Browsing by Author "Saunders-Smith, Terry"

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    Cost analysis and efficacy of recruitment strategies used in a large pragmatic community-based clinical trial targeting low-income seniors: a comparative descriptive analysis
    (2019-10-07) Kakumanu, Sravya; Manns, Braden J; Tran, Sophia; Saunders-Smith, Terry; Hemmelgarn, Brenda R; Tonelli, Marcello; Tsuyuki, Ross; Ivers, Noah; Southern, Danielle; Bakal, Jeff; Campbell, David J T
    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.
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    Exploring patient perspectives on the impact of resuming cost sharing: a qualitative analysis
    (2024-11-09) Tran, Sophia H. N.; Fletcher, Jane M.; McSweeney, Breanna; Saunders-Smith, Terry; Manns, Braden J.; Campbell, David J. T.
    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.
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    Pharmacist and patient perspectives on recruitment strategies for randomized controlled trials: a qualitative analysis
    (2020-10-31) Fletcher, Jane M; Saunders-Smith, Terry; Manns, Braden J; Tsuyuki, Ross; Hemmelgarn, Brenda R; Tonelli, Marcello; Campbell, David J T
    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.