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. Author manuscript; available in PMC: 2021 Jun 1.
Published in final edited form as: Contemp Clin Trials. 2020 Apr 19;93:106005. doi: 10.1016/j.cct.2020.106005

Protocol for an embedded pragmatic clinical trial to test the effectiveness of Aliviado Dementia Care in improving quality of life for persons living with dementia and their informal caregivers.

Alycia A Bristol 1, Kimberly A Convery 2,3, Victor Sotelo 4,5, Catherine E Schneider 6, Shih-Yin Lin 7, Jason Fletcher 8, Randall Rupper 9,10, James E Galvin 11,12, Abraham A Brody 13
PMCID: PMC7269690  NIHMSID: NIHMS1589265  PMID: 32320844

Abstract

Introduction:

Persons living with Alzheimer’s disease and related dementias (ADRD) frequently experience pain and behavioral and psychological symptoms of dementia (BPSD) which decrease quality of life (QOL) and influence caregiver burden. Home healthcare professionals however may underrecognize or lack the ability to manage BPSD.

Intervention:

This protocol describes an ADRD palliative quality assurance performance improvement program for home healthcare, Aliviado Dementia Care-Home Health Edition. It includes training, mentoring, and a toolbox containing intervention strategies.

Methods:

This embedded pragmatic clinical trial will utilize a multi-site, cluster randomized control design. Recruitment will occur from three home healthcare agencies located in New Jersey, Utah, and Florida. At each agency, care teams will be randomized as clusters and assigned to either the Aliviado Dementia Care program or usual care. We plan to enroll 345 persons living with ADRD and their informal caregiver dyads. The primary outcome will be to measure QOL in both the person living with ADRD and their informal caregiver, and emergency department visits and hospital admissions. Secondary outcomes in the person living with ADRD will include the examination of pain, BPSD, antipsychotic and analgesic use. Secondary outcomes in caregivers include burden, depressive symptoms, functional health and wellbeing, and healthcare utilization.

Conclusion:

This study will be the first large-scale embedded pragmatic clinical trial in home healthcare focused on care quality and outcomes in addressing QOL in ADRD. If proven successful, the intervention can then be disseminated to agencies throughout the country to improve the quality of care for this vulnerable, underserved population.

Keywords: dementia, behavioral and psychological symptoms of dementia, quality of life, home healthcare, informal caregivers, pragmatic clinical trial

Introduction

By 2030, the older adult population is expected to double.1 As adults age, the risk of developing dementia including Alzheimer’s disease and related dementias (ADRD) increases.2 Most persons living with ADRD are cared for in the community and have specific care needs related to the appropriate assessment of behavioral and psychological symptoms of dementia (BPSD) and treatment of pain. Common BPSD include depression, anxiety, delusions, hallucinations, irritability, agitation, personality changes and aggression. BPSD are associated with increased functional disability, caregiver burden and burnout, nursing home admission, progression of dementia, and weight loss.3–7 The majority of community residing persons living with ADRD rate pain as bothersome.8 Moreover, pain can be a significant trigger for BPSD when undertreated,9–11 resulting in depression and agitation.12,13 While pain14–16 and BPSDs are key symptoms, they are frequently under-recognized or inappropriately managed by clinicians. This is despite the presence of multiple clinical guidelines.6,17,18 Moreover, the failure to address pain and BPSD increases healthcare utilization, costs, caregiving burden, and institutionalization, while decreasing quality of life (QOL).18–25

Informal caregivers are also negatively affected by BPSD. Informal caregivers represent a broad range of friends and family who support up to 83% of the care provided to persons living with ADRD in the community setting.26 Informal caregivers aid in medication and BPSD management, interactions with healthcare professionals and adherence to treatment regimens.27 However, acting as informal caregivers places individuals at risk of caregiver burnout and negative mental and physical health outcomes for both the caregiver and the persons living with ADRD.27,28 The presence of BPSD in persons living with ADRD in particular has been linked to increased rates of caregiving burnout and decreased QOL, as caregivers struggle to manage pain and symptoms such as pain or aggression in addition to performing routine caregiving duties.19,29

Moreover, home healthcare clinicians often fail to recognize the important contributions of informal caregivers towards health outcomes of persons living with ADRD. Home healthcare is an interdisciplinary care team model that provides skilled care to homebound individuals in their place of residence. About 38.8% of hospitalized older adults were discharged with home healthcare between 2010–2016.30 Meanwhile, a large, and growing proportion of home healthcare patients are being directly admitted to home healthcare from the community setting.31 From 2001 to 2013, an 115% increase was seen in the home health admittance of community dwelling individuals.31 The increase in community dwelling individuals admittance to home health may be due to the growth of chronic conditions such as Alzheimer’s disease.31

Within skilled home healthcare, the majority of care is provided by registered nurses, physical therapists and occupational therapists, though other disciplines, such as social work and speech therapy can also perform visits. These home healthcare team members may lack training and systematic approaches for helping to address the care and needs of those persons living with ADRD, a growing population in this setting, including pain and BPSD management.32 A systematic review of interprofessional education regarding the care of persons living with ADRD demonstrated a dearth of interventional studies targeting home healthcare providers’ care of persons living with ADRD and caregivers’ QOL.33

Objectives

The purpose of this embedded, pragmatic, multi-site cluster randomized controlled trial (RCT) is to examine the effects of Aliviado Dementia Care program. This study aims to explore the effectiveness of the Aliviado Dementia Care program across 20 care teams at three participating home healthcare agencies in Florida, New Jersey, and Utah.

We hypothesize that persons living with ADRD cared for by an home healthcare team utilizing the Aliviado Dementia Care quality assurance performance improvement program will show reduced symptoms and improved ratings of pain, BPSD, and caregiver-related QOL at the end of the first 60-day home healthcare certification period compared to the control (usual care) group. Moreover, we hypothesize that informal caregivers of persons living with ADRD in the intervention group will show reduced ratings of burden and depression, and improved functional health and well-being at the end of the first 60-day home healthcare certification period compared to the control group. We also hypothesize that persons living with ADRD in the intervention group will show a reduction in emergency room visits and hospital admissions compared to the control (usual care) group, and a greater number of outpatient visits.

Methods: Participants, Interventions, and Outcomes

Description of the Intervention

Aliviado Dementia Care is a quality assurance performance improvement program designed to assist healthcare organizations in provided effective palliative care to persons living with ADRD. The Aliviado Dementia Care-Home Health Edition is specifically tailored towards home healthcare agencies. It consists of multiple components. Five 1-hour online interactive learning modules geared toward teaching registered nurses, physical therapists, and occupational therapists address how to: 1) understand the epidemiology, diagnosis, symptoms presentation, and treatment approaches for persons living with ADRD; 2) assess and manage pain; 3) assess and manage BPSD; and 4) communicate effectively between members of the home healthcare team, primary care providers, and caregivers.

Upon completion of the training modules, home healthcare clinicians will be provided with a toolbox of specific evidence-based ADRD staging instruments, pain and BPSD assessment instruments, a BPSD treatment algorithm, and BPSD care plans which have been integrated into the home healthcare agencies’ electronic health records. Additionally, clinicians will be provided with caregiver education pamphlets written in English and Spanish at a 6th to 8th grade reading level. The caregiver education pamphlets address specific symptoms and other caregiving tasks and provide simple explanations and tips for caregivers

The Aliviado Dementia Care program also includes a symptom assessment and treatment algorithm for BPSD. Together these elements help support home healthcare clinicians’ ability to manage pain and BPSD in persons living with ADRD and better support their caregivers. Much of the intervention has been described elsewhere.34

To support implementation of the intervention in the care teams, clinical champions will be selected in each care team by the agency’s leadership. The champions act as a resource for the home healthcare clinicians and aide in maintaining the fidelity of the intervention. The champions will receive two full days of interactive in-person didactic content, case studies, and role-playing simulation cases. Champions will then serve as resources for the other non-champion clinicians to support completion of the training program and continued implementation of the quality improvement program.

Trial Design

This study will utilize a multi-site, cluster RCT design. The unit of randomization will be the home healthcare team. persons living with ADRD and caregiver dyads will be recruited from those teams for the study. The Aliviado Dementia Care research team will be engaged in the recruitment of persons living with ADRD and their caregivers. Additionally, the research team will support collection of data addressing the primary and secondary outcomes.

