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Physician and professional caregiver perspectives on meaningful change to agitation behaviors in alzheimer’s dementia: insights from qualitative interviews
Introduction
Agitation is a common neuropsychiatric symptom of Alzheimer’s dementia (AD). In clinical practice, few measures are used for the regular assessment of agitation in AD patients. The Cohen-Mansfield Agitation Inventory (CMAI) is a comprehensive clinician reported outcome measure assessing the frequency with which 29 key agitation-related behaviors are observed (1-never to 7-several times an hour). The CMAI total score (ranging from 29-203) sums the frequency of these behaviors and has been used to support key efficacy endpoints in AD clinical trials.While prior research has conducted psychometric validation of the CMAI, limited qualitative evidence is available to characterize the clinical meaningfulness of changes in agitation behaviors as assessed by the CMAI. We conducted qualitative interviews with physicians and professional caregivers to characterize understandings of CMAI score change including clinical meaningfulness and perceptions of impact on individuals with AD and their family and caregivers.
Methods
One-on-one qualitative interviews were conducted with a sample of 15 AD-treating physicians and 15 professional caregivers. The protocol was reviewed and deemed exempt from institutional review board (IRB) oversight by Pearl IRB, and all study participants provided written informed consent. All interviews were audio-recorded and transcribed verbatim for qualitative analysis. A semi-structured interview guide was used in conjunction with a series of 9 patient vignettes, with each depicting the observed change in CMAI score profile over a 12-week study period using de-identified participant data from recent AD clinical trials (NCT01862640, NCT01922258, NCT03548584) to illustrate examples of different magnitudes of change (MOC) in the CMAI total score (see Fig 1).During interviews, vignettes were used to elucidate clinician and professional caregiver insights into the MOC in CMAI scores required to represent a clinically meaningful improvement in agitation behaviors, and the perceived impact of these changes to 1) clinical management of patients with AD, 2) day-to-day experiences of patients with AD, and 3) experiences of family/caregivers of AD patients.
Results
A total of 30 interviews were completed with physicians (8 neurologists and 7 geriatricians) and professional caregivers (13 registered nurses, 1 licensed practical nurse, and 1 physician assistant). The proportion of participants affirming clinical meaningfulness varied for both physicians and caregivers within and across the 9 vignettes presented, however the 4 vignettes corresponding to a total score reduction of 14 or greater were considered clinically meaningful to all participants. A majority of both physicians (8/13) and caregivers (7/13) found a total score reduction of 5 to be clinically meaningful, and some participants (2 caregivers; 0 physicians) articulated that changes as low as 1 point could be clinically meaningful depending on the type of behavior. When considering the influence of score changes on clinical management, physicians provided examples of how shifting behaviors would affect caregivers/family of patients and the possibility of modifications to treatment regimens (including changing dosage/tolerability, and combinations of various treatments) for optimal outcomes of increased safety and avoiding changes in care settings. Caregivers’ discussion of clinical management included concern for possible medication changes, and often focused on the ways in which behavior shifts would impact patients living in long-term care or home-based settings differently. Caregivers indicated concern for how vignettes representing change to unpredictable behaviors would impact the management of patients (i.e., one-on-one care and/or perceived ability/inability to redirect the patient). Notably caregivers, compared to physicians, more often asserted that patients would have some awareness of reduction in agitation behaviors as represented in the vignettes. Caregivers and physicians both indicated that reductions in CMAI total scores would generally have positive impacts on patients’ daily lives allowing for more meaningful interactions with family, caregiving staff, other residents, and the ability to engage in activities otherwise prohibited due to agitation behaviors.
Conclusions
Interviewed caregivers and physicians who regularly treat patients with AD describe significant burden associated with agitation behaviors and provided qualitative examples highlighting that even minor reductions in the frequency of such behaviors (i.e., as low as 1 point on the CMAI) can have meaningful benefits for the patient’s care, the burden on professional caregivers and family members, and patients’ day-to-day experiences. This qualitative data provides useful context for interpreting changes in agitation behavior as measured with scales such as the CMAI.
Authors
J Smith, B Talon, A Pena-Molina, K McCarrier, J Aggarwal
Journal
The American Journal of Geriatric Psychiatry
Therapeutic Area
Neurology
Center of Excellence
Patient-Centered outcomes
Year
2024
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