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Why do older adults decline participation in research results from two deprescribing clinical trials?

Research into deprescribing found that over 1,200 older adults declined enrollment in two specific clinical trials, citing three primary reasons for their decision. This article will explore the detailed reasons why do older adults decline participation in research results from two deprescribing clinical trials, based on the findings from the Shed-MEDS and VA DROP studies.

Quick Summary

Older adults primarily decline participation in deprescribing trials due to feeling overwhelmed by their health, a general lack of interest or mistrust in research, and specific hesitancy regarding the deprescribing process itself. Differences exist between Veterans and non-Veterans, with the former showing more mistrust and the latter feeling more overwhelmed.

Key Points

  • Feeling Overwhelmed: Many older adults decline participation due to being overwhelmed by their current health status and medical decisions during hospitalization [1.3, 2.3].

  • Mistrust of Research: A significant number of older adults, particularly Veterans, express a general lack of interest or mistrust of research and the healthcare system [1.4, 2.4].

  • Hesitancy toward Deprescribing: Patients often decline because they are comfortable with their current medication regimen or fear negative effects of a change, pointing to a need for better patient education [1.5, 2.5].

  • Patient-Centered Approach: Research indicates the need for tailored, patient-centered communication and recruitment strategies to effectively engage older adults [1.7, 2.7].

  • Addressing Barriers: Understanding these barriers allows for the development of more inclusive clinical trials that can improve the representation of older adults in research [1.7, 2.7].

  • Veteran Differences: Data shows notable differences in reasons for declining between Veterans and non-Veterans, highlighting the need for population-specific outreach [1.6, 2.6].

In This Article

Understanding the Landscape of Deprescribing Research

Deprescribing, the process of reducing or stopping medications that may be unnecessary or harmful, is a critical area of focus in modern geriatric medicine. Given the high rates of polypharmacy (taking multiple medications) among older adults, clinical trials focused on deprescribing are vital for improving safety and quality of life. However, these trials face significant recruitment challenges. A study evaluating the reasons older adults decline participation in two deprescribing clinical trials, Shed-MEDS and VA DROP, offers unique insights into these barriers, revealing consistent themes across a large cohort of hospitalized patients.

The Three Core Reasons for Declining Participation

According to the study published in Trials, researchers identified three overarching themes from the 1,226 eligible patients who declined enrollment [1.2, 2.2]:

1. Feeling Overwhelmed by Current Health Status

Many older adults were acutely ill during hospitalization when approached for the study, making trial participation feel like an added burden [1.3, 2.3]. Subthemes included the cognitive load of medical decisions, decision-making fatigue requiring more time, and inconvenient timing during a stressful hospital stay [1.3, 2.3]. Non-Veterans were more likely to cite feeling overwhelmed than Veterans [1.3, 2.3].

2. Lack of Interest or Mistrust of Research

This theme encompassed varied attitudes towards clinical trials and healthcare, being more prevalent in Veterans [1.4, 2.4]. Subthemes included simple disinterest, general mistrust of the healthcare system or research, and reluctance with consent paperwork [1.4, 2.4]. This highlights the need to build trust and effectively communicate trial benefits to older populations [1.4, 2.4].

3. Hesitancy to Participate in a Deprescribing Study

Hesitancy specifically regarding deprescribing was a key finding, suggesting potential enrollment bias [1.5, 2.5]. Concerns included comfort with the current regimen, belief that only their personal doctor should change medications, and negative past experiences with medication changes [1.5, 2.5]. This reveals patient attitudes toward medication changes as a significant barrier [1.5, 2.5].

Comparison of Reasons: Veterans vs. Non-Veterans

Reason for Declining Proportion of Non-Veterans Proportion of Veterans Insight
Feeling Overwhelmed 54% 35% Non-Veterans were more affected by their current acute health status and the stress of hospitalization [1.6, 2.6].
Lack of Interest/Mistrust 26% 42% Veterans showed a greater degree of mistrust in research, possibly stemming from past experiences [1.6, 2.6].
Hesitancy towards Deprescribing 23% 21% This reason was comparable across both groups, highlighting a shared apprehension [1.6, 2.6].

The differences between cohorts emphasize tailoring recruitment strategies to a population's background and concerns [1.6, 2.6].

Moving Forward: Informing Better Research Strategies

To increase older adult representation in clinical research, future deprescribing studies should address identified barriers [1.7, 2.7]. Strategies could include earlier engagement outside acute settings, building trust through community engagement or using patients' own care teams, patient-centered communication on polypharmacy risks and deprescribing benefits, and flexible protocol design [1.7, 2.7]. Understanding these reasons helps create more inclusive, effective clinical trials [1.7, 2.7].

For more detailed information on polypharmacy and deprescribing, you can read the National Institutes of Health's overview of deprescribing to reduce medication harms in older adults, available here.

Conclusion

The analysis of the Shed-MEDS and VA DROP trials reveals key reasons for older adults and surrogates declining research participation: feeling overwhelmed, mistrust of research, and hesitancy toward the intervention [1.8, 2.8]. These findings highlight the need for a more patient-centered approach in research design, recruitment, and communication to improve engagement and the generalizability of clinical evidence for this population [1.8, 2.8].

Frequently Asked Questions

Deprescribing is the process of safely reducing or stopping medications. It is studied in older adults because polypharmacy (taking multiple medications) is common in this population and can lead to adverse events, and deprescribing can improve safety and health outcomes.

Yes, there were significant differences. Veterans cited mistrust of research more frequently, while non-Veterans more often cited feeling overwhelmed by their health status as the primary reason for declining [1.6, 2.6].

Older adults, particularly during a hospitalization, may feel overwhelmed by the acute health event, the number of medical decisions they must make, and the burden of participation, making it a poor time to consider enrollment [1.3, 2.3].

Some older adults harbor a general mistrust of the healthcare system or research institutions, and may be unwilling to sign complex consent documents or participate in studies they don't fully understand [1.4, 2.4].

Hesitancy can stem from feeling comfortable and stable on their current medication regimen, a previous negative experience with a medication change, or a strong preference for their personal doctor to manage their medications [1.5, 2.5].

Researchers can improve participation by engaging patients in less acute settings, building trust through better communication, offering flexible protocols, and educating patients on the benefits of the research [1.7, 2.7].

Yes, the study indicated a potential enrollment bias towards older adults who were already more aware of and willing to consider deprescribing. Documenting reasons for declining helps researchers understand this potential bias and its implications for study results [1.5, 2.5].

References

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Medical Disclaimer

This content is for informational purposes only and should not replace professional medical advice. Always consult a qualified healthcare provider regarding personal health decisions.