Clinical trial NCT04610944: Changing Talk Online Training (CHATO) National Trial
Official title: Changing Talk Online Training (CHATO): A National Trial to Reduce Behavioral Symptoms in Long Term Care Residents With Alzheimer's Disease and Other Dementias
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Dementia
Alzheimer Disease
Communication
Keywords: Nursing home
Staff Training
Dementia
Alzheimer Disease
Behavioral and Psychological Symptoms of Dementia
Psychotropic Medication
Elderspeak
Nonpharmacological treatment for Dementia
Staff Communication
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: University of Iowa
First posted: 2020-11-02
Enrollment: 5043
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The National Plan to Address Alzheimer's disease has identified education of dementia care providers as a top priority to address the need for quality care for the population of persons with dementia that will triple in the next 30 years. This study will test new online interactive training for nursing home staff that improves staff communication and also reduces behavioral symptoms of persons with dementia that they care for. Innovative approaches to reach care providers are essential to achieve implementation of evidence-based practices to improve care.

Detailed description: A new person is diagnosed with Alzheimer's disease or other dementia every 65 seconds, and most persons living with dementia (PWD) spend the late stages of dementia in nursing homes (NHs) where shortages of staff and lack of dementia care skills limit quality of care. Care of PWD is complicated by behavioral and psychological symptoms of dementia (BPSD) such as aggression, vocal outbursts, wandering, and withdrawal that occur as PWD lose cognitive and communication abilities and cannot express their unmet physical and psychosocial needs. BPSD present to NH staff as resistiveness to care (RTC) that increases staff stress and costly time to complete care, often leading to staff turnover, injury, and inappropriate use of psychotropic medications to control BPSD. Although Center for Medicare and Medicaid Services (CMS) mandates and penalties have reduced NH antipsychotic medication use slightly, contraindicated use in NH residents remains a pervasive problem, causing harmful side effects and reducing the quality of life for PWD.

The PI and other researchers have empirically verified that RTC occurs when NH staff use elderspeak (speech similar to baby talk) that features inappropriately intimate terms of endearment (diminutives such as "honey"), belittling pronoun substitutions that imply dependence ("we" need a bath), and harsh task-oriented commands ("sit down"). Elderspeak conveys a message of disrespect and incompetence to residents who react with withdrawal or BPSD. Our R03 study established that when staff use elderspeak instead of normal adult communication, residents with dementia are more than twice as likely to exhibit BPSD (measured by coding RTC behavior in videos). Our subsequent R01 clinical trial verified that staff reduced their use of elderspeak communication after attending the three-session Changing Talk (CHAT) program and that this reduced RTC.

CHAT training is effective in changing staff communication practices and reducing RTC but requires an onsite trainer, limiting accessibility and feasibility for dissemination. Increasing access to this effective training, which improves communication and acts as a nonpharmacological intervention to reduce BPSD, is the next logical step. To facilitate dissemination, interactive online modules (CHATO) with the same CHAT content were developed and pilot-tested, establishing preliminary effects and increased participation by busy NH staff. We anticipate that this online training will increase access to training and the translation of evidence-based content and skill practice at reduced cost extending reach nationally to include small and rural NHs. Support for NH administrators will optimize staff engagement, implementation, and maintenance of CHATO skills in practice.

This competitive renewal resubmission builds on R01 NR011455, "Changing Talk to Reduce Resistiveness to Dementia Care" demonstrating the 3-session CHAT intervention decreased staff elderspeak and reduced resident RTC.13 Online CHATO modules provide asynchronous, independent access for busy NH staff. Linear mixed modeling will be used to compare CHATO and CONTROL group change in BPSD and psychotropic medication use (from CMS and Nursing Home Compare data). CHATO is an innovative nonpharmacological intervention that reduces BPSD. Online delivery will increase cost effectiveness.

