OverdoseNCT06456294
Evaluation of a Medication Health Center to Promote Opioid Safety
A study testing MHC Outreach Intervention in people with Overdose, run by Kaiser Permanente at 1 site in United States.
Trial summary
This study will assess the impact of an opioid safety clinic intervention for patients prescribed chronic opioid therapy. Outcomes are visits to the clinic, naloxone dispensings, Prescription Drug Monitoring reviews, and Urine Drug Screens conducted Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overdose
- What is being tested?
- MHC Outreach Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2022to 1 Jan 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Evaluation population:
- Eligible Clinics
- Patients prescribed Chronic Opioid Therapy
Eligibility Criteria for Clinics:
- Clinic leadership willing to be randomized to order of implementation
- Not a pilot location
Eligibility for an MHC visit included the following:
- Patients in the KPCO chronic opioid registry
- No Primary Care Physician (PCP) or MHC visit in the past 6 months
- Not managed by the Integrated Pain Service, a specialty pain service that takes care of the highest risk and most complex pain patients
Patients enter the chronic opioid registry if they fulfill any of the following criteria:
- 2 opioid fills in the last 90 days; fills should be separated by 27 days, or
- 1 opioid fill with pill number ≥100 pills in the last 90 days, or
- 1 long-acting/extended-release opioid fill in the last 90 days
Trial locations and contacts
1 site in 1 country.
About this study
This study will assess the impact of an opioid safety clinic intervention for patients prescribed chronic opioid therapy. Outcomes are visits to the clinic, naloxone dispensings, Prescription Drug Monitoring reviews, and Urine Drug Screens conducted
Read the detailed description
Given ongoing concerns about the risk of opioid overdose among people taking chronic opioid therapy for pain, Kaiser Permanente Colorado (KPCO) sought to develop a standardized approach to promote opioid safety. Operational stakeholders adapted an existing Opioid Safety Clinic model, tailored it for KPCO's context, and implemented it in three geographically dispersed KPCO clinics with leadership support. The approach was a multidisciplinary "Medication Health Center" to assess patients, educate them about overdose risk, provide naloxone, and ensure adherence to standard monitoring. Operations and the research team then collaborated to assess the effectiveness of the program to inform decisions to scale the program to other regions.
- Conditions
- Overdose
- Being tested
- MHC Outreach Intervention
- Keywords
- naloxone, opioids, safety
- Medical subject headings
- Drug Overdose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MHC Outreach InterventionBehavioural
Adult PC clinics are randomized to receive the MHC Outreach Intervention early (n=7 clinics) vs. delayed (n=7 clinics). In early intervention clinics, patients prescribed chronic opioid therapy, on a chronic opioid registry, and receiving their medication from the intervention clinic are sent emails and letters inviting them to schedule an MHC appointment. Clinical staff at the early intervention clinic are educated to encourage attendance. During MHC visits, MHC staff assess patients prescribed Chronic Opioid Therapy (COT), educate them about overdose, prescribe naloxone, and order guideline-concordant opioid monitoring.
| Study group | Role | What they receive |
|---|---|---|
| MHC Early Outreach Intervention | Experimental | Early implementation of a MHC outreach intervention program. Clinics in the early outreach intervention arm will be assigned to the MHC Direct patient outreach, where MHC staff will encourage patients to schedule an appointment with the MHC and primary care (PC) staff will be educated to encourage MHC visits. Receives: Behavioral: MHC Outreach Intervention |
| MHC Delayed Outreach Intervention | No intervention | Clinics in the usual care/delayed intervention arm will deliver usual care through the health plan, pharmacy and clinicians. As part of usual care, patients at these clinics can access naloxone through physician prescription or standing orders. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with a Medication Health Center visit
Medication Health Center (MHC) Visits will be assessed using data from the electronic medical record.
Measured: Outcomes are assessed in a two-month post-intervention period.
Secondary outcomes (3)
Number of participants with a Naloxone dispensing
Naloxone dispensings are assessed using data from the electronic medical record
Measured: Outcomes are assessed in a two-month post-intervention period.
Number of participants with a Prescription Drug Monitoring Program (PDMP) review
Prescription Drug Monitoring Program (PDMP) reviews are assessed using data from the electronic medical record
Measured: Outcomes are assessed in a two-month post-intervention period.
Number of participants with a Urine Drug Screens completed
Urine Drug Screens Completed are assessed using data from the electronic medical record
Measured: Outcomes are assessed in a two-month post-intervention period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start15 Jun 2022
- Primary completion3 Dec 2024 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverdoseStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06456294
- Sponsor's protocol ID
- 1840701
- Status last verified
- Jun 2024
- First submitted
- 7 Jun 2024
- Last updated
- 14 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Investigators interested in using the data from this study must submit a written request. Requests must address regulatory and compliance requirements for data usage. Investigators must outline the necessary resources required to support their data request, including personnel and infrastructure. The original study team will evaluate each request based on scientific merit, ethical considerations, and alignment with the original study's objectives. Deidentified electronic health record (EHR) data will be shared with investigators upon approval of written request. Investigators are responsible for obtaining necessary approvals and adhering to relevant laws and regulations and will be required to sign a Data Use Agreement (DUA) outlining the terms and conditions of data usage. The data sharing period is limited to three years following the publication of the primary study.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Medication Health Center to Promote Opioid Safety
- ClinicalTrials.gov ID
- NCT06456294
- Acronym / sponsor ID
- 1840701
- Conditions
- Overdose
- Keywords
- naloxone, opioids, safety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Study start
- 15 Jun 2022 (actual)
- Primary completion
- 3 Dec 2024 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 13 Jun 2024 (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.
This study will assess the impact of an opioid safety clinic intervention for patients prescribed chronic opioid therapy. Outcomes are visits to the clinic, naloxone dispensings, Prescription Drug Monitoring reviews, and Urine Drug Screens conducted
Detailed description
Given ongoing concerns about the risk of opioid overdose among people taking chronic opioid therapy for pain, Kaiser Permanente Colorado (KPCO) sought to develop a standardized approach to promote opioid safety. Operational stakeholders adapted an existing Opioid Safety Clinic model, tailored it for KPCO's context, and implemented it in three geographically dispersed KPCO clinics with leadership support. The approach was a multidisciplinary "Medication Health Center" to assess patients, educate them about overdose risk, provide naloxone, and ensure adherence to standard monitoring. Operations and the research team then collaborated to assess the effectiveness of the program to inform decisions to scale the program to other regions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MHC Early Outreach Intervention | Experimental | Behavioral: MHC Outreach InterventionEarly implementation of a MHC outreach intervention program. Clinics in the early outreach intervention arm will be assigned to the MHC Direct patient outreach, where MHC staff will encourage patients to schedule an appointment with the MHC and primary care (PC) staff will be educated to encourage MHC visits. |
| MHC Delayed Outreach Intervention | No intervention | –Clinics in the usual care/delayed intervention arm will deliver usual care through the health plan, pharmacy and clinicians. As part of usual care, patients at these clinics can access naloxone through physician prescription or standing orders. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| MHC Outreach InterventionAdult PC clinics are randomized to receive the MHC Outreach Intervention early (n=7 clinics) vs. delayed (n=7 clinics). In early intervention clinics, patients prescribed chronic opioid therapy, on a chronic opioid registry, and receiving their medication from the intervention clinic are sent emails and letters inviting them to schedule an MHC appointment. Clinical staff at the early intervention clinic are educated to encourage attendance. During MHC visits, MHC staff assess patients prescribed Chronic Opioid Therapy (COT), educate them about overdose, prescribe naloxone, and order guideline-concordant opioid monitoring. | Behavioural | MHC Early Outreach Intervention |
Primary outcome
Number of participants with a Medication Health Center visit
Time frame: Outcomes are assessed in a two-month post-intervention period.
Medication Health Center (MHC) Visits will be assessed using data from the electronic medical record.
3 secondary outcomes
Number of participants with a Naloxone dispensing
Time frame: Outcomes are assessed in a two-month post-intervention period.
Number of participants with a Prescription Drug Monitoring Program (PDMP) review
Time frame: Outcomes are assessed in a two-month post-intervention period.
Number of participants with a Urine Drug Screens completed
Time frame: Outcomes are assessed in a two-month post-intervention period.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2024.
- Individual participant dataSharing planned: Yes. Investigators interested in using the data from this study must submit a written request. Requests must address regulatory and compliance requirements for data usage. Investigators must outline the necessary resources required to support their data request, including personnel and infrastructure. The original study team will evaluate each request based on scientific merit, ethical considerations, and alignment with the original study's objectives. Deidentified electronic health record (EHR) data will be shared with investigators upon approval of written request. Investigators are responsible for obtaining necessary approvals and adhering to relevant laws and regulations and will be required to sign a Data Use Agreement (DUA) outlining the terms and conditions of data usage. The data sharing period is limited to three years following the publication of the primary study.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MHC Outreach Intervention in people with Overdose, run by Kaiser Permanente 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?
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: status not confirmed, as of the sponsor's last update on 14 Jun 2024. 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?
Results are not available in the source record.
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?
Number of participants with a Medication Health Center visit (time frame: Outcomes are assessed in a two-month post-intervention period.). 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 14 Jun 2024.