Reduction of Claustrophobia and Patient Motion After Training of MRI Personnel in Comfort TalkTM
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|ClinicalTrials.gov Identifier: NCT01563198|
Recruitment Status : Completed
First Posted : March 26, 2012
Results First Posted : April 14, 2017
Last Update Posted : April 14, 2017
|Condition or disease||Intervention/treatment||Phase|
|Claustrophobia Complication of Diagnostic Procedure||Behavioral: Comfort Talk®||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||97712 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Amelioration of Claustrophobia and Disruptive Patient Motion in MR Imaging|
|Study Start Date :||August 2011|
|Actual Primary Completion Date :||July 2015|
|Actual Study Completion Date :||February 17, 2016|
Experimental: Comfort Talk® Training
The MRI units of three clinical sites form the group. Their personnel will be trained to use Comfort Talk® to help patients who are claustrophobic, anxious, and/or cannot lie still to complete their tests
Behavioral: 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) [ Time Frame: 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) [ Time Frame: 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
- Change in No-Show Rates of Patients From the Average of the Baseline Year to the Average of One Year Post Training [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01563198
|United States, Massachusetts|
|Tufts Medical Center|
|Boston, Massachusetts, United States, 02111|
|Boston Medical Center|
|Boston, Massachusetts, United States, 02118|
|Brookline, Massachusetts, United States, 02446|
|United States, Ohio|
|Ohio State University Medical Center|
|Columbus, Ohio, United States, 43210|
|Principal Investigator:||Elvira V Lang, MD||Hypnalgesics, LLC|