NCT03444935

Brief Summary

This goal of this research is to examine the efficacy and feasibility of starting a phone call follow-up program for individuals discharged to the community after presenting to the Crisis Response Centre (CRC), a standalone mental health facility in Winnipeg, with suicidal ideation or behaviours. Currently there is no worldwide gold standard for how best to follow-up with individuals following presentations to health services with suicidal ideation or behaviours, despite the period immediately after discharge from mental health services being identified as a period of increased risk for death by suicide (Chung et al., 2017; Steeg et al., 2012). This risk is higher still for individuals who specifically had suicidal ideation or behaviours as a component of their reason for presenting to mental health services (Chung et al., 2017). One strategy that has been employed to mitigate this risk is brief contact interventions (BCI), which involves following up with people through text, phone calls, or written messages. Research has shown that this type of follow-up is well-received by individuals and although some studies have found this strategy reduces the rates of suicidal behaviours during this high-risk period, the overall literature shows mixed results (Miller et al., 2017; Exbrayat et al., 2017; Cebria et al., 2016; Milner et al., 2015; Morthorst et al., 2012; Fleischmann et al., 2008; Cedereke et al., 2002). Because the research on phone call follow up programs has been mixed, we will be conducting a brief trial to study the efficacy and feasibility of a phone call follow-up system in Winnipeg to inform whether or not this type of program would be of benefit to the community. In order to best study this, we will be conducting a randomized control trial for individuals who are discharged to the community after presenting to the CRC with a recent history of suicidal thoughts or behaviours. Participants will be randomized into either an intervention group or a control group. All participants will receive at least one and no more than five phone calls during the five-week period immediately following discharge from the CRC, and the content and timing of these phone calls will be different depending on which group a participant is randomized to. We will rely on both self-reported data, which will be collected in a formalized fashion, and data in the electronic medical records of participants to analyze this intervention. Our hypothesis is that the specific protocol we have designed to follow up with the intervention group will result in decreased suicidal thoughts and behaviours in the period immediately following discharge.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
83

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 19, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 26, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

May 14, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
5.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2025

Completed
Last Updated

May 16, 2025

Status Verified

May 1, 2025

Enrollment Period

1.6 years

First QC Date

February 19, 2018

Last Update Submit

May 12, 2025

Conditions

Keywords

PhoneBrief Contact InterventionCaring ContactFollow-upSuicideSuicidal IdeationSuicidal BehaviourSuicide Attempt

Outcome Measures

Primary Outcomes (2)

  • Suicidal ideation (frequency)

    Self-report of any thoughts of ending own life, from passive thoughts to formal plans.

    Self-report; outcome pertains to frequency over the entire five weeks.

  • Suicidal behaviours (frequency)

    Self-report that includes a gradation of behaviour: suicide attempt, interrupted attempt, aborted attempt, or suicide preparatory act (eg. writing suicide note, selling off possessions). Note that death by suicide is also included in this category (but will only be available if family/friends of participant reports).

    Self-report; outcome pertains to frequency over the entire five weeks.

Secondary Outcomes (5)

  • Non-suicidal self harm (frequency)

    Self-report; outcome pertains to frequency over the entire five weeks.

  • Health care utilization (frequency)

    Self-report; outcome pertains to frequency over the entire five weeks.

  • Perceived mental health

    Self-report; outcome pertains to frequency over the entire five weeks.

  • Perceived improvement in mental health

    Self-report; outcome pertains to perceived improvement since the date of enrollment.

  • Satisfaction with and perceived helpfulness of phone calls in reducing suicidal thoughts and behaviours.

    Self-report; outcome pertains to frequency over the entire five weeks.

Study Arms (2)

Intervention

EXPERIMENTAL

Participants randomized to the intervention group will receive a predetermined amount of follow-up phone calls after discharge from the Crisis Centre. They can expect a minimum of one call and a maximum of five calls over the five week period immediately following discharge to the community. The number and nature of phone calls they receive will be different from participants in the control group. Participants will be informed upon discharge of the dates they should anticipate phone calls, but it will not be revealed to them which group they were randomized to.

Behavioral: Follow-up phone call

Control

OTHER

Participants randomized to the control group will receive a predetermined amount of follow-up phone calls after discharge from the Crisis Centre. They can expect a minimum of one call and a maximum of five calls over the five week period immediately following discharge to the community. The number and nature of phone calls they receive will be different from participants in the intervention group. Participants will be informed upon discharge of the dates they should anticipate phone calls, but it will not be revealed to them which group they were randomized to.

Behavioral: Follow-up phone call

Interventions

Please see arm/group description.

ControlIntervention

Eligibility Criteria

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

You may qualify if:

  • Being discharged to the community from the Crisis Centre
  • At least 18 years old
  • Suicidal ideation or behaviour within one week of presentation to the CRC
  • Suicidal ideation = thoughts of suicide or death, ranging from passive thoughts to organized plans
  • Suicidal behaviour = suicide attempt, interrupted suicide attempt, aborted suicide attempt, suicide preparatory actions (eg. writing a suicide note, selling off/giving away all possessions)

You may not qualify if:

  • Medically or cognitively unable to participate
  • Having an insurmountable language barrier
  • Psychiatrist deems that this type of follow-up could be harmful for the patient
  • Living in an institutional setting
  • Patient being admitted to hospital/treatment facility as a result of their presentation to the Crisis Response Centre
  • Being enrolled in outreach/follow up program that would directly overlap with involvement in this study
  • No reliable access to phone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Crisis Response Centre

Winnipeg, Manitoba, R3E 0W2, Canada

Location

Related Publications (9)

  • Chung DT, Ryan CJ, Hadzi-Pavlovic D, Singh SP, Stanton C, Large MM. Suicide Rates After Discharge From Psychiatric Facilities: A Systematic Review and Meta-analysis. JAMA Psychiatry. 2017 Jul 1;74(7):694-702. doi: 10.1001/jamapsychiatry.2017.1044.

    PMID: 28564699BACKGROUND
  • Steeg S, Kapur N, Webb R, Applegate E, Stewart SL, Hawton K, Bergen H, Waters K, Cooper J. The development of a population-level clinical screening tool for self-harm repetition and suicide: the ReACT Self-Harm Rule. Psychol Med. 2012 Nov;42(11):2383-94. doi: 10.1017/S0033291712000347. Epub 2012 Mar 7.

    PMID: 22394511BACKGROUND
  • Fleischmann A, Bertolote JM, Wasserman D, De Leo D, Bolhari J, Botega NJ, De Silva D, Phillips M, Vijayakumar L, Varnik A, Schlebusch L, Thanh HT. Effectiveness of brief intervention and contact for suicide attempters: a randomized controlled trial in five countries. Bull World Health Organ. 2008 Sep;86(9):703-9. doi: 10.2471/blt.07.046995.

    PMID: 18797646BACKGROUND
  • Milner AJ, Carter G, Pirkis J, Robinson J, Spittal MJ. Letters, green cards, telephone calls and postcards: systematic and meta-analytic review of brief contact interventions for reducing self-harm, suicide attempts and suicide. Br J Psychiatry. 2015 Mar;206(3):184-90. doi: 10.1192/bjp.bp.114.147819.

    PMID: 25733570BACKGROUND
  • Miller IW, Camargo CA Jr, Arias SA, Sullivan AF, Allen MH, Goldstein AB, Manton AP, Espinola JA, Jones R, Hasegawa K, Boudreaux ED; ED-SAFE Investigators. Suicide Prevention in an Emergency Department Population: The ED-SAFE Study. JAMA Psychiatry. 2017 Jun 1;74(6):563-570. doi: 10.1001/jamapsychiatry.2017.0678.

    PMID: 28456130BACKGROUND
  • Cebria AI, Parra I, Pamias M, Escayola A, Garcia-Pares G, Punti J, Laredo A, Valles V, Cavero M, Oliva JC, Hegerl U, Perez-Sola V, Palao DJ. Effectiveness of a telephone management programme for patients discharged from an emergency department after a suicide attempt: controlled study in a Spanish population. J Affect Disord. 2013 May;147(1-3):269-76. doi: 10.1016/j.jad.2012.11.016. Epub 2012 Dec 6.

    PMID: 23219058BACKGROUND
  • Exbrayat S, Coudrot C, Gourdon X, Gay A, Sevos J, Pellet J, Trombert-Paviot B, Massoubre C. Effect of telephone follow-up on repeated suicide attempt in patients discharged from an emergency psychiatry department: a controlled study. BMC Psychiatry. 2017 Mar 20;17(1):96. doi: 10.1186/s12888-017-1258-6.

    PMID: 28320345BACKGROUND
  • Morthorst B, Krogh J, Erlangsen A, Alberdi F, Nordentoft M. Effect of assertive outreach after suicide attempt in the AID (assertive intervention for deliberate self harm) trial: randomised controlled trial. BMJ. 2012 Aug 22;345:e4972. doi: 10.1136/bmj.e4972.

    PMID: 22915730BACKGROUND
  • Cedereke M, Monti K, Ojehagen A. Telephone contact with patients in the year after a suicide attempt: does it affect treatment attendance and outcome? A randomised controlled study. Eur Psychiatry. 2002 Apr;17(2):82-91. doi: 10.1016/s0924-9338(02)00632-6.

    PMID: 11973116BACKGROUND

MeSH Terms

Conditions

SuicideSuicidal IdeationSuicide, AttemptedSelf-Injurious Behavior

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Laura Sutherland, MD

    Winnipeg Regional Health Authority

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Crisis Clinicians who consent individuals for participation will be masked from randomization. The randomization process will be completed by a different staff member separate from the Crisis Clinician to prevent allocation bias.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Participants are randomized to one of two groups: intervention or control. Participants will receive a set number of follow-up phone calls based on the group to which they are randomized.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PGY1 Psychiatry (University of Manitoba)

Study Record Dates

First Submitted

February 19, 2018

First Posted

February 26, 2018

Study Start

May 14, 2018

Primary Completion

January 1, 2020

Study Completion

March 20, 2025

Last Updated

May 16, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations