CommunicationNCT03901547
Emotion Regulation and Burnout Impact on Communication Documentation
A study testing Communication Skills Training, Profile feedback and Maslach burnout inventory in people with Communication, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial summary
This is a single-institution cohort study with two tiers. All participants receive the interventions in Tier 1. Tier 1 is an education study where participants can complete electronic surveys on their pre and post intervention confidence, perform two simulated patient encounters and have their documentation of… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Communication
- What is being tested?
- Communication Skills Training, Profile feedback and Maslach burnout inventory
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2019to 1 Jan 2022
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All second year (PGY-2) internal medicine residents
- All hematology-oncology fellows
Who cannot join
- Missed more than five days of the palliative care education elective
Trial locations and contacts
1 site in 1 country.
United States1 site
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03766
About this study
Official title: An Education and Behavioral, Single-center, Observational Cohort Study Evaluating the Effect of Emotion Regulation and Burnout on Medical Trainees' Learning and Documentation of Serious Illness Communication
This is a single-institution cohort study with two tiers. All participants receive the interventions in Tier 1. Tier 1 is an education study where participants can complete electronic surveys on their pre and post intervention confidence, perform two simulated patient encounters and have their documentation of electronic template monitored longitudinally over 12 months. Participants are free to opt out of any activity related to education assessment or system-based interventions to promote the use of learned skills (e.g. priming or profile feedback). Signed informed consent will Not be required for this tier. Tier 2 includes additional measurements to the Tier 1 activities, and a priming intervention (e.g. provided the names of patients they have have). Participants in Tier 2 complete psychological inventories at three time points to measure emotion regulation and burnout, and participate in a semi-structured interview. after completing the training, they will complete a "priming" intervention. The investigators will require signed informed consent to participate in Tier 2.
Read the detailed description
Before Communication Training Activities Tier 1 (education-only subjects): Three to four weeks prior to the subject's two-week palliative care elective they will be sent an email to complete an online confidence survey. They will receive email reminders to complete the survey until survey is completed.
Tier 2 (education + psychological measurements of subjects): Subjects will have reviewed and signed consent documentation. In addition to the above online confidence survey, they will also receive email to complete electronic ERSQ and MBI.
Two week palliative care elective Tier 1 - Integrated into the two-week elective with the palliative care department, subjects undergo a 1) four-hour training focused on the SICG©; 2) two simulated patient encounters with trained actors and feedback provided after training, 3) participant sent electronic notification to take post intervention survey of confidence Tier 2 - In addition to above, these subjects will also complete a Priming intervention. They will receive a list of patients whom 1) the study subjected documented at least one note on in the past and 2) have a high likelihood of serious illness as determined by an electronic process. This list will be shared securely through Dartmouth secure file electronically, and participants will be asked four "yes or no" questions for each patient: 1) do they believe the patient has serious illness?; 2) would you be surprised if the patient died within the next year?, 3) Is this patient an appropriate patient to use the serious illness conversation guide? and 4) If you saw this patient again, would you use the serious illness conversation guide with him/ her? Subjects will be asked to review no more than 30 patients. Subjects will be asked to return the completed email via Dartmouth secure file share.
Electronic communication every two months following completion of elective Tier 1 - Every two months after completing the training, participants will receive email compare his or her own documentation of the taught template to top and average performers (comparison results given are anonymous). Non-top and top performers will receive different messages, customized through pre-testing with non-study residents and fellows. For example: "Talking to patients about their values is important but can take some pre-visit planning. Choose a patient you will see in the next two weeks to use the SICG" (non top-performers) or "Good job! Talking to patients about their values is important. The way we continue to improve is by having more conversations. Choose a patient you will see in the next two weeks to use the SICG." (top-performers). At four months, subjects will be asked electronically to complete their final confidence survey.
Tier 2 - For this part of the study, identical to Tier 1
Semi-structured interviews Tier 2 only - Planned to occur about three months following training. Subjects are asked a series of questions designed to assess subject perception of serious illness communication, obstacles to implementing the training in practice, barriers to documentation and coaching sessions in real patient encounters with trained faculty. Interviews will be recorded, and expected duration is 20-40 minutes.
Simulated Patient encounter at six months Tier 1 - Subject is contacted to arrange one-hour for simulated patient encounter, about 20-30 minutes for skill practice and the remainder for debrief. Subject has permission from program to have this hour to be away from their clinical duties.
Tier 2 - identical to Tier 1.
Six and 12 month ERSQ and MBI assessment Tier 2 only - emails will be sent to subject to take ERSQ and MBI at month six and 12 following training
- Conditions
- Communication
- Being tested
- Communication Skills Training, Profile feedback, Maslach burnout inventory, Emotion Regulation Skills Question (ERSQ), Semi-structured interview
- Keywords
- documentation, serious illness
- Medical subject headings
- Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Communication Skills TrainingBehavioural
Education training in the serious illness communication guide (SICG) by Ariadne labs.
Profile feedbackBehavioural
Providing participants their personal documentation rate of SICG in the electronic medical record
Maslach burnout inventoryOther
Maslach burnout inventory
Emotion Regulation Skills Question (ERSQ)Other
This validated instrument consists of 27 items, and includes subscales related to nine competencies of coping with negative emotion (awareness, sensations, clarity, understanding, acceptance, tolerance, readiness to confront, compassionate self-support and modification) which can be summed to a total score (TOTAL). This validated instrument consists of 27 items, and includes subscales related to nine competencies of coping with negative emotion (awareness, sensations, clarity, understanding, acceptance, tolerance, readiness to confront, compassionate self-support and modification) which can be summed to a total score (TOTAL).
Semi-structured interviewOther
Interviewer asked subjects are a series of questions based on interview guide. Current guide designed to assess subject perception of implementation of training in clinical encounters, most recent encounter with patient with serious illness, barriers to documentation and coaching by faculty on communication. Interviews will be recorded and expected duration is 20-40 minutes.
PrimingBehavioural
Participants will be provided a list of 30 patients they have encountered before that 1) have at least one documented note and 2) have a high probability for having serious illness as determined by electronic medical record screening. Participants will be asked 4 "yes or no" questions on each patient. Questions: 1) do you believe this patient has serious illness?; 2) would you be surprised if this patient died in the next year?; 3) would the patient benefit from the serious illness conversation guide? and 4) If you saw this patient again, would you use the serious illness conversation guide with him/ her?
| Study group | Role | What they receive |
|---|---|---|
| Education and Documentation (Tier 1) | Other | Education only. Participants who do not wish to enroll in the behavioral observation group are followed in the education only. This includes participation in a two week palliative medicine elective which is a part of the medical trainees training and training in the serious illness communication guide (SICG). Participants can opt out of the pre and post training confidence surveys, and simulated patient encounters. Electronic documentation of the SICG by these trainees will be monitored prospectively. Participants will be provided reminders and profile information on their own documentation rate of the SICG via email and have the ability to opt out of receiving emails if they wish. Receives: Behavioral: Communication Skills Training; Behavioral: Profile feedback |
| Priming and additional measures (Tier 2) | Other | Education and behavioral observation cohort. These participants must sign an informed consent to participate in this part of the study. In addition to all of Tier 1 activities, participants also complete psychological inventories at three time points to measure emotion regulation and burnout, and participate in a semi-structured interview. Receives: Behavioral: Communication Skills Training; Behavioral: Profile feedback; Other: Maslach burnout inventory; Other: Emotion Regulation Skills Question (ERSQ); Other: Semi-structured interview; Behavioral: Priming |
What is being measured
The primary outcome is the main question the study is designed to answer.
Template use at 12 months
Documentation events in the electronic medical record using the dot-phrase or electronic template for the serious illness conversation guide
Measured: 12 months following training
Secondary outcomes (5)
post-intervention self-rated confidence
Using a 5 point Likert scale (i.e. 1=strongly disagree, 2=disagree, 3=neutral, 4=agree 5=strongly agree) participants were asked to rate their confidence in various communication skills domains pre- and post-intervention via online survey. The current version has 12 items that trainees rate their post-intervention confidence
Measured: Pre intervention and 4 months post intervention
performance in simulated patient encounters
Performance is measured by an internally developed checklist. A single independent observer, during simulated patient encounters, will evaluate trainees. One point is assigned for each item used by the trainee. The checklist contains three scores: conversation guide specific items (16 points), global communication skills (9 points), and a combined score (25 points). This checklist was developed internally and based on the experience training residents in the Serious Illness Conversation Guide (SICG).
Measured: Intervention start, 2 weeks and 6 months
semi-structured interview responses
Interviewer uses a semi-structured interview guide to ask open ended questions to participants. The current verison of the interview guide assesses participant experience in 3 broad areas: experience using training in clinical practice, most recent encounter with a patient with serious illness and experience receiving faculty coaching in communication skills. Interviews generally range from 15 to 40 minutes in length. Conversations will be recorded, transcribed, and analyzed qualitative for theme and content.
Measured: 4 months
emotion regulation skills
The emotion regulation skills questionnaire (ERSQ) is a validated instrument consists of 27 items, and includes subscales related to nine competencies of coping with negative emotion (awareness, sensations, clarity, understanding, acceptance, tolerance, readiness to confront, compassionate self-support and modification) which can be summed to a total score (TOTAL). The ERSQ assesses each skill by means of three items introduced by the phrase "In the last week…" and answered on a 5-point Likert-scale. Higher scores indicate stronger emotion regulation skills. The investigators will administer the ERSQ via online survey
Measured: start, 6 months and 12 months
Change in Burnout
The responses to the Maslach Burnout Inventory tool will be evaluated to measure change in burnout. This validated, psychological inventory consists of 22 items related to occupational burnout, and includes subscales related to Emotional exhaustion (EE; 9 items), Depersonalization (DP; 5-items), and Personal Accomplishment (PA; 8 items). The MBI assesses each item on a 7-point Likert-scale. Higher scores indicated greater burnout. The investigators will use the MBI / Human Services Survey for Medical Personnel administered via online survey
Measured: Baseline, 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2019
- Study start15 Sep 2019
- Primary completion30 May 2021 (estimated)
- Study completion1 Jan 2022
Why it stopped: Combination of no funding and time commitments on PI
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CommunicationStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Both groups get the same education intervention. Tier two gets additional measurement intervention and one additional system based intervention (e.g. priming) that Tier 1 does not.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Garrett T. Wasp, Dartmouth-Hitchcock Medical Center
- Investigators
- Garrett T Wasp, MD, Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03901547
- Sponsor's protocol ID
- D19033
- Status last verified
- Jul 2023
- First submitted
- 2 Apr 2019
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: At this point no plans to share individual data outside of study team. If study data were to be shared, the investigators would need to make sure it was anonymous and could not be traced back to specific individuals inn order to protect our participants
Publications
Bernacki R, Hutchings M, Vick J, Smith G, Paladino J, Lipsitz S, Gawande AA, Block SD. Development of the Serious Illness Care Program: a randomised controlled trial of a palliative care communication intervention. BMJ Open. 2015 Oct 6;5(10):e009032. doi: 10.1136/bmjopen-2015-009032.
PubMed 26443662Berking M, Poppe C, Luhmann M, Wupperman P, Jaggi V, Seifritz E. Is the association between various emotion-regulation skills and mental health mediated by the ability to modify emotions? Results from two cross-sectional studies. J Behav Ther Exp Psychiatry. 2012 Sep;43(3):931-7. doi: 10.1016/j.jbtep.2011.09.009. Epub 2011 Nov 27.
PubMed 22406495Ebert DD, Christ O, Berking M. Entwicklung und validierung eines fragebogens zur emotionsspezifischen selbsteinschätzung emotionaler kompetenzen (SEK-ES). Diagnostica. 2013;59(1):17-32. doi:10.1026/0012-1924/a000079.
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Education and Behavioral, Single-center, Observational Cohort Study Evaluating the Effect of Emotion Regulation and Burnout on Medical Trainees' Learning and Documentation of Serious Illness Communication
- ClinicalTrials.gov ID
- NCT03901547
- Acronym / sponsor ID
- D19033
- Conditions
- Communication
- Keywords
- documentation, serious illness
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Combination of no funding and time commitments on PI
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Study start
- 15 Sep 2019 (actual)
- Primary completion
- 30 May 2021 (estimated)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 3 Apr 2019 (actual)
- 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 is a single-institution cohort study with two tiers. All participants receive the interventions in Tier 1. Tier 1 is an education study where participants can complete electronic surveys on their pre and post intervention confidence, perform two simulated patient encounters and have their documentation of electronic template monitored longitudinally over 12 months. Participants are free to opt out of any activity related to education assessment or system-based interventions to promote the use of learned skills (e.g. priming or profile feedback). Signed informed consent will Not be required for this tier. Tier 2 includes additional measurements to the Tier 1 activities, and a priming intervention (e.g. provided the names of patients they have have). Participants in Tier 2 complete psychological inventories at three time points to measure emotion regulation and burnout, and participate in a semi-structured interview. after completing the training, they will complete a "priming" intervention. The investigators will require signed informed consent to participate in Tier 2.
Detailed description
Before Communication Training Activities Tier 1 (education-only subjects): Three to four weeks prior to the subject's two-week palliative care elective they will be sent an email to complete an online confidence survey. They will receive email reminders to complete the survey until survey is completed.
Tier 2 (education + psychological measurements of subjects): Subjects will have reviewed and signed consent documentation. In addition to the above online confidence survey, they will also receive email to complete electronic ERSQ and MBI.
Two week palliative care elective Tier 1 - Integrated into the two-week elective with the palliative care department, subjects undergo a 1) four-hour training focused on the SICG©; 2) two simulated patient encounters with trained actors and feedback provided after training, 3) participant sent electronic notification to take post intervention survey of confidence Tier 2 - In addition to above, these subjects will also complete a Priming intervention. They will receive a list of patients whom 1) the study subjected documented at least one note on in the past and 2) have a high likelihood of serious illness as determined by an electronic process. This list will be shared securely through Dartmouth secure file electronically, and participants will be asked four "yes or no" questions for each patient: 1) do they believe the patient has serious illness?; 2) would you be surprised if the patient died within the next year?, 3) Is this patient an appropriate patient to use the serious illness conversation guide? and 4) If you saw this patient again, would you use the serious illness conversation guide with him/ her? Subjects will be asked to review no more than 30 patients. Subjects will be asked to return the completed email via Dartmouth secure file share.
Electronic communication every two months following completion of elective Tier 1 - Every two months after completing the training, participants will receive email compare his or her own documentation of the taught template to top and average performers (comparison results given are anonymous). Non-top and top performers will receive different messages, customized through pre-testing with non-study residents and fellows. For example: "Talking to patients about their values is important but can take some pre-visit planning. Choose a patient you will see in the next two weeks to use the SICG" (non top-performers) or "Good job! Talking to patients about their values is important. The way we continue to improve is by having more conversations. Choose a patient you will see in the next two weeks to use the SICG." (top-performers). At four months, subjects will be asked electronically to complete their final confidence survey.
Tier 2 - For this part of the study, identical to Tier 1
Semi-structured interviews Tier 2 only - Planned to occur about three months following training. Subjects are asked a series of questions designed to assess subject perception of serious illness communication, obstacles to implementing the training in practice, barriers to documentation and coaching sessions in real patient encounters with trained faculty. Interviews will be recorded, and expected duration is 20-40 minutes.
Simulated Patient encounter at six months Tier 1 - Subject is contacted to arrange one-hour for simulated patient encounter, about 20-30 minutes for skill practice and the remainder for debrief. Subject has permission from program to have this hour to be away from their clinical duties.
Tier 2 - identical to Tier 1.
Six and 12 month ERSQ and MBI assessment Tier 2 only - emails will be sent to subject to take ERSQ and MBI at month six and 12 following training
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Both groups get the same education intervention. Tier two gets additional measurement intervention and one additional system based intervention (e.g. priming) that Tier 1 does not.
| Arm | Type | Receives |
|---|---|---|
| Education and Documentation (Tier 1) | Other | Behavioral: Communication Skills Training, Behavioral: Profile feedbackEducation only. Participants who do not wish to enroll in the behavioral observation group are followed in the education only. This includes participation in a two week palliative medicine elective which is a part of the medical trainees training and training in the serious illness communication guide (SICG). Participants can opt out of the pre and post training confidence surveys, and simulated patient encounters. Electronic documentation of the SICG by these trainees will be monitored prospectively. Participants will be provided reminders and profile information on their own documentation rate of the SICG via email and have the ability to opt out of receiving emails if they wish. |
| Priming and additional measures (Tier 2) | Other | Behavioral: Communication Skills Training, Behavioral: Profile feedback, Other: Maslach burnout inventory, Other: Emotion Regulation Skills Question (ERSQ), Other: Semi-structured interview, Behavioral: PrimingEducation and behavioral observation cohort. These participants must sign an informed consent to participate in this part of the study. In addition to all of Tier 1 activities, participants also complete psychological inventories at three time points to measure emotion regulation and burnout, and participate in a semi-structured interview. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All second year (PGY-2) internal medicine residents
- All hematology-oncology fellows
Key exclusion criteria (1 listed)
- Missed more than five days of the palliative care education elective
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 |
|---|---|---|
| Communication Skills TrainingEducation training in the serious illness communication guide (SICG) by Ariadne labs. | Behavioural | Education and Documentation (Tier 1), Priming and additional measures (Tier 2) |
| Profile feedbackProviding participants their personal documentation rate of SICG in the electronic medical record | Behavioural | Education and Documentation (Tier 1), Priming and additional measures (Tier 2) |
| Maslach burnout inventoryMaslach burnout inventory | Other | Priming and additional measures (Tier 2) |
| Emotion Regulation Skills Question (ERSQ)This validated instrument consists of 27 items, and includes subscales related to nine competencies of coping with negative emotion (awareness, sensations, clarity, understanding, acceptance, tolerance, readiness to confront, compassionate self-support and modification) which can be summed to a total score (TOTAL). This validated instrument consists of 27 items, and includes subscales related to nine competencies of coping with negative emotion (awareness, sensations, clarity, understanding, acceptance, tolerance, readiness to confront, compassionate self-support and modification) which can be summed to a total score (TOTAL). | Other | Priming and additional measures (Tier 2) |
| Semi-structured interviewInterviewer asked subjects are a series of questions based on interview guide. Current guide designed to assess subject perception of implementation of training in clinical encounters, most recent encounter with patient with serious illness, barriers to documentation and coaching by faculty on communication. Interviews will be recorded and expected duration is 20-40 minutes. | Other | Priming and additional measures (Tier 2) |
| PrimingParticipants will be provided a list of 30 patients they have encountered before that 1) have at least one documented note and 2) have a high probability for having serious illness as determined by electronic medical record screening. Participants will be asked 4 "yes or no" questions on each patient. Questions: 1) do you believe this patient has serious illness?; 2) would you be surprised if this patient died in the next year?; 3) would the patient benefit from the serious illness conversation guide? and 4) If you saw this patient again, would you use the serious illness conversation guide with him/ her? | Behavioural | Priming and additional measures (Tier 2) |
Primary outcome
Template use at 12 months
Time frame: 12 months following training
Documentation events in the electronic medical record using the dot-phrase or electronic template for the serious illness conversation guide
5 secondary outcomes
post-intervention self-rated confidence
Time frame: Pre intervention and 4 months post intervention
performance in simulated patient encounters
Time frame: Intervention start, 2 weeks and 6 months
semi-structured interview responses
Time frame: 4 months
emotion regulation skills
Time frame: start, 6 months and 12 months
Change in Burnout
Time frame: Baseline, 6 months and 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- Background: PubMed 26443662Bernacki R, Hutchings M, Vick J, Smith G, Paladino J, Lipsitz S, Gawande AA, Block SD. Development of the Serious Illness Care Program: a randomised controlled trial of a palliative care communication intervention. BMJ Open. 2015 Oct 6;5(10):e009032. doi: 10.1136/bmjopen-2015-009032.
- Background: PubMed 22406495Berking M, Poppe C, Luhmann M, Wupperman P, Jaggi V, Seifritz E. Is the association between various emotion-regulation skills and mental health mediated by the ability to modify emotions? Results from two cross-sectional studies. J Behav Ther Exp Psychiatry. 2012 Sep;43(3):931-7. doi: 10.1016/j.jbtep.2011.09.009. Epub 2011 Nov 27.
- BackgroundEbert DD, Christ O, Berking M. Entwicklung und validierung eines fragebogens zur emotionsspezifischen selbsteinschätzung emotionaler kompetenzen (SEK-ES). Diagnostica. 2013;59(1):17-32. doi:10.1026/0012-1924/a000079.
- Individual participant dataSharing planned: No. At this point no plans to share individual data outside of study team. If study data were to be shared, the investigators would need to make sure it was anonymous and could not be traced back to specific individuals inn order to protect our participants
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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.
Garrett T Wasp, MD principal investigator
Dartmouth-Hitchcock Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Communication Skills Training, Profile feedback and Maslach burnout inventory in people with Communication, run by Dartmouth-Hitchcock Medical Center 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: withdrawn, as of the sponsor's last update on 1 Aug 2023. 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 was withdrawn before enrolling participants, so there are no results.
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?
Template use at 12 months (time frame: 12 months following training). 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 NCT03901547, which also lists 3 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 1 Aug 2023.