NCT06636214

Brief Summary

The study will adapt and test the current CHATO training to be more culturally acceptable for nursing homes with diverse staff and residents.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,200

participants targeted

Target at P75+ for not_applicable

Timeline
37mo left

Started Aug 2026

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 23, 2024

Completed
17 days until next milestone

First Posted

Study publicly available on registry

October 10, 2024

Completed
1.9 years until next milestone

Study Start

First participant enrolled

August 31, 2026

Expected
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2029

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2029

Last Updated

August 11, 2025

Status Verified

August 1, 2025

Enrollment Period

3 years

First QC Date

September 23, 2024

Last Update Submit

August 6, 2025

Conditions

Keywords

ADRDNursing Home Staff CommunicationElderspeak

Outcome Measures

Primary Outcomes (6)

  • Test CHATO's effects on Behavioral and Psychological Symptoms of Dementia (BPSD) - Change in MDS E0200 pre/post intervention

    CMS 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.

    pre (3 months) / post (3 months) post intervention

  • Test CHATO's effects on Behavioral and Psychological Symptoms of Dementia (BPSD) - Change in MDS E0800 pre/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.

    pre (3 months) / post (3 months) post intervention

  • Test CHATO's effects on Behavioral and Psychological Symptoms of Dementia (BPSD) - Change in MDS E1100 pre/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.

    pre (3 months) / post (3 months) post intervention

  • Test CHATO's effects on psychotropic medication - Change in MDS N0410 pre/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

    pre (3 months) / post (3 months) post intervention

  • Test CHATO's effects on psychotropic medication - Change in NHQM Prescribed Antipsychotic pre/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.

    pre (3 months) / post (3 months) post intervention

  • Test CHATO's effects on psychotropic medication - Change in Survey 757 and 758 Noncompliance

    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).

    pre (3 months) / post (3 months) post intervention

Secondary Outcomes (3)

  • 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

Study Arms (2)

CHATO Inclusive Intervention

EXPERIMENTAL
Behavioral: CHATO-I

Waitlist Control

NO INTERVENTION

Interventions

CHATO-IBEHAVIORAL

Online communication education program

CHATO Inclusive Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Medicare certified NHs (N=40) caring for 75% White, non-Hispanic residents, and care 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).

You may not qualify if:

  • NHs serving 25% of residents admitted prior to age 65 will be excluded (screening out NHs serving primarily younger persons with serious mental illnesses).
  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Kristine Williams, RN, PhD

    University of Kansas

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristine Williams, RN, PhD

CONTACT

Carissa Coleman, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2024

First Posted

October 10, 2024

Study Start (Estimated)

August 31, 2026

Primary Completion (Estimated)

August 31, 2029

Study Completion (Estimated)

August 31, 2029

Last Updated

August 11, 2025

Record last verified: 2025-08