Claustrophobia, Complication of Diagnostic Procedure
Conditions
Keywords
Magnetic Resonance Imaging, Patient satisfaction, Diagnostic Imaging
Brief 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 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.
Interventions
BEHAVIORALComfort Talk® Training
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.
Sponsors
Ohio State University
Duke University
Hypnalgesics, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Must routinely perform MRI examinations * Must capture data on noncompletion of MRI scans
Exclusion criteria
* No dedicated MRI unit * Unable to reliably capture data on noncompletion of MRI scans
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Equipment Utilization Q4FY15 = Baseline Quarter (OSU) | 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) | 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) | 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) | 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) | 4 quarters | Completion rates of MRIs as a proportion of scans completed per given number of imaging slots available |
| Incompletions (Duke) | 9 months (3 months baseline, 6 months post training) | Patients who cannot complete their scan |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction in Q1FY16 (OSU) | 1 quarter | 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. |
| Patient Satisfaction Ranking in Q2FY16 (OSU) | 1 quarter | 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. |
| Patient Satisfaction Ranking in Q3FY16 (OSU) | 1 quarter | 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. |
| Oral Sedation Rate (Duke) | 9 months (3 months baseline, 6 months post training) | Patients who receive medical sedation on site |
| No-shows in Q3FY16 (OSU) | 1 quarter | Quarterly number of scheduled patients who do not show up for their appointments |
| General Anesthesia Rate (Duke) | 9 months (3 months baseline, 6 months post training) | Number of patients who receive general anesthesia on site |
| Disruptive Motion (Duke) | 9 months (3 months baseline, 6 months post training) | Patients on site who disrupt the scan by motion |
| No-shows (Duke) | 9 months (3 months baseline, 6 months post training) | Scheduled patients who do not show for their MRI examinations. |
| IV Sedation Rate (Duke) | 9 months (3 months baseline, 6 months post training) | Number of patients who receive intravenous (IV) sedation on site |
| No-shows in Q4FY15 = Baseline Quarter (OSU) | 1 quarter | Quarterly number of scheduled patients who do not show up for their appointments |
| No-shows in Q1FY16 (OSU) | 1 quarter | Quarterly number of scheduled patients who do not show up for their appointments |
| No-shows in Q2FY16 (OSU) | 1 quarter | Quarterly number of scheduled patients who do not show up for their appointments |
| Trend of No-shows Over All Quarters (OSU) | 4 quarters | Quarterly number of scheduled patients who do not show up for their appointments |
| Patient Satisfaction Ranking in Q4FY15 = Baseline Quarter (OSU) | 1 quarter | 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. |
Countries
United States
Participant flow
Recruitment details
At OSUMC randomization was maintained (3 trained, 3 control sites). At Duke University considerable staff cuts at the onset of the trial resulted in extensive staff rotations making maintenance of randomization impossible. Thus a pre-post training comparison for the 6 sites was done (pre-training baseline = control, post-training = training arm)
Pre-assignment details
Different participants were assessed at baseline and at each period after training. Clinical sites, not participants, were enrolled in the study. Note that participants refers to all patients scheduled to be examined on the available imaging slots, including patients who showed (completed) and those who were no-shows (not completed).
Participants by arm
| Arm | Count |
|---|---|
| Comfort Talk® Training OSU Three MRI clinical sites form the experimental group at OSU in a randomized assignment. Their personnel was 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 study.
Comfort Talk® Training: 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. | 0 |
| Comfort Talk® Training OSU Three MRI clinical sites form the experimental group at OSU in a randomized assignment. Their personnel was 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 study.
Comfort Talk® Training: 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. | 0 |
| Control OSU Three MRI sites at OSU were not trained in Comfort Talk®. | 0 |
| Control OSU Three MRI sites at OSU were not trained in Comfort Talk®. | 0 |
| Total | 0 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 11,650 | 0 / 8,605 | 0 / 4,446 | 0 / 9,658 |
| other Total, other adverse events | 0 / 11,650 | 0 / 8,605 | 0 / 4,446 | 0 / 9,658 |
| serious Total, serious adverse events | 0 / 11,650 | 0 / 8,605 | 0 / 4,446 | 0 / 9,658 |
Outcome results
Primary
Equipment Utilization in Q1FY16 (OSU)
Quarterly completion rate of MRIs as a proportion of scans completed per given number of imaging slots available
Time frame: 1 quarter
Population: Participants completing their scans
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Comfort Talk® Training | Equipment Utilization in Q1FY16 (OSU) | 0.832 Proportion of completed scans per slots |
| Control | Equipment Utilization in Q1FY16 (OSU) | 0.732 Proportion of completed scans per slots |
Comparison: Comparison among trained and untrained sitesp-value: <0.0001Chi-squared, Corrected
Comparison: Change in the average quarterly completion rate as compared to the baseline quarterp-value: 0.3037Chi-squared, Corrected
Comparison: Change in the average quarterly completion rate as compared to the baseline quarterp-value: <0.01Chi-squared, Corrected
Primary
Equipment Utilization in Q2FY16 (OSU)
Quarterly completion rate of MRIs as a proportion of scans completed per given number of imaging slots available
Time frame: 1 quarter
Population: Imaging slots available in the quarter
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Comfort Talk® Training | Equipment Utilization in Q2FY16 (OSU) | 0.839 Proportion of completed scans per slots |
| Control | Equipment Utilization in Q2FY16 (OSU) | 0.680 Proportion of completed scans per slots |
Comparison: Comparison among trained and untrained sitesp-value: <0.0001Chi-squared, Corrected
Comparison: Change in the average quarterly completion rate as compared to the baseline quarterp-value: 0.201Chi-squared
Comparison: Change in the average quarterly completion rate as compared to the baseline quarterp-value: <0.001Chi-squared
Primary
Equipment Utilization in Q3FY16 (OSU)
Quarterly completion rate of MRIs as a proportion of scans completed per given number of imaging slots available
Time frame: 1 quarter
Population: Imaging slots available in the quarter
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Comfort Talk® Training | Equipment Utilization in Q3FY16 (OSU) | 0.845 Proportion of completed scans per slots |
| Control | Equipment Utilization in Q3FY16 (OSU) | 0.647 Proportion of completed scans per slots |
Comparison: Comparison among trained and untrained sitesp-value: <0.0001Chi-squared
Comparison: Change in the quarterly equipment utilization rate as compared to the baseline quarter Q4FY15 over time and at sitesp-value: 0.303Chi-squared
Comparison: Change in the average quarterly completion rate as compared to the baseline quarterp-value: <0.001Chi-squared, Corrected
Primary
Equipment Utilization Over All Quarters (OSU)
Completion rates of MRIs as a proportion of scans completed per given number of imaging slots available
Time frame: 4 quarters
Population: Imaging slots available
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Comfort Talk® Training | Equipment Utilization Over All Quarters (OSU) | 0.836 Proportion of completed scans per slots |
| Control | Equipment Utilization Over All Quarters (OSU) | 0.705 Proportion of completed scans per slots |
p-value: <0.0001Chi-squared, Corrected
Primary
Equipment Utilization Q4FY15 = Baseline Quarter (OSU)
Quarterly completion rate of MRIs as a proportion of scans completed per given number of imaging slots available
Time frame: 1 quarter
Population: Imaging slots available in the quarter
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Comfort Talk® Training | Equipment Utilization Q4FY15 = Baseline Quarter (OSU) | 0.83 Proportion of completed scans per slots |
| Control | Equipment Utilization Q4FY15 = Baseline Quarter (OSU) | 0.77 Proportion of completed scans per slots |
Primary
Incompletions (Duke)
Patients who cannot complete their scan
Time frame: 9 months (3 months baseline, 6 months post training)
Population: Patients showing for their MRI scans
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Comfort Talk® Training | Incompletions (Duke) | 52 Participants |
| Control | Incompletions (Duke) | 27 Participants |
p-value: <0.0001Chi-squared
Secondary
Disruptive Motion (Duke)
Patients on site who disrupt the scan by motion
Time frame: 9 months (3 months baseline, 6 months post training)
Population: Patients showing for their MRI scans
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Comfort Talk® Training | Disruptive Motion (Duke) | 42 Participants |
| Control | Disruptive Motion (Duke) | 11 Participants |
p-value: <0.0001Chi-squared
Secondary
General Anesthesia Rate (Duke)
Number of patients who receive general anesthesia on site
Time frame: 9 months (3 months baseline, 6 months post training)
Population: Patients showing for their MRI scans
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Comfort Talk® Training | General Anesthesia Rate (Duke) | 29 Participants |
| Control | General Anesthesia Rate (Duke) | 55 Participants |
p-value: 0.5267Chi-squared
Secondary
IV Sedation Rate (Duke)
Number of patients who receive intravenous (IV) sedation on site
Time frame: 9 months (3 months baseline, 6 months post training)
Population: Patients showing for their MRI scans
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Comfort Talk® Training | IV Sedation Rate (Duke) | 103 Participants |
| Control | IV Sedation Rate (Duke) | 196 Participants |
p-value: 0.2396Chi-squared
Secondary
No-shows (Duke)
Scheduled patients who do not show for their MRI examinations.
Time frame: 9 months (3 months baseline, 6 months post training)
Population: Patients scheduled for MRI scans
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Comfort Talk® Training | No-shows (Duke) | 395 Participants |
| Control | No-shows (Duke) | 779 Participants |
p-value: <0.0001Chi-squared
Secondary
No-shows in Q1FY16 (OSU)
Quarterly number of scheduled patients who do not show up for their appointments
Time frame: 1 quarter
Population: Patients scheduled for MRI
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Comfort Talk® Training | No-shows in Q1FY16 (OSU) | 215 Participants |
| Control | No-shows in Q1FY16 (OSU) | 214 Participants |
Comparison: Comparison among trained and untrained sitesp-value: 0.2357Chi-squared, Corrected
Comparison: Change in the quarterly no-shows as compared to the baseline quarterp-value: 0.8523Chi-squared
Comparison: Change in the quarterly average no-show rate as compared to the baseline quarter at untrained sitesp-value: 0.5883Chi-squared
Secondary
No-shows in Q2FY16 (OSU)
Quarterly number of scheduled patients who do not show up for their appointments
Time frame: 1 quarter
Population: Patients scheduled for MRI
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Comfort Talk® Training | No-shows in Q2FY16 (OSU) | 214 Participants |
| Control | No-shows in Q2FY16 (OSU) | 213 Participants |
Comparison: Change in the quarterly no-shows compared to the baseline quarterp-value: 0.276Chi-squared
Comparison: Comparison among trained and untrained sitesp-value: 0.0195Chi-squared, Corrected
Comparison: Change in the quarterly no-shows as compared to the baseline quarter at untrained sitesp-value: 0.2764Chi-squared
Secondary
No-shows in Q3FY16 (OSU)
Quarterly number of scheduled patients who do not show up for their appointments
Time frame: 1 quarter
Population: Patients scheduled for MRI
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Comfort Talk® Training | No-shows in Q3FY16 (OSU) | 220 Participants |
| Control | No-shows in Q3FY16 (OSU) | 215 Participants |
Comparison: Comparison among trained and untrained sitesp-value: <0.01Chi-squared, Corrected
Comparison: Change in the quarterly average no show rate as compared to the baseline quarter for trained sitesp-value: 0.9012Chi-squared
Comparison: Change in the quarterly average no-show rate as compared to the baseline quarter for untrained sitesp-value: 0.9065Chi-squared, Corrected
Secondary
No-shows in Q4FY15 = Baseline Quarter (OSU)
Quarterly number of scheduled patients who do not show up for their appointments
Time frame: 1 quarter
Population: Scheduled patients
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Comfort Talk® Training | No-shows in Q4FY15 = Baseline Quarter (OSU) | 218 Participants |
| Control | No-shows in Q4FY15 = Baseline Quarter (OSU) | 216 Participants |
Secondary
Oral Sedation Rate (Duke)
Patients who receive medical sedation on site
Time frame: 9 months (3 months baseline, 6 months post training)
Population: Patients showing for their MRI scans
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Comfort Talk® Training | Oral Sedation Rate (Duke) | 100 Participants |
| Control | Oral Sedation Rate (Duke) | 128 Participants |
p-value: <0.0001Chi-squared
Secondary
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.
Time frame: 1 quarter
Population: Number of participants who returned surveys during that quarter.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Comfort Talk® Training | Patient Satisfaction in Q1FY16 (OSU) | 71.0 National Percentile Satisfaction Ranking | Standard Deviation 21.2 |
| Control | Patient Satisfaction in Q1FY16 (OSU) | 60.1 National Percentile Satisfaction Ranking | Standard Deviation 41.7 |
Secondary
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.
Time frame: 1 quarter
Population: Number of participants who returned surveys during that quarter.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Comfort Talk® Training | Patient Satisfaction Ranking in Q2FY16 (OSU) | 75.3 National Percentile Satisfaction Ranking | Standard Deviation 16.8 |
| Control | Patient Satisfaction Ranking in Q2FY16 (OSU) | 42.3 National Percentile Satisfaction Ranking | Standard Deviation 40.1 |
Secondary
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.
Time frame: 1 quarter
Population: Number of participants who returned surveys during that quarter.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Comfort Talk® Training | Patient Satisfaction Ranking in Q3FY16 (OSU) | 76.7 National Percentile Satisfaction Ranking | Standard Deviation 16.9 |
| Control | Patient Satisfaction Ranking in Q3FY16 (OSU) | 36 National Percentile Satisfaction Ranking | Standard Deviation 41.7 |
Secondary
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.
Time frame: 1 quarter
Population: Number of participants who returned surveys during that quarter.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Comfort Talk® Training | Patient Satisfaction Ranking in Q4FY15 = Baseline Quarter (OSU) | 42.3 National Satisfaction Ranking | Standard Deviation 35.2 |
| Control | Patient Satisfaction Ranking in Q4FY15 = Baseline Quarter (OSU) | 65.0 National Satisfaction Ranking | Standard Deviation 36.7 |
Secondary
Trend of No-shows Over All Quarters (OSU)
Quarterly number of scheduled patients who do not show up for their appointments
Time frame: 4 quarters
Population: Patients scheduled for MRI
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Comfort Talk® Training | Trend of No-shows Over All Quarters (OSU) | 867 Participants |
| Control | Trend of No-shows Over All Quarters (OSU) | 858 Participants |
Comparison: Comparison among trained and untrained sites over timep-value: <0.0001Chi-squared, Corrected