Trial Outcomes & Findings for Comfort Talk and Economic Outcomes in MRI (NCT NCT02427737)

Results Overview

Quarterly completion rate of MRIs as a proportion of scans completed per given number of imaging slots available

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

12 participants

Primary outcome timeframe

1 quarter

Results posted on

2019-09-12

Participant Flow

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)

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").

Unit of analysis: Imaging slots

Participant milestones

Participant milestones
Measure	Comfort Talk® Training MRI clinical sites form the experimental group. Their 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 study. Comfort 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 will entail 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.	Control MRI sites are not be trained in Comfort Talk®. Please note that at OSU both trained and control sites had a baseline and three post-training periods. At Duke, the data in the initial baseline period became the control data in a pre to post comparison for reasons explained above. Therefore Duke has only 2 time periods with the initial "Baseline" entered as "Control."
OSU Baseline Q4FY15 STARTED	4158 4754	3446 4219
OSU Baseline Q4FY15 COMPLETED	3940 4754	3230 4219
OSU Baseline Q4FY15 NOT COMPLETED	218 0	216 0
OSU Q1FY16 (First Post-Training Quarter) STARTED	4030 4583	3246 4144
OSU Q1FY16 (First Post-Training Quarter) COMPLETED	3815 4583	3032 4144
OSU Q1FY16 (First Post-Training Quarter) NOT COMPLETED	215 0	214 0
OSU Q2FY16(Second Post Training Quarter) STARTED	4121 4659	3070 4204
OSU Q2FY16(Second Post Training Quarter) COMPLETED	3907 4659	2857 4204
OSU Q2FY16(Second Post Training Quarter) NOT COMPLETED	214 0	213 0
OSU Q3FY16 (Third Post Training Quarter) STARTED	4148 4647	2931 4199
OSU Q3FY16 (Third Post Training Quarter) COMPLETED	3928 4647	2716 4199
OSU Q3FY16 (Third Post Training Quarter) NOT COMPLETED	220 0	215 0
Duke Pre- and Post-Training Groups STARTED	9658 9658	4446 4446
Duke Pre- and Post-Training Groups COMPLETED	8879 9658	4051 4446
Duke Pre- and Post-Training Groups NOT COMPLETED	779 0	395 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comfort Talk and Economic Outcomes in MRI

Baseline characteristics by cohort

Baseline data not reported

PRIMARY outcome

Timeframe: 1 quarter

Population: Imaging slots available in the quarter

Quarterly completion rate of MRIs as a proportion of scans completed per given number of imaging slots available

Outcome measures

Outcome measures
Measure	Comfort Talk® Training n=4754 Imaging slots 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. Comfort 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 will entail 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.	Control n=4219 Imaging slots MRI sites not trained in Comfort Talk®.
Equipment Utilization Q4FY15 = Baseline Quarter (OSU)	0.83 Proportion of completed scans per slots	0.77 Proportion of completed scans per slots

PRIMARY outcome

Timeframe: 1 quarter

Population: Participants completing their scans

Quarterly completion rate of MRIs as a proportion of scans completed per given number of imaging slots available

Outcome measures

Outcome measures
Measure	Comfort Talk® Training n=4583 Imaging slots 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. Comfort 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 will entail 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.	Control n=4144 Imaging slots MRI sites not trained in Comfort Talk®.
Equipment Utilization in Q1FY16 (OSU)	0.832 Proportion of completed scans per slots	0.732 Proportion of completed scans per slots

PRIMARY outcome

Timeframe: 1 quarter

Population: Imaging slots available in the quarter

Quarterly completion rate of MRIs as a proportion of scans completed per given number of imaging slots available

Outcome measures

Outcome measures
Measure	Comfort Talk® Training n=4659 Imaging Slots 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. Comfort 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 will entail 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.	Control n=4204 Imaging Slots MRI sites not trained in Comfort Talk®.
Equipment Utilization in Q2FY16 (OSU)	0.839 Proportion of completed scans per slots	0.680 Proportion of completed scans per slots

PRIMARY outcome

Timeframe: 1 quarter

Population: Imaging slots available in the quarter

Quarterly completion rate of MRIs as a proportion of scans completed per given number of imaging slots available

Outcome measures

Outcome measures
Measure	Comfort Talk® Training n=4647 Imaging slots 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. Comfort 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 will entail 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.	Control n=4199 Imaging slots MRI sites not trained in Comfort Talk®.
Equipment Utilization in Q3FY16 (OSU)	0.845 Proportion of completed scans per slots	0.647 Proportion of completed scans per slots

PRIMARY outcome

Timeframe: 4 quarters

Population: Imaging slots available

Completion rates of MRIs as a proportion of scans completed per given number of imaging slots available

Outcome measures

Outcome measures
Measure	Comfort Talk® Training n=18643 Imaging slots 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. Comfort 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 will entail 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.	Control n=16766 Imaging slots MRI sites not trained in Comfort Talk®.
Equipment Utilization Over All Quarters (OSU)	0.836 Proportion of completed scans per slots	0.705 Proportion of completed scans per slots

PRIMARY outcome

Timeframe: 9 months (3 months baseline, 6 months post training)

Population: Patients showing for their MRI scans

Patients who cannot complete their scan

Outcome measures

Outcome measures
Measure	Comfort Talk® Training n=4051 Participants 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. Comfort 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 will entail 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.	Control n=8879 Participants MRI sites not trained in Comfort Talk®.
Incompletions (Duke)	52 Participants	27 Participants

SECONDARY outcome

Timeframe: 1 quarter

Population: Scheduled patients

Quarterly number of scheduled patients who do not show up for their appointments

Outcome measures

Outcome measures
Measure	Comfort Talk® Training n=4158 Participants 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. Comfort 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 will entail 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.	Control n=3446 Participants MRI sites not trained in Comfort Talk®.
No-shows in Q4FY15 = Baseline Quarter (OSU)	218 Participants	216 Participants

SECONDARY outcome

Timeframe: 1 quarter

Population: Patients scheduled for MRI

Quarterly number of scheduled patients who do not show up for their appointments

Outcome measures

Outcome measures
Measure	Comfort Talk® Training n=4030 Participants 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. Comfort 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 will entail 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.	Control n=3246 Participants MRI sites not trained in Comfort Talk®.
No-shows in Q1FY16 (OSU)	215 Participants	214 Participants

SECONDARY outcome

Timeframe: 1 quarter

Population: Patients scheduled for MRI

Quarterly number of scheduled patients who do not show up for their appointments

Outcome measures

Outcome measures
Measure	Comfort Talk® Training n=4121 Participants 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. Comfort 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 will entail 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.	Control n=3070 Participants MRI sites not trained in Comfort Talk®.
No-shows in Q2FY16 (OSU)	214 Participants	213 Participants

SECONDARY outcome

Timeframe: 1 quarter

Population: Patients scheduled for MRI

Quarterly number of scheduled patients who do not show up for their appointments

Outcome measures

Outcome measures
Measure	Comfort Talk® Training n=4148 Participants 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. Comfort 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 will entail 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.	Control n=2931 Participants MRI sites not trained in Comfort Talk®.
No-shows in Q3FY16 (OSU)	220 Participants	215 Participants

SECONDARY outcome

Timeframe: 4 quarters

Population: Patients scheduled for MRI

Quarterly number of scheduled patients who do not show up for their appointments

Outcome measures

Outcome measures
Measure	Comfort Talk® Training n=16457 Participants 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. Comfort 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 will entail 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.	Control n=12693 Participants MRI sites not trained in Comfort Talk®.
Trend of No-shows Over All Quarters (OSU)	867 Participants	858 Participants

SECONDARY outcome

Timeframe: 1 quarter

Population: Number of participants who returned surveys during that 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.

Outcome measures

Outcome measures
Measure	Comfort Talk® Training n=116 Participants 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. Comfort 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 will entail 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.	Control n=71 Participants MRI sites not trained in Comfort Talk®.
Patient Satisfaction Ranking in Q4FY15 = Baseline Quarter (OSU)	42.3 National Satisfaction Ranking Standard Deviation 35.2	65.0 National Satisfaction Ranking Standard Deviation 36.7

SECONDARY outcome

Timeframe: 1 quarter

Population: Number of participants who returned surveys during that 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.

Outcome measures

Outcome measures
Measure	Comfort Talk® Training n=135 Participants 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. Comfort 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 will entail 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.	Control n=110 Participants MRI sites not trained in Comfort Talk®.
Patient Satisfaction in Q1FY16 (OSU)	71.0 National Percentile Satisfaction Ranking Standard Deviation 21.2	60.1 National Percentile Satisfaction Ranking Standard Deviation 41.7

SECONDARY outcome

Timeframe: 1 quarter

Population: Number of participants who returned surveys during that 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.

Outcome measures

Outcome measures
Measure	Comfort Talk® Training n=138 Participants 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. Comfort 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 will entail 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.	Control n=106 Participants MRI sites not trained in Comfort Talk®.
Patient Satisfaction Ranking in Q2FY16 (OSU)	75.3 National Percentile Satisfaction Ranking Standard Deviation 16.8	42.3 National Percentile Satisfaction Ranking Standard Deviation 40.1

SECONDARY outcome

Timeframe: 1 quarter

Population: Number of participants who returned surveys during that 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.

Outcome measures

Outcome measures
Measure	Comfort Talk® Training n=158 Participants 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. Comfort 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 will entail 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.	Control n=87 Participants MRI sites not trained in Comfort Talk®.
Patient Satisfaction Ranking in Q3FY16 (OSU)	76.7 National Percentile Satisfaction Ranking Standard Deviation 16.9	36 National Percentile Satisfaction Ranking Standard Deviation 41.7

SECONDARY outcome

Timeframe: 9 months (3 months baseline, 6 months post training)

Population: Patients showing for their MRI scans

Patients who receive medical sedation on site

Outcome measures

Outcome measures
Measure	Comfort Talk® Training n=4051 Participants 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. Comfort 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 will entail 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.	Control n=8879 Participants MRI sites not trained in Comfort Talk®.
Oral Sedation Rate (Duke)	100 Participants	128 Participants

SECONDARY outcome

Timeframe: 9 months (3 months baseline, 6 months post training)

Population: Patients showing for their MRI scans

Number of patients who receive intravenous (IV) sedation on site

Outcome measures

Outcome measures
Measure	Comfort Talk® Training n=4051 Participants 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. Comfort 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 will entail 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.	Control n=8879 Participants MRI sites not trained in Comfort Talk®.
IV Sedation Rate (Duke)	103 Participants	196 Participants

SECONDARY outcome

Timeframe: 9 months (3 months baseline, 6 months post training)

Population: Patients showing for their MRI scans

Number of patients who receive general anesthesia on site

Outcome measures

Outcome measures
Measure	Comfort Talk® Training n=4051 Participants 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. Comfort 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 will entail 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.	Control n=8879 Participants MRI sites not trained in Comfort Talk®.
General Anesthesia Rate (Duke)	29 Participants	55 Participants

SECONDARY outcome

Timeframe: 9 months (3 months baseline, 6 months post training)

Population: Patients showing for their MRI scans

Patients on site who disrupt the scan by motion

Outcome measures

Outcome measures
Measure	Comfort Talk® Training n=4051 Participants 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. Comfort 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 will entail 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.	Control n=8879 Participants MRI sites not trained in Comfort Talk®.
Disruptive Motion (Duke)	42 Participants	11 Participants

SECONDARY outcome

Timeframe: 9 months (3 months baseline, 6 months post training)

Population: Patients scheduled for MRI scans

Scheduled patients who do not show for their MRI examinations.

Outcome measures

Outcome measures
Measure	Comfort Talk® Training n=4446 Participants 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. Comfort 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 will entail 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.	Control n=9658 Participants MRI sites not trained in Comfort Talk®.
No-shows (Duke)	395 Participants	779 Participants

Adverse Events

Comfort Talk® Training (OSU)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control (OSU)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Baseline = Control (Duke)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Comfort Talk® Training (Duke)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Elvira V. Lang, MD (PI of SBIR grant sponsoring site-PIs); CEO

Hypnalgesics, LLC d/b/a Comfort Talk

Phone: 617 734 9087

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place