PC CARES for Suicide Prevention

Recruiting at 1 trial location

Overseen By Lisa Wexler, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

1075 Participants Needed

Trial Summary

What is the purpose of this trial?

This participatory, pragmatic efficacy-implementation trial evaluates the impact of Promoting Community Conversations About Research to End Suicide (PC CARES) to evaluate Learning Circle (LC) participant outcomes (AIM#1), community-wide diffusion effects, and efficacy by tracking youth impact (AIM#2), while finding sustainable ways to scale PC CARES to other Alaska Native (AN) communities (AIM#3).

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is PC CARES for Suicide Prevention safe for humans?

There is limited information on the safety of PC CARES for Suicide Prevention, as adverse events in suicide prevention trials are often underreported and inconsistently defined. However, using multiple methods like structured telephone follow-ups can improve the detection of adverse events, which is important for understanding safety in such interventions. ^{1 2 3 4 5}

What makes the PC CARES treatment unique for suicide prevention?

PC CARES is unique because it focuses on promoting community conversations to address suicide prevention, which is different from traditional treatments that often focus on individual therapy or medication. This approach emphasizes community engagement and dialogue to create a supportive environment for individuals at risk. ^{6 7 8 9 10}

Research Team

Lisa Wexler, PhD

Principal Investigator

Univer

Eligibility Criteria

This trial is for individuals in rural Alaska communities involved in or affected by suicide. It aims to include a broad range of participants without specific health-related inclusion or exclusion criteria listed.

Inclusion Criteria

I am 12 years or older and live or work in the specified area.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

PC CARES Intervention

Participants attend 1-5 sessions of the PC CARES curriculum, either virtually or in-person, focusing on suicide prevention and community engagement.

5 months

Monthly sessions

Community-Wide Data Collection

Data is collected from community members to assess the diffusion of learning and community-level changes.

5 months

Monthly data collection

Follow-up

Participants are monitored for changes in suicide prevention behaviors and community engagement.

6 months

1 month and 6 months follow-up visits

Treatment Details

Interventions

• Promoting Community Conversations About Research to End Suicide

Trial Overview The study tests the PC CARES program, which uses Learning Circles to encourage community discussions on suicide prevention. The goal is to see if this approach helps participants, spreads awareness community-wide, and can be sustainably expanded.

Participant Groups

Group I: PC CARES Intervention Experimental Treatment 1 Intervention

PC CARES Intervention Participants will attend 1-5 sessions of the PC CARES curriculum, either virtually or in-person. Investigators will collect data from this group at baseline, after each session they attend, and at follow-up.

Group II: No Intervention Active Control 1 Intervention

This group will not attend the PC CARES sessions. Investigators will collect data from adults and youth at baseline, at 5 monthly timepoints as learning circles are being conducted in the community, and at follow-up (after 1 month and 6 months).

Promoting Community Conversations About Research to End Suicide is already approved in United States for the following indications:

Approved in United States as PC CARES for:

• Suicide prevention in rural Alaska Native communities

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Norton Sound Health Corporation

Collaborator

Trials

5

Recruited

4,500+

Maniilaq Association

Collaborator

Trials

2

Recruited

1,200+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Yukon Kuskokwim Health Corporation

Collaborator

Trials

6

Recruited

5,600+

University of Alaska Fairbanks

Collaborator

Trials

10

Recruited

14,100+

Findings from Research

A qualitative study involving experienced suicide researchers revealed significant challenges in defining and reporting adverse events (AEs) and serious adverse events (SAEs) in suicide prevention trials, which complicates safety evaluations.

Participants emphasized the urgent need for clear and consistent definitions and reporting standards for AEs and SAEs to improve the comparability of studies and enhance safety monitoring in at-risk populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Variability in the definition and reporting of adverse events in suicide prevention trials: an examination of the issues and a proposed solution. Oquendo, MA., Feldman, S., Silverman, E., et al.[2022]

In the ED-SAFE study, structured telephone follow-up assessments were crucial for identifying adverse events (AEs), detecting 45% of total AEs that were missed by chart reviews alone.

The detection of suicide attempts varied significantly by method, with structured follow-ups identifying 59% of attempts compared to only 18% through chart reviews, highlighting the importance of using multiple detection methods in suicide research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using structured telephone follow-up assessments to improve suicide-related adverse event detection. Arias, SA., Zhang, Z., Hillerns, C., et al.[2021]

In a study involving 1329 patients from primary care settings in Australia and England, 5.3% reported safety incidents over the past year, with the most common issues being delays in accessing care and problems with diagnosis and assessment.

The study highlighted that patient-reported incidents often differ from those reported by staff, underscoring the importance of including patient perspectives to improve safety and service quality in primary care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nature and type of patient-reported safety incidents in primary care: cross-sectional survey of patients from Australia and England. Hernan, AL., Giles, SJ., Carson-Stevens, A., et al.[2023]

Involving patients and families in the aftermath of serious adverse events in Dutch mental healthcare is seen as valuable for emotional support and information sharing, but current policies only address their involvement to a limited extent.

Challenges such as privacy concerns and the nature of involuntary admissions complicate this involvement, highlighting the need for tailored approaches rather than a one-size-fits-all strategy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Involving Patients and Families in the Analysis of Suicides, Suicide Attempts, and Other Sentinel Events in Mental Healthcare: A Qualitative Study in The Netherlands. Bouwman, R., de Graaff, B., de Beurs, D., et al.[2023]

In a study involving 1618 first-time mothers, a new classification system for adverse events (AEs) was developed, distinguishing between Medical and Social AEs, with 1033 Medical and 257 Social events reported.

Poorer psycho-social status was a significant predictor for both types of AEs, with younger age and receiving benefits linked to Social AEs, while having a long-term illness and poorer mental health were associated with Medical AEs, highlighting the importance of considering social outcomes in safety monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Monitoring adverse social and medical events in public health trials: assessing predictors and interpretation against a proposed model of adverse event reporting. Moody, G., Addison, K., Cannings-John, R., et al.[2020]

The Kaleida Health Palliative Care Consultation Service employs a patient self-assessment tool to effectively evaluate the severity of physical symptoms in patients, which is crucial for tailoring end-of-life care.

This approach also helps in identifying patients' personal goals for their care, ensuring that treatment aligns with their preferences and needs during a critical time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Palliative care program uses self-assessment tool. Sawicki, PJ., Nahigian, E.[2010]

A culturally based palliative care tele-consult program was developed for rural African American and White elders, emphasizing the importance of cultural preferences in end-of-life care, and was found to be feasible to implement in a rural hospital setting.

Despite high satisfaction rates among caregivers, low referral rates from hospitalists (only 18 out of 28 eligible patients) were identified as a significant barrier to the program's success, highlighting the need for better integration of culturally sensitive care into existing healthcare practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing and Testing the Feasibility of a Culturally Based Tele-Palliative Care Consult Based on the Cultural Values and Preferences of Southern, Rural African American and White Community Members: A Program by and for the Community. Elk, R., Emanuel, L., Hauser, J., et al.[2020]

The implementation of a palliative care consultation service (PCCS) in a rural Appalachian hospital significantly improved pain and symptom management for seriously ill patients, as shown by reduced burden scores after consultation.

Patients and families rated the PCCS highly, with an 88.5% satisfaction score, and the service also resulted in substantial cost savings of $521 per patient per day, highlighting its efficacy and financial benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of a palliative care program in a rural Appalachian community hospital: a quality improvement process. Armstrong, B., Jenigiri, B., Hutson, SP., et al.[2019]

In a study involving 185 children with incurable cancer across 22 UK oncology centers, 77% of those with complete data were able to die at home, which aligns with the families' preferences for home death.

The outreach team model of palliative care, particularly the involvement of pediatric oncology outreach nurse specialists (POONSs), was crucial in facilitating home deaths, with many families reporting no need for hospital visits during the end-of-life care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Place and provision of palliative care for children with progressive cancer: a study by the Paediatric Oncology Nurses' Forum/United Kingdom Children's Cancer Study Group Palliative Care Working Group. Vickers, J., Thompson, A., Collins, GS., et al.[2022]

This research investigates how community engagement evolves in two compassionate communities projects in Montreal, using a community-based participatory action-research approach to gather data through focus groups, interviews, and observations.

The study aims to understand the impact of local context on community engagement processes and their outcomes, which could help improve access and quality of palliative care in the context of dying and grief.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How does community engagement evolve in different compassionate community contexts? A longitudinal comparative ethnographic research protocol. Lessard, É., Marcoux, I., Daneault, S., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Variability in the definition and reporting of adverse events in suicide prevention trials: an examination of the issues and a proposed solution. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Using structured telephone follow-up assessments to improve suicide-related adverse event detection. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Nature and type of patient-reported safety incidents in primary care: cross-sectional survey of patients from Australia and England. [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Involving Patients and Families in the Analysis of Suicides, Suicide Attempts, and Other Sentinel Events in Mental Healthcare: A Qualitative Study in The Netherlands. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Monitoring adverse social and medical events in public health trials: assessing predictors and interpretation against a proposed model of adverse event reporting. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Palliative care program uses self-assessment tool. [2010]

7. United States pubmed.ncbi.nlm.nih.gov

Developing and Testing the Feasibility of a Culturally Based Tele-Palliative Care Consult Based on the Cultural Values and Preferences of Southern, Rural African American and White Community Members: A Program by and for the Community. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

The impact of a palliative care program in a rural Appalachian community hospital: a quality improvement process. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Place and provision of palliative care for children with progressive cancer: a study by the Paediatric Oncology Nurses' Forum/United Kingdom Children's Cancer Study Group Palliative Care Working Group. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

How does community engagement evolve in different compassionate community contexts? A longitudinal comparative ethnographic research protocol. [2023]