Adapting the CHATO Communication Intervention for Diverse Nursing Home Communities
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,200
- 主要终点
- Test CHATO's effects on Behavioral and Psychological Symptoms of Dementia (BPSD) - Change in MDS E0800 pre/post intervention
研究概览
简要总结
This study will adapt and test online interactive training for nursing home staff that improves staff communication and reduces behavioral symptoms of persons with dementia that they care for. This research will adapt and test communication training to meet the needs of nursing homes to improve dementia care.
详细描述
A person is diagnosed with Alzheimer's disease or related dementia (AD/ADRD) every 65 seconds, and most persons living with dementia (PLWD) experience nursing home (NH) care at some stage. NH staff shortages and lack of dementia care skills limit care quality, especially in NHs with low income and resources. Care is complicated by the behavioral and psychological symptoms of dementia (BPSD) of PLWD who cannot express their unmet physical and psychosocial needs. BPSD increase staff stress and time to complete care and contribute to staff turnover, injury, and inappropriate psychotropic medication use.
The PI and other researchers have empirically verified that BPSD occur when staff use elderspeak (speech like 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 PLWD who react with withdrawal or BPSD. The investigators R03 study first established that elderspeak use more than doubled the occurrences of resident responses of BPSD (measured by timed sequential behavioral analyses of BPSD in relation to type of staff communication in video data). The investigators R01 trial (NR011455) confirmed that the three-session Changing Talk(CHAT) staff education intervention reduced staff elderspeak use that significantly reduced resident BPSD.The evidence-based CHAT intervention was transitioned to online modules (CHATO), maintaining content, active engagement, and application activities, with equal knowledge gain (mechanism of action) and improved participation and completion rates. The investigators are currently testing CHATO in a pragmatic national trial in 128 NHs (R01AG069171). However, NHs serving high minority-resident populations with fewer resources and staff and more frequent and serious care deficiencies, including high antipsychotic medication use rates, have been less likely to respond to recruitment and study participation. Research has established that tailoring interventions and intensification of recruitment and implementation approaches are frequently necessary to reach and achieve intervention success to overcome health care disparities in diverse care settings.
This study will first engage NH staff in completing the current CHATO training and providing in depth focus groups feedback. We will then integrate focus group findings with findings from our CHATO study and expert stakeholder panel advise to streamline content, improve format and user interface, and expand implementation support to create CHATO-I, designed to increase appropriateness and uptake across NH communities. The investigators will then conduct a cluster randomized trial in NHs (N=40). NHs will be randomized to intervention or waitlist control groups and one of two waves for staff completion of the CHATO-I intervention with high intensity implementation support. The investigators will test feasibility and acceptability and use hierarchical mixed modeling analyses to evaluate preliminary effects of the intervention on BPSD and psychoactive medication use by residents with dementia in a pragmatic evaluation of Electronic Medical Record (EMR) data.
Aim 1 (years 1 and 2): Tailor recruitment, implementation support, and intervention content and format appropriate for all NHs. Administrators, directors of nursing, and care staff including certified nursing assistants (CNAs) from six NHs (N=24) will complete current CHATO and participate in focus groups. Thematic analyses of transcribed recordings will identify tailoring modifications to support uptake across all varieties of NH communities. The ADAPT framework will guide CHATO to CHATO-I adaptation with support from expert consultants and stakeholders.
Aim 2 (years 3 to 5): Test feasibility, acceptability, and preliminary effects of CHATO-I in 40 NHs in a cluster-randomized waitlist-controlled trial. Enrollment and completion rates will be used to evaluate feasibility and acceptability (Aim 2a). Mixed modeling will evaluate change in resident BPSD and psychoactive medication use from eight quarters of Minimum Data Set (MDS) and Nursing Home Quality Measure (NHQM) data (Aim 2b). We hypothesize that CHATO-I will reduce resident BPSD and psychoactive medication use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- 是
入选标准
- •Medicare certified NHs (N=40) caring for residents diagnosed with AD/ADRD.
- •CNAs, nurses, and other direct care staff who are permanent employees of participating NHs and who provide direct care at least 8 hours weekly will complete the CHATO-I training, available by URL link.
- •All staff will be encouraged to participate as high staff participation is desired to achieve facility-wide communication change. NHs will provide the number of eligible staff participants.
- •Data for residents in participating NHs with AD/ADRD documented on the MDS Active Diagnoses list will be included in the analyses as well as MDS data for: age, sex, race and ethnicity, frailty (MDS-CHESS scale), and level of cognitive function (MDS Cognitive Performance Scale).
排除标准
- •NHs serving 25% of residents admitted prior to age 65 will be excluded (screening out NHs serving primarily younger persons with serious mental illnesses).
