Claustrophobia, Complication of Diagnostic Procedure
Conditions
Keywords
MRI departments and facilities, Noncompletion of MRI
Brief summary
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.
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, 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.
Interventions
BEHAVIORALComfort 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.
Sponsors
Tufts Medical Center
Boston Medical Center
Ohio State University
Hypnalgesics, LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Facilities performing MRI examinations * Facilities capturing data on noncompletion of MRI scans * Facilities willing to have their personnel trained * Facilities with personnel interested and willing to be trained * Facilities able to obtain IRB review
Exclusion criteria
* Facilities not performing MRI examinations * Facilities not capturing data on noncompletion of MRI scans * Facilities not willing to have their personnel trained * Facilities unable to obtain IRB review
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | Baseline average of one year plus post training average one year = 2 years | 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. |
| 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) | Baseline average of one year plus post training average one year = 2 years | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in No-Show Rates of Patients From the Average of the Baseline Year to the Average of One Year Post Training | Baseline average of one year plus post training average one year = 2 years | 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. |
Countries
United States
Participant flow
Pre-assignment details
Different participants were assessed at baseline and after training.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 49,733 |
| 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. | 3 |
| Total | 49,736 |
Baseline characteristics
| Characteristic | Comfort Talk® Training |
|---|---|
| Non-completion rate of all scheduled patients | 13.3 Percentage of all scheduled participants |
| Non-completion rate of showing-up patients | 2.3 Percentage of all showing-up patients |
| No-show rate | 11.2 Percentage of participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 43,816 |
| serious Total, serious adverse events | 0 / 43,816 |
Outcome results
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.
Time frame: Baseline average of one year plus post training average one year = 2 years
Population: 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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Comfort TalkTM Training | 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) | Non-completion Rate after Training | 10 Percentage of participants |
| Comfort TalkTM Training | 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) | Change from Baseline | -3.3 Percentage of participants |
Comparison: Change in Non-completion Rate of MRI Scans From Baseline at Average of One Year (All Schedule Patients)p-value: <0.0001Chi-squared
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
Time frame: Baseline average of one year plus post training average one year = 2 years
Population: 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).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Comfort TalkTM Training | 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) | Non-Completion Rate after Training | 1.4 Percentage of showing-up participants |
| Comfort TalkTM Training | 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) | Change from Baseline | -0.9 Percentage of showing-up participants |
p-value: <0.0001Chi-squared
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.
Time frame: Baseline average of one year plus post training average one year = 2 years
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Comfort TalkTM Training | Change in No-Show Rates of Patients From the Average of the Baseline Year to the Average of One Year Post Training | No-Show Rate After Training | 8.7 Percentage of participants |
| Comfort TalkTM Training | Change in No-Show Rates of Patients From the Average of the Baseline Year to the Average of One Year Post Training | Change From Baseline | -2.5 Percentage of participants |
p-value: <0.0001Chi-squared