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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06249204
Other study ID # CC3 - OH_Phase_3
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 5, 2022
Est. completion date June 30, 2025

Study information

Verified date February 2024
Source Alzheimer's Disease and Related Disorders Association, Inc
Contact Lorna Prophater, MS
Phone 937-610-7005
Email lprophater@alz.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this clinical trial is to compare staff outcomes in long-term care communities who participate in the intervention versus those who do not. The main questions it aims to answer are: 1. Is employee satisfaction impacted by the intervention and 2. Is dementia care confidence impacted by the intervention. Participants will include monthly coaching visits for the intervention group and completion of surveys pre, immediately post and three-months post. Researchers will compare the intervention group to the control group to see if the intervention impacted the outcomes.


Description:

Over a six-month coaching program period, staff members from care communities work with a coach to assess their current level of adoption of Dementia Care Practice Recommendations (DCPR) (published recommendations by Alzheimer's Association) and prioritize areas of need /focus. Teams meet with the coach virtually or in person for 1 hour each month during the six months. Through an action planning and implementation process, care communities are guided to make organization-wide, measurable changes in the areas of (1) policies and procedures, (2) education and training, and/or (3) care practices to increase and maintain person-centered care practices as outlined in the DCPR. Coaches provide ongoing support to the care community through telephone and email support between meetings. Control group will not receive any coaching intervention but receive monthly email (e.g., newsletter about Alzheimer's Association but not related to outcomes) from coaches for check-in. Alzheimer's Association (AA) hires coaches in study areas based on their skills, experiences, interests and enthusiasm. Each coach identifies and invites long-term care (i.e., nursing home and assisted living) communities using existing relationships between the AA Chapter and those communities. In addition, AA staff will work with a national and/or state-wide networking group /association, as well as the Association's Dementia Care Provider Round Tables. The investigators will also pull the list of nursing homes in the study areas from publicly available data (e.g., Definitive Healthcare). Once each care community is selected and has agreed to participate, DCPR coaches will request that the care community identify 4-6 staff members to serve on a Care Team. The consented care communities are randomly assigned to either a control or intervention group (1: 1 block randomization).


Recruitment information / eligibility

Status Recruiting
Enrollment 480
Est. completion date June 30, 2025
Est. primary completion date February 1, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria: - Licensed skilled nursing facilities - Licensed assisted living facilities - Located in the state of Ohio Exclusion Criteria: - Under the age of 18 - Without documented endorsement for participation from facility leadership

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Coaching Group
Over a six-month coaching program period, staff members from care communities work with a coach to assess their current level of adoption of Dementia Care Practice Recommendations (DCPR) (published recommendations by Alzheimer's Association) and prioritize areas of need /focus. Teams meet with the coach virtually or in person for 1 hour each month during the six months. Through an action planning and implementation process, care communities are guided to make organization-wide, measurable changes in the areas of (1) policies and procedures, (2) education and training, and/or (3) care practices to increase and maintain person-centered care practices as outlined in the DCPR. Coaches provide ongoing support to the care community through telephone and email support between meetings.

Locations

Country Name City State
United States Alzheimer's Association Chicago Illinois

Sponsors (2)

Lead Sponsor Collaborator
Alzheimer's Disease and Related Disorders Association, Inc University of Washington

Country where clinical trial is conducted

United States, 

References & Publications (1)

Fazio S, Pace D, Maslow K, Zimmerman S, Kallmyer B. Alzheimer's Association Dementia Care Practice Recommendations. Gerontologist. 2018 Jan 18;58(suppl_1):S1-S9. doi: 10.1093/geront/gnx182. No abstract available. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Staff Turnover Turnover rates are assessed monthly from pre-intervention to 3 months after completion of the intervention (9 times) for direct care staff (i.e., certified nursing assistants (CNAs), care aids and other equivalent, front-line care staff), health and social services staff (i.e., registered nurses (RNs), licensed practical nurses (LPNs), social services, activities staff), and leadership staff (i.e., directors of nursing, unit leaders, licensed administrators). Turnover rates (%) are calculated using the National Nursing Home Quality Improvement Campaign Staff Stability Tracking Tool v2.2, dividing the number terminated as of the last day of the month by the number employed as of the first day of the month. Monthly, from the month pre-intervention to 3 months after completion of the intervention (9 times)
Primary Employee Satisfaction Employee satisfaction was measured using the Centers for Medicare & Medicaid Services (CMS)'s Nursing Home Employee Satisfaction Survey. This tool contains 5 topic areas, including job satisfaction (9 items), team building and communication (10 items), scheduling and staffing (4 items), training (6 items), and management and leadership (6 items). Participants will answer on a scale from 1 (strongly disagree) to 5 (strongly agree). Average score overall and by topic areas will be calculated (range = 1 - 5), where a higher score indicates greater employee satisfaction. pre, immediately post, and 3-month post
Secondary Dementia care confidence Dementia care confidence is measured using the Confidence in Dementia Scale (CODES) The nine-item self-report questionnaire is scored on a 5-point scale with anchored ratings of 'not able', 'slightly able', 'somewhat able', 'mostly able', 'very able'. Total score ranges from 9 to 45, with a higher score signifying better confidence in working with people with dementia. pre, immediately post, and 3-month post
Secondary Person-centered practices Person-centered practices are measured using the Toolkit for Person-Centeredness in Assisted Living (workplace practices, individualized care and services, and caregiver-resident relationships domains). From this tool, three areas will be measured, including workplace practices (23 items), individualized care and services (8 items), and caregiver-resident relationships domains (7 items). Participants will answer on a 5-point scale from 1 (strongly disagree) to 5 (strongly agree). Average score overall and by areas will be calculated, and then multiply the average scores by 25. Total scores overall and by areas range between 25 and 100, with a higher score representing more person-centeredness. pre, immediately post, and 3-month post.
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