Opioid-use DisorderCOPENCT05028998
COVID-19-Related Opioid Treatment Policy Evaluation
An observational study of Opioid-use Disorder and Alcohol Use Disorder, run by Boston VA Research Institute, Inc. at 1 site in United States.
Trial summary
Our nation is facing the COVID-19 pandemic during an ongoing opioid epidemic. Effective treatment for patients with opioid use problems involves a treatment method called Medication-Assisted Treatment, or MAT. In MAT, patients receive a medication that reduces cravings and withdrawal symptoms and can prevent overdose. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Opioid-use Disorder, Alcohol Use Disorder
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2021to 31 Aug 2023
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Veterans Health Administration and non-Veterans Health Administration (commercially and Medicaid-covered individuals) patients with OUD and their matched AUD comparators will be included in Aim 1 and 2 analyses. These represent archival claims (non-Veterans Health Administration data) and electronic health record data (Veterans Health Administration). The population for Aim 3 will include veterans who are current or recent patients of Veterans Health Administration, seeking/having received treatment for OUD at Veterans Health Administration; non-veterans seeking/having received treatment for OUD outside Veterans Health Administration; clinicians who treat patients with OUD within or outside Veterans Health Administration; and policy/decision-makers with expertise in opioid and OUD treatment policy.
Who may be able to join
- VA patients with OUD who currently, or recently (within the past 6 months) receive(d) treatment for OUD from providers within Veterans Health Administration in the states of Massachusetts, Rhode Island, or New Hampshire.
- Non-Veteran patients with OUD (N=30) who currently, or recently (within the past 6 months) receive(d) treatment for OUD from providers outside Veterans Health Administration in the states of Massachusetts, Rhode Island, or New Hampshire.
- VA - OUD treatment providers who currently provide treatment for OUD within Veterans Health Administration, and have been a Veterans Health Administration provider of OUD treatment for at least one year in Massachusetts, Rhode Island, or New Hampshire.
- Non-VA OUD treatment providers who currently provide treatment for OUD outside of Veterans Health Administration, and have been a provider of OUD treatment for at least one year in Massachusetts, Rhode Island, or New Hampshire.
- OUD treatment and policy decision-makers who currently or recently (within past 6 months) hold/held positions within federal, state, or private organizations (e.g., Veterans Health Administration, SAMHSA) in which they are responsible for making and/or influencing significant decisions regarding the OUD treatment policy and/or the manner in which these are implemented.
Who cannot join
- Under 18
- Inability to speak fluent English
- Inability to provide a clear reporting of their experiences due to current influence of substances
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
VA Boston Healthcare System
Boston, Massachusetts, 02130
Risa Weisberg, PhD, VHABHS.COVID19PolicyStudy@va.gov
Nicholas Livingston, PhD
About this study
Official title: The Impact of COVID-19-related Medication Assisted Treatment Policy Changes on Care and Outcomes for Patients With Opioid Use Disorder
Our nation is facing the COVID-19 pandemic during an ongoing opioid epidemic. Effective treatment for patients with opioid use problems involves a treatment method called Medication-Assisted Treatment, or MAT. In MAT, patients receive a medication that reduces cravings and withdrawal symptoms and can prevent overdose. Patients also receive counseling. Because the medications that are used in MAT are controlled substances, this treatment is subject to a number of federal regulations. The need for social-distancing during the pandemic would have made following these regulations very difficult for patients and their providers. Because of these difficulties, the federal government eased regulations in March 2020, making it easier for patients to receive MAT with fewer (if any) in-person visits for medication and counseling. Our team is studying the effects of these policy changes on the treatment that patients with opioid use disorder receive and on their outcomes. We are using both quantitative analyses of large, existing databases and qualitative analyses of interviews with patients, providers, and policy-makers to study these effects.
Read the detailed description
The COVID-19 disease outbreak has occurred in the midst of a national opioid crisis, and poses significant risk for individuals with opioid use disorder (OUD). If existing in-person care delivery systems continued, patients would need to choose between risking exposure to the virus, or foregoing OUD treatment. Medication-assisted treatment (MAT), the gold-standard for treating OUD, involves daily medication (i.e., methadone or buprenorphine), close medication monitoring, and counseling sessions, all typically occurring in person. The medications used are schedule II and III controlled substances and are subject to greater federal regulations than medications for other substance use disorders (SUD), such as alcohol use disorder (AUD).3 To temper the impact of COVID-19 on OUD patients, in March 2020 the federal government temporarily, but dramatically, loosened MAT restrictions to expand treatment options, require fewer in-person visits, and prevent disruption to life-saving treatment.
This rapid shift in policy created a natural experiment, allowing for the evaluation of this MAT policy intervention on OUD patient care and outcomes. To examine the unknown effects of this intervention, we propose a mixed-methods, naturalistic experimental design involving quantitative analysis of large administrative and healthcare utilization datasets to evaluate the impact of MAT policy changes on patient care and outcomes. We will also compare OUD patient outcomes to those of AUD patients (analogue comparison group), for whom treatment was unaffected by MAT policy changes. We will then conduct interviews with patients, providers, and key MAT policy stakeholders, to understand perspectives on the impact of these COVID-19 related MAT policy changes on the lives and well-being of OUD patients, and guide policy decisions regarding whether or not to make these changes permanent. Given the general impact of the COVID-19 pandemic on patients and systems, we will compare outcomes for patients with OUD to analogue AUD patients, for whom there were no comparable medication policy changes in response to COVID-19.
Patients with OUD across three healthcare systems will be engaged in all steps of the research, including influencing the research design, assisting in determining key variables for Aims 1 and 2, collaborating in drafting our interview scripts for Aim 3, and assisting in interpreting our results and disseminating findings to patient stakeholders.
Aim 1. Using existing datasets, examine the effect of federal regulation changes on trends in delivery of MAT for OUD before and after pandemic onset, with a particular focus on prescription access, refills, and dosing schedules, as well as rates of in-person vs. telehealth medical and counseling visits.
Aim 2. Estimate the impact of the changes in OUD healthcare delivery on crucial patient outcomes (e.g., emergency department visits, detoxification, treatment retention, relapse, overdose, and mortality) by comparing patients with OUD vs. AUD (clinical analogue comparison group), across time (pre- and post-MAT policy changes).
Aim 3. Through in-depth, qualitative interviews and analyses, characterize patient, provider, and decision-maker perspectives on the impact of MAT policy changes in response to COVID-19 on patient access to MAT, health, functioning, and well-being.
Built-in reporting milestones will expedite data sharing to guide policy, provider, and patient decision-making as health care systems determine how to prepare for future pandemics, and post-COVID-19 pandemic care for OUD patients.
- Conditions
- Opioid-use Disorder, Alcohol Use Disorder
- Keywords
- opioid use disorder, methadone, buprenorphine
- Medical subject headings
- Opioid-Related Disorders, Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Veterans with Opioid Use Disorder receiving care through the Veterans Health Administration | Pre-existing medical records data for these individuals will be part of our Aim 1 and Aim 2 large quantitative database. Additionally, we will be recruiting 30 of these individuals to participate in our Aim 3 qualitative interviews. | |
| Veterans with Alcohol Use Disorder receiving care through the Veterans Health Administration | Pre-existing medical records data for these individuals will be part of our Aim 1 and Aim 2 large quantitative database. We will not be recruiting any of these individuals for Aim 3 qualitative interviews. | |
| Patients with Opioid Use Disorder for whom Market Scan Medicaid Claims data is available | Pre-existing medical records data for these individuals will be part of our Aim 1 and Aim 2 large quantitative database. We will not be recruiting any of these individuals for Aim 3 qualitative interviews. | |
| Patients with Alcohol Use Disorder for whom Market Scan Medicaid Claims data is available | Pre-existing medical records data for these individuals will be part of our Aim 1 and Aim 2 large quantitative database. We will not be recruiting any of these individuals for Aim 3 qualitative interviews. | |
| Patients with Opioid Use Disorder for whom Market Scan Commercial Insurance Claims data is available | Pre-existing medical records data for these individuals will be part of our Aim 1 and Aim 2 large quantitative database. We will not be recruiting any of these individuals for Aim 3 qualitative interviews. | |
| Patients with Alcohol Use Disorder for whom Market Scan Commercial Claims data is available | Pre-existing medical records data for these individuals will be part of our Aim 1 and Aim 2 large quantitative database. We will not be recruiting any of these individuals for Aim 3 qualitative interviews. | |
| Patients with Opioid Use Disorder receiving care outside of Veterans Health Administration | We will be recruiting 30 of these individuals to participate in our Aim 3 qualitative interviews. | |
| Opioid Use Disorder Treatment Providers who provide treatment in the Veterans Health Administration | We will be recruiting 15 of these individuals to participate in our Aim 3 qualitative interviews. | |
| Opioid Use Disorder Providers who treat outside the Veterans Health Administration | We will be recruiting 15 of these individuals to participate in our Aim 3 qualitative interviews. | |
| Opioid Use Disorder Treatment and Policy Decision Makers | We will be recruiting 20 of these individuals to participate in our Aim 3 qualitative interviews. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aim 1: Prescription medication access
Medication prescription fills, In-person prescribing, Telehealth prescribing for OUD and AUD (clinical comparator)
Measured: January 2019-December 2019; April 2020-March 2021
Aim 1: Patient-provider encounter
In-person counseling / psychotherapy, Telehealth counseling/ psychotherapy for OUD and AUD (clinical comparator)
Measured: January 2019-December 2019; April 2020-March 2021
Aim 2: Treatment retention/discontinuation
Medication treatment retention, as measured by continuous and treatment, for patients with OUD and AUD (comparator)
Measured: January 2019-December 2019; April 2020-March 2021
Aim 2: Adverse outcomes
Emergency Department visits, Detoxification treatment utilization, Overdose, Death, OUD/AUD Relapse for OUD and AUD (clinical comparator)
Measured: January 2019-December 2019; April 2020-March 2021
Aim 3: Semi-structured qualitative interview data from patients, providers, policy makers
[Qualitative] Patient, provider, and policy-maker perspectives regarding OUD treatment and OUD treatment policies, practices, and implementation during COVID-19
Measured: January 2019-December 2019; April 2020-March 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2021
- Study start15 Sep 2021
- Primary completion27 Jul 2023
- Study completion31 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid-use DisorderStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston VA Research Institute, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, Boston University, International Business Machines (IBM)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05028998
- Sponsor's protocol ID
- COVID-2020C2-11081
- Acronym
- COPE
- Status last verified
- Jul 2023
- First submitted
- 27 Aug 2021
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of COVID-19-related Medication Assisted Treatment Policy Changes on Care and Outcomes for Patients With Opioid Use Disorder
- ClinicalTrials.gov ID
- NCT05028998
- Acronym / sponsor ID
- COPE / COVID-2020C2-11081
- Conditions
- Opioid-use Disorder, Alcohol Use Disorder
- Keywords
- opioid use disorder, methadone, buprenorphine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Boston VA Research Institute, Inc.University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, Boston University, International Business Machines (IBM)
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- 27 Jul 2023 (actual)
- Study completion
- 31 Aug 2023 (estimated)
- First posted
- 31 Aug 2021 (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.
Our nation is facing the COVID-19 pandemic during an ongoing opioid epidemic. Effective treatment for patients with opioid use problems involves a treatment method called Medication-Assisted Treatment, or MAT. In MAT, patients receive a medication that reduces cravings and withdrawal symptoms and can prevent overdose. Patients also receive counseling. Because the medications that are used in MAT are controlled substances, this treatment is subject to a number of federal regulations. The need for social-distancing during the pandemic would have made following these regulations very difficult for patients and their providers. Because of these difficulties, the federal government eased regulations in March 2020, making it easier for patients to receive MAT with fewer (if any) in-person visits for medication and counseling. Our team is studying the effects of these policy changes on the treatment that patients with opioid use disorder receive and on their outcomes. We are using both quantitative analyses of large, existing databases and qualitative analyses of interviews with patients, providers, and policy-makers to study these effects.
Detailed description
The COVID-19 disease outbreak has occurred in the midst of a national opioid crisis, and poses significant risk for individuals with opioid use disorder (OUD). If existing in-person care delivery systems continued, patients would need to choose between risking exposure to the virus, or foregoing OUD treatment. Medication-assisted treatment (MAT), the gold-standard for treating OUD, involves daily medication (i.e., methadone or buprenorphine), close medication monitoring, and counseling sessions, all typically occurring in person. The medications used are schedule II and III controlled substances and are subject to greater federal regulations than medications for other substance use disorders (SUD), such as alcohol use disorder (AUD).3 To temper the impact of COVID-19 on OUD patients, in March 2020 the federal government temporarily, but dramatically, loosened MAT restrictions to expand treatment options, require fewer in-person visits, and prevent disruption to life-saving treatment.
This rapid shift in policy created a natural experiment, allowing for the evaluation of this MAT policy intervention on OUD patient care and outcomes. To examine the unknown effects of this intervention, we propose a mixed-methods, naturalistic experimental design involving quantitative analysis of large administrative and healthcare utilization datasets to evaluate the impact of MAT policy changes on patient care and outcomes. We will also compare OUD patient outcomes to those of AUD patients (analogue comparison group), for whom treatment was unaffected by MAT policy changes. We will then conduct interviews with patients, providers, and key MAT policy stakeholders, to understand perspectives on the impact of these COVID-19 related MAT policy changes on the lives and well-being of OUD patients, and guide policy decisions regarding whether or not to make these changes permanent. Given the general impact of the COVID-19 pandemic on patients and systems, we will compare outcomes for patients with OUD to analogue AUD patients, for whom there were no comparable medication policy changes in response to COVID-19.
Patients with OUD across three healthcare systems will be engaged in all steps of the research, including influencing the research design, assisting in determining key variables for Aims 1 and 2, collaborating in drafting our interview scripts for Aim 3, and assisting in interpreting our results and disseminating findings to patient stakeholders.
Aim 1. Using existing datasets, examine the effect of federal regulation changes on trends in delivery of MAT for OUD before and after pandemic onset, with a particular focus on prescription access, refills, and dosing schedules, as well as rates of in-person vs. telehealth medical and counseling visits.
Aim 2. Estimate the impact of the changes in OUD healthcare delivery on crucial patient outcomes (e.g., emergency department visits, detoxification, treatment retention, relapse, overdose, and mortality) by comparing patients with OUD vs. AUD (clinical analogue comparison group), across time (pre- and post-MAT policy changes).
Aim 3. Through in-depth, qualitative interviews and analyses, characterize patient, provider, and decision-maker perspectives on the impact of MAT policy changes in response to COVID-19 on patient access to MAT, health, functioning, and well-being.
Built-in reporting milestones will expedite data sharing to guide policy, provider, and patient decision-making as health care systems determine how to prepare for future pandemics, and post-COVID-19 pandemic care for OUD patients.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Veterans with Opioid Use Disorder receiving care through the Veterans Health Administration | – | –Pre-existing medical records data for these individuals will be part of our Aim 1 and Aim 2 large quantitative database. Additionally, we will be recruiting 30 of these individuals to participate in our Aim 3 qualitative interviews. |
| Veterans with Alcohol Use Disorder receiving care through the Veterans Health Administration | – | –Pre-existing medical records data for these individuals will be part of our Aim 1 and Aim 2 large quantitative database. We will not be recruiting any of these individuals for Aim 3 qualitative interviews. |
| Patients with Opioid Use Disorder for whom Market Scan Medicaid Claims data is available | – | –Pre-existing medical records data for these individuals will be part of our Aim 1 and Aim 2 large quantitative database. We will not be recruiting any of these individuals for Aim 3 qualitative interviews. |
| Patients with Alcohol Use Disorder for whom Market Scan Medicaid Claims data is available | – | –Pre-existing medical records data for these individuals will be part of our Aim 1 and Aim 2 large quantitative database. We will not be recruiting any of these individuals for Aim 3 qualitative interviews. |
| Patients with Opioid Use Disorder for whom Market Scan Commercial Insurance Claims data is available | – | –Pre-existing medical records data for these individuals will be part of our Aim 1 and Aim 2 large quantitative database. We will not be recruiting any of these individuals for Aim 3 qualitative interviews. |
| Patients with Alcohol Use Disorder for whom Market Scan Commercial Claims data is available | – | –Pre-existing medical records data for these individuals will be part of our Aim 1 and Aim 2 large quantitative database. We will not be recruiting any of these individuals for Aim 3 qualitative interviews. |
| Patients with Opioid Use Disorder receiving care outside of Veterans Health Administration | – | –We will be recruiting 30 of these individuals to participate in our Aim 3 qualitative interviews. |
| Opioid Use Disorder Treatment Providers who provide treatment in the Veterans Health Administration | – | –We will be recruiting 15 of these individuals to participate in our Aim 3 qualitative interviews. |
| Opioid Use Disorder Providers who treat outside the Veterans Health Administration | – | –We will be recruiting 15 of these individuals to participate in our Aim 3 qualitative interviews. |
| Opioid Use Disorder Treatment and Policy Decision Makers | – | –We will be recruiting 20 of these individuals to participate in our Aim 3 qualitative interviews. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Veterans Health Administration and non-Veterans Health Administration (commercially and Medicaid-covered individuals) patients with OUD and their matched AUD comparators will be included in Aim 1 and 2 analyses. These represent archival claims (non-Veterans Health Administration data) and electronic health record data (Veterans Health Administration). The population for Aim 3 will include veterans who are current or recent patients of Veterans Health Administration, seeking/having received treatment for OUD at Veterans Health Administration; non-veterans seeking/having received treatment for OUD outside Veterans Health Administration; clinicians who treat patients with OUD within or outside Veterans Health Administration; and policy/decision-makers with expertise in opioid and OUD treatment policy.
Key inclusion criteria (5 listed)
- VA patients with OUD who currently, or recently (within the past 6 months) receive(d) treatment for OUD from providers within Veterans Health Administration in the states of Massachusetts, Rhode Island, or New Hampshire.
- Non-Veteran patients with OUD (N=30) who currently, or recently (within the past 6 months) receive(d) treatment for OUD from providers outside Veterans Health Administration in the states of Massachusetts, Rhode Island, or New Hampshire.
- VA - OUD treatment providers who currently provide treatment for OUD within Veterans Health Administration, and have been a Veterans Health Administration provider of OUD treatment for at least one year in Massachusetts, Rhode Island, or New Hampshire.
- Non-VA OUD treatment providers who currently provide treatment for OUD outside of Veterans Health Administration, and have been a provider of OUD treatment for at least one year in Massachusetts, Rhode Island, or New Hampshire.
- OUD treatment and policy decision-makers who currently or recently (within past 6 months) hold/held positions within federal, state, or private organizations (e.g., Veterans Health Administration, SAMHSA) in which they are responsible for making and/or influencing significant decisions regarding the OUD treatment policy and/or the manner in which these are implemented.
Key exclusion criteria (3 listed)
- Under 18
- Inability to speak fluent English
- Inability to provide a clear reporting of their experiences due to current influence of substances
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Aim 1: Prescription medication access
Time frame: January 2019-December 2019; April 2020-March 2021
Medication prescription fills, In-person prescribing, Telehealth prescribing for OUD and AUD (clinical comparator)
Aim 1: Patient-provider encounter
Time frame: January 2019-December 2019; April 2020-March 2021
In-person counseling / psychotherapy, Telehealth counseling/ psychotherapy for OUD and AUD (clinical comparator)
Aim 2: Treatment retention/discontinuation
Time frame: January 2019-December 2019; April 2020-March 2021
Medication treatment retention, as measured by continuous and treatment, for patients with OUD and AUD (comparator)
Aim 2: Adverse outcomes
Time frame: January 2019-December 2019; April 2020-March 2021
Emergency Department visits, Detoxification treatment utilization, Overdose, Death, OUD/AUD Relapse for OUD and AUD (clinical comparator)
Aim 3: Semi-structured qualitative interview data from patients, providers, policy makers
Time frame: January 2019-December 2019; April 2020-March 2021
[Qualitative] Patient, provider, and policy-maker perspectives regarding OUD treatment and OUD treatment policies, practices, and implementation during COVID-19
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
Related trials for Opioid-use Disorder
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Enrolling by invitationObservational study
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
Substance Use Disorders (SUDs)
Not yet recruiting
Comprehensive Opioid Management and Breathing During Sleep
Sleep-Disordered Breathing, Chronic Opioid Use
Active, not recruitingPhase 2
Wellcome Leap Psilocybin for OUD
Opioid Use Disorder
Recruiting
Opioid and Pain Treatment in Indigenous Communities (OPTIC) Trial
Opioid Use Disorder, Opioid Misuse
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Opioid-use Disorder and Alcohol Use Disorder, run by Boston VA Research Institute, Inc. 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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 1 Aug 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Risa Weisberg, PhD (857-364-4035 ext. 44035, risa.weisberghawkins@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aim 1: Prescription medication access (time frame: January 2019-December 2019; April 2020-March 2021). The study lists 5 primary outcomes in all. 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 1 Aug 2023.