ClaustrophobiaComfortTalk®NCT02427737
Comfort Talk and Economic Outcomes in MRI
A study testing Comfort Talk® Training in people with Claustrophobia and Complication of Diagnostic Procedure, run by Hypnalgesics, LLC at 3 sites in United States.
Trial summary
Annually, an estimated 700,000 patients do not complete their scheduled MRI scans because of claustrophobia or inability to hold still. Training staffs working in MRI facilities to provide Comfort Talk® will enable patients to complete high quality imaging without medication, which will increase satisfaction and… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Claustrophobia, Complication of Diagnostic Procedure
- What is being tested?
- Comfort Talk® Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 3 sitesUnited States
- Study dates
- Apr 2015to 31 Jul 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Must routinely perform MRI examinations
- Must capture data on noncompletion of MRI scans
Who cannot join
- No dedicated MRI unit
- Unable to reliably capture data on noncompletion of MRI scans
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Hypnalgesics, LLC
Brookline, Massachusetts, 02446
Ohio State University Medical Center
Columbus, Ohio, 43210
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: Amelioration of Claustrophobia and Disruptive Patient Motion in MRI Imaging (Phase 2 Randomized Training of Sites)
Annually, an estimated 700,000 patients do not complete their scheduled MRI scans because of claustrophobia or inability to hold still. Training staffs working in MRI facilities to provide Comfort Talk® will enable patients to complete high quality imaging without medication, which will increase satisfaction and comfort while reducing sedation risks for patients, and increase efficiency and reduce loss of revenue for facilities. The effect of such training will be tested at 12 MRI sites in a randomized design. Outcome data will be collected for one year.
Read the detailed description
Claustrophobia and disruptive patient motion are common impediments to MRI examination, but they may be prevented or ameliorated with a non-pharmacologic behavioral intervention administered by trained staff. The potential benefits of such an intervention are highly significant, considering that the alternatives are to cancel the study or administer sedation. Inability to complete their MRI scans adversely affects an estimated 700,000 patients every year in the US. These patients are either deprived of a diagnosis, subject to diagnostic delays and interpretation errors due to motion artifact, or are exposed to risks of pharmacologic sedation, including death. The imaging facilities typically cannot fill the suddenly vacated examination slots in time before the next scheduled patient and incur considerable lost revenue and efficiency. A negative patient experience further jeopardizes Value-Based reimbursement by the Centers for Medicare and Medicaid Services (CMS) towards which patient satisfaction counts 30%. The long term goal is to provide a validated, clinically feasible means for non-pharmacologic amelioration of claustrophobia and disruptive patient motion, achieved by training facility staff in Comfort Talk®.
Comfort Talk® training consists of a proprietary, standardized R3 Process of Rapport, Relaxation, and Reframing including 2 x 8-hrs class-room interaction, onsite coaching, and institution-specific web-based support to help the MRI team to further develop its own language style and skill set.
The effect of Comfort Talk® training will be quantified in a prospective randomized design at 12 MRI satellites of the Ohio State University Medical Center and Duke University Medical Center. Return of investment of training will be based on a decision-analysis model with focus on number of scans performed, cancellations from no-shows and refusals; patients unable to start or complete a scan; and sedation rates in relation to capacity, cost, and reimbursement schedule. Patient satisfaction scores will be compared using Press Ganey national benchmark percentile rankings and CMS quality standards.
- Being tested
- Comfort Talk® Training
- Keywords
- Magnetic Resonance Imaging, Patient satisfaction, Diagnostic Imaging
- Medical subject headings
- Claustrophobia, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comfort Talk® TrainingBehavioural
Also called Self-hypnotic relaxation, Nonpharmacologic analgesia, Nonpharmacologic anxiolysis, Patient sedation without medication
Personnel of MRI units is trained in advanced rapport skills, patient-centered and hypnoidal language, correct use of suggestions and skills of tension diffusion. This entails 16 hrs classroom work, additional on-site post-training support, and access to a post-training support web module resulting in at least 20 hrs training.
| Study group | Role | What they receive |
|---|---|---|
| Comfort Talk® Training | Experimental | In the experimental group, MRI personnel is trained to use Comfort Talk® to help patients who are claustrophobic, anxious, and/or cannot lie still to complete their tests at the onset of the MRI scan. Receives: Behavioral: Comfort Talk® Training |
| Control | No intervention | MRI sites not trained in Comfort Talk®. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Equipment Utilization Q4FY15 = Baseline Quarter (OSU)
Quarterly completion rate of MRIs as a proportion of scans completed per given number of imaging slots available
Measured: 1 quarter
Equipment Utilization in Q1FY16 (OSU)
Quarterly completion rate of MRIs as a proportion of scans completed per given number of imaging slots available
Measured: 1 quarter
Equipment Utilization in Q2FY16 (OSU)
Quarterly completion rate of MRIs as a proportion of scans completed per given number of imaging slots available
Measured: 1 quarter
Equipment Utilization in Q3FY16 (OSU)
Quarterly completion rate of MRIs as a proportion of scans completed per given number of imaging slots available
Measured: 1 quarter
Equipment Utilization Over All Quarters (OSU)
Completion rates of MRIs as a proportion of scans completed per given number of imaging slots available
Measured: 4 quarters
Incompletions (Duke)
Patients who cannot complete their scan
Measured: 9 months (3 months baseline, 6 months post training)
Secondary outcomes (14)
No-shows in Q4FY15 = Baseline Quarter (OSU)
Quarterly number of scheduled patients who do not show up for their appointments
Measured: 1 quarter
No-shows in Q1FY16 (OSU)
Quarterly number of scheduled patients who do not show up for their appointments
Measured: 1 quarter
No-shows in Q2FY16 (OSU)
Quarterly number of scheduled patients who do not show up for their appointments
Measured: 1 quarter
No-shows in Q3FY16 (OSU)
Quarterly number of scheduled patients who do not show up for their appointments
Measured: 1 quarter
Trend of No-shows Over All Quarters (OSU)
Quarterly number of scheduled patients who do not show up for their appointments
Measured: 4 quarters
Patient Satisfaction Ranking in Q4FY15 = Baseline Quarter (OSU)
Quarterly percentile rankings of patients' "Overall Assesment" of their satisfaction on a national clinical survey instrument (Press Ganey). Percentile rankings are benchmarked on 1,028 MRI sites nationally, given in raw scores between 0 (worst) to 100 (best). The percentile rankings are based on the number of participants returning surveys in each group.
Measured: 1 quarter
Patient Satisfaction in Q1FY16 (OSU)
Quarterly percentile rankings of patients' "Overall Assesment" of their satisfaction on a national clinical survey instrument (Press Ganey). Percentile rankings are benchmarked on 1,028 MRI sites nationally, given in raw scores between 0 (worst) to 100 (best). The percentile rankings are based on the number of participants returning surveys in each group.
Measured: 1 quarter
Patient Satisfaction Ranking in Q2FY16 (OSU)
Quarterly percentile rankings of patients' "Overall Assesment" of their satisfaction on a national clinical survey instrument (Press Ganey). Percentile rankings are benchmarked on 1,028 MRI sites nationally, given in raw scores between 0 (worst) to 100 (best). The percentile rankings are based on the number of participants returning surveys in each group.
Measured: 1 quarter
Patient Satisfaction Ranking in Q3FY16 (OSU)
Quarterly percentile rankings of patients' "Overall Assesment" of their satisfaction on a national clinical survey instrument (Press Ganey). Percentile rankings are benchmarked on 1,028 MRI sites nationally, given in raw scores between 0 (worst) to 100 (best). The percentile rankings are based on the number of participants returning surveys in each group.
Measured: 1 quarter
Oral Sedation Rate (Duke)
Patients who receive medical sedation on site
Measured: 9 months (3 months baseline, 6 months post training)
IV Sedation Rate (Duke)
Number of patients who receive intravenous (IV) sedation on site
Measured: 9 months (3 months baseline, 6 months post training)
General Anesthesia Rate (Duke)
Number of patients who receive general anesthesia on site
Measured: 9 months (3 months baseline, 6 months post training)
Disruptive Motion (Duke)
Patients on site who disrupt the scan by motion
Measured: 9 months (3 months baseline, 6 months post training)
No-shows (Duke)
Scheduled patients who do not show for their MRI examinations.
Measured: 9 months (3 months baseline, 6 months post training)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2015 (estimated)
- Study startApr 2015
- Primary completion31 Jul 2017
- Study completion31 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for ClaustrophobiaStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The original model was to have parallel randomized MRI sites. This was possible at one participating institution, The Ohio State Universty Medical Center (OSU). For the second institution (Duke University) staff cuts resulted in personnel cross-over between test and control sites making randomization impossible. Therefore a sequential model was used compared data from the pre- to post training period for the Duke sites. In total 12 MRI entities contributed, six at OSU, and six at Duke. Also, Duke and OSU turned out to have different modes of data collection. OSU had fully automated capture of patients scheduled, showing, and completing their examination as well as a priori numbers of available imaging slots per time unit. Duke did not collect these data electronically so that personnel could only gather the pertinent measures by daily manual diary entry. Thus the mode of result presentation is not concordant in some aspects among sites.
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hypnalgesics, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ohio State University, Duke University
- Responsible party
- Principal investigator, Elvira V. Lang, MD, Hypnalgesics, LLC
- Investigators
- Elvira V Lang, MD, Principal investigator, Hypnalgesics, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02427737
- Sponsor's protocol ID
- 2CTOSUD2015
- Acronym
- ComfortTalk®
- Status last verified
- Aug 2019
- First submitted
- 20 Apr 2015
- Last updated
- 12 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Lang EV, Ward C, Laser E. Effect of team training on patients' ability to complete MRI examinations. Acad Radiol. 2010 Jan;17(1):18-23. doi: 10.1016/j.acra.2009.07.002. Epub 2009 Sep 5.
PubMed 19734060Lang EV, Yuh WT, Ajam A, Kelly R, Macadam L, Potts R, Mayr NA. Understanding patient satisfaction ratings for radiology services. AJR Am J Roentgenol. 2013 Dec;201(6):1190-5; quiz 1196. doi: 10.2214/AJR.13.11281.
PubMed 24261356Lang EV. A Better Patient Experience Through Better Communication. J Radiol Nurs. 2012 Dec 1;31(4):114-119. doi: 10.1016/j.jradnu.2012.08.001.
PubMed 23471099Flory N, Lang EV. Distress in the radiology waiting room. Radiology. 2011 Jul;260(1):166-73. doi: 10.1148/radiol.11102211. Epub 2011 Apr 7.
PubMed 21474702Lang EV, Hatsiopoulou O, Koch T, Berbaum K, Lutgendorf S, Kettenmann E, Logan H, Kaptchuk TJ. Can words hurt? Patient-provider interactions during invasive procedures. Pain. 2005 Mar;114(1-2):303-9. doi: 10.1016/j.pain.2004.12.028. Epub 2005 Jan 26.
PubMed 15733657Lang EV, Rosen MP. Cost analysis of adjunct hypnosis with sedation during outpatient interventional radiologic procedures. Radiology. 2002 Feb;222(2):375-82. doi: 10.1148/radiol.2222010528.
PubMed 11818602Lang EV, Benotsch EG, Fick LJ, Lutgendorf S, Berbaum ML, Berbaum KS, Logan H, Spiegel D. Adjunctive non-pharmacological analgesia for invasive medical procedures: a randomised trial. Lancet. 2000 Apr 29;355(9214):1486-90. doi: 10.1016/S0140-6736(00)02162-0.
PubMed 10801169Norbash A, Yucel K, Yuh W, Doros G, Ajam A, Lang E, Pauker S, Mayr N. Effect of team training on improving MRI study completion rates and no-show rates. J Magn Reson Imaging. 2016 Oct;44(4):1040-7. doi: 10.1002/jmri.25219. Epub 2016 Apr 6.
PubMed 27126735Ajam AA, Nguyen XV, Kelly RA, Ladapo JA, Lang EV. Effects of Interpersonal Skills Training on MRI Operations in a Saturated Market: A Randomized Trial. J Am Coll Radiol. 2017 Jul;14(7):963-970. doi: 10.1016/j.jacr.2017.03.015. Epub 2017 Apr 28.
PubMed 28461168Ladapo JA, Spritzer CE, Nguyen XV, Pool J, Lang E. Economics of MRI Operations After Implementation of Interpersonal Skills Training. J Am Coll Radiol. 2018 Dec;15(12):1775-1783. doi: 10.1016/j.jacr.2018.01.017. Epub 2018 Mar 9.
PubMed 29530323
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amelioration of Claustrophobia and Disruptive Patient Motion in MRI Imaging (Phase 2 Randomized Training of Sites)
- ClinicalTrials.gov ID
- NCT02427737
- Acronym / sponsor ID
- ComfortTalk® / 2CTOSUD2015
- Keywords
- Magnetic Resonance Imaging, Patient satisfaction, Diagnostic Imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Hypnalgesics, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Ohio State University, Duke University
- Study start
- Apr 2015
- Primary completion
- 31 Jul 2017 (actual)
- Study completion
- 31 Jul 2017 (actual)
- First posted
- 28 Apr 2015 (estimated)
- Results
- Posted 12 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Annually, an estimated 700,000 patients do not complete their scheduled MRI scans because of claustrophobia or inability to hold still. Training staffs working in MRI facilities to provide Comfort Talk® will enable patients to complete high quality imaging without medication, which will increase satisfaction and comfort while reducing sedation risks for patients, and increase efficiency and reduce loss of revenue for facilities. The effect of such training will be tested at 12 MRI sites in a randomized design. Outcome data will be collected for one year.
Detailed description
Claustrophobia and disruptive patient motion are common impediments to MRI examination, but they may be prevented or ameliorated with a non-pharmacologic behavioral intervention administered by trained staff. The potential benefits of such an intervention are highly significant, considering that the alternatives are to cancel the study or administer sedation. Inability to complete their MRI scans adversely affects an estimated 700,000 patients every year in the US. These patients are either deprived of a diagnosis, subject to diagnostic delays and interpretation errors due to motion artifact, or are exposed to risks of pharmacologic sedation, including death. The imaging facilities typically cannot fill the suddenly vacated examination slots in time before the next scheduled patient and incur considerable lost revenue and efficiency. A negative patient experience further jeopardizes Value-Based reimbursement by the Centers for Medicare and Medicaid Services (CMS) towards which patient satisfaction counts 30%. The long term goal is to provide a validated, clinically feasible means for non-pharmacologic amelioration of claustrophobia and disruptive patient motion, achieved by training facility staff in Comfort Talk®.
Comfort Talk® training consists of a proprietary, standardized R3 Process of Rapport, Relaxation, and Reframing including 2 x 8-hrs class-room interaction, onsite coaching, and institution-specific web-based support to help the MRI team to further develop its own language style and skill set.
The effect of Comfort Talk® training will be quantified in a prospective randomized design at 12 MRI satellites of the Ohio State University Medical Center and Duke University Medical Center. Return of investment of training will be based on a decision-analysis model with focus on number of scans performed, cancellations from no-shows and refusals; patients unable to start or complete a scan; and sedation rates in relation to capacity, cost, and reimbursement schedule. Patient satisfaction scores will be compared using Press Ganey national benchmark percentile rankings and CMS quality standards.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The original model was to have parallel randomized MRI sites. This was possible at one participating institution, The Ohio State Universty Medical Center (OSU). For the second institution (Duke University) staff cuts resulted in personnel cross-over between test and control sites making randomization impossible. Therefore a sequential model was used compared data from the pre- to post training period for the Duke sites. In total 12 MRI entities contributed, six at OSU, and six at Duke. Also, Duke and OSU turned out to have different modes of data collection. OSU had fully automated capture of patients scheduled, showing, and completing their examination as well as a priori numbers of available imaging slots per time unit. Duke did not collect these data electronically so that personnel could only gather the pertinent measures by daily manual diary entry. Thus the mode of result presentation is not concordant in some aspects among sites.
| Arm | Type | Receives |
|---|---|---|
| Comfort Talk® Training | Experimental | Behavioral: Comfort Talk® TrainingIn the experimental group, MRI personnel is trained to use Comfort Talk® to help patients who are claustrophobic, anxious, and/or cannot lie still to complete their tests at the onset of the MRI scan. |
| Control | No intervention | –MRI sites not trained in Comfort Talk®. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Must routinely perform MRI examinations
- Must capture data on noncompletion of MRI scans
Key exclusion criteria (2 listed)
- No dedicated MRI unit
- Unable to reliably capture data on noncompletion of MRI scans
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 |
|---|---|---|
| Comfort Talk® TrainingAlso: Self-hypnotic relaxation, Nonpharmacologic analgesia, Nonpharmacologic anxiolysis, Patient sedation without medicationPersonnel of MRI units is trained in advanced rapport skills, patient-centered and hypnoidal language, correct use of suggestions and skills of tension diffusion. This entails 16 hrs classroom work, additional on-site post-training support, and access to a post-training support web module resulting in at least 20 hrs training. | Behavioural | Comfort Talk® Training |
Primary outcome
Equipment Utilization Q4FY15 = Baseline Quarter (OSU)
Time frame: 1 quarter
Quarterly completion rate of MRIs as a proportion of scans completed per given number of imaging slots available
Equipment Utilization in Q1FY16 (OSU)
Time frame: 1 quarter
Quarterly completion rate of MRIs as a proportion of scans completed per given number of imaging slots available
Equipment Utilization in Q2FY16 (OSU)
Time frame: 1 quarter
Quarterly completion rate of MRIs as a proportion of scans completed per given number of imaging slots available
Equipment Utilization in Q3FY16 (OSU)
Time frame: 1 quarter
Quarterly completion rate of MRIs as a proportion of scans completed per given number of imaging slots available
Equipment Utilization Over All Quarters (OSU)
Time frame: 4 quarters
Completion rates of MRIs as a proportion of scans completed per given number of imaging slots available
Incompletions (Duke)
Time frame: 9 months (3 months baseline, 6 months post training)
Patients who cannot complete their scan
14 secondary outcomes
No-shows in Q4FY15 = Baseline Quarter (OSU)
Time frame: 1 quarter
No-shows in Q1FY16 (OSU)
Time frame: 1 quarter
No-shows in Q2FY16 (OSU)
Time frame: 1 quarter
No-shows in Q3FY16 (OSU)
Time frame: 1 quarter
Trend of No-shows Over All Quarters (OSU)
Time frame: 4 quarters
Patient Satisfaction Ranking in Q4FY15 = Baseline Quarter (OSU)
Time frame: 1 quarter
Patient Satisfaction in Q1FY16 (OSU)
Time frame: 1 quarter
Patient Satisfaction Ranking in Q2FY16 (OSU)
Time frame: 1 quarter
Patient Satisfaction Ranking in Q3FY16 (OSU)
Time frame: 1 quarter
Oral Sedation Rate (Duke)
Time frame: 9 months (3 months baseline, 6 months post training)
IV Sedation Rate (Duke)
Time frame: 9 months (3 months baseline, 6 months post training)
General Anesthesia Rate (Duke)
Time frame: 9 months (3 months baseline, 6 months post training)
Disruptive Motion (Duke)
Time frame: 9 months (3 months baseline, 6 months post training)
No-shows (Duke)
Time frame: 9 months (3 months baseline, 6 months post training)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19734060Lang EV, Ward C, Laser E. Effect of team training on patients' ability to complete MRI examinations. Acad Radiol. 2010 Jan;17(1):18-23. doi: 10.1016/j.acra.2009.07.002. Epub 2009 Sep 5.
- Background: PubMed 24261356Lang EV, Yuh WT, Ajam A, Kelly R, Macadam L, Potts R, Mayr NA. Understanding patient satisfaction ratings for radiology services. AJR Am J Roentgenol. 2013 Dec;201(6):1190-5; quiz 1196. doi: 10.2214/AJR.13.11281.
- Background: PubMed 23471099Lang EV. A Better Patient Experience Through Better Communication. J Radiol Nurs. 2012 Dec 1;31(4):114-119. doi: 10.1016/j.jradnu.2012.08.001.
- Background: PubMed 21474702Flory N, Lang EV. Distress in the radiology waiting room. Radiology. 2011 Jul;260(1):166-73. doi: 10.1148/radiol.11102211. Epub 2011 Apr 7.
- Background: PubMed 15733657Lang EV, Hatsiopoulou O, Koch T, Berbaum K, Lutgendorf S, Kettenmann E, Logan H, Kaptchuk TJ. Can words hurt? Patient-provider interactions during invasive procedures. Pain. 2005 Mar;114(1-2):303-9. doi: 10.1016/j.pain.2004.12.028. Epub 2005 Jan 26.
- Background: PubMed 11818602Lang EV, Rosen MP. Cost analysis of adjunct hypnosis with sedation during outpatient interventional radiologic procedures. Radiology. 2002 Feb;222(2):375-82. doi: 10.1148/radiol.2222010528.
- Background: PubMed 10801169Lang EV, Benotsch EG, Fick LJ, Lutgendorf S, Berbaum ML, Berbaum KS, Logan H, Spiegel D. Adjunctive non-pharmacological analgesia for invasive medical procedures: a randomised trial. Lancet. 2000 Apr 29;355(9214):1486-90. doi: 10.1016/S0140-6736(00)02162-0.
- Background: PubMed 27126735Norbash A, Yucel K, Yuh W, Doros G, Ajam A, Lang E, Pauker S, Mayr N. Effect of team training on improving MRI study completion rates and no-show rates. J Magn Reson Imaging. 2016 Oct;44(4):1040-7. doi: 10.1002/jmri.25219. Epub 2016 Apr 6.
- Results publication: PubMed 28461168Ajam AA, Nguyen XV, Kelly RA, Ladapo JA, Lang EV. Effects of Interpersonal Skills Training on MRI Operations in a Saturated Market: A Randomized Trial. J Am Coll Radiol. 2017 Jul;14(7):963-970. doi: 10.1016/j.jacr.2017.03.015. Epub 2017 Apr 28.
- Results publication: PubMed 29530323Ladapo JA, Spritzer CE, Nguyen XV, Pool J, Lang E. Economics of MRI Operations After Implementation of Interpersonal Skills Training. J Am Coll Radiol. 2018 Dec;15(12):1775-1783. doi: 10.1016/j.jacr.2018.01.017. Epub 2018 Mar 9.
- 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.
Elvira V Lang, MD principal investigator
Hypnalgesics, LLC
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comfort Talk® Training in people with Claustrophobia and Complication of Diagnostic Procedure, run by Hypnalgesics, LLC at 3 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 2 inclusion and 2 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 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Yes. Results are posted in the registry (first posted 12 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Equipment Utilization Q4FY15 = Baseline Quarter (OSU) (time frame: 1 quarter). The study lists 6 primary outcomes in all. 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 NCT02427737, which also lists 10 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 Sep 2019.