Clinical trial NCT04271046: STAR Caregivers - Virtual Training and Follow-up
Official title: STAR Caregivers - Virtual Training and Follow-up
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Disease
Dementia
Caregiver Burnout
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
name: University of Washington
First posted: 2020-02-17
Enrollment: 67
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The trial will use a parallel, two-arm, randomized trial design. Participants will be randomly assigned to the experimental intervention or control. Participants in the control condition will receive mailed material from the Alzheimer's Association, web links and template secure messages. Everyone will complete assessments at baseline, 8-weeks post-enrollment, and 6 months post-enrollment.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study evaluates the effectiveness of a caregiver outreach, training, and support program for caregivers of people with dementia who are using antipsychotic medication to manage agitation/aggression. The Investigators will conduct a randomized trial of the caregiver program compared to a control group to measure differences in caregiver burden and discontinuation of antipsychotic medication use. The results will help in expanding access to and delivery of empirically supported behavioral health services for caregivers and people with dementia.

Detailed description: Alzheimer's Disease and related dementias (ADRD) are debilitating conditions affecting more than 5 million Americans in 2014. With aging of the population it is projected that 8.4 million people will be diagnosed with ADRD over the next 15 years and health care costs attributable to ADRD are projected to be more than 1.2 trillion by 2050. Behavioral and Psychological Symptoms of Dementia (BPSD) (anxiety, agitation, depression) are common and often involve aggressive behavior towards family caregivers (CG) in response to unmet needs, discomfort, or frustration. BPSD are disturbing and frequently lead to caregivers seeking medication to control patient symptoms. Antipsychotic use in persons with dementia (PWD) more than doubles mortality risk; however, many caregivers are willing to accept those risks. The Choosing Wisely Guidelines from the American Psychiatric Association and American Geriatrics Society both recommend against prescribing antipsychotics as a first-line treatment for BPSD. STAR-Caregivers is an efficacious first-line behavioral treatment, endorsed by the Administration on Aging, that involves caregiver training to manage BPSD. However, the program has not been implemented widely - partly due to the cost of the programs, difficulty conducting outreach, and modality of training (in person with written materials). Adequate caregiver training and commensurate reduction in caregiver burden are the mediators (mechanisms) the Investigators will engage in this Stage III trial to reduce BPSD and discontinue antipsychotic medication use by PWD.

The STAR-Caregivers program is an education, training, and support intervention demonstrated efficacious in reducing BPSD. The original program involved 8 face-to-face, in-home training sessions and 4 follow-up phone calls. The condensed version involves 4 in-home sessions with 2 phone follow-ups.18 Neither of these is feasible from a payer perspective. The investigators propose to test a self-directed, remote version called STAR-virtual training and follow-up (STAR-VTF) that leverages secure email within the member portal at Kaiser Permanente Washington to improve access to training, fidelity to the STAR principles, and to lower the cost of the program.

The investigators propose a Stage III trial to ascertain the feasibility and acceptability of STAR-VTF in which (a) caregiver training materials are delivered electronically and learning is self-directed, (b) caregivers have one orientation phone visit with a social worker and (c) where caregivers receive ongoing support from a social worker via telephone and secure messaging in the web-based member portal. Investigators will compare outcomes in the STAR-VTF group to an attention control group (mailed material, links to websites, and generic secure messages).

The specific aims are:

Aim 1: Assess the feasibility and acceptability of conducting caregiver outreach, training, and support via social workers including: (1) willingness of caregivers to interact primarily through secure messaging (contact rates); and (2) willingness of caregivers to complete self-directed training (training completion rates).

Aim 2: Assess the feasibility and acceptability of the program from the payer perspective including: (1) average time spent per home-visit (including preparation and travel time); (2) average time per month spent responding to caregiver emails and coordinating care with primary care physicians; and (3 differences in face-to-face primary care, urgent care, and emergency department visit rates by PWD.

Aim 3: Test the hypotheses that (H1) caregiver participants in STAR-VTF will have lower levels of caregiver burden at 8 weeks and 6 months compared to an attention control group; and (H2) PWD participants in STAR-VTF will have lower rates of antipsychotic medication use at 6 months compared to control. Secondary outcomes are: caregiver depression and caregiver self-efficacy. The investigators propose to recruit 100 CG-PWD dyads (50 per arm).

This will be the first study to test a low intensity, self-directed caregiver training program with remote support from social workers. It will also be the first study to measure changes in antipsychotic medication use by PWD after caregiver training. Kaiser Permanente is an ideal setting because investigators have access to the complete electronic health record (EHR), prescription medication use, health care use, and demographic data. The investigators will be able to identify and enroll participants in real-time using an automated data "troll" as investigators have done previously. This study will be an important step in expanding access to training and support in a format that could be implemented within integrated delivery systems with capitated payments (i.e., Accountable Care Organizations). Growing use of EHR portals in these organizations will further increase demand for web-based care management/support. Demand will also increase as today's near-retirees, familiar with web-based applications, develop ADRD. Kaiser Permanente has pioneered such efforts and is the lead site in the Mental Health Research Network (MHRN). Findings from this study will inform a future multi-site pragmatic trial across the 13 health systems and 12 million enrollees in the MHRN.

Eligibility criteria: Current Criteria:

Investigators will identify and recruit Person with Dementia-Caregiver dyads in which the person with dementia has has made a healthcare visit in the last week where a diagnosis of Alzheimer's Disease or related dementia was recorded. Because we will enroll dyads, there are inclusion/exclusion criteria for both.

