: the primary objective of intervention 2 was to improve patient knowledge and participants’ self-management abilities including making positive health behavior changes including adherence to prescribed medications (especially statins and ACE-inhibitors/ARBs), healthy lifestyle choices, and smoking cessation for those who self-report smoking cigarettes.
Step 2—initial patient engagement: we conducted a series of ethnographic-style interviews where one academic researcher (DC, BM, TC) was paired with a marketing expert to visit the homes of ten purposively sampled community dwelling patients chosen on the basis of having low incomes and several chronic conditions that would qualify them for inclusion in this trial. Questions focused on their medical conditions and medications, to explore the perceived meaning and impacts of these in their daily lives. From this experience, we developed different patient phenotypes or archetypes, which was foundational to developing the intervention [
27].
Step 3—tailoring the intervention: beyond these patient archetypes, we used several individual measures to tailor the intervention for individuals’ situation. (1) The Necessity-Concerns framework [
28] was used to personalize the intervention to individuals’ circumstances and beliefs. We stratified individuals into categories of necessity-predominant beliefs (those who don’t believe their medications are necessary or helpful) and concerns-predominant beliefs (those who have concerns about side-effects, dependency or interactions). (2) Given that different types of messaging might be required for those who are non-adherent to their medications, we used validated instruments for assessing adherence at study baseline (Morisky Adherence Questionnaire) [
29] to assist in categorizing participants appropriately.
Step 4—procuring patient recommendations: we searched publicly accessible websites from professional societies and patient-information groups to obtain the medical information appropriate for trial participants. These included dietary and physical activity recommendations, scientifically-sound explanations of medication effects, and evidence of medication efficacy. These materials were reviewed by clinical committee members for appropriateness for inclusion.
Step 5—brand and message development: based on insights generated from the immersive patient research, the marketing team created a patient-facing brand and visual identity for the engagement platform. They then transformed physician-vetted medical information into messages that are easily understandable and relatable by the majority of potential participants. Specific messaging was developed to address each different patient archetype, adherence-state and beliefs-state described above.
Step 6—development of the online platform: the marketing team in conjunction with Locus Health, the health technology partner, then designed, developed and built an online portal for patients to interface with the design elements and messaging material developed in step 5. Participants who indicate a preference for an electronic mode of communication receive an email on a daily basis inviting them into their portal where they receive information, or are asked to respond to as series of cards. For each card completed, participants receive points which are tracked and make them eligible to receive virtual awards. This approach is designed to improve engagement with the platform through positive reinforcement.
Step 7—development of the analog platform: from previous studies in the area, we expected that at least half of study participants would not be able or willing to access the online platform [
30]. From the types of messaging developed in step 5, our marketing partners developed paper-based mailers that participants randomized to receive the self-management intervention receive weekly focusing on medication adherence and positive health behavior choices.
Step 8—development of the facilitated relay strategy: since only 50 % of Albertans with chronic diseases are taking guideline-recommended therapies [
10,
31], we developed personalized letters that would be sent to participants to take to their primary care provider and to their pharmacist. Where individuals are not currently prescribed both classes of recommended medications, the purpose of the letter is to remind the care provider about the evidence behind these therapies and strategies to attempt if the drugs had previously not been tolerated. For those who are on both statins and ACEi/ARBs at baseline, the letter simply informs their provider that they are enrolled in a clinical trial with a self-management intervention designed to assist them in working with the patient for improved heart health. These letters were pilot-tested with five primary care physicians and four pharmacists and refined based on the feedback received.
Step 9—focus group testing: once a preliminary version of the intervention was designed, we convened two focus groups of individuals (n = 6 and n = 8) who would meet inclusion criteria for the trial. We solicited their feedback about the various elements of the intervention (including the brand identity and visual design), receiving important comments and suggestions. For example, we heard that our initial design was too complex and that navigating the site was not intuitive. We also heard that the brand name of the platform was unpalatable and not easily relatable to focus group participants.
Step 10—intervention redesign: based on the feedback received in step 9, the marketing and health technology teams made further changes to the delivery platform. In response to feedback about overly complex design, the intervention was simplified and streamlined to increase usability. The platform was also renamed and rebranded as a result of focus group feedback.
Step 11—beta testing: 20 individuals were recruited to beta test the platform, including members of the study team, as well as older adults with chronic diseases. Users were given access to the electronic platform for a two-week period at which point all users were asked to complete a debriefing questionnaire, and qualitative debriefing interviews were undertaken with participating seniors.
Step 12—finalization of the components and implementation strategy for intervention 2: after completion of the above steps, we finalized the self-management intervention and describe below an overview of the patient experience:
Daily throughout study—participants receive an email with personalized messages around medication, adherence, relevant health behaviors or their specific chronic conditions. These emails encourage them to log in to their secure online portal for further information.
NOTE: those who choose to receive their intervention through non-electronic means receive weekly mailers instead of daily emails.
At 1 month—participants receive a letter reminding them to take their initial facilitated relay letters to their physician and pharmacist.
Monthly—all participants receive paper-based mailers through the postal mail system. These are designed to drive engagement with the platform and contain general information about healthy living, including anecdotes, recipes, and suggestions.
At 3 months—to decrease the risk of disengagement, participants receive a free gift (a branded re-useable shopping bag) thanking them for participating and encouraging them to continue.
At 3 months—participants who were not on either statins or ACEi/ARBs at baseline receive their second set of facilitated relay letters (on the importance of ACEi/ARB use) to take to their healthcare providers.
At 6 months—participants receive a menu in the mail inviting them to select one of two free gifts, which include a new upgraded pedometer, or a tailored and branded health tracking book.
At 6 months—participants also complete their 6-month follow-up survey, including updated information on medication use and adherence—which will inform future interactions with the platform.
Daily/weekly/monthly interactions continue through the duration of the trial.
Sequence generation and allocation concealment
Once baseline surveys have been returned to the study team and we have verified eligibility, randomization to the interventions will occur in a 1:1:1:1 fashion via a computer generated randomization program.
A randomized treatment allocation table was created on October 28, 2015 using sealedenvelope.com. Four treatment groups were used (intervention 1 only, intervention 2 only, interventions 1 and 2, and no intervention/control). Variable block sizes were used and the list length was 7200. Randomization was stratified by age (<70 years, ≥70 years); income (< $30,000, ≥$30,000); and sex (Male, Female).
Study data will be collected and managed using REDCap electronic data capture tools hosted at the University of Calgary, in collaboration with the Cumming School of Medicine. The randomization module was enabled in REDCap, and the allocation table produced by Sealed Envelope was imported into the web-based application. Patients will be entered into the database and randomized, in a concealed fashion, according to this table by the study coordinating centre.