Clinical trial NCT03849937: Changing Talk Online (CHATO) Study
Official title: Changing Talk Online (CHATO): A Pragmatic Trial to Reduce Behavioral Symptoms in Dementia Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Staff Attitude
Dementia
Keywords: Behavioral and Psychological Symptoms of Dementia
Psychotropic Medication
Elderspeak
Staff Training
Staff Communication
Nonpharmacological treatment for Dementia
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: University of Iowa
First posted: 2019-02-21
Enrollment: 219
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The research design is a randomized clinical trial. An initial nursing home will be used to test feasibility. Six nursing homes will be randomly assigned to intervention or wait-list control groups.
Primary purpose: OTHER

Brief summary: Objectives AIM 1. Establish acceptability and preliminary efficacy of online CHATO modules through pilot testing with NH staff.

AIM 2. Develop and pilot test the data collection tool with consultant and advisory panel input. Interviews of NH administrators and staff who participate in the pilot testing of CHATO and a process evaluation will be used to identify and develop supports for implementation and sustainability in preparation for future CHATO testing.

Design and Outcomes The R61 will prepare for the R01 pragmatic trial by establishing feasibility of online modules and preliminary efficacy of CHATO with NH staff. The research design is a randomized clinical trial. One NH will provide initial feasibility testing. Any modifications to the modules will be made. Then six nursing homes (estimated N=150 staff) will be randomly assigned to intervention or wait-list control groups. The primary outcome will be knowledge gain for staff completing CHATO training. Additional outcomes include resident quality measures related to behavioral and psychological symptoms of dementia (BPSD) on both resident and facility levels and facility level data related to inappropriate use of psychotropic medications to control BPSD. Implementation strategies will be assessed by survey and leadership interviews completed by an external evaluator.

Interventions and Duration Changing Talk Online (CHATO) training is a course is to increase awareness of the importance of effective communication with older adults and to use evidence-based person-centered communication during interactions with older adults in nursing homes and other health care settings. The total program is approximately 3 hours, split into 3 modules. Each module is approximately an hour, depending on the individual user. Each NH will work with the research team for three months to plan, implement, and collect data.

Sample Size and Population This course is designed for staff in nursing homes, independent and assisted living, and health care settings in the community that include registered nurses, nursing assistants, nursing home dieticians, direct care professionals, other administrations and support employees. All the employees at all seven nursing homes will be asked to participate. Assignment of NHs to intervention and wait-list control groups will be at random. A sample of 150 training participants are estimated.

Detailed description: Background on Condition, Disease, or Other Primary Study Focus: The population afflicted with Alzheimer's disease and other dementias will expand from 5 to 16 million by 2050, increasing dementia care costs from $259 billion to $1.1 trillion. Of today's 1.4 million nursing home (NH) residents, 61% have moderate to severe dementia, and up to 90% of them exhibit behavioral and psychological symptoms of dementia (BPSD) such as physical and verbal aggression, agitation, and wandering. These behaviors are associated with depression as well as reduced quality of life and lower survival rates in persons with dementia (PWD). BPSD also stress family caregivers and precipitate NH placement. In the NH, BPSD increase time to provide care, and NH staff, primarily Certified Nursing Assistants (CNAs) who provide most direct care, report that BPSD represent the most stressful aspect of their job. Considering additional costs for CNA burnout and turnover, It is estimated that BPSD increase costs of dementia care by 25 to 35%. With national NH rates for a semi-private room of $82,200 per year, reducing BPSD may save up to $20,000 per resident annually.

As cognitive and communication abilities decline due to dementia, NH residents become unable to convey care preferences and needs and staff communication becomes infantilizing, impersonal, and task-oriented resulting in BPSD. As verified in the investigator's past research using behavioral coding and sequential analyses of video-recorded care, staff elderspeak (communication that sounds like baby talk) is linked to resident resistiveness to care (RTC), a subset of BPSD that disrupt nursing care. NH residents were more than twice as likely to be resistive to care when staff used elderspeak compared to normal communication. Thus, improving communication has great potential as a nonpharmacological intervention to reduce BPSD in NH care.

Study Rationale: The Communication Predicament of Aging theory establishes the link between elderspeak and BPSD. Elderspeak derives from stereotypical views of older adults as less competent than younger persons. When younger people talk with older adults, they modify their speech by simplifying, clarifying, and altering the underlying affective quality of messages. The resulting implicit message of incompetence begins a negative feedback loop for older persons, who react with depression, withdrawal, and dependency. Elderspeak is especially threatening to self-concept and personhood, critical to the wellbeing of PWD who are likely to respond with BPSD. The Need-driven Dementia-compromised Behavior model recognizes BPSD as the expression of unmet needs of PWD. Communication, that staff can modify to prevent BPSD, is an essential constant part of the environment connecting PWD to others and affirming their self-concept.

