Suicide PreventionNCT02996344
Suicide Prevention Training for PC Providers-in-training
A study testing Didactic training and Standardized patient interaction in people with Suicide Prevention, run by University of Rochester at 1 site in United States.
Trial summary
This randomized control study responds to the need for effective suicide prevention education/training that is grounded in adult learning theory and advances in education, in the context of a changing health care landscape where primary care providers are likely to encounter suicidal individuals. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suicide Prevention
- What is being tested?
- Didactic training and Standardized patient interaction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2016to 7 Jun 2018
- Phase
- Interventional
- 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
Who may be able to join
- trainee in family medicine residency, pediatrics residency, or nurse practitioner program at URMC.
- speaks/writes English.
Who cannot join
- on academic probation
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester Medical Center
Rochester, New York, 14642
About this study
Official title: Suicide Prevention Training for Primary Care Providers-in-training
This randomized control study responds to the need for effective suicide prevention education/training that is grounded in adult learning theory and advances in education, in the context of a changing health care landscape where primary care providers are likely to encounter suicidal individuals. The study will test the effectiveness of suicide prevention education for providers-in-training by comparing two conditions: 1) A Control learning group: includes suicide prevention didactics (Commitment to Living: Primary Care) delivered online via brief videos, and 2) An Experimental learning group: includes didactics plus two standardized patient (SP) interactions. One Experimental learning group SP interaction will be in person and the other will be conducted remotely using a secure webcam service (OoVoo). All SP interactions will be recorded. Both groups will be compared in terms of their suicide prevention skills using an SP 'test case' at 6-month follow up. The primary research question is to learn about the impact of practice (though SP simulation) over and above didactics alone.
Read the detailed description
Suicide is a national public health crisis and a critical patient safety issue. Suicide is the 10th leading cause of death overall and, shockingly, the 2nd leading cause of death in adolescents and young adults (15-34 years old). 1 A recent U.S. study of suicide reported that 45% of individuals who died by suicide had contact with primary care services within one month before their death. 2 Another study found that 80% of youth who died by suicide saw their primary care provider within the year of their death. 3 Patient safety is compromised when primary care providers lack the knowledge and skills to assess and respond to patients at risk for suicide.
This randomized control study responds to the need for effective suicide prevention education/training that is grounded in adult learning theory and advances in education, in the context of a changing health care landscape where primary care providers are likely to encounter suicidal individuals. 4 We will test the effectiveness of suicide prevention education for providers-in-training by comparing two conditions: 1) A Control learning group: includes suicide prevention didactics (Commitment to Living: Primary Care) delivered online via brief videos, and 2) An Experimental learning group: includes didactics plus two standardized patient (SP) interactions. One Experimental learning group SP interaction will be in person and the other will be conducted remotely using a secure webcam service (OoVoo). All SP interactions will be recorded. Both groups will be compared in terms of their suicide prevention skills using an SP 'test case' at 6-month follow up. The primary research question is to learn about the impact of practice (though SP simulation) over and above didactics alone. The hypotheses are as follows:
H1: All subjects will demonstrate improved suicide prevention knowledge from pre to post didactics and maintain improvement 6 months after didactics.
H2: Subjects in the experimental learning group will report greater satisfaction with the training, greater self-efficacy in identifying and responding to patients at risk for suicide, greater intention to use, as well as use of suicide prevention skills.
H3: Subjects in the experimental learning group will also be more skillful in responding to patients at risk for suicide (in an SP interview, measured by objective observed ratings) compared to the control learning group 6 months after didactics.
Exploratory Aims: We will examine moderators of outcomes, differences among SP simulations (i.e., face-to-face vs. telehealth modalities), and if there is growth in improved skills observed over multiple SP experiences in the experimental learning group.
- Conditions
- Suicide Prevention
- Being tested
- Didactic training, Standardized patient interaction
- Medical subject headings
- Suicide Prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Didactic trainingOther
Six online training modules pertaining to suicide prevention in primary care.
Standardized patient interactionOther
Two standardized patient practice interactions - 1 face-to-face, 1 remote/telehealth.
| Study group | Role | What they receive |
|---|---|---|
| Didactic training | Active comparator | Behavioral; participants will view the approximately one hour Commitment to Living: Primary Care (CTL:PC) didactic training videos. Receives: Other: Didactic training |
| Didactics and standardized patients | Experimental | Behavioral; participants will view the approximately one hour Commitment to Living: Primary Care (CTL:PC) didactic training videos plus two practice standardized patient interactions. Receives: Other: Didactic training; Other: Standardized patient interaction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean score using the Commitment to Living: Primary Care Observational Rating form
Each participant will be evaluated via standardized patient interactions which are video taped and reliably coded using the Commitment to Living: Primary Care Observational Rating form. Score will range from 0 - 32.
Measured: through study completion, an average of 6 months
Secondary outcomes (7)
Changes in suicide prevention knowledge
Participants will complete a 17-item knowledge questionnaire prior to and following the online didactic training. Number of correct responses will be compared.
Measured: 1 day following enrollment and 15 days from enrollment
Changes in suicide prevention self-efficacy
Participants will complete a 20-item 5-point likert scale self-efficacy questionnaire prior to and following the online didactic training. Average responses will be compared.
Measured: 1 day following enrollment and 15 days from enrollment
Changes in suicide prevention knowledge
Participants will complete a 17-item knowledge questionnaire following the online didactic training and end of study. Number of correct responses will be compared.
Measured: 15 days from enrollment and through study completion, an average of 6 months
Number of participants intending to transfer training to practice
Participants will complete a 8-item intentions to use training in practice on a 5-item likert scale questionnaire following the online didactic training and end of study. Number of participants who report positive intentions to use the training in practice will be compared.
Measured: 15 days from enrollment and through study completion, an average of 6 months
Changes in suicide prevention self-efficacy
Participants will complete a 20-item 5-point likert scale self-efficacy questionnaire following the online didactic training and end of study. Average responses will be compared.
Measured: 15 days from enrollment and through study completion, an average of 6 months
Use of suicide prevention skills
Participants will self-report whether they used suicide prevention skills in practice on 0-4 point likert scale, with 0 defined as no use and 4 as frequently used.
Measured: through study completion, an average of 6 months
Feedback on training
Participants will provide feedback on their experience with suicide prevention training on 15 items using a 5-point likert scale.
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2016 (estimated)
- Study start15 Mar 2016
- Primary completion7 Jun 2018
- Study completion7 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Suicide PreventionStudies of the same condition, open and under way.
- More trials run by University of RochesterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wendi Cross, University of Rochester
- Investigators
- Wendi F Cross, PhD, Principal investigator, Associate Professor of Psychiatry (Psychology) and Pediatrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02996344
- Sponsor's protocol ID
- 00061161
- Status last verified
- Feb 2020
- First submitted
- 24 Oct 2016
- Last updated
- 12 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Ahmedani BK, Simon GE, Stewart C, Beck A, Waitzfelder BE, Rossom R, Lynch F, Owen-Smith A, Hunkeler EM, Whiteside U, Operskalski BH, Coffey MJ, Solberg LI. Health care contacts in the year before suicide death. J Gen Intern Med. 2014 Jun;29(6):870-7. doi: 10.1007/s11606-014-2767-3. Epub 2014 Feb 25.
PubMed 24567199Bridge JA, Horowitz LM, Fontanella CA, Grupp-Phelan J, Campo JV. Prioritizing research to reduce youth suicide and suicidal behavior. Am J Prev Med. 2014 Sep;47(3 Suppl 2):S229-34. doi: 10.1016/j.amepre.2014.06.001.
PubMed 25145744Wei LJ. An application of an urn model to the design of sequential controlled trials. Journal of the American Statistical Association. 1978;73(363):559-563.
Pisani AR, Cross WF, Watts A, Conner K. Evaluation of the Commitment to Living (CTL) curriculum: a 3-hour training for mental health professionals to address suicide risk. Crisis. 2012 Jan 1;33(1):30-8. doi: 10.1027/0227-5910/a000099.
PubMed 21940243Aiken LS, West SG. Multiple regression: Testing and interpreting interactions. Newbury Park, CA: Sage; 1991.
Cross WF, West JC, Pisani AR, Crean HF, Nielsen JL, Kay AH, Caine ED. A randomized controlled trial of suicide prevention training for primary care providers: a study protocol. BMC Med Educ. 2019 Feb 14;19(1):58. doi: 10.1186/s12909-019-1482-5.
PubMed 30764814
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Suicide Prevention Training for Primary Care Providers-in-training
- ClinicalTrials.gov ID
- NCT02996344
- Acronym / sponsor ID
- 00061161
- Conditions
- Suicide Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- 15 Mar 2016 (actual)
- Primary completion
- 7 Jun 2018 (actual)
- Study completion
- 7 Jun 2018 (actual)
- First posted
- 19 Dec 2016 (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.
This randomized control study responds to the need for effective suicide prevention education/training that is grounded in adult learning theory and advances in education, in the context of a changing health care landscape where primary care providers are likely to encounter suicidal individuals. The study will test the effectiveness of suicide prevention education for providers-in-training by comparing two conditions: 1) A Control learning group: includes suicide prevention didactics (Commitment to Living: Primary Care) delivered online via brief videos, and 2) An Experimental learning group: includes didactics plus two standardized patient (SP) interactions. One Experimental learning group SP interaction will be in person and the other will be conducted remotely using a secure webcam service (OoVoo). All SP interactions will be recorded. Both groups will be compared in terms of their suicide prevention skills using an SP 'test case' at 6-month follow up. The primary research question is to learn about the impact of practice (though SP simulation) over and above didactics alone.
Detailed description
Suicide is a national public health crisis and a critical patient safety issue. Suicide is the 10th leading cause of death overall and, shockingly, the 2nd leading cause of death in adolescents and young adults (15-34 years old). 1 A recent U.S. study of suicide reported that 45% of individuals who died by suicide had contact with primary care services within one month before their death. 2 Another study found that 80% of youth who died by suicide saw their primary care provider within the year of their death. 3 Patient safety is compromised when primary care providers lack the knowledge and skills to assess and respond to patients at risk for suicide.
This randomized control study responds to the need for effective suicide prevention education/training that is grounded in adult learning theory and advances in education, in the context of a changing health care landscape where primary care providers are likely to encounter suicidal individuals. 4 We will test the effectiveness of suicide prevention education for providers-in-training by comparing two conditions: 1) A Control learning group: includes suicide prevention didactics (Commitment to Living: Primary Care) delivered online via brief videos, and 2) An Experimental learning group: includes didactics plus two standardized patient (SP) interactions. One Experimental learning group SP interaction will be in person and the other will be conducted remotely using a secure webcam service (OoVoo). All SP interactions will be recorded. Both groups will be compared in terms of their suicide prevention skills using an SP 'test case' at 6-month follow up. The primary research question is to learn about the impact of practice (though SP simulation) over and above didactics alone. The hypotheses are as follows:
H1: All subjects will demonstrate improved suicide prevention knowledge from pre to post didactics and maintain improvement 6 months after didactics.
H2: Subjects in the experimental learning group will report greater satisfaction with the training, greater self-efficacy in identifying and responding to patients at risk for suicide, greater intention to use, as well as use of suicide prevention skills.
H3: Subjects in the experimental learning group will also be more skillful in responding to patients at risk for suicide (in an SP interview, measured by objective observed ratings) compared to the control learning group 6 months after didactics.
Exploratory Aims: We will examine moderators of outcomes, differences among SP simulations (i.e., face-to-face vs. telehealth modalities), and if there is growth in improved skills observed over multiple SP experiences in the experimental learning group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Didactic training | Active comparator | Other: Didactic trainingBehavioral; participants will view the approximately one hour Commitment to Living: Primary Care (CTL:PC) didactic training videos. |
| Didactics and standardized patients | Experimental | Other: Didactic training, Other: Standardized patient interactionBehavioral; participants will view the approximately one hour Commitment to Living: Primary Care (CTL:PC) didactic training videos plus two practice standardized patient interactions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- trainee in family medicine residency, pediatrics residency, or nurse practitioner program at URMC.
- speaks/writes English.
Key exclusion criteria (1 listed)
- on academic probation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Didactic trainingSix online training modules pertaining to suicide prevention in primary care. | Other | Didactic training, Didactics and standardized patients |
| Standardized patient interactionTwo standardized patient practice interactions - 1 face-to-face, 1 remote/telehealth. | Other | Didactics and standardized patients |
Primary outcome
Mean score using the Commitment to Living: Primary Care Observational Rating form
Time frame: through study completion, an average of 6 months
Each participant will be evaluated via standardized patient interactions which are video taped and reliably coded using the Commitment to Living: Primary Care Observational Rating form. Score will range from 0 - 32.
7 secondary outcomes
Changes in suicide prevention knowledge
Time frame: 1 day following enrollment and 15 days from enrollment
Changes in suicide prevention self-efficacy
Time frame: 1 day following enrollment and 15 days from enrollment
Changes in suicide prevention knowledge
Time frame: 15 days from enrollment and through study completion, an average of 6 months
Number of participants intending to transfer training to practice
Time frame: 15 days from enrollment and through study completion, an average of 6 months
Changes in suicide prevention self-efficacy
Time frame: 15 days from enrollment and through study completion, an average of 6 months
Use of suicide prevention skills
Time frame: through study completion, an average of 6 months
Feedback on training
Time frame: through study completion, an average of 6 months
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 12 Feb 2020.
- Background: PubMed 24567199Ahmedani BK, Simon GE, Stewart C, Beck A, Waitzfelder BE, Rossom R, Lynch F, Owen-Smith A, Hunkeler EM, Whiteside U, Operskalski BH, Coffey MJ, Solberg LI. Health care contacts in the year before suicide death. J Gen Intern Med. 2014 Jun;29(6):870-7. doi: 10.1007/s11606-014-2767-3. Epub 2014 Feb 25.
- Background: PubMed 25145744Bridge JA, Horowitz LM, Fontanella CA, Grupp-Phelan J, Campo JV. Prioritizing research to reduce youth suicide and suicidal behavior. Am J Prev Med. 2014 Sep;47(3 Suppl 2):S229-34. doi: 10.1016/j.amepre.2014.06.001.
- BackgroundWei LJ. An application of an urn model to the design of sequential controlled trials. Journal of the American Statistical Association. 1978;73(363):559-563.
- Background: PubMed 21940243Pisani AR, Cross WF, Watts A, Conner K. Evaluation of the Commitment to Living (CTL) curriculum: a 3-hour training for mental health professionals to address suicide risk. Crisis. 2012 Jan 1;33(1):30-8. doi: 10.1027/0227-5910/a000099.
- BackgroundAiken LS, West SG. Multiple regression: Testing and interpreting interactions. Newbury Park, CA: Sage; 1991.
- Derived from this study: PubMed 30764814Cross WF, West JC, Pisani AR, Crean HF, Nielsen JL, Kay AH, Caine ED. A randomized controlled trial of suicide prevention training for primary care providers: a study protocol. BMC Med Educ. 2019 Feb 14;19(1):58. doi: 10.1186/s12909-019-1482-5.
- Individual participant dataSharing planned: No
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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.
Wendi F Cross, PhD principal investigator
Associate Professor of Psychiatry (Psychology) and Pediatrics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Didactic training and Standardized patient interaction in people with Suicide Prevention, run by University of Rochester at 1 site 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 2 inclusion and 1 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 12 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Mean score using the Commitment to Living: Primary Care Observational Rating form (time frame: through study completion, an average of 6 months). 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 NCT02996344, which also lists 6 linked publications.
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 12 Feb 2020.