Questionnaires and SurveysNCT02140177
Ask Suicide-Screening Questions to Everyone in Medical Settings (asQ em): Development of a Suicide Risk Screening Instrument for Adult Medical Inpatients
An observational study of Questionnaires and Surveys, run by National Institute of Mental Health (NIMH) at 4 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Questionnaires and Surveys
- How many people
- 740 participants
- Where
- 4 sitesUnited States
- Study dates
- 14 May 2014to 28 Feb 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This is a prospective, cross-sectional multisite study. We will enroll adult patients, ages 18 years and older, admitted to identified inpatient medical units during designated data collections days. Patients will be recruited at the NIH CC as well as Walter Reed National Military Medical Center (WRNMMC), Rhode Island Hospital (RIH), and John Peter Smith Hospital (JPS).
Who may be able to join
- 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:
- they are admitted as an inpatient on the designated medical units;
- they are 18 and older;
- they are capable of providing consent;
- 5) they have not previously been enrolled in this study.
Who cannot join
- Patients will be excluded if:
- 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);
- they have been already enrolled during a previous visit;
- they are unwilling to provide consent;
- the patient is non-English speaking (because ASIQ has not been validated in languages other than English).
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
John Peter Smith Hospital
Fort Worth, Texas, 76104
Rhode Island Hospital
Providence, Rhode Island, 02903
About this study
Official title: Ask Suicide-Screening Questions to Everyone in Medical Settings (asQ'em): Development of a Suicide Risk Screening Instrument for Adult Medical Inpatients
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.
Read more
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.
Read the 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 be a prospective, cross-sectional multisite study with patients enrolled from the NIH CC, Walter Reed National Military Medical Center, Rhode Island Hospital, and John Peter SmithHospital. The total planned sample size will be 810 (180 from WRNMMC, 180 from RIH, 200 from JPS, and 250 from NIH CC). 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. Additionally, we hope to pilot the Suicide Implicit Association Test (S-IAT) in a subsample of recruited patients. The S-IAT is a brief computer task which measures a person s implicit association between self and either life or death . We expect to demonstrate that the S-IAT is feasible to administer in the inpatient medical setting thereby providing a potential alternative to self-report questionnaires for assessing patients thoughts about death or suicide.
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.
- Conditions
- Questionnaires and Surveys
- Keywords
- Screening, Adults, Medical Inpatients, Suicide
- Medical subject headings
- Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adult Medical Inpatients | Adult medical inpatients; We will enroll adult patients, ages 18 years and older, admitted to identified inpatient medical units during designated data collections days. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short measures of suicide risk
Short measures of suicide risk
Measured: Ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2014 (estimated)
- Study start14 May 2014
- Primary completion31 Dec 2019
- Study completion28 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Questionnaires and SurveysStudies of the same condition, open and under way.
- More trials run by National Institute of Mental Health (NIMH)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 740 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Lisa M Horowitz, Ph.D., Principal investigator, National Institute of Mental Health (NIMH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02140177
- Sponsor's protocol ID
- 140109
- Other IDs
- 14-M-0109
- Status last verified
- Oct 2020
- First submitted
- 14 May 2014
- Last updated
- 8 Oct 2020
- Results posted
- No
Publications
Mournet AM, Bridge JA, Ross A, Powell D, Snyder DJ, Claassen CA, Wharff EA, Pao M, Horowitz LM. A Comparison of Suicide Attempt Histories of Pediatric and Adult Medical Inpatients and Implications for Screening. Arch Suicide Res. 2022 Jul-Sep;26(3):1541-1555. doi: 10.1080/13811118.2021.1931596. Epub 2021 Jun 8.
PubMed 34101537
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ask Suicide-Screening Questions to Everyone in Medical Settings (asQ'em): Development of a Suicide Risk Screening Instrument for Adult Medical Inpatients
- ClinicalTrials.gov ID
- NCT02140177
- Acronym / sponsor ID
- 140109
- Conditions
- Questionnaires and Surveys
- Keywords
- Screening, Adults, Medical Inpatients, Suicide
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 740 participants (actual)
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- 14 May 2014 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 16 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 be a prospective, cross-sectional multisite study with patients enrolled from the NIH CC, Walter Reed National Military Medical Center, Rhode Island Hospital, and John Peter SmithHospital. The total planned sample size will be 810 (180 from WRNMMC, 180 from RIH, 200 from JPS, and 250 from NIH CC). 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. Additionally, we hope to pilot the Suicide Implicit Association Test (S-IAT) in a subsample of recruited patients. The S-IAT is a brief computer task which measures a person s implicit association between self and either life or death . We expect to demonstrate that the S-IAT is feasible to administer in the inpatient medical setting thereby providing a potential alternative to self-report questionnaires for assessing patients thoughts about death or suicide.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult Medical Inpatients | – | –Adult medical inpatients; We will enroll adult patients, ages 18 years and older, admitted to identified inpatient medical units during designated data collections days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is a prospective, cross-sectional multisite study. We will enroll adult patients, ages 18 years and older, admitted to identified inpatient medical units during designated data collections days. Patients will be recruited at the NIH CC as well as Walter Reed National Military Medical Center (WRNMMC), Rhode Island Hospital (RIH), and John Peter Smith Hospital (JPS).
Key inclusion criteria (5 listed)
- 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:
- they are admitted as an inpatient on the designated medical units;
- they are 18 and older;
- they are capable of providing consent;
- 5) they have not previously been enrolled in this study.
Key exclusion criteria (5 listed)
- 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);
- they have been already enrolled during a previous visit;
- they are unwilling to provide consent;
- the patient is non-English speaking (because ASIQ has not been validated in languages other than English).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Short measures of suicide risk
Time frame: Ongoing
Short measures of suicide risk
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Derived from this study: PubMed 34101537Mournet AM, Bridge JA, Ross A, Powell D, Snyder DJ, Claassen CA, Wharff EA, Pao M, Horowitz LM. A Comparison of Suicide Attempt Histories of Pediatric and Adult Medical Inpatients and Implications for Screening. Arch Suicide Res. 2022 Jul-Sep;26(3):1541-1555. doi: 10.1080/13811118.2021.1931596. Epub 2021 Jun 8.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa M Horowitz, Ph.D. principal investigator
National Institute of Mental Health (NIMH)
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Questionnaires and Surveys, run by National Institute of Mental Health (NIMH) at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short measures of suicide risk (time frame: Ongoing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02140177, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2020.