- •CNAs, nurses, and other direct care staff who do not meet the inclusion criteria.
- •Resident data excluded from MDS includes 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 response to staff (MDS section B).
研究组 & 干预措施
Waitlist Control
CHATO Inclusive Intervention
干预措施: CHATO-I (Behavioral)
结局指标
主要结局
Test CHATO's effects on Behavioral and Psychological Symptoms of Dementia (BPSD) - Change in MDS E0800 pre/post intervention
时间窗: pre (3 months) / post (3 months) post intervention
CMS MDS Quarterly data - E0800 Rejection of Care - Presence and Frequency over past 7 days; The steps for assessment are to review the medical record, observe the resident in a variety of situations, and interview staff, across all shifts and disciplines. If the resident exhibits behavior that appears to communicate a rejection of care (and that rejection behavior has not been previously determined to be consistent with the resident's values or goals), ask him or her directly whether the behavior is meant to decline or refuse care. Coding Instruction: Code 0, behavior not exhibited, Code 1, behavior of this type occurred 1-3 days, Code 2, behavior of this type occurred 4-6 days, but less than daily, or Code 3, behavior of this type occurred daily.
Test CHATO's effects on Behavioral and Psychological Symptoms of Dementia (BPSD) - Change in MDS E1100 pre/post intervention
时间窗: pre (3 months) / post (3 months) post intervention
CMS MDS Quarterly data - E1100 Change in Behavioral or Other Symptoms: The steps for assessment are review responses provided to items E0100-E1000 on the current MDS assessment, compare with responses provided on prior MDS assessment, and then taking all of these MDS items into consideration, make a global assessment of the change in behavior from the most recent to the current MDS. Rate the overall behavior as same, improved, or worse. Coding Instructions: Code 0, same: if overall behavior is the same (unchanged), Code 1, improved: if overall behavior is improved, Code 2, worse: if overall behavior is worse, or Code 3, N/A: if there was no prior MDS assessment of this resident.
Test CHATO's effects on psychotropic medication - Change in MDS N0410 pre/post intervention
时间窗: pre (3 months) / post (3 months) post intervention
CMS MDS Quarterly data - N0410 Medications Received: The steps for assessment are review the resident's medical record for documentation that any of these medications were received by the resident during the 7-day look-back period (or since admission/entry or reentry if less than 7 days) and review documentation from other health care settings where the resident may have received any of these medications while a resident of the nursing home (e.g., valium given in the emergency room). Coding Instructions: N0410A, Antipsychotic,N0410B, Antianxiety, N0410C, Antidepressant, N0410D, Hypnotic, N0410E, Anticoagulant, N0410F, Antibiotic, N0410G, Diuretic
Test CHATO's effects on psychotropic medication - Change in NHQM Prescribed Antipsychotic pre/post intervention
时间窗: pre (3 months) / post (3 months) post intervention
CMS Quarterly Nursing Home Quality Measure: Prescribed Antipsychotic (Long-stay quality measure 419) The percentage of long-stay residents who are receiving antipsychotic drugs in a 7-day look-back period. Exclusions: Residents with a diagnosis of schizophrenia, Tourette's syndrome, or Huntington's disease. Reported by nursing homes quarterly and gathered from Nursing Home Compare.
Test CHATO's effects on psychotropic medication - Change in Survey 757 and 758 Noncompliance
时间窗: pre (3 months) / post (3 months) post intervention
Survey 757 and 758 (prior 319), Noncompliance due to unnecessary medications and level of deficiency - Noncompliance due to unnecessary medications and level of deficiency (immediate jeopardy, actual harm, no actual harm \& isolated, pattern and occurrence).
Test CHATO's effects on Behavioral and Psychological Symptoms of Dementia (BPSD) - Change in MDS E0200 pre/post intervention
时间窗: pre (3 months) / post (3 months) post intervention
Center for Medicare and Medicaid Services (CMS) Minimum Data Set (MDS) Quarterly data - E0200 Presence and Frequency of Behavioral Symptoms in the last 7 days; The steps for assessment are to review the medical record, observe the resident in a variety of situations, and interview staff, across all shifts and disciplines. Coding Instruction: Code 0, behavior not exhibited, Code 1, behavior of this type occurred 1-3 days, Code 2, behavior of this type occurred 4-6 days, but less than daily, or Code 3, behavior of this type occurred daily.
次要结局
- Analyze NH strategies to engage staff and maximize CHATO effects _ Change in Knowledge at post intervention(post intervention)
- Analyze NH strategies to engage staff and maximize CHATO effects _ Change in Communication Ratings(post intervention)
- Analyze NH strategies to engage staff and maximize CHATO effects _ Implementation Strategies utilized during the training phase(post intervention)
