Dementia Symptom Management at Home Program

Study Overview
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Brief Summary
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Alzheimer's Disease and Related Disorders (dementia) poses a significant challenge to our public health. While many persons with dementia are cared for by friends and family in the community with the assistance of home healthcare, most home healthcare clinicians and agencies are ill prepared to care for this population and therefore have difficulty assisting patients and caregivers in maintaining quality of life leading to adverse patient outcomes, increased caregiver stress and burnout, and healthcare utilization. This study will therefore utilize a cluster randomized controlled design at 3 study sites to examine the ability of a multi-component evidence-based practice primary palliative care quality improvement program for home healthcare registered nurses, occupational therapists and physical therapists to improve the quality of life and reduce healthcare utilization for persons with dementia and their informal caregiver.

Official Title
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A Multisite Cluster RCT of the Dementia Symptom Management at Home Program

Conditions
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Dementia

Intervention / Treatment
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* Behavioral: DSM-H
* Behavioral: Standard of Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: PWD over the age of 65 Admitted to one of the three HHC agencies The patient and family caregiver speak English and/or Spanish. The informal caregiver is ≥18 years of age and spends at least 8 hours per week with the patient. Patients who score ≥6 on the Quick Dementia Rating Scale (at least mild impairment). Exclusion Criteria: Patients with a separate Axis 1 diagnosis other than forms of dementia, depression or anxiety. PWD residing in assisted living facilities or board and care homes PWD solely receiving infusion or home health aide services.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: QI program care<br>DSM-H performance improvement program Patients in the performance improvement group will receive care from a care team who has received the DSM-H performance improvement program | Behavioral: DSM-H<br>* Multi-modal quality improvement program for improving the quality of care provided to PWD-informal caregiver dyads through HHC<br>|
| Active Comparator: Control<br>provide usual carereceive usual care from a care team who has not received the performance improvement program | Behavioral: Standard of Care<br>* Subjects receive care through usual home healthcare assignment process.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Quality of Life-Alzheimer's Disease Score | 13-item measurement of Alzheimer's disease patients' health-related quality of life (HRQOL) by proxy (caregiver) assessment. Each item is rated on a 4-point Likert scale ranging from 1 (poor) to 4 (excellent). The total score is the sum of responses; higher scores indicate greater HRQOL. An increase in scores indicates HRQOL increased during the observational period. | Baseline, Day 60 | 
| Change in Caregiver-Targeted Quality of Life Measure Score | The Caregiver-Targeted Quality of Life (CG-QOL) measure covers 10 dimensions of QOL relevant to caregivers of persons with dementia. The CG-QOL comprises 80 items distributed across 10 scales: assistance with ADLs, assistance with IADLs, personal time, role limitation due to caregiving, family involvement, demands of caregiving, worry, caregiver feelings, spirituality and faith, benefits of caregiving. The total score ranges from 0-100; higher scores indicate greater quality of life. An increase in scores indicates quality of life improved over the observational period. | Baseline, Day 60 | 
| Number of ER Visits by Patients with Dementia (PWD) during Study Period | Measured through interviews with the informal caregiver using the Resource Utilization Inventory. | Up to Day 60 | 
| Number of PWD Inpatient Admissions during Study Period | Measured through interviews with the informal caregiver using the Resource Utilization Inventory. | Up to Day 60 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pain Assessment In Advanced Dementia (PAINAD) Score | 5-item assessment of pain in individuals with advanced dementia. Items are ranked on a 3-point Likert scale from 0 to 2. The total score is the sum of responses and ranges from 0 (no pain) to 10 (severe pain). An increase in scores indicates pain increased during the observational period. | Baseline, Day 60 | 
| Change in Neuropsychiatric Inventory Questionnaire (NPI-Q) Score | 13-item tool that measures caregiver perceptions of Behavioral and Psychological Symptoms of Dementia (BPSD). For each item, The severity of the reported symptoms is assessed on a 3-point scale. The total severity score ranges from 0 to 36 with higher scores representing worse severity. An increase in score indicates severity of BPSD increased during the observational period. | Baseline, Day 60 | 
| Number of PWD who Use Antipsychotics during Study Period | Measured via patient medication record. | Up to Day 60 | 
| Number of PWD who Use Analgesics during Study Period | Measured via patient medication record. | Up to Day 60 | 
| Number of PWD Outpatient Visits during Study Period |  | Up to Day 60 | 
| Number of PWD Primary Care Provider Contacts during Study Period |  | Up to Day 60 | 
| Change in Zarit Burden Inventory Score among Caregivers | 22-item self-assessment of burden experienced by caregivers. Items are ranked on a Likert scale from 0 (never) to 4 (nearly always). The total score is the sum of responses and ranges from 0 to 88, where: 0 - 21 = little or no burden; 21 - 40 = mild to moderate burden; 41 - 60 = moderate to severe burden; and 61 - 88 = severe burden. An increase in scores indicates burden increased during the observational period. | Baseline, Day 60 | 
| Change in Public Health Questionnaire-9 (PHQ-9) Score among Caregivers | 9-item measurement of depression in which caregivers indicate how often they have been bothered by specific problems over the previous 2 weeks. Items are ranked on 4-point Likert scale ranging from 0 (not at all) to 3 (nearly every day). The total score is the sum of responses and ranges from 0 to 27; higher scores indicate greater severity of depression. | Baseline, Day 60 | 
| Change in Short-Form-12 (SF-12) Score among Caregivers | 12-item tool that measures functional health and well-being. Two summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12). Physical and Mental Health Composite Scores (PCS & MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. | Baseline, Day 60 |