SPECIFIC AIMS:

1. AIM 1. Test effects of CHATO on BPSD and psychotropic medication use in 120 NHs. Hypothesis: Reductions in BPSD and psychotropic medication use (extracted from CMS Minimum Data set and Nursing Home Compare Quality Measures) will occur for individual residents and within NH facilities in the CHATO vs CONTROL group.
2. AIM 2. Test strategies to engage staff and maximize CHATO effects. We will conduct a mixed-method process evaluation evaluating implementation strategies and supports to assist NHs in approach, motivation, and incentives to improve dissemination. NH characteristics and implementation strategies used will be analyzed in relation to participation rates, knowledge gain, and changes in primary outcomes. Interviews and focus groups will be conducted by our external evaluator. Hypothesis: Primary outcomes will vary by secondary outcomes; identifying most effective NH characteristics and strategies for implementation.
3. AIM 3. Evaluate cost and sustainability. Data envelopment analysis will identify CHATO costs in relation to BPSD reductions. NHs will complete a 1-year follow-up survey to report on their adoption and maintenance. Hypothesis: BPSD reductions will vary in cost; identifying the most efficient means of dissemination and NH sustainability will vary depending on adoption factors.

Eligibility criteria: Inclusion Criteria:

* Nursing Homes that serve people with dementia.
* Nursing Homes that have internet available for staff to complete the CHATO training.
* Nursing Homes that are willing to complete leadership interviews and surveys.
* CNAs and nurses who are permanent employees of participating NHs and who provide direct care at least 8 hours weekly will complete the CHATO training, available by URL link. All staff will be encouraged to participate as participation by as many staff as possible is desired to achieve facility-wide communication change.
* Data for residents in participating NHs with Alzheimer's disease or non- Alzheimer's dementia documented on the MDS Active Diagnoses list will be included in the analyses.

Exclusion Criteria:

* Assisted Living facilities or other types of facilities are excluded due to lack of MDS data as well as NHs that previously participated in other CHAT/CHATO studies.
* Exclusion criteria from MDS include active psychiatric diagnoses (bipolar disorder, major depressive episode, schizophrenia or schizoaffective disorder, mood disorder with psychotic features, psychotic symptoms, hallucinations or delusions); terminal illness (on hospice); and lack of verbal or non-verbal response to staff (MDS section B).

Primary outcomes:
measure: AIM 1. Test CHATO's effects on Behavioral and Psychological Symptoms of Dementia (BPSD) - Change in MDS E0200 at 3 and 6 months
timeFrame: Pre 1(6 months), Pre 2 (3 months), Post 1(3 months), Post 2 (6 months)
measure: AIM 1. Test CHATO's effects on Behavioral and Psychological Symptoms of Dementia (BPSD) - Change in MDS E0800 at 3 and 6 months
timeFrame: Pre 1(6 months), Pre 2 (3 months), Post 1(3 months), Post 2 (6 months)
measure: AIM 1. Test CHATO's effects on Behavioral and Psychological Symptoms of Dementia (BPSD) - Change in MDS E1100 at 3 and 6 months
timeFrame: Pre 1(6 months), Pre 2 (3 months), Post 1(3 months), Post 2 (6 months)
measure: AIM 1. Test CHATO's effects on psychotropic medication - Change in MDS N0410 at 3 and 6 months
timeFrame: Pre 1(6 months), Pre 2 (3 months), Post 1(3 months), Post 2 (6 months)
measure: AIM 1. Test CHATO's effects on psychotropic medication - Change in NHQM Prescribed Antipsychotic at 3 and 6 months
timeFrame: Pre 1(6 months), Pre 2 (3 months), Post 1(3 months), Post 2 (6 months)
measure: AIM 1. Test CHATO's effects on psychotropic medication - Change in HIS F329 Noncompliance at 1 year
timeFrame: Pre (1 year), Post (1 year)
measure: AIM 2. Analyze NH strategies to engage staff and maximize CHATO effects _ Change in Knowledge at 3 months
timeFrame: Pre (1 month), Post (3 months)
measure: AIM 2. Analyze NH strategies to engage staff and maximize CHATO effects _ Change in Communication Ratings at 3 months
timeFrame: Pre (1 month), Post (3 months)
measure: AIM 2. Analyze NH strategies to engage staff and maximize CHATO effects _ Implementation Strategies utilized during the training phase (3 months)
timeFrame: Post (3 months)
Secondary outcomes:
measure: AIM 3. Evaluate CHATO Cost (3 months of training)
timeFrame: Post (3 months)
measure: Aim 3. Evaluate CHATO Sustainability (1 year post-training)
timeFrame: Post (1 year)
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas School of Nursing
state: Kansas
Study officials:
References: