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临床试验/NCT03849937
NCT03849937已完成不适用

Changing Talk Online (CHATO): A Pragmatic Trial to Reduce Behavioral Symptoms in Dementia Care

University of Kansas Medical Center4 个研究点 分布在 1 个国家目标入组 219 人开始时间: 2019年9月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
219
试验地点
4
主要终点
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.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

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.

时间窗: Baseline, 1 month

NH Level Deidentified Resident data from nursing homes

Knowledge Gain Scores for CHATO Training Participants

时间窗: Baseline, 1 month, 3 months

CHATO Knowledge Test was given to participants pre training and post training. Scoring: 13 items scored incorrect (0) or correct (1). Test score was calculated as the percentage of correct answers (0-100%). The mean percentage was used for each group in the the analysis. Two forms (Forms A and B) measures knowledge gained from training.

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.

时间窗: Baseline, 1 month

NH Level Deidentified Resident data from nursing homes

Communication Rating Scores for CHATO Training Participants

时间窗: Baseline (pre-training), 1 month (post-training)

Participant watches a video and answers questions testing their ability to visually and audibly identify effective vs ineffective communication strategies and recognize elderspeak vs. person-centered care. Effective rating: mean score for one item scored 1 = Ineffective to 5 = Effective; lower score indicates improvement. Appropriate rating: mean score for one item scored 1 = Inappropriate to 5 = Appropriate; lower score indicates improvement. Recognizes elderspeak subscale: mean score for 6-items scored yes (1) or no (0); higher score indicates improvement. Recognizes person-centered communication subscale: mean score for 3-items scored yes (1) or no (0); lower score indicates improvement.

次要结局

  • Number of Implementation Strategies Used in Each Nursing Home (Nursing Home Level Data)(1 month (post training))
  • Artifacts of Culture Change Scores Per Nursing Home to Assess Nursing Home Practices, Environment, and Staffing (Nursing Home Level Training)(1 month (post training))
  • Nursing Home Implementation Strategies Assessed by Interviews Will be Described, Categorized, and Correlated With Participation Rates.(1 month (post training))
  • The Cost Associated With Hypothesized BPSD Reductions After the CHATO Training Will be Calculated Using Primary Outcomes and Wage Data.(1 month (post training))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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