Opioid-use DisorderNCT02926482
Intervention to Expand Opioid Use Disorder Treatment Pharmacotherapy Prescribers
A study testing Prescriber Recruitment Bundle (PRB) in people with Opioid-use Disorder, run by University of Wisconsin, Madison at 3 sites in United States.
Trial summary
This is a cluster-randomized controlled trial designed to increase the availability of buprenorphine and extended-release naltrexone treatment capacity for opioid use disorder (OUD). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Opioid-use Disorder
- What is being tested?
- Prescriber Recruitment Bundle (PRB)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 3 sitesUnited States
- Study dates
- 26 Oct 2016to Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Organizations that are publicly funded through the Substance Abuse and Prevention Treatment (SAPT) block grant, and had more than 100 admissions/annum about their interest in greater buprenorphine prescribing capacity.
- Organizations in the states of Florida, Ohio, and Wisconsin.
Who cannot join
- Organizations that are not publicly funded through the SAPT block grant, or do not have interest in expanding their buprenorphine prescribing capacity.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Ohio Department of Mental Health and Addiction Services
Columbus, Ohio, 43215-3430
Center for Health Enhancement Systems
Madison, Wisconsin, 53706
Florida Alcohol and Drug Abuse Association
Tallahassee, Florida, 32308
About this study
Official title: Test of a Workforce Development Intervention to Expand Buprenorphine Prescribers
This is a cluster-randomized controlled trial designed to increase the availability of buprenorphine and extended-release naltrexone treatment capacity for opioid use disorder (OUD). The intervention being tested is a bundle of OUD pharmacotherapy capacity building practices called the Prescriber Recruitment Bundle (PRB). For the study, 70 organizations will be identified and recruited, and those organizations will then be randomized into one of two arms: 1) control, and 2) intervention: organizations implementing the PRB using the Network for Improvement of Addiction Treatment (NIATx) Organizational Change Model. The primary research question is to test the impact of the PRB, relative to the control, on increasing buprenorphine treatment slots and extended-release naltrexone capacity and the number of patients receiving these pharmacotherapies.
Read the detailed description
Overdoses due to non-medical use of prescription opioids and other opiates have become the leading cause of accidental deaths in the United States. Buprenorphine and extended-release naltrexone are key evidence-based interventions available to addiction treatment providers to treat opioid use disorder (OUD) and prevent overdose deaths. However, organizations' efforts to provide these pharmacotherapies have been hindered by limited success in recruiting providers (physicians, nurse practitioners, and physician assistants) to prescribe the medications. The addiction field has not historically attracted physicians and limits on access are compounded by buprenorphine's unique regulatory situation, in which physicians and other prescribers must apply for a waiver that allows them buprenorphine prescribing slots to treat 30 patients in the first year and 100 in the following years.
This study will address this emerging need to increase access to buprenorphine and extended-release naltrexone by testing a bundle of practices, called the Prescriber Recruitment Bundle (PRB), which aims to recruit prescribers licensed to prescribe buprenorphine to work with addiction treatment organizations. The PRB consists of the following elements, a) candidate identification strategies, b) prescriber education forums, c) prescriber-friendly workflow and risk-reduction strategies, d) academic detailing to recruit OUD prescribers, e) telemedicine to provide access to OUD pharmacotherapies, and f) organizational leadership and culture to support building OUD pharmacotherapy capacity.
In this cluster randomized controlled trial, the primary research question is to test the impact of the PRB implemented in conjunction with the NIATx organizational change model, relative to the control, on increasing the number of buprenorphine treatment slots and extended-release naltrexone capacity and increasing the number of patients receiving buprenorphine and extended-release naltrexone in the participating addiction treatment organizations. The secondary research question is to test if the PRB affects factors likely to be associated with prescriber recruitment, including: resources dedicated to prescriber recruitment, prescriber recruiter motivation, and current employed physician satisfaction. Lastly, qualitative methods will be used to study the context and processes that influence PRB adoption and fidelity and to understand and develop a deeper understanding of how the PRB influences recruitment beyond the existing study variables.
- Conditions
- Opioid-use Disorder
- Being tested
- Prescriber Recruitment Bundle (PRB)
- Keywords
- Evidence-based practice implementation, Buprenorphine, Addiction treatment, Extended-release naltrexone, Addiction
- Medical subject headings
- Opioid-Related Disorders, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prescriber Recruitment Bundle (PRB)Behavioural
Also called PRB
The Prescriber Recruitment Bundle (PRB) is a bundle pharmacotherapy capacity building practices. The PRB to be implemented contains the following elements, a) candidate identification strategies, b) prescriber education forums, c) prescriber-friendly workflow and risk-reduction strategies, d) academic detailing to recruit OUD prescribers, e) telemedicine, and f) organizational leadership and culture to support building OUD pharmacotherapy capacity.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | This arm will include 35 organizations who receive access to the Prescriber Recruitment Bundle (PRB) materials online via a secure website. |
| PRB: organizations implementing the PRB | Experimental | This arm will include 35 organizations that will implement the intervention, the Prescriber Recruitment Bundle (PRB) using the NIATx Organizational Change Model (a model developed by our center research team). Receives: Behavioral: Prescriber Recruitment Bundle (PRB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Buprenorphine slots and extended naltrexone capacity survey
Monthly number of assigned and open buprenorphine slots as well as extended-release naltrexone capacity and administrations over the past month.
Measured: Monthly; beginning in Month 13 (April 2017) and continuing up to Month 50.
Secondary outcomes (3)
Organizational survey
Measures PRB implementation fidelity
Measured: Annual data collection, starting in Month 13 (April 2017) and continuing to Month 38.
Physician Satisfaction
Collected via the "Physician Worklife Survey." Quantitative measure of a physician (or other prescribers) job satisfaction.
Measured: Annual data collection; starting in Month 13 (April 2017) and continuing up to Month 38.
Qualitative surveys
Measure of an addiction treatment organization's resources dedicated to prescriber recruitment. Participants will read statements regarding their organization's resources dedicated to prescriber recruitment, and their responses are recorded on a scale of 1-5, where 1 corresponds to "Not True" or "Strongly Disagree" and 5 corresponds to "Very True" or "Strongly Agree."
Measured: Twice; first in Month 22 (January 2018) and again in Month 43.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2016 (estimated)
- Study start26 Oct 2016
- Primary completionOct 2019
- Study completionOct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (31)Papers the sponsor has linked to this study.
- Other trials for Opioid-use DisorderStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Todd Molfenter, Principal investigator, Center for Health Enhancement Systems Studies, University of Wisconsin-Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02926482
- Sponsor's protocol ID
- 2016-0486
- Other IDs
- 1R01DA041415, A195010, ENGR/INDUSTRIAL ENGR
- Status last verified
- Oct 2020
- First submitted
- 9 Sep 2016
- Last updated
- 13 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Chen LH, Hedegaard H, Warner M. Drug-poisoning Deaths Involving Opioid Analgesics: United States, 1999-2011. NCHS Data Brief. 2014 Sep;(166):1-8.
PubMed 25228059Berglund M. A better widget? Three lessons for improving addiction treatment from a meta-analytical study. Addiction. 2005 Jun;100(6):742-50. doi: 10.1111/j.1360-0443.2005.01106.x.
PubMed 15918803Mattick RP, Breen C, Kimber J, Davoli M. Buprenorphine maintenance versus placebo or methadone maintenance for opioid dependence. Cochrane Database Syst Rev. 2014 Feb 6;2014(2):CD002207. doi: 10.1002/14651858.CD002207.pub4.
PubMed 24500948Jones CM, Campopiano M, Baldwin G, McCance-Katz E. National and State Treatment Need and Capacity for Opioid Agonist Medication-Assisted Treatment. Am J Public Health. 2015 Aug;105(8):e55-63. doi: 10.2105/AJPH.2015.302664. Epub 2015 Jun 11.
PubMed 26066931Molfenter T, Kim JS, Quanbeck A, Patel-Porter T, Starr S, McCarty D. Testing use of payers to facilitate evidence-based practice adoption: protocol for a cluster-randomized trial. Implement Sci. 2013 May 10;8:50. doi: 10.1186/1748-5908-8-50.
PubMed 23663749Molfenter T, Sherbeck C, Zehner M, Starr S. Buprenorphine Prescribing Availability in a Sample of Ohio Specialty Treatment Organizations. J Addict Behav Ther Rehabil. 2015;4(2):1000140. doi: 10.4172/2324-9005.1000140.
PubMed 26380328Stein BD, Gordon AJ, Dick AW, Burns RM, Pacula RL, Farmer CM, Leslie DL, Sorbero M. Supply of buprenorphine waivered physicians: the influence of state policies. J Subst Abuse Treat. 2015 Jan;48(1):104-11. doi: 10.1016/j.jsat.2014.07.010. Epub 2014 Aug 2.
PubMed 25218919Klein KJ, Conn AB, Sorra JS. Implementing computerized technology: an organizational analysis. J Appl Psychol. 2001 Oct;86(5):811-24. doi: 10.1037/0021-9010.86.5.811.
PubMed 11596799Tremblay MA, Blanchard CM, Taylor S, Pelletier LG, Villeneuve M. Work Extrinsic and Intrinsic Motivation Scale: Its value for organizational psychology research. Canadian Journal of Behavioural Science/Revue canadienne des sciences du comportement. 2009;41(4):213-226.
