Trial Outcomes & Findings for Reduction of Claustrophobia and Patient Motion After Training of MRI Personnel in Comfort TalkTM (NCT NCT01563198)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

97712 participants

Primary outcome timeframe

Baseline average of one year plus post training average one year = 2 years

Results posted on

2017-04-14

Participant Flow

Different participants were assessed at baseline and after training.

Unit of analysis: Clinical sites

Participant milestones

Participant milestones
Measure	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.
Baseline STARTED	49733 3
Baseline COMPLETED	49733 3
Baseline NOT COMPLETED	0 0
After Training STARTED	47979 3
After Training COMPLETED	47979 3
After Training NOT COMPLETED	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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).

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Comfort Talk® Training n=3 MRI sites 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.
No-show rate	11.2 Percentage of participants n=49733 Participants
Non-completion rate of showing-up patients	2.3 Percentage of all showing-up patients n=44140 Participants • 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).
Non-completion rate of all scheduled patients	13.3 Percentage of all scheduled participants n=49733 Participants

PRIMARY outcome

Timeframe: 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

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.

Outcome measures

Outcome measures
Measure	Comfort TalkTM Training n=97712 Participants 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.
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
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

PRIMARY outcome

Timeframe: 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).

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

Outcome measures

Outcome measures
Measure	Comfort TalkTM Training n=87956 Participants 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.
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
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

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Comfort TalkTM Training n=97712 Participants 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.
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
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

Adverse Events

Comfort TalkTM Training

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)

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