Acute PainNCT03537573
Provider-Targeted Behavioral Interventions to Prevent Unsafe Opioid Prescribing for Acute Pain in Primary Care
A study testing Opioid Justification and Provider Comparison in people with Acute Pain and Headache, run by University of Pittsburgh at 1 site in United States.
Trial summary
The investigators will assess whether behavioral science-based interventions can "nudge" providers towards more evidence-based care for patients with acute non-cancer pain. Aim 1) Among opioid naïve primary care patients with acute non-cancer pain, compare the effect of the provider-targeted behavioral interventions… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Pain, Headache, Musculoskeletal Pain
- What is being tested?
- Opioid Justification and Provider Comparison
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22,616 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Sep 2018to 28 Feb 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older; ii) index outpatient encounter with International Classification of Disease (ICD)-10 code for acute neck, back, or other musculoskeletal and headache diagnosis ("acute" defined as no similar diagnosis in past 3 months).
- Primary care provider (MD, Doctor of Osteopathy (DO), Physician Assistant (PA), Nurse Practitioner (NP)) at participating practice
Who cannot join
- Cancer diagnosis (other than non-melanoma skin cancer)
- Receipt of opioid prescription within 12 months of index outpatient encounter
- Providers
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
UPMC Community Medicine Incorporated
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Provider-Targeted Behavioral Interventions to Prevent Unsafe Opioid Prescribing for Acute Non-Cancer Pain in Primary Care
The investigators will assess whether behavioral science-based interventions can "nudge" providers towards more evidence-based care for patients with acute non-cancer pain.
Aim 1) Among opioid naïve primary care patients with acute non-cancer pain, compare the effect of the provider-targeted behavioral interventions (opioid justification and provider comparison), individually and in combination, on initial opioid prescription, initial use of non-opioid management, and patient-reported pain and function.
Read more
Aim 2) Compare the effect of the 2 provider-targeted behavioral interventions, individually and in combination, on unsafe opioid prescribing and transition to chronic opioid therapy.
Aim 3) Assess provider satisfaction and experience with the provider-targeted behavioral interventions.
Hypotheses:
Aim 1, H1a: Compared with the guideline (usual care) alone, the addition of the opioid justification and provider comparison behavioral interventions will be associated with a decreased proportion of opioid prescription and increased proportion of non-opioid management at the initial outpatient visit for acute non-cancer pain.
Aim 1, H1b: Compared with usual care (guideline) alone, the addition of the opioid justification and provider comparison behavioral interventions will be associated with no difference in patient-reported pain, function, and satisfaction at 1, 6, and 12 months.
Aim 2, H2: Compared with the usual care (guideline), the addition of opioid justification and provider comparison behavioral interventions will be associated with a decreased proportion of patients receiving unsafe opioid therapy and a decreased proportion of patients transitioning to chronic opioid therapy.
Study Design: Pragmatic, cluster-randomized clinical trial in 48 primary care clinics.
Study Population: The patient population will be 19,855 opioid naïve adults who present to clinic with acute uncomplicated musculoskeletal pain or headache.
Primary and Secondary Outcomes: The primary outcome measures will be receipt of an initial opioid prescription and unsafe opioid prescribing. Secondary outcomes will be non-opioid pain management, and, in 514 patients, patient-reported pain and function.
Analytic Plan: The investigators will test for differences in the primary and secondary outcomes among the 4 intervention groups.
Once completed, the project will provide evidence that health systems and other stakeholders need to implement interventions to prevent unsafe opioid prescribing.
- Conditions
- Acute Pain, Headache, Musculoskeletal Pain
- Being tested
- Usual Care/Guideline, Opioid Justification, Provider Comparison
- Keywords
- Pragmatic clinical trial, Primary care, Provider-targeted, Behavioral intervention, Electronic health record
- Medical subject headings
- Acute Pain, Headache, Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual Care/GuidelineBehavioural
The Usual Care group (also known as the Guideline group) follows the recent CDC guidelines and, when triggered by an opioid prescription during a qualifying visit, will be delivered real-time in a short checklist of recommendations to: 1) check the state-specific Prescription Drug Monitoring Program; 2) assess risk factors for opioid-related harms (e.g., history of substance use disorder, history of mental health problems, benzodiazepine use); 3) avoid extended-release or long-acting opioids; 4) use a low dose of immediate-release opioid for short period of time (3-7 days); and 5) consider non-opioid management such as acetaminophen, non-steroidal anti-inflammatory agents (NSAIDS), and physical therapy. Epic EHR order sets will be linked to enable easing ordering of non-opioid therapy.
Opioid JustificationBehavioural
Providers will be required asked to enter a free text justification for their decision to prescribe an opioid analgesic for the acute pain condition. The provider will be notified that the justification provided will be visible in the Epic EHR. The provider has the option of entering a justification or not. If no justification is entered, nothing will be entered into the record (i.e., the Opioid Justification area in the encounter record will be left blank). The provider does not need to enter a justification if they choose to cancel the opioid prescription.
Provider ComparisonBehavioural
Providers will receive monthly feedback via e-mail on their status in regards to initial opioid prescriptions for acute pain, adherence to safe opioid prescribing guidelines, and proportion of patients started on opioids or acute pain who transition to chronic opioid therapy (> 3 months). Providers in the lowest decile overall for proportion of patients with initial opioid prescriptions, unsafe opioid prescribing, and transition to chronic opioid therapy (> 3 months) will be given positive feedback for providing high quality, evidence-based care to their patients with acute pain. Providers outside the lowest decile will be notified they are outside the high quality, evidence-based care range and will be provided with their proportions compared to the high performers.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care/Guideline | Active comparator | The Usual Care group (also known as the Guideline group) follows the recent Center for Disease Control (CDC) guidelines and, when triggered by an opioid prescription during a qualifying visit, will be delivered real-time in a short checklist of recommendations to: 1) check the state-specific Prescription Drug Monitoring Program; 2) assess risk factors for opioid-related harms (e.g., history of substance use disorder, history of mental health problems, benzodiazepine use); 3) avoid extended-release or long-acting opioids; 4) use a low dose of immediate-release opioid for short period of time (3-7 days); and 5) consider non-opioid management such as acetaminophen, non-steroidal anti-inflammatory agents (NSAIDS), and physical therapy. Epic EHR order sets will be linked to enable easing ordering of non-opioid therapy. Receives: Behavioral: Usual Care/Guideline |
| Guideline + Opioid Justification (OJ) | Experimental | Providers will be required asked to enter a free text justification for their decision to prescribe an opioid analgesic for the acute pain condition. The provider will be notified that the justification provided will be visible in the Epic EHR. The provider has the option of entering a justification or not. If no justification is entered, nothing will be entered into the record (i.e., the Opioid Justification area in the encounter record will be left blank). The provider does not need to enter a justification if they choose to cancel the opioid prescription. Receives: Behavioral: Usual Care/Guideline; Behavioral: Opioid Justification |
| Guideline + Provider Comparison (PC) | Experimental | Providers will receive monthly feedback via e-mail on their status in regards to initial opioid prescriptions for acute pain, adherence to safe opioid prescribing guidelines, and proportion of patients started on opioids f or acute pain who transition to chronic opioid therapy (> 3 months). Providers in the lowest decile overall for proportion of patients with initial opioid prescriptions , unsafe opioid prescribing, and transition to chronic opioid therapy (> 3 months) will be given positive feedback for providing high quality, evidence-based care to their patients with acute pain. Providers outside the lowest decile will be notified they are outside the high quality, evidence-based care range and will be provided with their proportions compared to the high performers. Receives: Behavioral: Usual Care/Guideline; Behavioral: Provider Comparison |
| Guideline + OJ + PC | Experimental | This arm will include the guideline, opioid justification, and provider comparison described above. Receives: Behavioral: Usual Care/Guideline; Behavioral: Opioid Justification; Behavioral: Provider Comparison |
What is being measured
The primary outcome is the main question the study is designed to answer.
Initial Opioid Prescription
Initial opioid prescription (yes/no) (Primary) (Hypothesis 1a). Opioid prescription at qualifying clinic visit, measured via electronic health record (EHR).
Measured: 1 day (assessed on day of initial qualifying clinic visit
Secondary outcomes (8)
Initial non-opioid management
Initial non-opioid management (yes/no) (Secondary) (Hypothesis 1a). Defined as order for any non-opioid management strategy at baseline (e.g., non-opioid medication, physical therapy, behavioral therapy), measured via EHR.
