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Research engagement and experiences of patients pre- and post-implant of a left ventricular assist device from the mechanical circulatory support measures of adjustment and quality of life (MCS A-QOL) study

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Abstract

Purpose

Adults living with mechanical circulatory support (MCS) present with unique challenges (e.g., left ventricular assist device [LVAD]-related self-care, adverse events) to research study enrollment, engagement, and completion. The purpose of this study was to understand the experiences of adults with MCS who were eligible for and enrolled in a study of health-related quality of life (HRQOL).

Methods

In a secondary analysis of data from the Mechanical Circulatory Support: Measures of Adjustment and Quality of Life study, we used a mixed-methods approach to evaluate research engagement and experiences among adults preparing to undergo or currently living with MCS implant. First, we assessed the cascade of study engagement. Second, we assessed research experiences using a structured interview developed for this study.

Results

Of 1011 participants approached for the study, 86.7% enrolled, 12.7% declined, and 0.6% were ineligible. Of 877 participants enrolled, 272 were pre-implant (of whom 88% completed assessments; “respondents”) and 605 were post-implant (of whom 74% completed assessments). Only 14% of respondents reported difficulty completing the questionnaires, 54% had previously used an iPad to complete questionnaires, and 62% reported that their experience was “as expected.” Respondents qualitatively described both positive (e.g., value of research) and negative (e.g., too much time) research experiences, difficulties completing questionnaires (e.g., online platform, health literacy issues), and provided recommendations for the questionnaires and delivery.

Conclusions

Participants enjoyed participating in HRQOL research focused on MCS and had unique perspectives for improving the questionnaires. It is important to minimize the burden of participation and critical to be flexible to meet participant preferences for research engagement.

Trial registration

NCT03044535 (accessible at https://clinicaltrials.gov/ct2/show/NCT03044535), registered February 7, 2017.

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Data availability

Data are available from the corresponding author upon request.

Code availability

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Acknowledgements

This work was supported by the National Heart, Lung, and Blood Institute (Grant No. 1R01HL130502-01, co-PIs Grady KL & Hahn EA). We thank Katy Wortman, Peter Cummings, and Sarah Buono for their assistance with data management and quality assurance.

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Authors and Affiliations

  1. Departments of Psychiatry and Behavioral Sciences and Preventive Medicine, Northwestern University Feinberg School of Medicine, 750 N Lake Shore Drive, Chicago, IL, 60611, USA

    Allison J. Carroll

  2. Departments of Medical Social Sciences and Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA

    Elizabeth A. Hahn

  3. Department of Surgery, Division of Cardiac Surgery and Department of Medicine, Division of Cardiology, Northwestern University Feinberg School of Medicine, Chicago, IL, USA

    Kathleen L. Grady

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  1. Allison J. Carroll
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  3. Kathleen L. Grady
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Contributions

All authors contributed to the study conception and design as well as material preparation, data collection and analysis. The first draft of the manuscript was written by AJC and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.

Corresponding author

Correspondence to Allison J. Carroll.

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Conflict of interest

KLG is a consultant for Amgen, Inc. AJC and EAH declare they have no relevant financial or non-financial interests to disclose.

Ethical approval

Approval was obtained from the Institutional Review Board of Northwestern University and by each site’s Institutional Review Board. The procedures used in this study adhere to the tenets of the Declaration of Helsinki.

Consent to participate

Informed consent was obtained from all individual participants included in the study.

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Not applicable.

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Carroll, A.J., Hahn, E.A. & Grady, K.L. Research engagement and experiences of patients pre- and post-implant of a left ventricular assist device from the mechanical circulatory support measures of adjustment and quality of life (MCS A-QOL) study. Qual Life Res 31, 2457–2470 (2022). https://doi.org/10.1007/s11136-022-03111-4

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