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Comfort Talk and Economic Outcomes in MRI (ComfortTalk®)

H

Hypnalgesics

Status

Completed

Conditions

Complication of Diagnostic Procedure
Claustrophobia

Treatments

Behavioral: Comfort Talk® Training

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT02427737
2CTOSUD2015

Details and patient eligibility

About

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.

Full 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.

Enrollment

12 patients

Sex

All

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

12 participants in 2 patient groups

Comfort Talk® Training
Experimental group
Description:
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.
Treatment:
Behavioral: Comfort Talk® Training
Control
No Intervention group
Description:
MRI sites not trained in Comfort Talk®.

Trial documents
1

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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