Measured: 1 day (assessed on day of initial qualifying clinic visit)
Change in Patient Reported Pain and Function
Change in Patient Reported Pain and Function (Secondary) (Hypothesis 1b). Measured by the 3-item Pain/Enjoyment/General Activities (PEG) instrument in clinic at baseline and via brief web survey or telephone interview
Measured: Assessed at 1, 6, and 12 months after initial qualifying clinic visit
Unsafe opioid prescribing at 3 months
Defined over the prior 3 months as any of: a) receipt of initial extended release/long-acting opioid for acute pain; b) > 100 morphine milligram equivalent dose per day; c) opioid prescription in patients with substance use disorder or concurrent benzodiazepine prescription.
Measured: 3 months after initial qualifying clinic visit
Unsafe opioid prescribing at 6 months
Defined over the prior 3 months as any of: a) receipt of initial extended release/long-acting opioid for acute pain; b) > 100 morphine milligram equivalent dose per day; c) opioid prescription in patients with substance use disorder or concurrent benzodiazepine prescription.
Measured: 6 months after initial qualifying clinic visit
Unsafe opioid prescribing at 12 months
Defined over the prior 3 months as any of: a) receipt of initial extended release/long-acting opioid for acute pain; b) > 100 morphine milligram equivalent dose per day; c) opioid prescription in patients with substance use disorder or concurrent benzodiazepine prescription.
Measured: 12 months after initial qualifying clinic visit
Chronic opioid therapy at 3 months
Chronic opioid therapy (Secondary) (Hypothesis 2). Ongoing, chronic opioid therapy will be measured via EHR
Measured: 3 months after initial qualifying clinic visit
Chronic opioid therapy at 6 months
Chronic opioid therapy (Secondary) (Hypothesis 2). Ongoing, chronic opioid therapy will be measured via EHR
Measured: 6 months after initial qualifying clinic visit
Chronic opioid therapy at 12 months
Chronic opioid therapy (Secondary) (Hypothesis 2). Ongoing, chronic opioid therapy will be measured via EHR
Measured: 12 months after initial qualifying clinic visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2018
- Study start23 Sep 2018
- Primary completion31 Jan 2020
- Study completion28 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute PainStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Factorial
- Model description
- 48 primary care clinics (N=19,855 patients participants anticipated) randomized to 4 arms in 2x2 factorial design
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 22,616 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, Geisinger Clinic, University of Utah
- Responsible party
- Sponsor
- Investigators
- Kevin L Kraemer, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03537573
- Sponsor's protocol ID
- STUDY20110336
- Other IDs
- UOP-1609-36881
- Status last verified
- Jun 2023
- First submitted
- 29 Apr 2018
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kraemer KL, Althouse AD, Salay M, Gordon AJ, Wright E, Anisman D, Cochran G, Fischer G, Gellad WF, Hamm M, Kern M, Wasan AD. Effect of Different Interventions to Help Primary Care Clinicians Avoid Unsafe Opioid Prescribing in Opioid-Naive Patients With Acute Noncancer Pain: A Cluster Randomized Clinical Trial. JAMA Health Forum. 2022 Jul 29;3(7):e222263. doi: 10.1001/jamahealthforum.2022.2263. eCollection 2022 Jul.
PubMed 35983579
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Provider-Targeted Behavioral Interventions to Prevent Unsafe Opioid Prescribing for Acute Non-Cancer Pain in Primary Care
- ClinicalTrials.gov ID
- NCT03537573
- Acronym / sponsor ID
- STUDY20110336
- Conditions
- Acute Pain, Headache, Musculoskeletal Pain
- Keywords
- Pragmatic clinical trial, Primary care, Provider-targeted, Behavioral intervention, Electronic health record
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22,616 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, Geisinger Clinic, University of Utah
- Study start
- 23 Sep 2018 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 25 May 2018 (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.
The investigators will assess whether behavioral science-based interventions can "nudge" providers towards more evidence-based care for patients with acute non-cancer pain.
Aim 1) Among opioid naïve primary care patients with acute non-cancer pain, compare the effect of the provider-targeted behavioral interventions (opioid justification and provider comparison), individually and in combination, on initial opioid prescription, initial use of non-opioid management, and patient-reported pain and function.
Aim 2) Compare the effect of the 2 provider-targeted behavioral interventions, individually and in combination, on unsafe opioid prescribing and transition to chronic opioid therapy.
Aim 3) Assess provider satisfaction and experience with the provider-targeted behavioral interventions.
Hypotheses:
Aim 1, H1a: Compared with the guideline (usual care) alone, the addition of the opioid justification and provider comparison behavioral interventions will be associated with a decreased proportion of opioid prescription and increased proportion of non-opioid management at the initial outpatient visit for acute non-cancer pain.
