Prevention of Suicidal Behaviour With Telemedicine Techniques

Prevention of Suicidal Behaviour in High Risk Patients With Telemedicine Techniques

This is a multicenter controlled intervention study that aims to assess the efficacy of a telephone follow-up program for the prevention of suicidal behavior in adults discharged from general hospitals after a suicide attempt.

The hypothesis is that the implementation of this program is associated with reduced rates of suicide reattempts in these patients and also with delayed reattempts in them.

Study Overview

• Status: Completed
• Conditions: Suicide, Attempted
• Intervention / Treatment: Behavioral: Telephone follow up; Behavioral: Treatment as usual

Detailed Description

Justification: Suicide is a global public health concern and is the leading cause of avoidable death in the Basque Country (Spain). The use of telemedicine techniques applied to high risk patients has shown to be useful in the prevention of suicide and suicidal behavior.

Objectives: To assess the efficacy of a telephone follow-up program for the prevention of suicidal behavior in patients who recently attempted suicide.

Design: This is a multicenter, prospective intervention study, non-randomized and with control group.

Method: A sample of adults discharged from 2 general hospitals after a suicide attempt are enrolled in a telephone follow-up program which is added to their usual treatment (TAU). The program consists of 5 short calls made by nurses during 6 months. The calls are intended to: 1) Assess the risk of suicide in that moment, 2) Improve patient's adherence to treatments, and 3) Provide general psychoeducation guidelines. The control group is composed of patients discharged from a third general hospital after a suicide attempt. These receive TAU but are not enrolled in the telephone follow-up.

Evaluation: All patients are followed during 12 months. Main outcome measures include the percentage of patients that make a second attempt and the average time to reattempt.

Patients sign and informed consent.

• Study Type: Interventional
• Enrollment (Actual): 651
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adult patients discharged from a General Hospital after a suicide attempt and who live in the same health sector as the hospital.
• The suicide attempt must have been made within 24 hours prior to the appointment in the Emergency Service.

Exclusion Criteria:

• Patient with severe cognitive difficulties and in general any self-injury in which the patient does not understand the meaning or potential consequences of such behavior.
• Patients in which a regular telephone contact is not possible.
• Patients in which the psychiatrist who evaluates the case deems inappropriate their inclusion.
• Patients who remain hospitalized 6 months after the attempt.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Telephone follow up; Patients discharged from hospital A and B after a suicide attempt receive a protocolized telephone follow which is added to their usual treatment (TAU). Calls are made by nurses at weeks 1,2,4,12 and 24 after the index suicide attempt. TAU: Includes whatever treatment the doctor decides to offer to that patient (psychopharmacology, psychotherapy etc).	Behavioral: Telephone follow up; Already described in previous page; Behavioral: Treatment as usual; Already described in previous page
ACTIVE_COMPARATOR: Control; Patients discharged from hospital C after a suicide attempt receive treatment as usual (whatever treatment the doctor decides to offer to that patient: psychopharmacology, psychotherapy etc).	Behavioral: Treatment as usual; Already described in previous page

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of participants in each group that make a second attempt	(Included in the title)	0-12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average number of days from the first attempt to the second, in each group	(Included in the title)	0-12 months
Mean number of reattempts in each group	(Included in the title)	0-12 months
Percentage of participants in each group requiring hospitalization after the suicide attempt	(Included in the title)	0-12 months

Collaborators and Investigators

• Sponsor: Osakidetza
• Collaborators: Eusko Jaurlaritza

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2014
• Primary Completion (ACTUAL): March 31, 2017
• Study Completion (ACTUAL): March 31, 2017

Study Registration Dates

• First Submitted: January 31, 2017
• First Submitted That Met QC Criteria: February 1, 2017
• First Posted (ESTIMATE): February 3, 2017

Study Record Updates

• Last Update Posted (ACTUAL): April 9, 2018
• Last Update Submitted That Met QC Criteria: April 6, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: prevention; telemedicine; suicide, attempted
• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Suicide; Suicide, Attempted
• Other Study ID Numbers: 2017AG01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No