SBIR-STTR Award

Amelioration of Claustrophobia and Disruptive Patient Motion in Mr Imaging
Award last edited on: 4/11/16

Sponsored Program
SBIR
Awarding Agency
NIH : NCCAM
Total Award Amount
$1,641,524
Award Phase
2
Solicitation Topic Code
-----

Principal Investigator
Elvira V Lang

Company Information

Hypnalgesics LLC

157 Ivy Street
Brookline, MA 02446
   (617) 734-9087
   info@hypnalgesics.com
   www.hypnalgesics.com
Location: Single
Congr. District: 04
County: Norfolk

Phase I

Contract Number: 1R43AT006296-01A1
Start Date: 8/1/11    Completed: 7/31/13
Phase I year
2011
Phase I Amount
$267,500
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 TalkTM 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 TalkTM 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.

Public Health Relevance:
Annually, an estimated 700,000 patients do not complete their scheduled MRI scans because of claustrophobia or inability to hold still. Training staff working in MRI facilities to provide Comfort TalkTM promises to enable patients to complete and obtain high quality imaging without medication, which will increase comfort and reduce sedation risks for the patients, and increase efficiency and reduce loss of revenue for the facilities.

Thesaurus Terms:
Academic Medical Centers;Affect;Android;Area;Behavior;Behavior Conditioning Therapy;Behavior Modification;Behavior Therapy;Behavior Treatment;Behavioral Conditioning Therapy;Behavioral Modification;Behavioral Therapy;Behavioral Treatment;Boston;Cessation Of Life;Claustrophobias;Clinical;Clinical Evaluation;Clinical Testing;Communities;Conditioning Therapy;Critiques;Death;Development;Devices;Diagnosis;Diagnostic;Drugs;Economics;Education For Intervention;Educational Intervention;Educational Process Of Instructing;Educational Workshop;Eldec;Electronics;Ero Test;Estratest;Evaluation;Event;Feedback;General Radiology;Glosso-Sterandryl;Goals;Health Care Professional;Health Professional;Healthcare;Healthcare Professional;Human Resources;Hypnosis;Image;Instruction Intervention;Internet;Intervention;Intervention Strategies;Loinc Axis 4 System;Language;Licensing;Life;Life Style Modification;Mr Imaging;Mr Tomography;Mri;Mri Scans;Magnetic Resonance Imaging;Magnetic Resonance Imaging Scan;Malogen;Manpower;Marketing;Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance;Medical Center;Medication;Metandren;Metric;Motion;Multimedia;Multimedium;Nmr Imaging;Nmr Tomography;Neohombreol M;Nuclear Magnetic Resonance Imaging;Nurses;Ohio;On-Line Systems;Online Systems;Orchisterone-M;Oreton Methyl;Outcome;Participant;Patient Schedules;Patients;Performance;Pharmaceutic Preparations;Pharmaceutical Preparations;Phase;Physicians;Preparation;Radiology;Radiology Specialty;Relaxation Technics;Relaxation Techniques;Risk;Sample Size;Schedule;Sedation Procedure;Site;Societies;Structure;System;Teaching;Techniques;Testing;Testomet;Testotonic B;Testovis;Testred;Time;Trainers Training;Training;Training Intervention;Training Support;University Medical Centers;Visit;Www;Work;Workshop;Zeugmatography;Base;Behavior Intervention;Behavioral Intervention;Clinical Test;Design;Designing;Developmental;Drug/Agent;Health Care;Hypnotic;Imaging;Instructional Intervention;Instrument;Interventional Strategy;Lifestyle Modification;Meetings;Online Computer;Operation;Personnel;Portability;Prevent;Preventing;Prototype;Research Clinical Testing;Satisfaction;Sedation;Skills;Web;Web Based;World Wide Web

Phase II

Contract Number: 5R43AT006296-02
Start Date: 8/1/11    Completed: 6/30/14
Phase II year
2012
(last award dollars: 2015)
Phase II Amount
$1,374,024

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 TalkTM 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 TalkTM 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.