Caring Contacts for Suicide Prevention

(SPRING Trial)

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: St. Luke's Health System, Boise, Idaho

Disqualifiers: Previous trial participation, Cognitive impairment, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 12 months

849 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

What data supports the effectiveness of the treatment Caring Contacts for Suicide Prevention?

Research shows that follow-up phone calls after hospital discharge can improve patient satisfaction and reduce emergency visits, suggesting that regular contact, like Caring Contacts, may help people feel supported and prevent crises. ^{1 2 3 4 5}

Is Caring Contacts for Suicide Prevention safe for humans?

There is no specific safety data available for Caring Contacts, but general research on suicide prevention trials highlights the importance of clear reporting of adverse events (unwanted effects) to ensure participant safety. ^{6 7 8 9 10}

How is the Caring Contacts treatment different from other treatments for suicide prevention?

Caring Contacts is unique because it involves sending brief, caring messages to individuals, expressing unconditional care and concern, which can be done by someone the recipient knows or even by a stranger. This approach is simple, cost-effective, and can be easily scaled, making it different from more traditional, resource-intensive therapies. ^{11 12 13 14 15}

What is the purpose of this trial?

Pragmatic randomized controlled trial to compare the effectiveness of two-way Caring Contacts text messages vs. one-way Caring Contacts text messages vs. enhanced usual care for suicide prevention in adults and adolescents.

Research Team

Anna K Radin, DrPH, MPH

Principal Investigator

St. Luke's Health System

Eligibility Criteria

The SPRING Trial is for adolescents (12-17 years) and adults (18+) who show signs of suicide risk based on the Columbia Suicide Severity Rating Scale or provider notes. Participants must be able to communicate via text, phone calls, and emails in English. Those with hearing impairments can receive accommodations.

Inclusion Criteria

If you've said "yes" to at least one question on the Columbia Suicide Severity Rating Scale (C-SSRS) at a St. Luke's Health System clinic, or if your health record or a note from a visit shows that you might be at risk for suicide.

You can receive phone calls.

You can get emails.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either two-way or one-way Caring Contacts text messages, or enhanced usual care for suicide prevention

12 months

Text messages sent periodically

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Baseline, 3 months, 6 months, 12 months

Treatment Details

Interventions

• Caring Contacts

Trial Overview This trial tests suicide prevention strategies by comparing two-way vs. one-way Caring Contacts text messages against enhanced usual care to see which is more effective in preventing suicide among at-risk individuals.

Participant Groups

Group I: Two-Way Caring Contacts Texts (CC2) Experimental Treatment 1 Intervention

In addition to receiving enhanced usual care as described below, a series of 25 standardized outgoing Caring Contacts text messages will be sent to participants randomized to the CC2 intervention arm through our online texting platform. To remind participants that they can respond, the outgoing texts will periodically invite replies in a non-demanding way, e.g., "Hope you're doing well this week, Anna. Feel free to text me back if you feel like it, I'm here for you." Responses to CC2 participant replies will be unscripted and individually tailored.

Group II: One-Way Caring Contacts Texts (CC1) Experimental Treatment 1 Intervention

In addition to receiving enhanced usual care as described below, CC1 participants will be sent 25 caring texts, such as "Even though know we do not personally know each other, we truly value your wellbeing and are thinking of you. If you'd like to connect with someone, feel free to call or text 988 anytime - their team would be happy to hear from you." CC1 participants will not be able to reply to the texts and the online texting platform will block incoming messages. This will be clearly communicated to CC1 participants during the informed consent process and they will be asked to sign off on understanding this and other key points before enrolling in the study.

Group III: Enhanced Usual Care (UC) Active Control 1 Intervention

Participants randomized to the UC arm will receive best available usual care from the health system, such as standardized clinical assessments, the safety planning intervention or other intervention(s), appropriate referrals and/or medication management through a system wide electronic health record system-assisted suicide care clinical workflow. Usual care will vary based on patient clinical needs, availability of providers/staff, and provider clinical judgment. Following study enrollment, all participants will be given a list of resources, offered a warm hand-off to 988, and encouragement to call or text 988 as needed. During the baseline survey, participants will have the opportunity to opt into a call from the follow-up team to develop or revise a safety plan.

Caring Contacts is already approved in United States, European Union for the following indications:

Approved in United States as Caring Contacts for:

• Suicide prevention in adults and adolescents

Approved in European Union as Caring Contacts for:

• Suicide prevention in high-risk individuals

Who Is Running the Clinical Trial?

St. Luke's Health System, Boise, Idaho

Lead Sponsor

Trials

4

Recruited

3,000+

University of Washington

Collaborator

Trials

1,858

Recruited

2,023,000+

Idaho Crisis & Suicide Hotline

Collaborator

Trials

3

Recruited

3,000+

American Foundation for Suicide Prevention

Collaborator

Trials

36

Recruited

10,500+

Idaho Crisis & Suicide Hotline

Collaborator

Trials

3

Recruited

3,000+

Findings from Research

A nursing discharge plan that includes thorough information about health status and post-hospitalization care significantly improves treatment adherence among psychiatric patients, as shown in a study of 135 patients.

Higher patient satisfaction with nursing care is linked to better adherence to treatment plans, suggesting that effective communication and education from nurses empower patients to manage their conditions more effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of a nursing discharge programme to improve medication adherence and patient satisfaction in the psychiatric intensive care unit. Virgolesi, M., Pucciarelli, G., Colantoni, AM., et al.[2018]

A follow-up phone call from a pharmacist two days after hospital discharge significantly increased patient satisfaction with medication instructions (86% vs. 61% for the control group).

The intervention also led to better health outcomes, with only 10% of patients in the phone call group returning to the emergency department within 30 days, compared to 24% in the control group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of follow-up telephone calls to patients after hospitalization. Dudas, V., Bookwalter, T., Kerr, KM., et al.[2019]

Switching from manual white boards to electronic bed boards significantly improved the quality of patient data communication among caregivers.

The implementation involved a process redesign team that focused on enhancing the processes of patient care, leading to standardized data display across care centers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

From airports to care centers. Transferring information technology to support patient care reengineering. Vogel, LH., Bonomo, C., Yang, A.[2019]

A follow-up phone call from a pharmacist two days after hospital discharge significantly increased patient satisfaction with medication instructions (86% vs. 61% for the control group).

The intervention also led to better health outcomes, with only 10% of patients in the phone call group returning to the emergency department within 30 days, compared to 24% in the control group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of follow-up telephone calls to patients after hospitalization. Dudas, V., Bookwalter, T., Kerr, KM., et al.[2022]

The quality improvement project aimed to enhance patient education and satisfaction while also reducing 30-day readmission rates for stroke patients.

A follow-up telephone call was made 72 hours after discharge to assess and support patients, indicating a proactive approach to post-discharge care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stroke Transitions of Care. Ross, SY., Roberts, S., Taggart, H., et al.[2018]

A total of 11,999 Adverse Drug Events (ADEs) were identified from 244,992 hospital admissions, indicating a prevalence of 4.9 ADEs per 100 admissions, particularly affecting older adults and linked to longer hospital stays.

Clinical Coding Surveillance (CCS) proved to be a reliable method for monitoring ADEs, with 91% accuracy in classifying ADEs based on clinical documentation, suggesting it can effectively enhance patient safety in hospitals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and reliability of clinical coding surveillance for the routine monitoring of adverse drug events in New Zealand hospitals. Ng, J., Andrew, P., Muir, P., et al.[2019]

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]

The Copenhagen Hospital Corporation successfully implemented a reporting system for adverse events, resulting in 6011 reported incidents over three years, indicating a strong safety culture among staff.

The organization conducted 92 root cause analyses during this period, focusing on both optional and mandatory reports, which highlights their commitment to understanding and preventing future adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Adverse events management. Methods and results of a development project]. Rabøl, LI., Jensen, EB., Hellebek, AH., et al.[2006]

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]

About 63% of long-term care facilities in the Czech Republic have some form of adverse event reporting process, but many of these systems are underdeveloped and rely mainly on paper records.

Interviews revealed that while staff recognize the importance of reporting adverse events, there is a significant gap in knowledge and skills needed to create effective reporting systems, indicating a need for better training and resources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse event reporting in Czech long-term care facilities. Hěib, Z., Vychytil, P., Marx, D.[2016]

A study involving 666 participants (331 patients and 335 healthcare providers) found that adding an introductory phone call to Caring Contacts did not significantly reduce loneliness compared to sending messages without the call.

The results suggest that Caring Contacts can be effectively implemented without the added complexity of introductory calls, maintaining their potential to support individuals with adverse mental health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative effectiveness of two versions of a caring contacts intervention in healthcare providers, staff, and patients for reducing loneliness and mental distress: A randomized controlled trial. Radin, AK., Shaw, J., Brown, SP., et al.[2023]

Caring Contacts, which are supportive text messages sent to military personnel at risk of suicide, showed a significant reduction in the odds of experiencing suicidal ideation and attempts compared to standard care, suggesting they may be a valuable addition to mental health interventions.

While the primary outcomes did not show significant effects, the secondary outcomes indicated that participants receiving Caring Contacts had lower rates of suicidal ideation and attempts, highlighting the potential of this low-cost intervention in preventing suicidality among military service members.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Augmenting Standard Care for Military Personnel With Brief Caring Text Messages for Suicide Prevention: A Randomized Clinical Trial. Comtois, KA., Kerbrat, AH., DeCou, CR., et al.[2022]

The study analyzed 90 caring messages written by 15 peer veterans, revealing three key themes: Shared Military Service, Care, and Overcoming Adversity, which reflect the unique experiences and support among veterans.

These peer-generated messages may enhance feelings of belonging and social support for veterans after psychiatric treatment, potentially improving the effectiveness of existing suicide prevention interventions like Caring Letters.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peer-Written Caring Letters for Veterans after a Suicidal Crisis. Ton, AT., Carter, SP., Leitner, R., et al.[2023]

In a pilot study involving 100 recently discharged psychiatric patients, Caring Contacts showed a potential benefit in reducing the worsening of mental health symptoms and suicidal ideation shortly after discharge, particularly on day 4 post-discharge.

Although there were no significant differences between the Caring Contacts and control groups overall, the results suggest that Caring Contacts may help mitigate distress in the immediate post-discharge period, indicating the need for further research with larger sample sizes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Caring Contacts to Reduce Psychiatric Morbidity Following Hospitalization During the COVID-19 Pandemic: A Pilot Randomized Controlled Trial. Holman, S., Steinberg, R., Sinyor, M., et al.[2023]

The study aims to adapt the Caring Contacts suicide prevention approach for use in a VA emergency department, targeting veterans during a critical transition period after discharge.

A pilot program will be conducted to gather qualitative data from staff and stakeholders, which will help create an implementation toolkit for spreading this effective intervention to other VA facilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adapting and implementing Caring Contacts in a Department of Veterans Affairs emergency department: a pilot study protocol. Landes, SJ., Kirchner, JE., Areno, JP., et al.[2022]

References

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

The effectiveness of a nursing discharge programme to improve medication adherence and patient satisfaction in the psychiatric intensive care unit. [2018]

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

The impact of follow-up telephone calls to patients after hospitalization. [2019]

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

From airports to care centers. Transferring information technology to support patient care reengineering. [2019]

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

The impact of follow-up telephone calls to patients after hospitalization. [2022]

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

Stroke Transitions of Care. [2018]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Feasibility and reliability of clinical coding surveillance for the routine monitoring of adverse drug events in New Zealand hospitals. [2019]

7. 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]

8. Denmark pubmed.ncbi.nlm.nih.gov

[Adverse events management. Methods and results of a development project]. [2006]

9. England pubmed.ncbi.nlm.nih.gov

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

10. England pubmed.ncbi.nlm.nih.gov

Adverse event reporting in Czech long-term care facilities. [2016]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Comparative effectiveness of two versions of a caring contacts intervention in healthcare providers, staff, and patients for reducing loneliness and mental distress: A randomized controlled trial. [2023]

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

Effect of Augmenting Standard Care for Military Personnel With Brief Caring Text Messages for Suicide Prevention: A Randomized Clinical Trial. [2022]

13. England pubmed.ncbi.nlm.nih.gov

Peer-Written Caring Letters for Veterans after a Suicidal Crisis. [2023]

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

Caring Contacts to Reduce Psychiatric Morbidity Following Hospitalization During the COVID-19 Pandemic: A Pilot Randomized Controlled Trial. [2023]

15. England pubmed.ncbi.nlm.nih.gov

Adapting and implementing Caring Contacts in a Department of Veterans Affairs emergency department: a pilot study protocol. [2022]