Aim 1, H1b: Compared with usual care (guideline) alone, the addition of the opioid justification and provider comparison behavioral interventions will be associated with no difference in patient-reported pain, function, and satisfaction at 1, 6, and 12 months.
Aim 2, H2: Compared with the usual care (guideline), the addition of opioid justification and provider comparison behavioral interventions will be associated with a decreased proportion of patients receiving unsafe opioid therapy and a decreased proportion of patients transitioning to chronic opioid therapy.
Study Design: Pragmatic, cluster-randomized clinical trial in 48 primary care clinics.
Study Population: The patient population will be 19,855 opioid naïve adults who present to clinic with acute uncomplicated musculoskeletal pain or headache.
Primary and Secondary Outcomes: The primary outcome measures will be receipt of an initial opioid prescription and unsafe opioid prescribing. Secondary outcomes will be non-opioid pain management, and, in 514 patients, patient-reported pain and function.
Analytic Plan: The investigators will test for differences in the primary and secondary outcomes among the 4 intervention groups.
Once completed, the project will provide evidence that health systems and other stakeholders need to implement interventions to prevent unsafe opioid prescribing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- 48 primary care clinics (N=19,855 patients participants anticipated) randomized to 4 arms in 2x2 factorial design
| Arm | Type | Receives |
|---|---|---|
| Usual Care/Guideline | Active comparator | Behavioral: Usual Care/GuidelineThe Usual Care group (also known as the Guideline group) follows the recent Center for Disease Control (CDC) guidelines and, when triggered by an opioid prescription during a qualifying visit, will be delivered real-time in a short checklist of recommendations to: 1) check the state-specific Prescription Drug Monitoring Program; 2) assess risk factors for opioid-related harms (e.g., history of substance use disorder, history of mental health problems, benzodiazepine use); 3) avoid extended-release or long-acting opioids; 4) use a low dose of immediate-release opioid for short period of time (3-7 days); and 5) consider non-opioid management such as acetaminophen, non-steroidal anti-inflammatory agents (NSAIDS), and physical therapy. Epic EHR order sets will be linked to enable easing ordering of non-opioid therapy. |
| Guideline + Opioid Justification (OJ) | Experimental | Behavioral: Usual Care/Guideline, Behavioral: Opioid JustificationProviders will be required asked to enter a free text justification for their decision to prescribe an opioid analgesic for the acute pain condition. The provider will be notified that the justification provided will be visible in the Epic EHR. The provider has the option of entering a justification or not. If no justification is entered, nothing will be entered into the record (i.e., the Opioid Justification area in the encounter record will be left blank). The provider does not need to enter a justification if they choose to cancel the opioid prescription. |
| Guideline + Provider Comparison (PC) | Experimental | Behavioral: Usual Care/Guideline, Behavioral: Provider ComparisonProviders will receive monthly feedback via e-mail on their status in regards to initial opioid prescriptions for acute pain, adherence to safe opioid prescribing guidelines, and proportion of patients started on opioids f or acute pain who transition to chronic opioid therapy (> 3 months). Providers in the lowest decile overall for proportion of patients with initial opioid prescriptions , unsafe opioid prescribing, and transition to chronic opioid therapy (> 3 months) will be given positive feedback for providing high quality, evidence-based care to their patients with acute pain. Providers outside the lowest decile will be notified they are outside the high quality, evidence-based care range and will be provided with their proportions compared to the high performers. |
| Guideline + OJ + PC | Experimental | Behavioral: Usual Care/Guideline, Behavioral: Opioid Justification, Behavioral: Provider ComparisonThis arm will include the guideline, opioid justification, and provider comparison described above. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Primary care provider (MD, Doctor of Osteopathy (DO), Physician Assistant (PA), Nurse Practitioner (NP)) at participating practice
Key exclusion criteria (4 listed)
- Providers
- 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 |
|---|---|---|
