Impact of SystemCHANGE™ Intervention on Medication Adherence in Older Adults with Heart Failure: A Mixed Methods Feasibility Study
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Background: Nearly 50% of people with heart failure do not adhere to their medication regimens, leading to increased health care costs and poor patient outcomes. The purpose of this study was to examine the feasibility and acceptability of a SystemCHANGE™ intervention in improving medication adherence in older adults with heart failure. Methods: Adults 50 or older with heart failure who self-administer diuretics were screened for two months using electronic monitoring to determine baseline adherence scores. If adherence scores were below 88%, the participant was randomized into either the SystemCHANGE™ or attention control group. The attention control group received education using American Heart Association heart failure brochures. The SystemCHANGE™ intervention consisted of changing the individual’s environment by incorporating medication taking into existing routines, using small experiments with feedback, and receiving support from people who impact routines. Demographics, medication adherence scores using a medication events monitoring system (MEMS), and acceptability and feasibility measures were collected throughout the study and analyzed. Results: Thirty participants were enrolled in the study. Sixteen participants had medication adherence rates greater than 88%, therefore exiting the study. Eleven participants did not complete the screening phase. Three participants were eligible to be randomized in the intervention or attention control group but only two agreed to continue with the study, leaving one participant in each group. The participant in the SystemCHANGE™ group did not complete the study. The screening sample was majority African American males (66.7%). The average adherence score of those who did not complete the screening phase was 65.6% versus 96% for those who did complete screening phase. Challenges were noted by participants in utilizing the MEMS caps during the screening phase. Conclusion: Future studies need to focus on understanding barriers and facilitators to participation in a research study of this nature. Lessons learned include using multiple recruitment sites, more education on MEMS use, and consideration of the Hawthorne effect. Major protocol revisions are needed to recruit and retain the proposed population.
Table of Contents
Introduction -- Literature review -- Methods -- Results -- Discussion -- Appendix A. Design diagram -- Appendix B. SC protocol checklist -- Appendix C. Important people form -- Appendix D. Life routines form -- Appendix E. Cycles form -- Appendix F. Possible solutions form -- Appendix G. Intervention steps 3-4 -- Appendix H. Education protocol checklist -- Appendix I. 6-item mental status screen -- Appendix J. Demographic information form -- Appendix K. Systems thinking scale -- Appendix L. KCCQ Spertus & Jones 2015 -- Appendix M. Acceptability questionnaire -- Appendix N. Medication Event Monitor (MEMS) diary -- Appendix O. MEMS education -- Appendix P. ECHO study screening for eligibility form --Appendix Q. Phone script