Participants

Persons with dementia inclusion criteria:

Aged ≥ 65 years Confirmed diagnosis of Alzheimer's Disease related disorders (ADRD) from the patient Electronic Health Record (EHR) or primary care physician KP members for a minimum of 180 days prior to the index visit date. Expected to live \>= 6 months from enrollment

Persons with dementia exclusion criteria:

* A diagnosis of bipolar disorder or schizophreniform disorder
* The primary care physician's opinion is that the person with dementia is expected to live less than 6 months.
* Less that 65 years of age
* Primary language is not English (patient requires a translator).

Caregiver inclusion criteria:

* Aged ≥ 21 years
* Lives with person with dementia or within 8 miles
* Provides at least 8 hours of care per week
* Have access to a computer or other device where they can access MyChart, personal email, and websites to complete online training
* Use MyChart to email the doctors that care for the PWD they are caring for

Caregivers exclusion criteria:

* Diagnosis of Alzheimer's Disease or related disorders.
* Less than 21 years of age
* Are not the spouse, or adult child
* Unable to read and speak English
* Do not have access to a computer or other device where they can access MyChart, personal email, and websites to complete online training
* Do not use MyChart to email to doctors that care for the PWD they are caring for.

Previous Criteria:

Participants

The investigators will identify and recruit Person with Dementia-Caregiver dyads in which the person with dementia has filled a new prescription for an antipsychotic medication. Because we will enroll dyads, there are inclusion/exclusion criteria for both.

Persons with dementia inclusion criteria:

* Aged ≥ 65 years
* Diagnosis of Alzheimer's Disease related dementia (ADRD)
* A new prescription for an antipsychotic medication
* Living at home
* Expected to live \>= 6 months from enrollment

Persons with dementia exclusion criteria:

* A diagnosis of bipolar disorder or schizophreniform disorder
* Living in an assisted living, skilled nursing facility, or memory facility
* The primary care physician's opinion is that the person with dementia is expected to live less than 6 months.

Caregiver inclusion criteria:

* Aged ≥ 21 years
* Lives with person with dementia or within 8 miles
* Provides at least 8 hours of care per week

Caregivers exclusion criteria:

\* Diagnosis of Alzheimer's Disease or related disorders.

Primary outcomes:
measure: Change in Caregiver Burden
timeFrame: Change from baseline caregiver burden at 6 months.
Secondary outcomes:
measure: Change in Caregiver Depression
timeFrame: 6 months from baseline
measure: Change in Caregiver Self-efficacy
timeFrame: Change from baseline caregiver mastery at 6 months.
measure: Kingston Caregiver Stress Scale
timeFrame: 6 months from baseline
measure: Number of Caregivers Who Responded to Surveys at 8-weeks
timeFrame: 8 weeks from baseline
measure: Number of Caregivers Who Responded to Surveys at 6-months
timeFrame: 6 months from baseline
measure: Number of Dyads Who Complete STAR-C VTF Online Training
timeFrame: 8 weeks from baseline
measure: Number of Inpatient Visits Had by Patient With Dementia
timeFrame: End of follow-up (6 months)
measure: Number of Primary Care Visits Had by Patient With Dementia
timeFrame: End of follow-up (6 months)
measure: Number of Emergency Department Visits Had by Patient With Dementia
timeFrame: End of follow-up (6 months)
measure: Antipsychotic Prescription Fills Rate for Patient With Dementia
timeFrame: After 8 weeks in the study
measure: Antipsychotic Prescription Refill Rate for Patient With Dementia
timeFrame: 8 weeks after initial prescription
measure: Dementia Severity Rating Scale (DSRS) - Memory
timeFrame: 6 months from baseline
measure: Dementia Severity Rating Scale (DSRS) - Speech and Language
timeFrame: 6 months from baseline
measure: Dementia Severity Rating Scale (DSRS) - Recognition of Family Members
timeFrame: 6 months from baseline
measure: Dementia Severity Rating Scale (DSRS) - Orientation to Time
timeFrame: 6 months from baseline
measure: Dementia Severity Rating Scale (DSRS) - Orientation to Place
timeFrame: 6 months from baseline
measure: Dementia Severity Rating Scale (DSRS) - Ability to Make Decisions
timeFrame: 6 months from baseline
measure: Dementia Severity Rating Scale (DSRS) - Social & Community Activity
timeFrame: 6 months from baseline
measure: Dementia Severity Rating Scale (DSRS) - Home Activities & Responsibilities
timeFrame: 6 months from baseline
measure: Dementia Severity Rating Scale (DSRS) - Personal Care - Cleanliness
timeFrame: 6 months from baseline
measure: Dementia Severity Rating Scale (DSRS) - Eating
timeFrame: 6 months from baseline
measure: Dementia Severity Rating Scale (DSRS) - Control of Urination and Bowels
timeFrame: 6 months from baseline
measure: Dementia Severity Rating Scale (DSRS) - Ability to Get From Place to Place
timeFrame: 6 months from baseline
Other outcomes:
measure: Functional Activities Questionnaire (FAQ)
timeFrame: 6 months from baseline
Locations:
city: Seattle
country: United States
facility: Kaiser Permanente Washington Health Research Institute
state: Washington
Study officials:
References: