NCT03849937

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
219

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2019

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 22, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 21, 2019

Completed
6 months until next milestone

Study Start

First participant enrolled

September 3, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2020

Completed
12 months until next milestone

Results Posted

Study results publicly available

August 19, 2021

Completed
Last Updated

September 27, 2021

Status Verified

August 1, 2021

Enrollment Period

9 months

First QC Date

January 22, 2019

Results QC Date

May 27, 2021

Last Update Submit

August 30, 2021

Conditions

Keywords

Behavioral and Psychological Symptoms of DementiaPsychotropic MedicationElderspeakStaff TrainingStaff CommunicationNonpharmacological treatment for Dementia

Outcome Measures

Primary Outcomes (4)

  • Knowledge Gain Scores for CHATO Training Participants

    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.

    Baseline, 1 month, 3 months

  • Communication Rating Scores for CHATO Training Participants

    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.

    Baseline (pre-training), 1 month (post-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.

    NH Level Deidentified Resident data from nursing homes

    Baseline, 1 month

  • 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.

    NH Level Deidentified Resident data from nursing homes

    Baseline, 1 month

Secondary Outcomes (4)

  • 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)

Study Arms (2)

Intervention

EXPERIMENTAL

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

Behavioral: Changing Talk Online (CHATO)

Waitlist Control

ACTIVE COMPARATOR

After the intervention group takes the training, the waitlist control group will crossover and take the training.

Behavioral: Changing Talk Online (CHATO)

Interventions

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

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 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.

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 the CHAT study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Iowa School of Nursing

Iowa City, Iowa, 52242, United States

Location

University of Kansas School of Nursing

Kansas City, Kansas, 66160, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

DementiaBehavior

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Results Point of Contact

Title
Kristine Williams, RN, PhD, FNP-BC, FGSA, FAAN, E. Jean Hill Professor
Organization
University of Kansas School of Nursing

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2019

First Posted

February 21, 2019

Study Start

September 3, 2019

Primary Completion

May 31, 2020

Study Completion

August 31, 2020

Last Updated

September 27, 2021

Results First Posted

August 19, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations