Clinical trial NCT04320004: Evaluation of a Medication Disposal Program in Primary Care
Official title: Implementation and Evaluation of Clinic-based Medication Disposal Procedures to Reduce Unwanted and Unused Controlled Substances in Homes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid-Related Disorders
Keywords: opioid
medication disposal
medication safety
Lead sponsor: Geisinger Clinic
Sponsor class: OTHER
First posted: 2020-03-24
Enrollment: 1159
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: The investigators will use a cluster-randomized stepped-wedge design, using clinics as clusters (i.e., all clinics participate in all arms, but not all at the same time) to compare two main interventions (education only vs. education + mail-back bag) to baseline/usual care. In addition, the investigators will randomize patients in both intervention arms to receive or not to receive an added telephone reminder call through interactive voice response (IVR). The primary outcome of the study, medication disposal actions taken by the patient, will be assessed by a telephone survey.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Evidence from recent trials primarily in the post-surgical patient population prescribed opioids for acute pain suggest patients more often properly dispose of unused opioids if instructed by a healthcare professional, if provided education on proper storage and disposal, and provided a physical medication disposal product (e.g. mail back bags). It is not clear how this evidence applied to patients in primary care will be readily adopted and sustained by practices and if the effectiveness will be comparable to that seen in other more controlled studies, largely limited to the surgical population. The objective of this trial is to evaluate a multifaceted program for safe medication disposal in primary care. Interventions include real-time best practice reminders to providers, educational materials mailed to patients, disposal mail-back bags supplied to patients and reminder phone calls. Proper medication disposal after 30 days following order will be assessed by telephone survey.

Our aims are to:

1. Evaluate a targeted intervention on patient's newly prescribed opioids within primary care.
2. Determine factors that influence patient action to remove unused opioid medications from the home.

Detailed description: Prospective studies affirm that education and advice from providers to dispose of unused medications modestly improves medication disposal rates. Two recently published randomized controlled trials demonstrate improved disposal rates when a system for medication disposal, namely a medication disposal bag (e.g. return envelope or activated charcoal) were supplied to patients or caregivers. The impact of education and physical disposal mechanism inferred a greater magnitude of effect than education alone.

Research Design The investigators will use a cluster-randomized stepped-wedge design, using clinics as clusters (i.e., all clinics participate in all arms, but not all at the same time) to compare two main interventions (education only vs. education + mail-back bag). In addition, the investigators will randomize patients in both intervention arms to receive or not to receive an added telephone reminder call through interactive voice response (IVR). The primary outcome of the study, medication disposal actions taken by the patient, will be assessed by a telephone survey.

Study Population The investigators will enroll patients newly prescribed an opioid medication within one of the participating clinics. For patients younger than 18 years old, the investigators will follow clinic procedures for the engagement of parents or guardians; the investigators anticipate that management of medications in this population is largely handled by the guardian or parent and therefore these patients are of key interest when studying proper medication storage and disposal.

Interventions

(1) baseline; (2) education at the clinic level; (3) educational materials mailed to the patient's home; (4) mail back bags mailed to patient's homes and (5) IVR reminder calls

The study will enroll 13 clinics into the intervention with one clinic serving as an initial pilot. Feasibility and troubleshooting of the interventions will be tested within the pilot clinic; the pilot clinic will not be included within the final analysis.

All clinics will initially be assessed at baseline (usual care) followed by education only for approximately 3 months until the targeted quota of patients for the clinic is achieved. Following this attainment, new patients will begin receiving mail-back bags in addition to the education for the remainder of the enrollment period, in order to create the two main patient groups. Approximately 50% of patients during both education only and mail back bag stages of enrollment will be selected for IVR reminder calls, using a random number generator method.

Evaluation of safe medication disposal at 30-45 days post initial opioid prescription will be conducted through a telephone survey.

Eligibility criteria: Inclusion Criteria:

* Any patient receiving a new opioid prescription in a face-to-face or telehealth encounter in select Community Medicine Service Line practices.
* "New opioid prescription" is defined as a prescription for an opioid medication, Categories II-V (not anti-tussive) to a patient who has no opioid on current medication profile and no opioid prescriptions in the previous 3 months.
* Preferred language, as documented in the electronic health record (EHR), is English.
* Providers in participating primary care practices who receive the Best Practice Alert (BPA) for eligible patients.

Exclusion Criteria:

* none

Primary outcomes:
measure: Disposal of unused opioid following new opioid prescription
timeFrame: 30-45 days post new opioid prescription
Secondary outcomes:
measure: Patient satisfaction with medication mail back disposal bag
timeFrame: 30-45 days post new opioid prescription
measure: Second prescription of opioid within 60 days post new opioid prescription
timeFrame: 60 days post new opioid prescription
Other outcomes:
Locations:
city: Danville
country: United States
facility: Geisinger
state: Pennsylvania
Study officials:
affiliation: Geisinger Clinic
name: Eric Wright, PharmD,MPH
role: PRINCIPAL_INVESTIGATOR
References: