Evidence-based, non-pharmacological interventions that address the behavioral and psychological symptoms of dementia (BPSD) are a particularly high priority for nursing homes (NHs), where over 50% of long-stay residents have Alzheimer's disease-related dementias (ADRD) and the off-label use of antipsychotic medications to address BPSD is contraindicated due to serious adverse consequences. Studies have demonstrated that individualized music can reduce anxiety, decrease negative affect or depression, and control physically-agitated behaviors in people with ADRD. Eliciting musical memories using familiar or preferred music may decrease feelings of isolation and anxiety, as musical memories are encoded in areas of the brain affected later in the ADRD process than areas of the brain involved in verbal memory and executive functioning. MUSIC & MEMORYSM (M&M) is a music program that involves using inexpensive iPod technology to deliver individualized music to people with ADRD. The intervention's potential is illustrated powerfully in the award-winning 2014 documentary, Alive Inside, which shows residents with severe dementia begin to move, sing, and interact with others when listening to their favorite music on iPods. Retrospective Brown University analyses found that residents' BPSD symptoms decreased faster among NHs participating in M&M vs. pair-matched controls. However, state demonstration programs and other projects demonstrate that implementation of M&M varies widely. As a first step to standardizing delivery of the program and evaluating efficacy, Brown and its partners developed an implementation guide, integrating experiences from statewide efforts with qualitative data about NH best practices. We propose to standardize the introduction and implementation of M&M during a one-year R21 pilot and then to test the impact of implementing M&M on NH residents' BPSD outcomes during a four-year R33 pragmatic trial. During the pilot, we will test a step-by-step protocol and validate data transfer and measurement procedures in four different NHs, one from each of four participating corporations; during the pragmatic trial, we will conduct a wedge-based, pragmatic cluster randomized controlled trial (RCT) and estimate the impact of M&M on residents' behaviors and medication use, as well as examine factors associated with variation in NHs' adherence to the program in 66 facilities. Using a waiting list control design will allow us to iteratively refine training and measurement, as needed, between waves of participating facilities. In both the pilot and the pragmatic trial, we will implement the program as a facility-level, protocol- driven, quality improvement project, targeting all eligible (moderate to severe ADRD) residents in participating facilities. We will conduct analyses using iPod metadata, electronic health record data, and Minimum Data Set resident assessments, all of which can be linked to Medicare enrollment and vital status data.
Our findings will be relevant to public health because they will provide insight into how well the popular MUSIC & MEMORYSM (M&M) individualized music program improves outcomes among nursing home residents with Alzheimer's disease and related dementias. Although many nursing homes and other care providers are using M&M, its impact has not been rigorously evaluated, and we do not know what characterizes effective implementation. If the program improves the behavioral and psychological symptoms associated with dementia, as preliminary data from Brown University suggests, it may prove to be an effective non-pharmacological approach to addressing behaviors without the use of antipsychotic medications, which are not advised for use in this population and carry significant risks.
