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Preventing Opioid Misuse Through Safe Opioid Use Agreements Between Patients and Surgical Providers

NCT ID: NCT06167759

Last Updated: 2023-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-05

Study Completion Date

2024-04-30

Brief Summary

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The effect of pain agreements to reduce opioid misuse is an accepted practice in many settings, but it has never been applied to the acute care setting. Pain agreements are considered the standard of care for chronic pain management reliant on opioid prescribing, and they are a mandated component of care in many states. Therefore, the adjunct of safe opioid use agreements into acute pain management offers a logical extension of current practices from chronic pain management.

This study will test the use of agreements to improve safe opioid use to prevent misuse and opioid-related harm.

Detailed Description

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Conditions

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Opioid Use Inguinal Hernia Ventral Hernia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Opioid Use Agreement

Patients in this group will be administered a safe opioid use agreement by the research coordinator. This agreement is in addition to any routine education and counseling provided by the surgical team.

Group Type EXPERIMENTAL

Opioid Use Agreement

Intervention Type OTHER

This was previously developed specifically for surgical patients using a modified Delphi method with a group of experts (including surgeons, nurses, advanced practices providers, quality improvement experts, and patients).

Standard of Care

Patients in this group will receive standard care which includes safe opioid education from the surgical care team.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Opioid Use Agreement

This was previously developed specifically for surgical patients using a modified Delphi method with a group of experts (including surgeons, nurses, advanced practices providers, quality improvement experts, and patients).

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Adult patients (at least 18 years of age), of any gender, who speak English or Spanish, undergoing general surgery procedures with a high likelihood of receiving an opioid prescription (bariatric, inguinal hernia, or ventral hernia), who have their preoperative appointment at UT Physicians Health Center at Memorial Hermann Sugar Land Medical Plaza, Lyndon Baines Johnson, and Bellaire

Exclusion Criteria

Patients with a known allergy or contra-indication to opioids, pregnancy, signification cognitive impairment, history of opioid misuse/abuse, chronic opioid use, readmission before the follow up appointment
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Northwestern University

OTHER

Sponsor Role collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Jonah Stulberg

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jonah J Stulberg, MD

Role: PRINCIPAL_INVESTIGATOR

UTHealth

Locations

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UT Physicians-MIST Bellaire Clinic

Bellaire, Texas, United States

Site Status

Lyndon B. Johnson General Hospital

Houston, Texas, United States

Site Status

UT Physicians-MIST Sugar Land Clinic

Sugar Land, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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HSC-MS-22-0807

Identifier Type: -

Identifier Source: org_study_id