Clinical trial NCT06722027: CCSH (Compassion-Centered Spiritual Health) for Teams
Official title: Compassion-Centered Spiritual Health Interventions for Teams (CCSH-TI) With Faculty and Staff
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Health Behavior
Keywords: Behavioral Intervention
Healthcare provider burnout
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2024-12-09
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a longitudinal, randomized pilot study of 80 employees working in inter-professional oncologic teams. Employees will be randomized by team (using a random number generator in Microsoft Excel) to receive CCSH-TI or to a TAU "treatment as usual" (TAU) group.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Emory Spiritual Health has developed a Compassion-Centered Spiritual Health group-based intervention, called CCSH Interventions for Teams, and are enrolling staff and providers into the groups in this randomized study design. The groups will meet once every other week for 60 minutes for 8 weeks (4 sessions total).

The investigators will evaluate the feasibility and acceptability of this novel team-based intervention that includes mindfulness and compassion-based approaches with mixed-role oncology teams. Employees (n = 80; nurses, advanced practice providers (APPs), physicians, staff) working at an NCI- designated Comprehensive Cancer Center will be randomized by team (8-12 employees/group) to Compassion Centered Spiritual Health Team Intervention (CCSH-TI) or TAU (Treatment as Usual) group. The research objective is to evaluate the feasibility and acceptability of CCSH-TI, and to develop and validate a novel, low-burden ambulatory assessment "toolkit" to improve the measurement of psychological safety and burnout.

Detailed description: Current interventions to reduce provider burnout are only minimally effective. To overcome the barriers to achieving success in burnout prevention interventions, the investigators propose Compassion Centered Spiritual Health Team Intervention (CCSH-TI), a 4-session intervention delivered by healthcare chaplains to mixed-role interprofessional teams that includes mindfulness and compassion-based approaches to bolster resilience, compassion for self and others, and psychological safety. The research team will conduct a mixed-method feasibility and acceptability study of CCSH-TI with mixed-role oncology teams. Employees (n = 80; nurses, advanced practice providers (APPs), physicians, staff) working at an NCI-designated Comprehensive Cancer Center will be randomized by team (8-12 employees/group) to CCSH-TI or to TAU (Treatment as Usual) group, who has access to all well-being resources and activities available to them as employees. Self-report surveys and focus group discussions will be used to evaluate the feasibility and acceptability of CCSH-TI. The investigators will also collect self-report surveys, ecological momentary assessments (EMA), and the electronically activated recorder (EAR) data at 3 timepoints (before CCSH-TI (T1), immediately after completion of CCSH-TI (T2), and 12-weeks after completion (LT), and characterize data completion to evaluate the feasibility of data collection methods for a future randomized control trial. Informed consent will be obtained from study participants in-person. The duration of the study will be 22-23 weeks (from consent to completion of data collection).

Eligibility criteria: Inclusion Criteria:

* Full-time employees working in oncology teams at Winship Cancer Institute;
* Employees working in intensive care at Emory University St. Joseph hospital.

Exclusion Criteria:

* Less than 18 years old

Primary outcomes:
measure: Proportion of eligible employees who enroll and are willing to be randomized
timeFrame: BaselineI (T1), immediately post-intervention (T2), and 12-weeks post-intervention (LT)
measure: Number of participants that attended and completed the three assessment timepoints
timeFrame: BaselineI (T1), immediately post-intervention (T2), and 12-weeks post-intervention (LT)
measure: Retention rates at three assessment timepoints
timeFrame: BaselineI (T1), immediately post-intervention (T2), and 12-weeks post-intervention (LT)
measure: Satisfaction score
timeFrame: Immediately post-intervention (T2), and 12-weeks post-intervention (LT)
measure: Perceived credibility score
timeFrame: Immediately post-intervention (T2), and 12-weeks post-intervention (LT)
measure: Perceived intervention benefit
timeFrame: Immediately post-intervention (T2), and 12-weeks post-intervention (LT)
measure: Acceptability of wearing the Electronically Activated Recorder (EAR)
timeFrame: BaselineI (T1), immediately post-intervention (T2), and 12-weeks post-intervention (LT)
measure: Number of EMA dropouts
timeFrame: BaselineI (T1), immediately post-intervention (T2), and 12-weeks post-intervention (LT)
measure: Percentage (%) of items completed using EMA
timeFrame: BaselineI (T1), immediately post-intervention (T2), and 12-weeks post-intervention (LT)
Secondary outcomes:
measure: Change in Agency for Healthcare Research and Quality's TeamSTEPPS ® Teamwork Perceptions Questionnaire (T-TPQ) score
timeFrame: BaselineI (T1), immediately post-intervention (T2), and 12-weeks post-intervention (LT)
measure: Change in Psychological safety scale score
timeFrame: BaselineI (T1), immediately post-intervention (T2), and 12-weeks post-intervention (LT)
measure: Change in Professional Fulfillment Index Score
timeFrame: BaselineI (T1), immediately post-intervention (T2), and 12-weeks post-intervention (LT)
measure: EMA (ecological momentary assessment) questionnaire score
timeFrame: BaselineI (T1), immediately post-intervention (T2), and 12-weeks post-intervention (LT)
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory Winship Cancer Institute
state: Georgia
city: Atlanta
country: United States
facility: Emory University St. Joseph hospital
state: Georgia
Study officials:
affiliation: Emory University
name: Jennifer Mascaro, PhD
role: PRINCIPAL_INVESTIGATOR
References: