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| Name | Class |
|---|---|
| Tufts Medical Center | OTHER |
| Boston Medical Center | OTHER |
| Ohio State University | OTHER |
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Annually, an estimated 700,000 patients do not complete their scheduled MRI scans because of claustrophobia or inability to hold still. Training staff working in MRI facilities to provide Comfort Talk® promises to enable patients to complete and obtain high quality imaging without medication, which will increase comfort and reduce sedation risks for the patients, and increase efficiency and reduce loss of revenue for the facilities.
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, or are exposed to risks of pharmacologic sedation, including death. The imaging facilities in turn, typically cannot fill the suddenly vacated examination slots in time before the next scheduled patient and thus incur considerable lost revenue and efficiency. 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 MRI staff to use advanced rapport skills and comforting language to help patients. Phase I will design and perform a formative evaluation of a Comfort Talk® Training intervention so that definitive testing of the hypothesized benefits for the intervention can be accomplished in Phase II.
In Specific Aim 1 the Comfort TalkTM intervention sequence will be designed to include training in advanced rapport skills, using basic comforting language and avoiding negative language for all facility staff (including receptionists, technologists, nurses, and physicians). A core of licensed healthcare professionals will be taught how to guide patients in self-hypnotic relaxation techniques, using scripts, found to be safe and effective in the radiology department. Techniques are designed to easily integrate into the normal workflow without adding time. Training will include 2x8 hrs live at three test sites. Acceptance, observation of staff behavior, qualitative feedback, and rates of noncompletion will be used to assess efficacy of training, guide prototype development, and develop train-the-trainer materials. Using in-market piloting techniques, niche applications with their metrics will be explored to develop situation-specific supplemental materials. In Aim 2 an interactive web-based electronic platform will be developed to supplement training and provide post-training support. It will provide scenarios and practice applications, guided dialogue options, functions for online live interactive classes, and interface with smartphones. The prototype will be beta-tested with 20 experts in hypnosis and refined through user input from the test sites. Aim 3 is to conduct a formative evaluation of the entire Comfort Talk® intervention. Effects will be evaluated in 3-months intervals and compared to baseline performance. Criteria will include acceptance, qualitative feedback, content mastery, staff behavior, rates of noncompletion, patient recall and satisfaction. Additional metrics identified through in-market exploration will be analyzed for their potential as economic drivers and evaluation instruments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Comfort Talk® Training | Experimental | The MRI units of three clinical sites form the group. Their personnel will be trained to use Comfort Talk® to help patients who are claustrophobic, anxious, and/or cannot lie still to complete their tests |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comfort Talk® | Behavioral | Personnel of MRI units will be trained in advanced rapport skills, patient-centered and hypnoidal language, correct use of suggestions and skills of tension diffusion. This will entail 16 hrs class room work, additional on-site post-training support, and access to a post-training support web module resulting in at least 20 hrs training. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Non-completion Rate of MRI Scans From the Average of the Baseline Year to the Average of One Year Post Training (All Scheduled Patients) | The sites will be followed for an average of one year after training in Comfort Talk and non-completion rates will be compared to the baseline values of non-completion among all scheduled patients. | Baseline average of one year plus post training average one year = 2 years |
| Change in Non-completion Rate of MRI Scans From the Average of the Baseline Year to the Average of One Year Post Training (Showing-Up Patients Only) | The change in non-completion rate of MRI scans, obtained for the year prior to Comfort Talk® training at baseline, to the average one year post training was assessed | Baseline average of one year plus post training average one year = 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Change in No-Show Rates of Patients From the Average of the Baseline Year to the Average of One Year Post Training | The sites will be followed for an average of one year after training in Comfort Talk and no-show rates will be compared to the baseline values of non-completion among all scheduled patients which were also collected over 1 year. | Baseline average of one year plus post training average one year = 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elvira V Lang, MD | Hypnalgesics, LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States | ||
| Boston Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19734060 | Background | 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. | |
| 10801169 | Background | Lang 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. |
| Label | URL |
|---|---|
| Explanation of Comfort TalkTM and access to Post-Training Support Module | View source |
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Different participants were assessed at baseline and after training.
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| ID | Title | Description |
|---|---|---|
| FG000 | Comfort TalkTM Training | The MRI units of three clinical sites form the group. Their personnel will be trained to use Comfort TalkTm to help patients who are claustrophobic, anxious, and/or cannot lie still to complete their tests Comfort Talk: Personnel of MRI units will be trained in advanced rapport skills, patient-centered and hypnoidal language, correct use of suggestions and skills of tension diffusion. This will entail 16 hrs class room work, additional on-site post-training support, and access to a post-training support web module resulting in at least 20 hrs training. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline |
| |||||||||||||
| After Training |
|
We obtained cumulative data from patients completion rates, thus no individual patient data on age, gender, ethnicity are available. MR departments per se do not have personal characteristics.
| ID | Title | Description |
|---|---|---|
| BG000 | Comfort Talk® Training | The MRI units of three clinical sites form the group. Their personnel will be trained to use Comfort TalkTm to help patients who are claustrophobic, anxious, and/or cannot lie still to complete their tests Comfort Talk: Personnel of MRI units will be trained in advanced rapport skills, patient-centered and hypnoidal language, correct use of suggestions and skills of tension diffusion. This will entail 16 hrs class room work, additional on-site post-training support, and access to a post-training support web module resulting in at least 20 hrs training. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Measure Analysis Population Description: We obtained cumulative data from patients' show-up and completion rates, thus no individual patient data on age, gender, ethnicity are available. MR departments per se do not have personal characteristics. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Non-completion Rate of MRI Scans From the Average of the Baseline Year to the Average of One Year Post Training (All Scheduled Patients) | The sites will be followed for an average of one year after training in Comfort Talk and non-completion rates will be compared to the baseline values of non-completion among all scheduled patients. | Participants were from MRI 3 sites whose teams were trained in Comfort Talk®. In this analysis all patients who were scheduled for scans during the baseline year and the year after training were included | Posted | Number | Percentage of participants | Baseline average of one year plus post training average one year = 2 years |
|
One year starting with the training
Adverse events were monitored during the training days of the MRI teams. Then assessment was non-systematic in that we would have reported adverse events if they had become known or being collected after training. Patients at risk were only those in the post-training period who showed up at the facility including those who completed their scans and also those who did not.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Comfort TalkTM Training | The MRI units of three clinical sites form the group. Their personnel will be trained to use Comfort TalkTm to help patients who are claustrophobic, anxious, and/or cannot lie still to complete their tests Comfort Talk: Personnel of MRI units will be trained in advanced rapport skills, patient-centered and hypnoidal language, correct use of suggestions and skills of tension diffusion. This will entail 16 hrs class room work, additional on-site post-training support, and access to a post-training support web module resulting in at least 20 hrs training. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elvira V. Lang, MD (PI of SBIR grant) | Hypnalgesics, LLC d/b/a Comfort Talk | 617 734 9087 | drevlang@gmail.com |
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| ID | Term |
|---|---|
| D000098452 | Claustrophobia |
| ID | Term |
|---|---|
| D010698 | Phobic Disorders |
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
| D013678 | Technology, Pharmaceutical |
| D008919 | Investigative Techniques |
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|
|
| Boston |
| Massachusetts |
| 02118 |
| United States |
| Hypnalgesics, LLC | Brookline | Massachusetts | 02446 | United States |
| Ohio State University Medical Center | Columbus | Ohio | 43210 | United States |
| 27126735 | Result | Norbash 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. |
| 24261356 | Result | Lang 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. |
| Sponsor website and background information; description of techniques used | View source |
| MRI sites |
|
| Count of Participants |
| Participants |
| Participants |
|
|
| Sex: Female, Male | Measure Analysis Population Description: We obtained cumulative data from patients' show-up and completion rates, thus no individual patient data on age, gender, ethnicity are available. MR departments per se do not have personal characteristics. | Count of Participants | Participants | Participants |
|
|
| Race (NIH/OMB) | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants | Participants |
|
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| No-show rate | Number | Percentage of participants | Participants |
|
|
| Non-completion rate of showing-up patients | Participants were from 3 MRI sites whose teams were trained in Comfort Talk®. In this analysis only patients who showed up at the MRI sites at baseline were included (all participants - no-shows). | Number | Percentage of all showing-up patients | Participants |
|
|
| Non-completion rate of all scheduled patients | Participants were from 3 MRI sites whose teams were trained in Comfort Talk®. In this analysis all patients scheduled for an MRI at baseline were included as denominator. | Number | Percentage of all scheduled participants | Participants |
|
|
|
|
|
| Primary | Change in Non-completion Rate of MRI Scans From the Average of the Baseline Year to the Average of One Year Post Training (Showing-Up Patients Only) | The change in non-completion rate of MRI scans, obtained for the year prior to Comfort Talk® training at baseline, to the average one year post training was assessed | Participants were from 3 MRI sites whose teams were trained in Comfort Talk®. In this analysis only patients who showed up at the MRI sites at baseline year and the year after training were included (all participants minus no-shows). | Posted | Number | Percentage of showing-up participants | Baseline average of one year plus post training average one year = 2 years |
|
|
|
|
| Secondary | Change in No-Show Rates of Patients From the Average of the Baseline Year to the Average of One Year Post Training | The sites will be followed for an average of one year after training in Comfort Talk and no-show rates will be compared to the baseline values of non-completion among all scheduled patients which were also collected over 1 year. | Participants were from MRI 3 sites whose teams were trained in Comfort Talk®. In this analysis all patients who were scheduled for scans during the baseline year and the year after training were included. | Posted | Number | Percentage of participants | Baseline average of one year plus post training average one year = 2 years |
|
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| 0 |
| 43,816 |
| 0 |
| 43,816 |
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