Visit Schedule

Assessments used to collect data will be administered in the persons living with ADRD ‘s home at the following time points: visit 1 (start of care +/-3 days), visit 2 (day 15 +/− 3), visit 3 (day 30 +−3), and the final visit (day 60 +/− 5). These assessments are collected regardless of whether the persons living with ADRD remains a patient of the home healthcare agency.

Outcome Measures

The primary outcomes for the study will be (1) persons living with ADRD and caregiver QOL, and (2) number of ED visits and rates of persons living with ADRD hospitalization at 30 and 60 days. The QOL of persons living with ADRD and caregivers will be collected using the Quality of Life in Alzheimer’s Disease (QOL-AD)35 and The Caregiver Targeted Quality of Life tool (CGQOL).36 ED visits and hospitalization rates will be collected from the caregiver utilizing the Resource Utilization in Dementia v3.2 questionnaire.37

Secondary outcomes include the presence and severity of pain and BPSD as well as the use of antipsychotic and analgesic medications in the persons living with ADRD. Other secondary outcomes will include informal caregiver burden, depression, functional health and well-being, the number of outpatient visits and contacts with the primary care provider. (See Table 1).

Table 1:

Primary Outcomes

Outcome Measurement Tool Collection Timepoint Target
Quality of Life (QOL) The Quality of Life in Alzheimer’s Disease (QOL-AD)35
The Caregiver Targeted Quality of Life tool (CGQOL)36 		Visits 1, 4
Visits 1, 4		 persons living with ADRD
Caregiver
Emergency Department Visits and Rates of persons living with ADRD Hospitalization Resource Utilization in Dementia v3.2 questionnaire37 Visit 2, 4 persons living with ADRD
Secondary Outcomes
Presence and Severity of BPSDs Neuropsychiatric Inventory Questionnaire (NPI-Q)47 Visits 1–4 persons living with ADRD
Presence and Severity of Pain PAINAD48 and Brief Pain Inventory Short Form (BPI)49 Visits 1–4 persons living with ADRD
Analgesic and Antipsychotic Use Pill bottle review and interview Visits 1–4 persons living with ADRD
Caregiver Burden Zarit Burden Inventory50 Visits 1, 4 Caregiver
Depressive Symptoms Public Health Questionnaire 9 (PHQ-9)51 Visits 1, 4 Caregiver
Functional health and well-being Short Form Health Survey (SF-12)52
Katz Activities of Daily Living (ADLs)39
Lawton Instruments of ADLs.40
Charlson Comorbidity Index53 		Visits 1, 4
Visits 1–4
Visits 1–4
Visit 1		 Caregiver
persons living with ADRD
persons living with ADRD
persons living with ADRD and Caregiver
Care Satisfaction Home Health Care Consumer Assessment of Healthcare Providers (HHCAHPS) Visit 4 persons living with ADRD
Other Healthcare Utilization Measures Resource Utilization in Dementia v3.2 questionnaire37 Visit 2, 4 persons living with ADRD and Caregiver
Covariates
Presence and Stage of Dementia Quick Dementia Rating Scale (QDRS)54 Visit 1 persons living with ADRD
Delirium 3D-CAM46 Visits 1–4 persons living with ADRD
Health Literacy Short Assessment of Health Literacy (SAHL)55 Visit 1 Caregiver
Sociodemographics date of birth, sex, gender, sexual preference, education level, race, ethnicity, language, religion, marital status, household number Visit 1 persons living with ADRD and Caregiver
Medication record and usage, caregiver and home health care visits by discipline Chart Data N/A persons living with ADRD
Healthcare Utilization in month prior to enrollment Resource Utilization in Dementia v3.2 questionnaire37 Visit 1 persons living with ADRD and Caregiver
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Other Variables

Additional variables will be collected and utilized to describe the population in each arm and control for imbalances. In addition, sociodemographic data, health literacy,38 social supports, and health and functional status39–42 data will be collected (see Table 1).

Setting

Participants will be recruited from three participating home healthcare agencies located in Florida (3 clusters), New Jersey (12 clusters), and Utah (5 clusters). Home healthcare teams will be randomized into intervention (Aliviado Dementia Care) and control groups.

