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Journal Article

Current Evidence of Randomized Clinical Trials on Hospice-Eligible Patients With Agitation and Dementia: A Narrative Review

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Abstract

Background

Agitation is one of the most distressing behavioral symptoms among hospice-eligible patients with dementia. It compromises patient comfort, increases caregiver burden, and undermines the quality of end-of-life care. Although pharmacologic treatments are frequently used, evidence guiding their safe and effective use in this population remains limited.

Objective

To identify and synthesize existing randomized controlled trials (RCTs) that evaluated interventions for agitation in hospice-eligible patients with dementia, and to assess the quality and relevance of current evidence.

Methods

A narrative review was conducted using systematic search strategies to identify RCTs published between 1990 and 2024 across 8 databases. Studies were included if they (1) focused on hospice-eligible patients with dementia, (2) targeted agitation as a major outcome, and (3) used an RCT design. Studies lacking eligibility criteria, non-RCTs, and non-English articles were excluded.

Results

Of 44 articles screened, only 3 met the inclusion criteria: 2 studies tested nonpharmacological interventions (Namaste and Balancing Arousal Controls Excesses) and 1 tested a pharmacological intervention (sertraline). Results from the nonpharmacological interventions were mixed, and the pharmacologic trial showed no difference between treatment and placebo. Common limitations included small sample sizes, lack of racial and gender diversity, and absence of home-based hospice settings.

Significance of results

There is a critical gap in high-quality and generalizable evidence to guide agitation management at the end of life for patients with dementia. Addressing this gap is essential to improving not only symptom control but also to preserving dignity and reducing caregiver distress in hospice care. Future trials must include diverse populations, incorporate home-based hospice settings, and rigorously evaluate both pharmacologic and nonpharmacologic interventions to support compassionate, patient-centered care.

This review highlights urgent gaps in research and care delivery, underscoring the need for inclusive and scalable intervention designs to address agitation at the end of life.

The full article can be viewed at Palliative & Supportive Care.

Wang, O. Y., Calev, N., Mintzer, J., Fritts, A., Molina-Henry, D. P., Grill, J. D., & Raman, R. (2025). Current evidence of randomized clinical trials on hospice-eligible patients with agitation and dementia: A narrative review. Palliative & Supportive Care23, e209.