NCT05806112

Brief Summary

The goal of this clinical trial is to compare Integrated Resiliency Training and Task Sharing (IRTTS) to Workplace Improvement Learning Collaborative (WILC) in group homes for adults with serious mental illness and/or intellectual and developmental disabilities. The main questions it aims to answer are:

  • Is IRTTS superior to WILC in improving residential care worker (RCW) resiliency; stress management and burnout; depression and anxiety; and positive health behaviors?
  • Is IRTTS superior to WILC in improving RCW turnover/retention; RCW sick days/absenteeism; and group home safety and resident incidents?
  • What are the barriers, facilitators, and resources required to successfully implement IRTTS and WILC? Participants may engage in training sessions, collaborate with residents and other RCWs in their group homes, attend meetings with RCWs from other group homes, complete surveys, participate in focus groups, and/or give qualitative interviews. Researchers will compare IRTTS to WILC to see which intervention should be implemented to achieve the greatest improvement in RCW resiliency and greatest reduction in burnout and turnover in group homes for adults with serious mental illness and/or developmental and intellectual disabilities.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
900

participants targeted

Target at P75+ for not_applicable

Timeline
22mo left

Started Mar 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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 Progress64%
Mar 2023Feb 2028

Study Start

First participant enrolled

March 1, 2023

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

March 27, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 10, 2023

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2028

Last Updated

April 10, 2023

Status Verified

April 1, 2023

Enrollment Period

5 years

First QC Date

March 27, 2023

Last Update Submit

April 6, 2023

Conditions

Keywords

group homeresiliencyresidential care workerburnoutturnover

Outcome Measures

Primary Outcomes (3)

  • Resilience (baseline)

    Resilience is assessed using the Current Experiences Scale (CES). The CES is a 23-item measure with total scores that can range from 0 to 115, with higher scores indicating greater resiliency.

    Baseline

  • Resilience (3-month follow-up)

    Resilience is assessed using the Current Experiences Scale (CES). The CES is a 23-item measure with total scores that can range from 0 to 115, with higher scores indicating greater resiliency.

    3-months

  • Resilience (12-month follow-up)

    Resilience is assessed using the Current Experiences Scale (CES). The CES is a 23-item measure with total scores that can range from 0 to 115, with higher scores indicating greater resiliency.

    12-months

Study Arms (2)

Integrated Resiliency Training and Task Sharing

EXPERIMENTAL

A multi-component intervention combining resiliency training and task sharing implemented at the site-level (microsystem).

Behavioral: Resiliency TrainingBehavioral: Task Sharing

Workplace Improvement Learning Collaborative

EXPERIMENTAL

A workplace improvement learning collaborative implemented at the organization level (mesosystem).

Behavioral: Workplace Improvement Learning Collaborative

Interventions

The Stress Management and Resiliency Training: Relaxation Response Resiliency Program (SMART-3RP) has been shown to be effective in improving resilience and reducing distress among individuals across different populations and settings. The SMART-3RP enhances resilience by 1) teaching tools to elicit the relaxation response (RR) to offset negative effects of chronic stress; 2) improving stress management and awareness; and 3) promoting growth enhancement and agency to effect positive change. It blends stress coping principles from mind-body, cognitive-behavioral, and positive psychology theory to teach skills to advance each of these resiliency processes. The training will be delivered in six 50-minute virtual group sessions with 2 optional "booster sessions" available for those who desire additional sessions to further consolidate the core resiliency skills.

Also known as: The Stress Management and Resiliency Training: Relaxation Response Resiliency Program, SMART-3RP
Integrated Resiliency Training and Task Sharing
Task SharingBEHAVIORAL

Task Sharing is a process involving health care workers in partnership with others in which workers retain many of their primary tasks, but some tasks are completed collaboratively or by other workers or volunteers in a shared effort. Study coaches will work with the group home directors and RCWs to identify shared tasks that may be conducted by peers or resident volunteers by task co-assignment with supervision and support. Task co-assignments will be discussed in routine house meetings occurring on a weekly basis and incorporated into a jointly developed "house plan". The house plan will engage staff and residents to identify shared activities to reduce the burden on RCWs through task co-assignment and team-based efforts aimed at tasks that create unnecessary burden and stress for RCWs, yet do not require RCWs to complete them.

Integrated Resiliency Training and Task Sharing

The Workplace Improvement Learning Collaborative (WILC) consists of identifying major sources of RCW burnout across the system and then instituting an organizational (agency-wide) measure to address the identified sources of burnout by restructuring tasks (e.g., reducing administrative burdens, increasing workflow efficiencies) through a virtual earning collaborative with group home leaders. Learning collaboratives commonly use a structured framework within which teams learn about research and best practices, apply quality-improvement methods, and exchange their experiences in making improvements with the widespread use of such collaboratives. Program Directors will participate in a learning collaborative facilitated by trained and certified study coaches to identify and collaboratively develop and implement effective strategies to address root causes of RCW burnout across group homes and program directors assigned to the WILC intervention.

Workplace Improvement Learning Collaborative

Eligibility Criteria

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

You may qualify if:

  • Permanent-salary staff working in participating group homes

You may not qualify if:

  • Temp staff and per diem workers
  • Staff working in group homes not included in this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Burnout, PsychologicalDepressionAnxiety DisordersSedentary Behavior

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehaviorMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of the Mongan Institute at Massachusetts General Hospital

Study Record Dates

First Submitted

March 27, 2023

First Posted

April 10, 2023

Study Start

March 1, 2023

Primary Completion (Estimated)

February 28, 2028

Study Completion (Estimated)

February 28, 2028

Last Updated

April 10, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations