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Ask Suicide-Screening Questions to Everyone in Medical Settings (asQ em): Development of a Suicide Risk Screening Instrument for Adult Medical Inpatients

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2016 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )
ClinicalTrials.gov Identifier:
NCT02140177
First received: May 14, 2014
Last updated: August 31, 2016
Last verified: July 2016
  Purpose

Background:

- Suicide is the 10th leading cause of death for U.S. adults. Medically ill people are at an increased risk of suicide. Most people who have killed themselves went to a healthcare provider within 3 months of their death. More and more, hospitals are being asked to assess people for signs of suicide risk so that they can get the help they need. If nurses and doctors can find out who is at risk they can make sure these people get help in the hospital.

The asQ em (Ask Suicide-Screening Questions to Everyone in Medical Settings) is a brief questionnaire. It was created to detect suicidal thoughts and behaviors in hospitalized people. Researchers would like to further develop this tool and figure out which are the best questions to ask patients.

Objective:

- To determine the best questions for healthcare providers to ask people with medical illnesses to see if they are having suicidal thoughts or planning to hurt themselves.

Eligibility:

- NIH Clinical Center patients over age 18.

Design:

  • Participants will be asked questions about how they have been feeling in the past few weeks. They will be asked questions about depression, anxiety, and suicidal thoughts and behaviors. They also will be asked some background questions.
  • It will take approximately 15 to 30 minutes to answer the questions.

Condition
Depression
Cancer
Chronic Illness

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Ask Suicide-Screening Questions to Everyone in Medical Settings (asQ'em): Development of a Suicide Risk Screening Instrument for Adult Medical Inpatients

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Frequencies of positive responses to all asQem candidate items and ASIQ/BSI items. [ Time Frame: ongoing ]
    This outcome measure will assist in identifying which of the asQem candidate items are the most sensitive and specific to detecting suicide risk.


Estimated Enrollment: 610
Study Start Date: May 2014
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Detailed Description:

In 2010, the Joint Commission (JC) issued a Sentinel Event Alert highlighting the need to detect suicide risk in all non-behavioral patients in medical settings. Detecting suicide risk among medical patients is important because this population is at elevated risk for suicidal thoughts and behaviors, and because for many of these patients, a medical visit is their only portal into mental health services. Of note, the vast majority of people who die by suicide visit a medical setting, such as an inpatient oncology unit, more frequently than a psychiatric setting in the months leading up to their death. Thus, the inpatient medical setting is an important stakeholder in decreasing suicide-related morbidity and mortality. Physicians and nurses working in non-mental health settings require tools to guide them in recognizing patients at risk. Nonetheless, there are currently no suicide screening instruments designed specifically for assessing suicide risk in an adult inpatient medical population.

In 2012, our study team conducted a Quality Improvement Project (QIP) at the National Institutes of Health Clinical Center (NIH CC) which demonstrated that the asQ em (Ask Suicide-Screening Questions to Everyone in Medical Settings), a brief instrument piloted to detect suicidal thoughts and behaviors among adult medical inpatients, was both feasible to administer and acceptable to both patients and staff. Extending this work, the aim of this current study is to further develop and psychometrically validate the asQ em among adult medical inpatients. While most inpatients will not be at imminent risk for suicide, we hypothesize that the asQ em will identify a number of patients who screen positive for suicide risk on a longer gold standard instrument, and that they are thus not only at risk for suicidal behavior in the future, but are also experiencing significant emotional distress and therefore warrant further mental health evaluation and recommendations for follow-up treatment.

This study will initially be comprised of medically ill inpatients at the NIH CC. We plan to expand the study to two other sites: the University of North Carolina's North Carolina Cancer Hospital (UNC) and Rhode Island Hospital (RIH). The total sample size will be 540 (180 per site). We will administer several short measures of suicide risk: the 20 asQ'em candidate items; a criterion standard Adult Suicidal Ideation Questionnaire (ASIQ); two questions which assess for suicidal behavior from a second criterion standard, the Beck Scale for Suicide Ideation (BSI); a brief depression screen, the Patient Health Questionnaire (PHQ-9); and an exploratory variable questionnaire, to all eligible inpatients aged 18 years and older. The ultimate goal of this project is the development of a validated risk of suicide screening instrument that can be administered rapidly by non-mental health clinicians to medical inpatients and in turn, connecting those in need with mental health services.

Future studies will focus on examining the practical implications of nurses administering the asQ em as standard of care during the admission process on a medical inpatient unit and validating the asQ em in non-English speaking patients, addressing a critical gap in suicide prevention research. In addition, examining the long-term clinical impact of screening general medical patients for suicide risk with the asQ em and linking those in need with mental health services and/or other interventions will be important next steps.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

All adult medical inpatients, ages 18 and older, who are admitted to selected medical units during data collection weeks will be approached for enrollment. Patients will be included if:

  1. they are admitted as an inpatient on the designated medical units;
  2. they are 18 and older;
  3. they are capable of providing consent;

5) they have not previously been enrolled in this study.

EXCLUSION CRITERIA:

Patients will be excluded if:

  1. they are medically or cognitively unable to participate in the screening or assessment (e.g., sustained altered level of consciousness, psychosis, hostile behavior, unremitting distress, intubation, persistent vomiting, severe pain, acute or worsening medical acuity);
  2. they have been already enrolled during a previous visit;
  3. they are unwilling to provide consent;
  4. the patient is non-English speaking (because ASIQ has not been validated in languages other than English).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02140177

Contacts
Contact: Lisa M Horowitz, Ph.D. (301) 435-6052 horowitzl@mail.nih.gov

Locations
United States, Maryland
Walter Reed National Military Medical Center Recruiting
Bethesda, Maryland, United States, 20889
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
United States, Rhode Island
Rhode Island Hospital Recruiting
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Lisa M Horowitz, Ph.D. National Institute of Mental Health (NIMH)
  More Information

Additional Information:
Publications:
Responsible Party: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT02140177     History of Changes
Other Study ID Numbers: 140109  14-M-0109 
Study First Received: May 14, 2014
Last Updated: August 31, 2016
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Screening
Adults
Medical Inpatients
Suicide

Additional relevant MeSH terms:
Suicide
Chronic Disease
Self-Injurious Behavior
Behavioral Symptoms
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on September 23, 2016