Clinical trial NCT06232577: 5x-Multiplier vs 3-Tier Model for Discharge Opioid Prescriptions After Intra-abdominal Cancer Surgery: A Randomized Clinical Trial
Official title: 5x-Multiplier vs 3-Tier Model for Discharge Opioid Prescriptions After Intra-abdominal Cancer Surgery: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Intra-abdominal Cancer
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2024-01-31
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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 algorithm/model.

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.

Eligibility criteria: Inclusion Criteria:

* Participants ≥18 years of age
* Participants undergoing any of the following abdominal surgeries on an elective basis at MD Anderson Cancer Center:
* Open pancreatectomy
* Open hepatectomy
* Open resection of retroperitoneal sarcoma
* Open nephrectomy
* Open cytoreductive surgery (in ovarian cancer)
* Participants with a planned inpatient admission of at least 48 hours after surgery
* Opioid-naive patients who use less than or equal to 7.5 mg OME per day (on average) during the 30 days prior to consent
* Participants able to understand and willing to sign an informed consent document
* English and non-English-speaking participants

Exclusion Criteria:

* Participants requiring non-elective (emergent or urgent) surgery will be excluded
* Participants with a current or previous history of substance abuse disorder, including alcohol or drugs
* Participants prescribed long-acting chronic pain medications
* Participants using hydromorphone or fentanyl or under the care of a chronic pain specialist
* Participants unable or unwilling to participate in follow-up study requirements (e.g., QOL surveys, opioid log)
* Participants discharged on palliative or hospice care
* Participants with a history of allergic reactions to opioids
* Participants enrolled in any other opioid discharge protocol
* Participants who are pregnant
* Participants who are cognitively impaired

Primary outcomes:
measure: Safety and adverse events (AEs)
timeFrame: Through study completion; an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Ching-Wei D Tzeng, MD
role: PRINCIPAL_INVESTIGATOR
References: