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Abstract Introduction The ACCESS trial showed that those who received a copayment elimination benefit had a modest improvement in their adherence to medications, but no improvement in clinical outcomes. This is consistent with other studies that have demonstrated that time-limited copayment elimination was welcomed by participants. However, the removal of such benefits can be problematic, as participants may have become accustomed to receiving the benefit, and made changes to their spending that would need to be reconsidered. We aimed to explore participants’ experience with resuming cost sharing for their medications at the end of the ACCESS trial and if this experience influenced their willingness to participate in future trials like ACCESS. Methods We conducted semi-structured interviews with 21 former participants of the ACCESS trial who were receiving the copayment elimination intervention, with discussions focused on the loss of the copayment elimination. The interviews were recorded, transcribed, and analyzed in duplicate using thematic analysis. Results Four primary themes emerged from the analysis, including emotionality regarding loss of benefits; notification of benefit termination, describing tangible losses from coverage ending, but resistance to acknowledging negative impacts; and acceptability of receiving a temporary financial benefit. Many participants described negative emotions around the loss of coverage and concern about affording care for their chronic diseases. Despite negative emotions about the end of their study benefit, participants generally had a positive view of the study and would participate again in a future study of this nature. Conclusion The positive tangible and emotional benefits of the copayment elimination over 3 years outweighed the negative emotions and impacts associated with having to become reaccustomed to life without it. Patient and public contribution Within the ACCESS trial, participants were involved in the design, modification, and implementation of the program using multiple focus groups. The current study aimed to engage patients to provide input on their experience and engagement with the copayment elimination program.

Background: The Assessing Outcomes of Enhanced Chronic Disease Care Through Patient Education and a Value-based Formulary Study (ACCESS) was a 2 x 2 factorial randomized trial that tested the impact of a tailored self-management education support (SMES) program, which demonstrated a 22% reduction in adverse clinical events. We sought to qualitatively explore participants’ perspectives on the SMES intervention, and the ways in which it may have improved self-management skills. Methods: We used a qualitative descriptive approach and conducted individual semistructured interviews. We conducted inductive and deductive thematic analysis using NVivo 12 (QSR International, Burlington, MA). Results: We interviewed 20 participants who had recently completed the 3-year SMES intervention. The following 3 main themes emerged from the data: (i) empowerment; (ii) intervention acceptability; and (iii) suggestions for improvement. Regarding empowerment, we identified subthemes of health literacy, self-efficacy, self-management, and active role in health. Several participants reported that empowerment promoted health behaviour change or improved confidence in self-management. Regarding acceptability, we identified subthemes of ease of use and presentation style. Most participants expressed positive feelings toward the intervention and felt that it was easy to understand. Finally, we identified subthemes of learning style, content, and engagement strategies, within the theme of suggestions for improvement. Some participants said that the messages were too general and did not fully address the complex health concerns they had. Conclusions: Our results highlighted key strategies to promote patient engagement and self-management behaviours and demonstrated how they may have been used to improve clinical endpoints. Additionally, we demonstrated the novel use of marketing principles in SMES interventions. Résumé: Contexte: L’étude ACCESS (pour Assessing Outcomes of Enhanced Chronic Disease Care Through Patient Education and a Value-based Formulary Study) était un essai à répartition aléatoire avec un plan factoriel 2 x 2 qui a mesuré l’effet d’un programme personnalisé de soutien à la formation sur l’autogestion dans laquelle une réduction de 22 % des événements cliniques défavorables a été observée. Notre objectif était de réaliser une exploration qualitative du point de vue des patients au sujet de l’intervention et des façons dont elle a permis d’améliorer leurs habiletés d’autogestion. Méthodologie: Nous avons utilisé une approche descriptive et qualitative et nous avons mené des entretiens individuels semi-structurés auprès des participants. Des analyses thématiques inductive et déductive ont été réalisées avec NVivo 12 (QSR International, Burlington MA). Résultats: Des entretiens ont été menés auprès de 20 personnes ayant récemment terminé l’intervention de 3 ans. Les données recueillies ont permis de cerner 3 thèmes principaux : (i) l’autonomisation; (ii) l’acceptabilité de l’intervention; et (iii) les suggestions pour l’amélioration du programme. En ce qui concerne l’autonomisation des patients, nous avons relevé les sous-thèmes de la littératie dans le domaine de la santé, de l’auto-efficacité, de l’autogestion et de la participation active dans le domaine de la santé. Plusieurs participants ont mentionné que l’autonomisation avait favorisé des changements de comportements liés à la santé ou avait amélioré leur niveau de confiance quant à leur autogestion. Pour ce qui est de l’acceptabilité, nous avons noté les sous-thèmes de la facilité d’utilisation et du style des présentations. La plupart des participants ont exprimé une opinion favorable au sujet de l’intervention et la trouvaient facile à comprendre. En dernier lieu, nous avons relevé les thèmes des styles d’apprentissage, du contenu et des stratégies de mobilisation, que nous avons regroupés sous le thème des suggestions d’amélioration. Certains participants ont mentionné que les messages étaient trop généraux et n’abordaient pas leurs préoccupations complexes liées à la santé. Conclusions: Les résultats que nous avons obtenus ont mis en évidence des stratégies clés pour favoriser la participation des patients et leurs comportements d’autogestion et la façon dont elles ont pu améliorer les résultats cliniques de patients. De plus, nous avons démontré une nouvelle utilisation de principes tirés du domaine du marketing dans des interventions de soutien à la formation sur l’autogestion.

