Opioid SafetyISOPNCT02791399
A Patient-Centered Intervention to Improve Opioid Safety
A study testing ISOP Intervention with the Nurse Care Manager in people with Opioid Safety and Prescription Opioid Misuse, run by VA Office of Research and Development at 1 site in United States.
Trial summary
This is a randomized controlled trial of a multifaceted intervention designed to improve the safety of opioid prescribing. The specific aims of this study are to: (a) evaluate whether a multifaceted intervention (Improving the Safety of Opioid Prescribing; ISOP) enhances opioid safety, (b) assess whether participation… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Safety, Prescription Opioid Misuse, Chronic Pain
- What is being tested?
- ISOP Intervention with the Nurse Care Manager
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 286 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Mar 2016to 31 Oct 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Enrollment in primary care at the VA Portland Health Care System
- Receiving long-term opioid therapy (for at least 3 months) for chronic pain unrelated to a life-limiting disease
- Able to read and write in English
Who cannot join
- Age younger than 18 years old
- On opioid therapy for palliative or end-of-life care
- Current enrollment in an opioid substitution program
- Lack of access to a telephone
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Portland Health Care System, Portland, OR
Portland, Oregon, 97207-2964
About this study
This is a randomized controlled trial of a multifaceted intervention designed to improve the safety of opioid prescribing. The specific aims of this study are to: (a) evaluate whether a multifaceted intervention (Improving the Safety of Opioid Prescribing; ISOP) enhances opioid safety, (b) assess whether participation in ISOP impacts the clinician-patient relationship, and (c) explore to what extent ISOP is associated with changes in pain and pain-related function.
Read the detailed description
The investigators will randomize primary care providers (PCPs) at the VA Portland Health Care System to either ISOP or the control condition; patients will be nested by clinician status. All PCPs who enroll will participate in either a two-hour educational workshop or the two-hour educational workshop + nurse care manager (NCM). The NCM will maintain a registry of enrolled patients, track opioid medication-related events from the medical record, and provide decision support to PCPs for issues related to prescription opioid safety. The NCM will also meet individually with enrolled participants to discuss strategies for preventing/reducing opioid side effects, preventing diversion, and providing rationale for screening for prescription opioid misuse. The investigators will recruit patients who are already prescribed chronic opioid therapy for chronic non-cancer pain. Participants will be enrolled for one year. Outcomes will be measured at baseline, and 6 and 12 months after enrollment.
- Conditions
- Opioid Safety, Prescription Opioid Misuse, Chronic Pain
- Being tested
- ISOP Intervention with the Nurse Care Manager
- Keywords
- opioid safety, opioid misuse, opioid abuse, patient-centered, opioid, opiate, chronic pain, primary care, Veteran, clinical care
- Medical subject headings
- Opioid-Related Disorders, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ISOP Intervention with the Nurse Care ManagerBehavioural
A Nurse Care Manager (NCM) will maintain a registry of enrolled patients, track opioid medication-related events from the medical record, and provide decision support to Primary Care Providers for issues related to prescription opioid safety. The NCM will also meet individually with enrolled participants in the intervention group to discuss strategies for preventing/reducing opioid side effects, preventing diversion, and providing rationale for screening for prescription opioid misuse.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Treatment as usual |
| ISOP Intervention | Experimental | Primary care providers and PACT nurses will participate in the same workshop as those randomized to the control condition (or academic detailing for those unable to attend the workshop). Clinicians randomized to the intervention will additionally collaborate with a nurse care manager (NCM) who will maintain a registry of enrolled patients, track UDT administrations and results, query prescription drug monitoring databases, monitor other evidence of potential problems, and collaborate with expert consultants to provide decision support when patients have evidence of prescription opioid misuse or abuse. The NCM will also meet with patients to discuss methods to reduce opioid adverse effects, prevent misuse, and provide rationale for prescription opioid adherence monitoring. Receives: Behavioral: ISOP Intervention with the Nurse Care Manager |
What is being measured
The primary outcome is the main question the study is designed to answer.
Current Opioid Misuse Measure (COMM)
The Current Opioid Misuse Measure (COMM) is an assessment of self-reported risk of prescription opioid misuse. There are 17 items, each rated on a scale of 0 (never) to 4 (very often). Total scores range from 0 - 68, with higher scores indicating a greater risk of prescription opioid misuse.
Measured: Data collected at baseline, 6 months, and 12 months.
Urine Drug Test
Participants will complete urine drug tests (UDTs) to evaluate for presence of substances. UDTs will evaluate for cannabis, cocaine, amphetamines, benzodiazepines, barbiturates, opioids, and opiates. Study results are dichotomous.
Measured: Data collected at baseline, 6 months, and 12 months
Secondary outcomes (1)
Chronic Pain Grade
The Chronic Pain Grade is a 7-item self-report measure that provides global scores of pain intensity and function. Scores for each subscale range from 0 - 100. Higher scores indicate more severe pain or more impairment in function. Pain intensity and function were tested in a non-inferiority analysis.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2016 (estimated)
- Study start23 Mar 2016
- Primary completion15 Oct 2019
- Study completion31 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Opioid SafetyStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 286 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Benjamin J. Morasco, PhD MA, Principal investigator, VA Portland Health Care System, Portland, OR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02791399
- Sponsor's protocol ID
- IIR 14-020
- Other IDs
- 9024
- Acronym
- ISOP
- Status last verified
- Jul 2023
- First submitted
- 1 Jun 2016
- Last updated
- 27 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Maloy PE, Iacocca MO, Morasco BJ. CE: Implementing Guidelines for Treating Chronic Pain with Prescription Opioids. Am J Nurs. 2019 Nov;119(11):22-29. doi: 10.1097/01.NAJ.0000605344.99391.78.
PubMed 31651495Morasco BJ, Adams MH, Maloy PE, Hooker ER, Iacocca MO, Krebs EE, Carr TP, Lovejoy TI, Saha S, Dobscha SK. Research methods and baseline findings of the improving the safety of opioid therapy (ISOT) cluster-randomized trial. Contemp Clin Trials. 2020 Mar;90:105957. doi: 10.1016/j.cct.2020.105957. Epub 2020 Feb 13.
PubMed 32061968Morasco BJ, Iacocca MO, Lovejoy TI, Dobscha SK, Deyo RA, Cavese JA, Hyde S, Yarborough BJH. Utility of the Pain Medication Questionnaire to predict aberrant urine drug tests: Results from a longitudinal cohort study. Psychol Serv. 2021 Aug;18(3):319-327. doi: 10.1037/ser0000471. Epub 2020 Jul 16.
PubMed 32673038Wilson AC, Morasco BJ, Holley AL, Feldstein Ewing SW. Patterns of opioid use in adolescents receiving prescriptions: The role of psychological and pain factors. Am Psychol. 2020 Sep;75(6):748-760. doi: 10.1037/amp0000697.
PubMed 32915020Bryson WC, Morasco BJ, Cotton BP, Thielke SM. Cannabis Use and Nonfatal Opioid Overdose among Patients Enrolled in Methadone Maintenance Treatment. Subst Use Misuse. 2021;56(5):697-703. doi: 10.1080/10826084.2021.1892137. Epub 2021 Mar 22.
PubMed 33749499Magaletta PR, Morasco BJ. Perspectives on opioid misuse from public service psychology: An introduction. Psychol Serv. 2021 Aug;18(3):285-286. doi: 10.1037/ser0000485.
PubMed 34370491Borsari B, Li Y, Tighe J, Manuel JK, Gokbayrak NS, Delucchi K, Morasco BJ, Abadjian L, Cohen BE, Baxley C, Seal KH. A pilot trial of collaborative care with motivational interviewing to reduce opioid risk and improve chronic pain management. Addiction. 2021 Sep;116(9):2387-2397. doi: 10.1111/add.15401. Epub 2021 Jan 27.
PubMed 33405304Morasco BJ, Smith N, Dobscha SK, Deyo RA, Hyde S, Yarborough BJ. Prospective Investigation of Factors Associated with Prescription Opioid Dose Escalation among Patients in Integrated Health Systems. J Gen Intern Med. 2020 Dec;35(Suppl 3):895-902. doi: 10.1007/s11606-020-06250-x. Epub 2020 Nov 3.
PubMed 33145684Morasco BJ, Adams MH, Hooker ER, Maloy PE, Krebs EE, Lovejoy TI, Saha S, Dobscha SK. A Cluster-Randomized Clinical Trial to Decrease Prescription Opioid Misuse: Improving the Safety of Opioid Therapy (ISOT). J Gen Intern Med. 2022 Nov;37(15):3805-3813. doi: 10.1007/s11606-022-07476-7. Epub 2022 Mar 16.
PubMed 35296983
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Patient-Centered Intervention to Improve Opioid Safety
- ClinicalTrials.gov ID
- NCT02791399
- Acronym / sponsor ID
- ISOP / IIR 14-020
- Conditions
- Opioid Safety, Prescription Opioid Misuse, Chronic Pain
- Keywords
- opioid safety, opioid misuse, opioid abuse, patient-centered, opioid, opiate, chronic pain, primary care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 286 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 23 Mar 2016 (actual)
- Primary completion
- 15 Oct 2019 (actual)
- Study completion
- 31 Oct 2020 (actual)
- First posted
- 6 Jun 2016 (estimated)
- Results
- Posted 6 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized controlled trial of a multifaceted intervention designed to improve the safety of opioid prescribing. The specific aims of this study are to: (a) evaluate whether a multifaceted intervention (Improving the Safety of Opioid Prescribing; ISOP) enhances opioid safety, (b) assess whether participation in ISOP impacts the clinician-patient relationship, and (c) explore to what extent ISOP is associated with changes in pain and pain-related function.
Detailed description
The investigators will randomize primary care providers (PCPs) at the VA Portland Health Care System to either ISOP or the control condition; patients will be nested by clinician status. All PCPs who enroll will participate in either a two-hour educational workshop or the two-hour educational workshop + nurse care manager (NCM). The NCM will maintain a registry of enrolled patients, track opioid medication-related events from the medical record, and provide decision support to PCPs for issues related to prescription opioid safety. The NCM will also meet individually with enrolled participants to discuss strategies for preventing/reducing opioid side effects, preventing diversion, and providing rationale for screening for prescription opioid misuse. The investigators will recruit patients who are already prescribed chronic opioid therapy for chronic non-cancer pain. Participants will be enrolled for one year. Outcomes will be measured at baseline, and 6 and 12 months after enrollment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Treatment as usual |
| ISOP Intervention | Experimental | Behavioral: ISOP Intervention with the Nurse Care ManagerPrimary care providers and PACT nurses will participate in the same workshop as those randomized to the control condition (or academic detailing for those unable to attend the workshop). Clinicians randomized to the intervention will additionally collaborate with a nurse care manager (NCM) who will maintain a registry of enrolled patients, track UDT administrations and results, query prescription drug monitoring databases, monitor other evidence of potential problems, and collaborate with expert consultants to provide decision support when patients have evidence of prescription opioid misuse or abuse. The NCM will also meet with patients to discuss methods to reduce opioid adverse effects, prevent misuse, and provide rationale for prescription opioid adherence monitoring. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Enrollment in primary care at the VA Portland Health Care System
- Receiving long-term opioid therapy (for at least 3 months) for chronic pain unrelated to a life-limiting disease
- Able to read and write in English
Key exclusion criteria (4 listed)
- Age younger than 18 years old
- On opioid therapy for palliative or end-of-life care
- Current enrollment in an opioid substitution program
- Lack of access to a telephone
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 |
|---|---|---|
| ISOP Intervention with the Nurse Care ManagerA Nurse Care Manager (NCM) will maintain a registry of enrolled patients, track opioid medication-related events from the medical record, and provide decision support to Primary Care Providers for issues related to prescription opioid safety. The NCM will also meet individually with enrolled participants in the intervention group to discuss strategies for preventing/reducing opioid side effects, preventing diversion, and providing rationale for screening for prescription opioid misuse. | Behavioural | ISOP Intervention |
Primary outcome
Current Opioid Misuse Measure (COMM)
Time frame: Data collected at baseline, 6 months, and 12 months.
The Current Opioid Misuse Measure (COMM) is an assessment of self-reported risk of prescription opioid misuse. There are 17 items, each rated on a scale of 0 (never) to 4 (very often). Total scores range from 0 - 68, with higher scores indicating a greater risk of prescription opioid misuse.
Urine Drug Test
Time frame: Data collected at baseline, 6 months, and 12 months
Participants will complete urine drug tests (UDTs) to evaluate for presence of substances. UDTs will evaluate for cannabis, cocaine, amphetamines, benzodiazepines, barbiturates, opioids, and opiates. Study results are dichotomous.
1 secondary outcome
Chronic Pain Grade
Time frame: One year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 31651495Maloy PE, Iacocca MO, Morasco BJ. CE: Implementing Guidelines for Treating Chronic Pain with Prescription Opioids. Am J Nurs. 2019 Nov;119(11):22-29. doi: 10.1097/01.NAJ.0000605344.99391.78.
- Results publication: PubMed 32061968Morasco BJ, Adams MH, Maloy PE, Hooker ER, Iacocca MO, Krebs EE, Carr TP, Lovejoy TI, Saha S, Dobscha SK. Research methods and baseline findings of the improving the safety of opioid therapy (ISOT) cluster-randomized trial. Contemp Clin Trials. 2020 Mar;90:105957. doi: 10.1016/j.cct.2020.105957. Epub 2020 Feb 13.
- Results publication: PubMed 32673038Morasco BJ, Iacocca MO, Lovejoy TI, Dobscha SK, Deyo RA, Cavese JA, Hyde S, Yarborough BJH. Utility of the Pain Medication Questionnaire to predict aberrant urine drug tests: Results from a longitudinal cohort study. Psychol Serv. 2021 Aug;18(3):319-327. doi: 10.1037/ser0000471. Epub 2020 Jul 16.
- Results publication: PubMed 32915020Wilson AC, Morasco BJ, Holley AL, Feldstein Ewing SW. Patterns of opioid use in adolescents receiving prescriptions: The role of psychological and pain factors. Am Psychol. 2020 Sep;75(6):748-760. doi: 10.1037/amp0000697.
- Results publication: PubMed 33749499Bryson WC, Morasco BJ, Cotton BP, Thielke SM. Cannabis Use and Nonfatal Opioid Overdose among Patients Enrolled in Methadone Maintenance Treatment. Subst Use Misuse. 2021;56(5):697-703. doi: 10.1080/10826084.2021.1892137. Epub 2021 Mar 22.
- Results publication: PubMed 34370491Magaletta PR, Morasco BJ. Perspectives on opioid misuse from public service psychology: An introduction. Psychol Serv. 2021 Aug;18(3):285-286. doi: 10.1037/ser0000485.
- Results publication: PubMed 33405304Borsari B, Li Y, Tighe J, Manuel JK, Gokbayrak NS, Delucchi K, Morasco BJ, Abadjian L, Cohen BE, Baxley C, Seal KH. A pilot trial of collaborative care with motivational interviewing to reduce opioid risk and improve chronic pain management. Addiction. 2021 Sep;116(9):2387-2397. doi: 10.1111/add.15401. Epub 2021 Jan 27.
- Results publication: PubMed 33145684Morasco BJ, Smith N, Dobscha SK, Deyo RA, Hyde S, Yarborough BJ. Prospective Investigation of Factors Associated with Prescription Opioid Dose Escalation among Patients in Integrated Health Systems. J Gen Intern Med. 2020 Dec;35(Suppl 3):895-902. doi: 10.1007/s11606-020-06250-x. Epub 2020 Nov 3.
- Results publication: PubMed 35296983Morasco BJ, Adams MH, Hooker ER, Maloy PE, Krebs EE, Lovejoy TI, Saha S, Dobscha SK. A Cluster-Randomized Clinical Trial to Decrease Prescription Opioid Misuse: Improving the Safety of Opioid Therapy (ISOT). J Gen Intern Med. 2022 Nov;37(15):3805-3813. doi: 10.1007/s11606-022-07476-7. Epub 2022 Mar 16.
- 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.
Benjamin J. Morasco, PhD MA principal investigator
VA Portland Health Care System, Portland, OR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ISOP Intervention with the Nurse Care Manager in people with Opioid Safety and Prescription Opioid Misuse, run by VA Office of Research and Development 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 3 inclusion and 4 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 27 Jul 2023. 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?
Yes. Results are posted in the registry (first posted 6 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Current Opioid Misuse Measure (COMM) (time frame: Data collected at baseline, 6 months, and 12 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02791399, which also lists 9 linked publications.
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 27 Jul 2023.