Opioid-Related DisordersNCT04320004
Evaluation of a Medication Disposal Program in Primary Care
A study testing Education, Education with Reminder and Education + Disposal Bag in people with Opioid-Related Disorders, run by Geisinger Clinic at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Opioid-Related Disorders
- What is being tested?
- Education, Education with Reminder and Education + Disposal Bag
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,159 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2020to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Implementation and Evaluation of Clinic-based Medication Disposal Procedures to Reduce Unwanted and Unused Controlled Substances in Homes
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:
- Evaluate a targeted intervention on patient's newly prescribed opioids within primary care.
- Determine factors that influence patient action to remove unused opioid medications from the home.
Read the 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.
- Conditions
- Opioid-Related Disorders
- Being tested
- Education, Education with Reminder, Education + Disposal Bag, Education + Disposal Bag with Reminder
- Keywords
- opioid, medication disposal, medication safety
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationBehavioural
Subject receives education
Education with ReminderBehavioural
Subject receives education with reminder
Education + Disposal BagBehavioural
Subject receives education and disposal bag
Education + Disposal Bag with ReminderBehavioural
Subject receives education + disposal bag with reminder
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Behavioral: Education + Disposal Bag with Reminder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disposal of unused opioid following new opioid prescription
Proportion of patients with unused opioid medication who dispose opioid as assessed by telephone survey
Measured: 30-45 days post new opioid prescription
Secondary outcomes (2)
Patient satisfaction with medication mail back disposal bag
Patient satisfaction with mail-back bag, as assessed by telephone survey
Measured: 30-45 days post new opioid prescription
Second prescription of opioid within 60 days post new opioid prescription
Prescription order for second opioid prescription as assessed by electronic health record
Measured: 60 days post new opioid prescription
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2020
- Study start1 May 2020
- Primary completion6 May 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid-Related DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- 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.
- Masking
- None (open label)
- Enrolment
- 1,159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Geisinger Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric Wright, Geisinger Clinic
- Investigators
- Eric Wright, PharmD,MPH, Principal investigator, Geisinger Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04320004
- Sponsor's protocol ID
- 2019-0606
- Status last verified
- Sep 2021
- First submitted
- 18 Mar 2020
- Last updated
- 22 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation and Evaluation of Clinic-based Medication Disposal Procedures to Reduce Unwanted and Unused Controlled Substances in Homes
- ClinicalTrials.gov ID
- NCT04320004
- Acronym / sponsor ID
- 2019-0606
- Conditions
- Opioid-Related Disorders
- Keywords
- opioid, medication disposal, medication safety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,159 participants (actual)
- Lead sponsor
- Geisinger ClinicUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 6 May 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 24 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Evaluate a targeted intervention on patient's newly prescribed opioids within primary care.
- 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: EducationIf 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. |
| Education Intervention with Reminder | Active comparator | Behavioral: Education with ReminderThis 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. |
| Education + Disposal Bag Intervention | Active comparator | Behavioral: Education + Disposal BagIf 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. |
| Education + Disposal Bag Intervention with Reminder | Active comparator | Behavioral: Education + Disposal Bag with ReminderThis 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EducationSubject receives education | Behavioural | Education Intervention |
| Education with ReminderSubject receives education with reminder | Behavioural | Education Intervention with Reminder |
| Education + Disposal BagSubject receives education and disposal bag | Behavioural | Education + Disposal Bag Intervention |
| Education + Disposal Bag with ReminderSubject receives education + disposal bag with reminder | Behavioural | Education + Disposal Bag Intervention with Reminder |
Primary outcome
Disposal of unused opioid following new opioid prescription
Time frame: 30-45 days post new opioid prescription
Proportion of patients with unused opioid medication who dispose opioid as assessed by telephone survey
2 secondary outcomes
Patient satisfaction with medication mail back disposal bag
Time frame: 30-45 days post new opioid prescription
Second prescription of opioid within 60 days post new opioid prescription
Time frame: 60 days post new opioid prescription
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Wright, PharmD,MPH principal investigator
Geisinger Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education, Education with Reminder and Education + Disposal Bag in people with Opioid-Related Disorders, run by Geisinger Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disposal of unused opioid following new opioid prescription (time frame: 30-45 days post new opioid prescription). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2021; AzTrials last refreshed its copy on 30 Oct 2026.