Evaluation of a Medication Disposal Program in Primary Care

NCT04320004 | Completed

• 1 other identifier: 2019-0606
• Study Type: interventional
• Target: 1,159
• Locations: 1 country
• Sites: 1

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

Conditions

Opioid-Related Disorders

Keywords

opioid; medication disposal; medication safety

Outcome Measures

Primary Outcomes (1)

• Disposal of unused opioid following new opioid prescription

  Proportion of patients with unused opioid medication who dispose opioid as assessed by telephone survey

  30-45 days post new opioid prescription

Secondary Outcomes (2)

• Patient satisfaction with medication mail back disposal bag

  30-45 days post new opioid prescription

• Second prescription of opioid within 60 days post new opioid prescription

  60 days post new opioid prescription

Study Arms (5)

Baseline

NO INTERVENTION

Participating clinics will enter a baseline period where no interventions are used, but survey collection of baseline information about patient storage and disposal is collected. The baseline period varies depending on the cohort timing for each clinic but will last a minimum of one month for each clinic. In order to generate a survey list, the investigators will institute a "silent best practice alert (BPA)" in these clinics. This "Silent BPA" is not seen by providers, but a silent report is generated for reporting purposes, and for the study team to generate the baseline survey list.

Education Intervention

ACTIVE COMPARATOR

If a patient meets study criteria, an alert will fire in the EHR to remind the provider to discuss proper storage and disposal of the opioid medication with the subject. Following the subject's visit, participants will be mailed an education packet consisting of a cover letter and a flyer detailing the importance of medication disposal of unused opioids and instructing how to properly dispose. Between 30-45 days following the new opioid prescription, the survey call center will contact subjects by telephone to interview them regarding opioid prescription disposition and actions taken to disposal of any leftover medications, household information, their satisfaction with interventions, including provider-based education, and mailed educational material.

Behavioral: Education

Education Intervention with Reminder

ACTIVE COMPARATOR

This arm will follow the Education Intervention arm (BPA, provider education, mailed education and follow up survey) Approximately 50% of patients in the Education Intervention arm will be randomized to receive an interactive voice response (IVR) telephone call approximately 14 calendar days following receipt of his/her new opioid prescription. The IVR is intended to remind patients/caregivers to properly dispose of any unused medication and gather information from the patient on any disposal actions the patient has taken.

Behavioral: Education with Reminder

Education + Disposal Bag Intervention

ACTIVE COMPARATOR

If a patient meets study criteria, an alert will fire in the EHR to remind the provider to discuss proper storage and disposal of the opioid medication with the subject. Following the subject's visit, participants will be mailed an education packet consisting of a cover letter and a flyer detailing the importance of medication disposal of unused opioids and instructing how to properly dispose plus a postage paid medication disposal mail bag and instructions for use. Between 30-45 days following the new opioid prescription, the survey unit will contact subjects by telephone to interview them regarding opioid prescription disposition and actions taken to disposal of any leftover medications, household information, their satisfaction with interventions, including provider-based education, mailed educational material and mail-back bags.

Behavioral: Education + Disposal Bag

Education + Disposal Bag Intervention with Reminder

ACTIVE COMPARATOR

This arm will follow the Education+ Disposal Bag Intervention arm (BPA, provider education, mailed education+ disposal bag and follow up survey) Approximately 50% of patients in the Education + Disposal Bag Intervention arm will be randomized to receive an interactive voice response (IVR) telephone call approximately 14 calendar days following receipt of his/her new opioid prescription. The IVR is intended to remind patients/caregivers to properly dispose of any unused medication and gather information from the patient on any disposal actions the patient has taken.

Behavioral: Education + Disposal Bag with Reminder

Interventions

Education BEHAVIORAL

Subject receives education

Education Intervention

Education with Reminder BEHAVIORAL

Subject receives education with reminder

Education Intervention with Reminder

Education + Disposal Bag BEHAVIORAL

Subject receives education and disposal bag

Education + Disposal Bag Intervention

Education + Disposal Bag with Reminder BEHAVIORAL

Subject receives education + disposal bag with reminder

Education + Disposal Bag Intervention with Reminder

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• none

Sponsors & Collaborators

• Geisinger Clinic: lead

Study Sites (1)

Geisinger

Danville, Pennsylvania, 17822, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Eric Wright, PharmD,MPH

  Geisinger Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: March 18, 2020
• First Posted: March 24, 2020
• Study Start: May 1, 2020
• Primary Completion: May 6, 2021
• Study Completion: June 30, 2021
• Last Updated: September 22, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)