The Dementia Symptom Management at Home Program

Study Overview
=================
Brief Summary
-----------------
Persons with dementia and their caregivers are often cared for in the community through home healthcare (HHC). While these patients and their caregivers need significant help and often have difficulty maintaining their quality of life, home healthcare clinicians are often unprepared to care for this population. This study will therefore examine the ability of an integrated, multi-pronged evidence-based practice intervention for home healthcare registered nurses, occupational therapists and physical therapists, the DSM-H, to improve the quality of care and quality of life for persons with dementia and their family caregiver. The investigators will enroll persons with dementia and their family caregiver upon admission to the HHC agency and examine their quality of life over 60 days following admission, comparing those who receive the intervention to those who serve as controls.

Detailed Description
-----------------
The Dementia Symptom Management at Home (DSM-H) Program is an integrated bundled implementation science intervention to improve interprofessional care in home healthcare (HHC). It consists of training, assessment instruments, patient-caregiver centered care plans and workflow changes. The investigators will perform a cluster randomized controlled clinical trial at a single, urban, non-profit HHC agency, randomizing care teams to either be trained in performing the intervention or serve as controls. The aims of this program are to examine the efficacy of this program to: Aim 1: Measure the effects of DSM-H on pain, neuropsychiatric symptoms, and caregiver rated QOL in the person with dementia receiving HHC. Aim 2: Assess the effects of DSM-H on QOL, burden and depression for the informal caregiver of persons with dementia receiving HHC. Aim 3: Assess the effects of DSM-H on the number of emergency room visits and hospital admissions.

Official Title
-----------------
The Dementia Symptom Management at Home Program: A Bundled Interprofessional Intervention to Improve Dementia Patient-Caregiver Dyad Quality of Care and Quality of Life Through Home Healthcare.

Conditions
-----------------
Dementia

Intervention / Treatment
-----------------
* Behavioral: Dementia Symptom Management at Home Program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient-caregiver dyad admitted to the HHC agency Patients must be 65 or older and speak English and/or Spanish. Patient must have an informal caregiver who is at least 18 years old and spends at least 8 hours per week with the patient. Patients must score greater than 4 on the cognitive subscale of the Healthy Aging Brain Care Monitor signifying at least mild impairment Exclusion Criteria: Patients with concomitant axis I disorders other than dementia, depression, adjustment disorders, sleep disorders. Patients being seen only in the behavioral health unit without another skilled need.

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Dyads in this arm will receive care provided by an interprofessional team trained through the DSM-H to provide patient/caregiver-centered dementia care through home healthcare. | Behavioral: Dementia Symptom Management at Home Program<br>* The DSM-H is a multi-modal interprofessional intervention that includes: 1. intensive training of clinician mentors; 2. disseminated online training for Registered Nurses, Physical Therapists, Occupational Therapists; 3. implementation of evidence-based care plans, assessment instruments, and teaching handouts.<br>* Other names: DSM-H;|
| No Intervention: Control<br>Dyads in this arm will receive usual care provided in the home healthcare setting. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Person With Dementia Quality of Life | Quality of Life in Alzheimer's Disease survey instrument | 60 Days | 
| Caregiver Quality of Life | Caregiver Targeted Quality of Life survey instrument | 60 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Person with Dementia Pain | Pain Assessment in Advanced Dementia or Brief Pain Inventory survey instrument | 60 days | 
| Person with Dementia Neuropsychiatric Symptom Burden | Healthy Aging Brain Care Monitor survey instrument | 60 days | 
| Caregiver Depression | Public Health Questionnaire-9 survey instrument | 60 days | 
| Person with Dementia ER Visits | Resource Utilization Inventory survey instrument | 30, 60 days | 
| Person with Dementia Hospital Admissions | Resource Utilization Inventory survey instrument | 30, 60 days | 
| Person with Dementia Functional Status | Katz Activities of Daily Living and Lawton Instrumental Activities of Daily Living assessments | 60 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dementia, neuropsychiatric symptoms, implementation science, depression, pain