Eligibility criteria

Inclusion Criteria

Participants are eligible if they meet the following criteria: (1) are over the age of 65; (2) admitted to one of the three participating home healthcare agencies; (3) speak English and/or Spanish; (4) have a caregiver 18 years or older who spends at least 8 hour per week with the persons living with ADRD; (5) score at least 6+ on the Quick Dementia Rating Scale43 (demonstrating mild impairment or worse).43

Exclusion Criteria

Participants will be excluded if they meet any of the following criteria: (1) have a separate Axis 1 diagnosis other than forms of dementia, depression, or anxiety; (2) are solely receiving infusion or home health aide services; (3) reside in assisted living facilities or board and care homes. Exclusion criteria #3 is applied because in assisted living facilities, caregiving is mostly likely provided by formal or professional caregivers.44 Additionally, differences in how care is perceived may be influenced based upon the care setting.44

Recruitment and Informed Consent

The research team will contact potential subjects using a REDCap database of referrals to screen for eligibility. The research team will provide an overview of the Aliviado Dementia Care study and will complete a screening assessment for eligibility. The level of the persons living with ADRD ‘s cognitive impairment will be assessed through the caregivers’ reporting of the persons living with ADRD ‘s symptoms and behaviors through the use of the Quick Dementia Rating Scale.43 The Quick Dementia Rating Scale is an instrument with validity comparable to clinician administered cognitive rating scales.43 A persons living with ADRD who scores >6 on the Quick Dementia Rating Scale43 will meet eligibility for study inclusion as this score indicates mild impairment. A score of >6 on the Quick Dementia Rating Scale is similar to a score of <23 on the Folstein Mini-Mental Status Exam or the Montreal Cognitive Assessment. A home visit will be scheduled within three business days of admission to complete the subject consent process.

Written consent forms will be provided to both the persons living with ADRD and caregiver participants, including information describing the Aliviado Dementia Care program, study procedures, and potential risks. Participants will receive a verbal explanation of the purposes, procedures, and potential risks of the study and of their rights as research participants. The research team member performing the consent will answer any questions at time of consenting, and further questions may be asked of the PI. The persons living with ADRD and caregiver will sign separate informed consent document prior to any procedures relating to the study. A copy of the signed informed consent documents will be given to the participants for their records. A copy will also be placed within the participants’ research record.

Capacity for consent for persons living with ADRD will be assessed by the research team member using a standardized 3-question approach.45 The standardized consent questions will consist of (1) What is the purpose of this study, (2) What are the risks, (3) What are the benefits? The interviewer will then assess persons living with ADRD ‘s ability to answer the three questions and will score each response as either 0 (incapable), 1 (questionable), or 2 (capable). The score will then be totaled. A score lower than three will be considered a demonstration that the persons living with ADRD lacks capacity to consent. The PI and site PI will provide training to the research staff and sign off on competency to perform this capacity assessment prior to being allowed to obtain consent. Training will include use of case studies and examples to assess ability to perform the consent process.

If persons living with ADRD lack capacity to consent, their enrollment will be contingent upon consent provided by their legally authorized representative or a legal surrogate as determined by their state of residence. This may or not be the caregiver. If it is not the caregiver also being enrolled in the study, the IRB has issued a temporary waiver of written documentation of consent to allow the legally authorized representative/surrogate to verbally consent over phone. They must then sign the written consent within 15 days. Once consent on the behalf of the persons living with ADRD has been acquired, the persons living with ADRD will be asked to assent verbally and by signature. If the persons living with ADRD provides verbal assent but is unable to provide their signature due to disability (cognitive/physical), the research staff member will note on the consent form that the persons living with ADRD provided verbal consent but was unable to sign.

Data Analysis

Power Analysis

Based upon power analysis linear mixed models assuming an intra-class coefficient of .05, and covariates accounting for 15% of the variance in outcome requires 15 dyads per cluster and 20 clusters (10 per arm) to detect a medium-sized treatment effect (δ = .45) with 80% power. Recruitment will continue until reaching 15 completed cases in each cluster (N=300). Anticipating a 15% dropout21,36 over the 60-day period will require a recruitment goal of 345 dyads (persons living with ADRD and Caregiver). Sampling will occur at the New Jersey site with an anticipated 207 dyads enrolled with expectation of 180 complete dyad cases. Sampling in Utah will seek to include 86 dyads enrolled with expectation of 75 complete dyad cases. Sampling in Florida is anticipated to result in recruitment of 52 dyads enrolled with expectation of 45 complete cases.

Randomization and Subject Assignment

Randomization will occur through the use of SAS 9.4. Healthcare teams will be treated as clusters and randomized in strata by agency and geographic location. Randomization of healthcare teams as clusters will support the assignment of matched care teams to either the Aliviado Dementia Care quality improvement program or the control group. The study PI will inform home healthcare agencies which teams will serve as intervention or control.

Randomization by patient is not feasible as patients are seen by care teams in a given geographic region. Patients in the intervention group will receive care from a care team who has received the Aliviado Dementia Care quality assurance performance improvement program and those in the control will receive usual care from a care team who has not received the program. Patients at the study sites receive care from members of the same team, removing potential for patients to receive care from a combination of care teams. Care team staff do not generally interact thus limiting the potential for contamination.

Subjects will be assigned through usual practice to the care team serving the geographic area they live in. Individuals will be sequentially recruited as they are referred from agencies. Clinicians will be enrolled sequentially if they are eligible. All study personnel with the exception of the lead site PI and study statistician will be blinded to the assignment of the clinicians to the Aliviado Dementia Care performance improvement or usual care team. The PI is not blinded to individual cases as he trains the champions in the intervention, which prevents the ability to blind. However, the PI is not involved in individual data collection process and is blinded from any analyses performed on study outcomes until the end of data collection.

Data Collection and Management

All data other than the consent forms will be collected and maintained electronically. Data collection will be the responsibility of the clinical trial staff at the site, under supervision of the site PI. The investigator will ensure the accuracy, completeness, legibility, and timeliness of the data reported.

REDCap, a 21 CFR Part 11-compliant data capture system will be utilized for management of the study record, recruitment, enrollment. Qualtrics will be utilized for collection of primary data from the persons living with ADRD and caregiver. The data systems include password protection and internal quality checks, such as automatic range checks to identify data that appear inconsistent, incomplete, or inaccurate. Clinical data will include data home healthcare agencies are required to report to the Centers for Medicare and Medicaid, specifically the Home Health Outcome and Assessment Information Set (OASIS). Additionally, chart data will be cleaned and entered into a separate study database specific for this purpose.

Clinical site monitoring will be performed by the biostatistician and PI to ensure appropriate and complete targeting of prospective subjects. Monthly meetings will be held to ensure intervention fidelity. Each research site will perform internal quality management of study conduct, data collection, documentation, and completion.

Data Analysis

We will first compare cohorts based on sociodemographic data and comorbidities using descriptive statistics and t-tests. We will then perform time trend analysis using repeated measure multivariate mixed effects liner models (PROC MCM in SAS) for all non-utilization outcomes. Utilization outcomes will be analyzed through logistic regression for odds of hospitalization or ER visit and Poisson Count regression (PROC GENMOD in SAS) for total number of hospitalizations and ER visits. Both will use random effects to account for clustering. We will also perform exploratory analyses to examine: (1) difference between gold standard measurement by trained research coordinators with chart data collected by practicing home healthcare clinicians; (2) the effect of activities of daily living function on non-QOL outcomes; and (3) the interaction of caregiver and PWD primary and secondary outcomes.

Ethics and Disseminations

Research Ethics Approval

The study protocol and informed consent forms were reviewed and approved by the sponsor and applicable institutional review boards (IRBs) with respect to scientific content and compliance with applicable research and human subjects regulations. IRB approval was first obtained from NYU School of Medicine, followed by approval from the other study sites. Approval of the protocol occurred on December 23, 2017.

Ethical and Safety Considerations

This study presents a minimal risk for participants, as it is an evidence-based implementation science intervention. Investigators will monitor for the occurrence of adverse events or serious adverse events. Adverse events represent any illness, experience, or symptom which may occur or worsen during the course of this study. Per review of the NIH appointed Data Safety Monitoring Board (see below), because this is a minimal risk embedded pragmatic trial, the adverse event that will be monitored for is worsening of depression symptoms in caregivers through use of the PHQ-9 validated tool. Serious adverse events represent fatal, life-threatening, prolonged hospital stay, resistant or significant disability or incapacity, congenital anomaly, or an important medical event. This study will monitor the following serious adverse events: caregiver attempted suicide, delirium, ER visit, hospitalization or death of caregiver or persons living with ADRD, elder neglect or abuse, or environmental dangers in the home, particularly unsecured firearms.

