NCT04610944

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.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
5,043

participants targeted

Target at P75+ for not_applicable

Timeline
1mo left

Started Apr 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not 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

Study Progress99%
Apr 2021May 2026

First Submitted

Initial submission to the registry

September 18, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 2, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

April 26, 2021

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2026

Expected
Last Updated

April 30, 2026

Status Verified

April 1, 2026

Enrollment Period

5 years

First QC Date

September 18, 2020

Last Update Submit

April 24, 2026

Conditions

Keywords

Nursing homeStaff TrainingDementiaAlzheimer DiseaseBehavioral and Psychological Symptoms of DementiaPsychotropic MedicationElderspeakNonpharmacological treatment for DementiaStaff Communication

Outcome Measures

Primary Outcomes (9)

  • AIM 1. Test CHATO's effects on Behavioral and Psychological Symptoms of Dementia (BPSD) - Change in MDS E0200 at 3 and 6 months

    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 1(6 months), Pre 2 (3 months), Post 1(3 months), Post 2 (6 months)

  • AIM 1. Test CHATO's effects on Behavioral and Psychological Symptoms of Dementia (BPSD) - Change in MDS E0800 at 3 and 6 months

    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 1(6 months), Pre 2 (3 months), Post 1(3 months), Post 2 (6 months)

  • AIM 1. Test CHATO's effects on Behavioral and Psychological Symptoms of Dementia (BPSD) - Change in MDS E1100 at 3 and 6 months

    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 1(6 months), Pre 2 (3 months), Post 1(3 months), Post 2 (6 months)

  • AIM 1. Test CHATO's effects on psychotropic medication - Change in MDS N0410 at 3 and 6 months

    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 1(6 months), Pre 2 (3 months), Post 1(3 months), Post 2 (6 months)

  • AIM 1. Test CHATO's effects on psychotropic medication - Change in NHQM Prescribed Antipsychotic at 3 and 6 months

    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 1(6 months), Pre 2 (3 months), Post 1(3 months), Post 2 (6 months)

  • AIM 1. Test CHATO's effects on psychotropic medication - Change in HIS F329 Noncompliance at 1 year

    Annual Health Inspection Survey - F329 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 (1 year), Post (1 year)

  • AIM 2. Analyze NH strategies to engage staff and maximize CHATO effects _ Change in Knowledge at 3 months

    CHAT Scale - Two forms (Forms A and B), 13 questions, measures knowledge gained from training.

    Pre (1 month), Post (3 months)

  • AIM 2. Analyze NH strategies to engage staff and maximize CHATO effects _ Change in Communication Ratings at 3 months

    Communication Rating Sheet - 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.

    Pre (1 month), Post (3 months)

  • AIM 2. Analyze NH strategies to engage staff and maximize CHATO effects _ Implementation Strategies utilized during the training phase (3 months)

    A descriptive implementation survey created by the investigators will identify the approach types (Implementation Teams, Champions, Stakeholders, Location of training, NH Communication Plan, Discussion Types, and Incentives), motivation to participate in research, and NH level evaluation.

    Post (3 months)

Secondary Outcomes (2)

  • AIM 3. Evaluate CHATO Cost (3 months of training)

    Post (3 months)

  • Aim 3. Evaluate CHATO Sustainability (1 year post-training)

    Post (1 year)

Study Arms (2)

Intervention

EXPERIMENTAL

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

Behavioral: Changing Talk Online (CHATO)

Waitlist Control

ACTIVE COMPARATOR

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

Behavioral: Changing Talk Online (CHATO)

Interventions

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

InterventionWaitlist Control

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas School of Nursing

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

DementiaAlzheimer DiseaseCommunicationBehavior

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersTauopathiesNeurodegenerative Diseases

Study Design

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

Study Record Dates

First Submitted

September 18, 2020

First Posted

November 2, 2020

Study Start

April 26, 2021

Primary Completion

April 30, 2026

Study Completion (Estimated)

May 31, 2026

Last Updated

April 30, 2026

Record last verified: 2026-04

Locations