Ignite Creation Date:
2024-05-06 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06232577
Status:
RECRUITING
Last Update Posted:
2024-05-07
First Post:
2024-01-22
Brief Title:
5x-Multiplier vs 3-Tier Model for Discharge Opioid Prescriptions After Intra-abdominal Cancer Surgery A Randomized Clinical Trial
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
5x-Multiplier vs 3-Tier Model for Discharge Opioid Prescriptions After Intra-abdominal Cancer Surgery A Randomized Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To compare 2 different models for prescribing opioid pain medication to provide better pain control to participants with an abdominal cancer who are having surgery
Detailed Description:
Primary Objectives
The co-primary objectives of this study are as follows
1 To determine differences in the initial OME prescribed upon discharge between each algorithmmodel
1 To determine OME usage by day 14 after hospital discharge
Secondary Objectives
Secondary objectives are as follows
1 To determine rates of patients with zero OME upon discharge
2 To determine rates of OME refill requests and completions at 15- and 30-days post-operation
3 To determine number of unused or leftover pills at 15- and 30-days post- operation
4 To determine persistent opioid use at 30-days 3-months and 6-months post-operation
5 To elucidate patient prescriber and oncologic factors predictive of persistent opioid use
6 To assess quality of life using patient-reported outcomes at 30-days 3-months and 6-months post-operation
7 To determine patient satisfaction with either prescribing model
The co-primary objectives of this study are as follows
1 To determine differences in the initial OME prescribed upon discharge between each algorithmmodel
1 To determine OME usage by day 14 after hospital discharge
Secondary Objectives
Secondary objectives are as follows
1 To determine rates of patients with zero OME upon discharge
2 To determine rates of OME refill requests and completions at 15- and 30-days post-operation
3 To determine number of unused or leftover pills at 15- and 30-days post- operation
4 To determine persistent opioid use at 30-days 3-months and 6-months post-operation
5 To elucidate patient prescriber and oncologic factors predictive of persistent opioid use
6 To assess quality of life using patient-reported outcomes at 30-days 3-months and 6-months post-operation
7 To determine patient satisfaction with either prescribing model
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2024-00632 | OTHER | NCI-CTRP Clinical Registry | None |