Any adverse or serious adverse event will be immediately reported to the site-PI and overall PI, who will follow standard care procedures by notifying the subject’s health care provider (if not already notified). Any adverse or serious adverse event found to be related to the trial will trigger notification of the IRB of record and data safety monitoring board for further review.

The site-PI and PI will be notified regarding imminent home safety threats or hazards, suspected elder abuse or neglect, and caregiver depression. Upon notification, a telephone triage will be performed and standard clinical practice will be followed by notifying the subject’s primary care provider to advise of the situation.

In this study, a data safety monitoring board was appointed by the National Institute on Aging to ensure safety of participants in the study. The data safety monitoring board is composed of three independent members, who have no role or professional conflict with this study, no affiliation with any of the study sites, and has not served as an author or co-author on a grant or manuscript together with the PI or site PIs within the last three years in accordance with National Institute on Aging guidelines, and was appointed by the agency director. The data safety monitoring board will meet bi-annually or as needed and will monitor primary, secondary outcomes, serious adverse events or adverse events, performance and recruitment by site as well as any other safety issues or risks to persons living with ADRD and/or caregiver. The data safety monitoring board approved the initial study protocol on November 20, 2017.

The data safety monitoring board has also required delirium assessments be conducted to safeguard and monitor vulnerable subjects during high risk periods. Subject who are enrolled into the study within 30-days post hospitalization discharge are most at risk. The factor in support of monitoring patients for delirium rests on the concern that clinicians responding to BPSD may unintentionally overlook symptoms of delirium. Therefore, it was determined that during each time point, research coordinators will administer the 3D-CAM46 instrument to assess for delirium.

Dissemination

This study will comply with NIH Public Access Policy and ensure the public has access to the published results of NIH funded research. This trial is registered through clinicaltrials.gov (NCT03255967). Moreover, the results of this study will be used to actively engage with healthcare partners to disseminate the results and support the care of the persons living with ADRD in home and community-based settings.

Conclusion

The Aliviado Dementia Care program represents a key program targeting the quality of life for persons with dementia and informal caregivers. The Aliviado Dementia Care program is one of the first programs specifically targeting home healthcare agencies’ ability to improve quality of care for persons living with ADRD and their caregivers through recognizing and supporting evidence-based treatment for persons living with ADRD s. This embedded pragmatic clinical trial will provide critical information regarding the efficacy and effectiveness of the intervention verses usual care. If successful, this study will support implementation of Aliviado Dementia Care in home healthcare and potentially lead to tailoring for other healthcare settings.

Funding:

NIH/NIA

Grant#:R01AG056610

The funding source had no role in the design of this study and will not have any role during execution, analyses, interpretation of the data or decision to submit results

Footnotes

Trial registration: Clinical Trials.gov: NCT03255967

Conflict of Interests:

Dr. Brody has received consulting fees from Abbott Nutrition.

Dr. Galvin has received consulting fees from Biogen, Axovant, Roche, Eisai, Lilly, Bracket, and Medavante and has licensing agreements with Roche, Lilly, Biogen, Quintiles, Roobrik, Continuum Clinical, and Langland.

Contributor Information

Alycia A. Bristol, NYU Rory Meyers College of Nursing.

Kimberly A. Convery, The Hartford Institute for Geriatric Nursing; NYU Rory Meyers College of Nursing.

Victor Sotelo, The Hartford Institute for Geriatric Nursing; NYU Rory Meyers College of Nursing.

Catherine E. Schneider, NYU Rory Meyers College of Nursing.

Shih-Yin Lin, NYU Rory Meyers College of Nursing.

Jason Fletcher, NYU Rory Meyers College of Nursing.

Randall Rupper, University of Utah School of Medicine; George E. Wahlen Department of Veterans Affairs Medical Center, VA Salt Lake City Health Care System, Geriatric Research, Education and Clinical Center, Salt Lake City, Utah.

James E. Galvin, Comprehensive Center for Brain Health; University of Miami Miller School of Medicine.

Abraham A. Brody, Hartford Institute for Geriatric Nursing.

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