Changing Talk Online Training (CHATO) National Trial

NCT ID: NCT04610944

Last Updated: 2025-06-11

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 5043 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-26
• Study Completion Date: 2026-05-31

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.

Conditions

Dementia; Alzheimer Disease; Communication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Intervention

Intervention nursing homes will receive the training and control nursing homes will complete assessments, but not receive the training.

Group Type: EXPERIMENTAL

Changing Talk Online (CHATO)

Intervention Type: BEHAVIORAL

Three, one-hour training modules highlighting barriers and ineffective communication behaviors with older adults while teaching and modeling alternative, effective communication.

Waitlist Control

After the intervention nursing homes complete the training, the waitlist control nursing homes will crossover and complete the training.

Group Type: ACTIVE_COMPARATOR

Changing Talk Online (CHATO)

Intervention Type: BEHAVIORAL

Three, one-hour training modules highlighting barriers and ineffective communication behaviors with older adults while teaching and modeling alternative, effective communication.

Interventions

Changing Talk Online (CHATO)

Three, one-hour training modules highlighting barriers and ineffective communication behaviors with older adults while teaching and modeling alternative, effective communication.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Iowa

OTHER

Sponsor Role: collaborator

University of Kansas Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Kansas School of Nursing

Kansas City, Kansas, United States

Countries

United States

Other Identifiers

9R01AG069171-06A1

Identifier Type: NIH

Identifier Source: org_study_id

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