AMPED Outcomes Registry of Post-ED Pain Management
| Tracking Information | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | June 20, 2012 | ||||||||||||||||||||
| Last Updated Date | March 22, 2013 | ||||||||||||||||||||
| Start Date ICMJE | July 2012 | ||||||||||||||||||||
| Estimated Primary Completion Date | June 2014 (final data collection date for primary outcome measure) | ||||||||||||||||||||
| Current Primary Outcome Measures ICMJE |
Clinical Outcomes of pain control measures [ Time Frame: 5 days ] [ Designated as safety issue: No ]
|
||||||||||||||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||||||||
| Change History | Complete list of historical versions of study NCT01626235 on ClinicalTrials.gov Archive Site | ||||||||||||||||||||
| Current Secondary Outcome Measures ICMJE |
Satisfaction and Economic Outcomes [ Time Frame: 5 days ] [ Designated as safety issue: Yes ]
|
||||||||||||||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||||||
| Descriptive Information | |||||||||||||||||||||
| Brief Title ICMJE | AMPED Outcomes Registry of Post-ED Pain Management | ||||||||||||||||||||
| Official Title ICMJE | Acute Management of Pain From the Emergency Department: A National, Emergency Department-Based Prospective Post-Intervention Registry of Non-Opioid and Opioid Management of Acute Pain | ||||||||||||||||||||
| Brief Summary | Study aims to assess patient-recorded outcomes of pain control medications prescribed in the ER after visits for specific painful injuries/illnesses. |
||||||||||||||||||||
| Detailed Description | Multicenter, observational, prospective, out-of-hospital registry collecting clinical, satisfaction, quality of life, and healthcare resource utilization from subjects discharged after ED care for a specific acute pain syndrome with a clinician-determined analgesic regimen. Subjects are stratified by diagnosis and by regimen based on the treating clinician's judgment. The registry study is independent of ED care and clinician's decision-making. |
||||||||||||||||||||
| Study Type ICMJE | Observational | ||||||||||||||||||||
| Study Design ICMJE | Time Perspective: Prospective | ||||||||||||||||||||
| Target Follow-Up Duration | Not Provided | ||||||||||||||||||||
| Biospecimen | Not Provided | ||||||||||||||||||||
| Sampling Method | Non-Probability Sample | ||||||||||||||||||||
| Study Population | 1,000 patients with specific musculoskeletal or visceral pain syndrome |
||||||||||||||||||||
| Condition ICMJE |
|
||||||||||||||||||||
| Intervention ICMJE | Not Provided | ||||||||||||||||||||
| Study Group/Cohort (s) |
|
||||||||||||||||||||
| Publications * | Not Provided | ||||||||||||||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||||||||||||||
| Recruitment Information | |||||||||||||||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||||||||||||||
| Estimated Enrollment ICMJE | 1000 | ||||||||||||||||||||
| Estimated Completion Date | June 2014 | ||||||||||||||||||||
| Estimated Primary Completion Date | June 2014 (final data collection date for primary outcome measure) | ||||||||||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||||||||||||||||
| Gender | Both | ||||||||||||||||||||
| Ages | 18 Years and older | ||||||||||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||||||||||
| Contacts ICMJE |
|
||||||||||||||||||||
| Location Countries ICMJE | United States | ||||||||||||||||||||
| Administrative Information | |||||||||||||||||||||
| NCT Number ICMJE | NCT01626235 | ||||||||||||||||||||
| Other Study ID Numbers ICMJE | RRR-LUIT-01 | ||||||||||||||||||||
| Has Data Monitoring Committee | No | ||||||||||||||||||||
| Responsible Party | Radnor Registry Research, Inc | ||||||||||||||||||||
| Study Sponsor ICMJE | Radnor Registry Research, Inc | ||||||||||||||||||||
| Collaborators ICMJE | Luitpold Pharmaceuticals | ||||||||||||||||||||
| Investigators ICMJE |
|
||||||||||||||||||||
| Information Provided By | Radnor Registry Research, Inc | ||||||||||||||||||||
| Verification Date | March 2013 | ||||||||||||||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||||||||||||||