N/A
N=7,604
Comfort Talk and Economic Outcomes in MRI
Claustrophobia · Complication of Diagnostic Procedure
Bottom Line
View on ClinicalTrials.gov: NCT02427737 ↗Enrolled (actual)
7,604
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcome: Primary: Equipment Utilization Q4FY15 = Baseline Quarter (OSU) — 0.83; 0.77 Proportion of completed scans per slots
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Comfort Talk® Training (Behavioral)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Hypnalgesics, LLC
- Primary completion
- Jul 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Equipment Utilization Q4FY15 = Baseline Quarter (OSU) |
0.83; 0.77 | — |
| PRIMARY Equipment Utilization in Q1FY16 (OSU) |
0.832; 0.732 | <0.0001 sig |
| PRIMARY Equipment Utilization in Q2FY16 (OSU) |
0.839; 0.680 | <0.0001 sig |
| PRIMARY Equipment Utilization in Q3FY16 (OSU) |
0.845; 0.647 | <0.0001 sig |
| PRIMARY Equipment Utilization Over All Quarters (OSU) |
0.836; 0.705 | <0.0001 sig |
| PRIMARY Incompletions (Duke) |
52; 27 | <0.0001 sig |
| SECONDARY No-shows in Q4FY15 = Baseline Quarter (OSU) |
218; 216 | — |
| SECONDARY No-shows in Q1FY16 (OSU) |
215; 214 | 0.2357 |
| SECONDARY No-shows in Q2FY16 (OSU) |
214; 213 | 0.0195 sig |
| SECONDARY No-shows in Q3FY16 (OSU) |
220; 215 | <0.01 sig |
| SECONDARY Trend of No-shows Over All Quarters (OSU) |
867; 858 | <0.0001 sig |
| SECONDARY Patient Satisfaction Ranking in Q4FY15 = Baseline Quarter (OSU) |
42.3; 65.0 | — |
| SECONDARY Patient Satisfaction in Q1FY16 (OSU) |
71.0; 60.1 | — |
| SECONDARY Patient Satisfaction Ranking in Q2FY16 (OSU) |
75.3; 42.3 | — |
| SECONDARY Patient Satisfaction Ranking in Q3FY16 (OSU) |
76.7; 36 | — |
| SECONDARY Oral Sedation Rate (Duke) |
100; 128 | <0.0001 sig |
| SECONDARY IV Sedation Rate (Duke) |
103; 196 | 0.2396 |
| SECONDARY General Anesthesia Rate (Duke) |
29; 55 | 0.5267 |
| SECONDARY Disruptive Motion (Duke) |
42; 11 | <0.0001 sig |
| SECONDARY No-shows (Duke) |
395; 779 | <0.0001 sig |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02427737). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.