Psychotropic medications are often used inappropriately to control BPSD in NH residents with dementia. Alarmingly high rates persist, despite negative outcomes, an FDA black box warning of increased mortality for older adults with dementia, and a recent Centers for Medicare and Medicaid Services (CMS) mandate to reduce off-label prescribing of antipsychotics. CMS and the National Partnership to Improve Dementia Care target reductions in psychotropic drug use as top priority. Despite reductions in antipsychotic rates (one type of psychotropic medication) ranging from 3 to 12% from 2011-2016, up to 20% of NH residents received inappropriate antipsychotic medication in 2017. Research demonstrates that educating direct care providers in behavioral interventions to control BPSD also reduces psychotropic drug use (antipsychotics, hypnotics, antidepressants, antianxiety, sedative, anticonvulsant and mood stabilizers), although evidence is limited by lack of rigorous clinical trials that also evaluate approaches that influence intervention effects.

The recently completed R01 clinical trial that tested Changing Talk (CHAT) communication training (NR011455) provides preliminary data for this CHATO pilot. CHAT decreased staff elderspeak that reduced resident RTC and increased staff awareness of elderspeak's negative effects. CHAT NHs also saw a significant reduction in psychotropic medication use after the training versus averaged state rates. Despite the success of CHAT in reducing elderspeak and RTC, investigators found challenges to educating NH staff that limited participation in CHAT including turnover, absenteeism, heavy workloads, and personal conflicts. Each CHAT session was held multiple days and times. Still, as few as 44% of staff in one NH completed at least two of the three sessions, although this rate is higher than that noted for other NH staff training programs. Although successful in reducing RTC, the classroom format limits staff access and participation and feasibility for widespread dissemination. Creative, efficient approaches are needed to overcome NH staff education barriers. An online web conference training with multiple NHs as an alternative format was first evaluated for increasing access and dissemination. However, engagement of individual staff was limited with this approach. To facilitate dissemination, online CHAT modules (CHATO) were developed to provide the same CHAT content with asynchronous and independent access for busy NH staff.

The PI worked with an instructional designer, item writer, and media team to transition CHAT content, including 20 video clips of NH staff-resident interactions, to the online CHATO modules. Scripts from the original CHAT were narrated to maintain content, integrating adult learning theories and principles for online learning, and eliminating a need for advanced literacy skills. Interactive scenario and game-based activities engage staff. For example, participants watch a video clip, select problem communication in the transcript, type their improved communication, and compare it to suggested corrections. Moderated online discussions are included in the modules that are supported on Training-Source.org, a free and publicly available learning portal. IT functionality and content equivalency of the newly developed CHATO online modules was demonstrated by a convenient university-affiliated sample of nurses, CNAs, and students with NH experience. Although the group testing CHATO may not represent all NH staff, findings confirm that CHATO is feasible and comparable in content and effects.

While CHAT effectively reduced RTC, the in-person classroom format required an onsite interventionist, which limits accessibility and feasibility for dissemination. A pilot test of acceptability and preliminary efficacy of online CHATO modules is the next logical step. The pilot will prepare for a pragmatic clinical trial that will test the effects of improved staff communication (from CHATO) on resident BPSD and effects on psychotropic medication use. This research will address the gap in rigorous trials testing nonpharmacological interventions to decrease BPSD that also identify strategies to improve intervention dissemination. The goal is to increase access to CHATO training, as a tool to reduce BPSD and inappropriate psychotropic medication use to improve dementia care.

STUDY DESIGN

The R61 will prepare for the R01 pragmatic trial by establishing feasibility of online modules and preliminary efficacy of CHATO with NH staff. The research design is a randomized clinical trial. One NH will provide initial feasibility testing. Any modifications to the modules will be made. Then 6 nursing homes (estimated N=150 staff) will be randomly assigned to intervention or wait-list control groups. The primary outcome will be knowledge gain for staff completing CHATO training. Additional outcomes include resident quality measures related to behavioral and psychological symptoms of dementia (BPSD) on both resident and facility levels and facility level data related to inappropriate use of psychotropic medications to control BPSD.

Staff Knowledge Gain. At time 1, nursing home staff in both groups will complete baseline pre-tests of knowledge and rating of communication. The immediate intervention group will then complete the online CHATO modules within a one-month period. This includes assessments of post-test knowledge, communication rating, program evaluation, and diffusion of innovation surveys at Time 2. Also, at Time 2, the wait-list control group will repeat the pre-tests of knowledge and communication rating and will then complete the CHATO online module training over a one-month period, followed by Time 3 collection of post-test knowledge, communication rating, program evaluation, and diffusion of innovation surveys. Knowledge gain and communication rating data will be compared between the intervention and wait-list control groups and within nursing homes before and after the CHATO training. The immediate and wait-list groups will be compared at baseline to identify important covariates for analyses of changes in outcomes. Changes in knowledge from Time 1 (baseline) to Time 2 will be compared between immediate and wait-list groups using model estimates obtained with a linear mixed model (LMM) approach to account for repeated measures and clustering within nursing homes. Next, pre- to post-training changes in knowledge will be combined for immediate and wait-list groups and also tested using LMM approach.

Resident Quality Measure Outcomes. In addition, nursing homes in both groups will provide monthly summary reports for behavioral symptom occurrence for the facility (in aggregate as well as for individual residents \[deidentified\]). A nursing home aggregate antipsychotic medication use report will also be collected and analyzed. The BPSD and medication reports will be provided for the one-month period before baseline data collection and for each month thereafter until the post-training assessment of the wait-listed nursing homes is completed (a total of seven months for both groups). Resident outcomes data will be compared between the intervention and wait-list control groups and within nursing homes before and after the CHATO training. Initially, seven months of data will be plotted to examine changes in nursing homes and resident outcomes. Pre- to post-training differences will be compared between immediate and wait-listed groups with a LMM approach.

Implementation Strategies and Process Evaluation. An Implementation Toolkit for NHs and a CHATO Training Manual have been created to provide support and implementation suggestions to pilot nursing homes. Several consultants provided feedback and additional resources to be included in these materials. Each NH will be given a three-month period to complete the CHATO training. One month for orientation, team development, and planning, one month to complete the three-week training, and one month for staff recognition and follow up. The CHATO Research Team will meet with the NH leadership at the beginning and end of this three-month period, manage CHATO training virtual discussion board, and provide technical assistance as necessary. The process evaluation includes an online implementation survey which identifies the strategies NHs used to implement the training and includes the Artifacts of Culture survey. The survey uses the Diffusion of Innovation framework and mirrors the Implementation Toolkit. Additional process evaluation activities include: Leadership phone interviews completed by the consultants and external evaluators at LeadingAge and open-ended questions asked of direct care staff in the CHATO virtual discussion.

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 and who provide direct care at least 8 hours weekly will be invited to complete the CHATO training, available by URL link.
* Other personnel, such as housekeeping, dietary, and administrators may also participate. Participation by as many staff as possible is desired to achieve facility-wide communication change.
* Aggregate, deidentified data for residents with Alzheimer's disease or non-Alzheimer's dementia documented on the MDS Active Diagnoses list.

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 the CHAT study.

Primary outcomes:
measure: Knowledge Gain Scores for CHATO Training Participants
timeFrame: Baseline, 1 month, 3 months
measure: Communication Rating Scores for CHATO Training Participants
timeFrame: Baseline (pre-training), 1 month (post-training)
measure: BPSD Reports for the One-month Period Before Baseline Data Collection and One Month After Will be Compared Between the Intervention and Wait-list Control Groups and Within Nursing Homes Before and After the CHATO Training.
timeFrame: Baseline, 1 month
measure: Psychotropic Medication Reports for the One-month Period Before Baseline Data Collection and One Month After Will be Compared Between the Intervention and Wait-list Control Groups and Within Nursing Homes Before and After the CHATO Training.
timeFrame: Baseline, 1 month
Secondary outcomes:
measure: Number of Implementation Strategies Used in Each Nursing Home (Nursing Home Level Data)
timeFrame: 1 month (post training)
measure: Artifacts of Culture Change Scores Per Nursing Home to Assess Nursing Home Practices, Environment, and Staffing (Nursing Home Level Training)
timeFrame: 1 month (post training)
measure: Nursing Home Implementation Strategies Assessed by Interviews Will be Described, Categorized, and Correlated With Participation Rates.
timeFrame: 1 month (post training)
measure: The Cost Associated With Hypothesized BPSD Reductions After the CHATO Training Will be Calculated Using Primary Outcomes and Wage Data.
timeFrame: 1 month (post training)
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa School of Nursing
state: Iowa
city: Kansas City
country: United States
facility: University of Kansas School of Nursing
state: Kansas
Study officials:
References:
citation: Williams KN, Coleman CK, Perkhounkova Y, Beachy T, Hein M, Shaw CA, Berkley A. Moving Online: A Pilot Clinical Trial of the Changing Talk Online Communication Education for Nursing Home Staff. Gerontologist. 2021 Nov 15;61(8):1338-1345. doi: 10.1093/geront/gnaa210.