| Usual Care/GuidelineThe Usual Care group (also known as the Guideline group) follows the recent CDC guidelines and, when triggered by an opioid prescription during a qualifying visit, will be delivered real-time in a short checklist of recommendations to: 1) check the state-specific Prescription Drug Monitoring Program; 2) assess risk factors for opioid-related harms (e.g., history of substance use disorder, history of mental health problems, benzodiazepine use); 3) avoid extended-release or long-acting opioids; 4) use a low dose of immediate-release opioid for short period of time (3-7 days); and 5) consider non-opioid management such as acetaminophen, non-steroidal anti-inflammatory agents (NSAIDS), and physical therapy. Epic EHR order sets will be linked to enable easing ordering of non-opioid therapy. | Behavioural | Guideline + OJ + PC, Guideline + Opioid Justification (OJ), Guideline + Provider Comparison (PC), Usual Care/Guideline |
| Opioid JustificationProviders will be required asked to enter a free text justification for their decision to prescribe an opioid analgesic for the acute pain condition. The provider will be notified that the justification provided will be visible in the Epic EHR. The provider has the option of entering a justification or not. If no justification is entered, nothing will be entered into the record (i.e., the Opioid Justification area in the encounter record will be left blank). The provider does not need to enter a justification if they choose to cancel the opioid prescription. | Behavioural | Guideline + OJ + PC, Guideline + Opioid Justification (OJ) |
| Provider ComparisonProviders will receive monthly feedback via e-mail on their status in regards to initial opioid prescriptions for acute pain, adherence to safe opioid prescribing guidelines, and proportion of patients started on opioids or acute pain who transition to chronic opioid therapy (> 3 months). Providers in the lowest decile overall for proportion of patients with initial opioid prescriptions, unsafe opioid prescribing, and transition to chronic opioid therapy (> 3 months) will be given positive feedback for providing high quality, evidence-based care to their patients with acute pain. Providers outside the lowest decile will be notified they are outside the high quality, evidence-based care range and will be provided with their proportions compared to the high performers. | Behavioural | Guideline + OJ + PC, Guideline + Provider Comparison (PC) |
Primary outcome
Initial Opioid Prescription
Time frame: 1 day (assessed on day of initial qualifying clinic visit
Initial opioid prescription (yes/no) (Primary) (Hypothesis 1a). Opioid prescription at qualifying clinic visit, measured via electronic health record (EHR).
8 secondary outcomes
Initial non-opioid management
Time frame: 1 day (assessed on day of initial qualifying clinic visit)
Change in Patient Reported Pain and Function
Time frame: Assessed at 1, 6, and 12 months after initial qualifying clinic visit
Unsafe opioid prescribing at 3 months
Time frame: 3 months after initial qualifying clinic visit
Unsafe opioid prescribing at 6 months
Time frame: 6 months after initial qualifying clinic visit
Unsafe opioid prescribing at 12 months
Time frame: 12 months after initial qualifying clinic visit
Chronic opioid therapy at 3 months
Time frame: 3 months after initial qualifying clinic visit
Chronic opioid therapy at 6 months
Time frame: 6 months after initial qualifying clinic visit
Chronic opioid therapy at 12 months
Time frame: 12 months after initial qualifying clinic visit
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 8 Oct 2024.
- Derived from this study: PubMed 35983579Kraemer KL, Althouse AD, Salay M, Gordon AJ, Wright E, Anisman D, Cochran G, Fischer G, Gellad WF, Hamm M, Kern M, Wasan AD. Effect of Different Interventions to Help Primary Care Clinicians Avoid Unsafe Opioid Prescribing in Opioid-Naive Patients With Acute Noncancer Pain: A Cluster Randomized Clinical Trial. JAMA Health Forum. 2022 Jul 29;3(7):e222263. doi: 10.1001/jamahealthforum.2022.2263. eCollection 2022 Jul.
- Individual participant dataSharing planned: No
Related trials for Acute Pain
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruitingPhase 2
A Clinical Trial of MK-6916 in Participants With Pain After Bunion Removal Surgery (MK-6916-007)
Pain Management
Not yet recruitingPhase 2
Investigating the Analgesic Potential of (2R,6R)-HNK in Acute Pain in Healthy Volunteers
Healthy Volunteers
Not yet recruiting
Post-operative Pain and Clinical Outcome After Single-cone Obturation With a Calcium Silicate-based Versus Epoxy Resin Sealer
Post Operative Pain, Acute, Irreversible Pulpitis (Toothache)
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.
Kevin L Kraemer, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Opioid Justification and Provider Comparison in people with Acute Pain and Headache, run by University of Pittsburgh 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 2 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 8 Oct 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?
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?
Initial Opioid Prescription (time frame: 1 day (assessed on day of initial qualifying clinic visit). 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 NCT03537573, which also lists 1 linked publication.
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 8 Oct 2024.