Introduction: Health care providers face a multitude of challenges in providing care to patients with diabetes who are experiencing homelessness. Considering the unique circumstance faced by this population, mainstream services must be adapted and tailored to meet patients’ needs. The objective of this study was to explore both the barriers faced by providers and programs in offering comprehensive diabetes care to these patients, and their suggested areas for improvement. Methods: We conducted semi-structured interviews with providers who care for patients who have diabetes and/or who experience homelessness. Participants included primary care providers, specialist physicians, dietitians, shelter staff, outreach workers, and diabetes educators in five Canadian centres (n=96). Responses were analyzed using qualitative thematic analysis. Results: Barriers most frequently cited by providers were a lack of resources for staff. Other challenges included policy barriers (restrictions on billing codes, care professionals’ scope of practice, and the structure of financial support for this population), duplication of services, and alternative priorities of care. Participants identified several strategies to improve care, which targeted the following spheres: location of service provision and coordination of care, policy changes, and extending funding and resources for staff, such as augmented funding to hire allied health professionals in outpatient settings and increasing outreach capabilities. Conclusion: Programs that strive to address the unique needs of clients experiencing homelessness face numerous challenges. Unique potential solutions to these barriers, such as service provision in a convenient location involving social and health services, incorporating allied health care providers in care to a greater extent, and updating policies to reflect the social complexity of the population can improve diabetes care.

Abstract Background Although recruitment is a major challenge for most randomized controlled trials, few report on the difficulties of recruitment, or how it might be enhanced. The objective of our study was to qualitatively explore the experiences of both patients and pharmacists related to recruitment for ACCESS, a large trial involving low-income seniors, given that two of our most successful recruitment strategies were direct patient recruitment materials and use of community pharmacists. Methods Using qualitative descriptive methods, we collected data from pharmacists and study participants. Pharmacists were asked about their impressions of the study, as well as challenges they faced and methods they used to recruit potential participants. Focus groups with trial participants centered on the patient recruitment materials. Interviews and focus groups were recorded, transcribed and analyzed using thematic analysis. Results Pharmacists noted that their first impressions of the study were positive as they described being enticed to help the study team by the potential benefit of copayment elimination for their patients and the low time commitment. Pharmacists noted they were more likely to recruit if they were well informed on the study, as they could answer their patients’ questions. Participants noted that their primary motivations for participating were the tangible benefits of free medications and the intrinsic value of participating in research. Conclusions We noted that recruitment through pharmacies was an effective method as most patients have trusting relationships with their pharmacist. To optimize recruitment through pharmacies, study procedures should be straightforward, and pharmacists need to be equipped with good knowledge of the study. When promoting a study to potential participants, messaging should ensure the individuals are aware of the tangible benefits of participation while still presenting a full overview of the trial. Trial registration Trial Registration Number: NCT02579655 – initially registered Oct 19, 2015.

Abstract Objective One of the most challenging parts of running clinical trials is recruiting enough participants. Our objective was to determine which recruitment strategies were effective in reaching specific subgroups. Study design and setting We assessed the efficacy and costs of the recruitment strategies used in the Assessing Outcomes of Enhanced Chronic Disease Care Through Patient Education and a Value-based Formulary Study (ACCESS) in Alberta, Canada. Results Twenty percent of the study budget ($354,330 CAD) was spent on recruiting 4013 participants, giving an average cost per enrolled of $88 CAD. Pharmacies recruited the most participants (n = 1217), at a cost of $128/enrolled. ”Paid media” had the highest cost ($806/enrolled), whereas ”word of mouth” and ”unpaid media” had the lowest (~$3/enrolled). Participants enrolled from ”seniors outreach” had the lowest baseline quality of life and income, while participants from ”word of mouth” had the lowest educational attainment. Conclusion The ”health care providers” strategies were especially successful — at a moderate cost per enrolled. The "media" strategies were less effective, short lasting, and more costly. No strategy was singularly effective in recruiting our targeted groups, emphasizing the importance of utilizing a variety of strategies to reach recruitment goals. Trial registration ClinicalTrials.gov, NCT02579655. Registered on 19 October 2015.