Williams ES, Konrad TR, Linzer M, McMurray J, Pathman DE, Gerrity M, Schwartz MD, Scheckler WE, Van Kirk J, Rhodes E, Douglas J. Refining the measurement of physician job satisfaction: results from the Physician Worklife Survey. SGIM Career Satisfaction Study Group. Society of General Internal Medicine. Med Care. 1999 Nov;37(11):1140-54. doi: 10.1097/00005650-199911000-00006.
PubMed 10549616Centers for Disease Control and Prevention (CDC). Vital Signs: Opioid painkiller prescribing. 2014.
Soumerai SB, Avorn J. Principles of educational outreach ('academic detailing') to improve clinical decision making. JAMA. 1990 Jan 26;263(4):549-56.
PubMed 2104640Goldstein MG, Niaura R, Willey C, Kazura A, Rakowski W, DePue J, Park E. An academic detailing intervention to disseminate physician-delivered smoking cessation counseling: smoking cessation outcomes of the Physicians Counseling Smokers Project. Prev Med. 2003 Feb;36(2):185-96. doi: 10.1016/s0091-7435(02)00018-x.
PubMed 12590994McCarty D, Gustafson DH, Wisdom JP, Ford J, Choi D, Molfenter T, Capoccia V, Cotter F. The Network for the Improvement of Addiction Treatment (NIATx): enhancing access and retention. Drug Alcohol Depend. 2007 May 11;88(2-3):138-45. doi: 10.1016/j.drugalcdep.2006.10.009. Epub 2006 Nov 28.
PubMed 17129680Hoffman KA, Ford JH 2nd, Choi D, Gustafson DH, McCarty D. Replication and sustainability of improved access and retention within the Network for the Improvement of Addiction Treatment. Drug Alcohol Depend. 2008 Nov 1;98(1-2):63-9. doi: 10.1016/j.drugalcdep.2008.04.016. Epub 2008 Jun 18.
PubMed 18565693
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Test of a Workforce Development Intervention to Expand Buprenorphine Prescribers
- ClinicalTrials.gov ID
- NCT02926482
- Acronym / sponsor ID
- 2016-0486
- Conditions
- Opioid-use Disorder
- Keywords
- Evidence-based practice implementation, Buprenorphine, Addiction treatment, Extended-release naltrexone, Addiction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 26 Oct 2016 (actual)
- Primary completion
- Oct 2019 (actual)
- Study completion
- Oct 2019 (actual)
- First posted
- 6 Oct 2016 (estimated)
- 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 is a cluster-randomized controlled trial designed to increase the availability of buprenorphine and extended-release naltrexone treatment capacity for opioid use disorder (OUD). The intervention being tested is a bundle of OUD pharmacotherapy capacity building practices called the Prescriber Recruitment Bundle (PRB). For the study, 70 organizations will be identified and recruited, and those organizations will then be randomized into one of two arms: 1) control, and 2) intervention: organizations implementing the PRB using the Network for Improvement of Addiction Treatment (NIATx) Organizational Change Model. The primary research question is to test the impact of the PRB, relative to the control, on increasing buprenorphine treatment slots and extended-release naltrexone capacity and the number of patients receiving these pharmacotherapies.
Detailed description
Overdoses due to non-medical use of prescription opioids and other opiates have become the leading cause of accidental deaths in the United States. Buprenorphine and extended-release naltrexone are key evidence-based interventions available to addiction treatment providers to treat opioid use disorder (OUD) and prevent overdose deaths. However, organizations' efforts to provide these pharmacotherapies have been hindered by limited success in recruiting providers (physicians, nurse practitioners, and physician assistants) to prescribe the medications. The addiction field has not historically attracted physicians and limits on access are compounded by buprenorphine's unique regulatory situation, in which physicians and other prescribers must apply for a waiver that allows them buprenorphine prescribing slots to treat 30 patients in the first year and 100 in the following years.
This study will address this emerging need to increase access to buprenorphine and extended-release naltrexone by testing a bundle of practices, called the Prescriber Recruitment Bundle (PRB), which aims to recruit prescribers licensed to prescribe buprenorphine to work with addiction treatment organizations. The PRB consists of the following elements, a) candidate identification strategies, b) prescriber education forums, c) prescriber-friendly workflow and risk-reduction strategies, d) academic detailing to recruit OUD prescribers, e) telemedicine to provide access to OUD pharmacotherapies, and f) organizational leadership and culture to support building OUD pharmacotherapy capacity.
In this cluster randomized controlled trial, the primary research question is to test the impact of the PRB implemented in conjunction with the NIATx organizational change model, relative to the control, on increasing the number of buprenorphine treatment slots and extended-release naltrexone capacity and increasing the number of patients receiving buprenorphine and extended-release naltrexone in the participating addiction treatment organizations. The secondary research question is to test if the PRB affects factors likely to be associated with prescriber recruitment, including: resources dedicated to prescriber recruitment, prescriber recruiter motivation, and current employed physician satisfaction. Lastly, qualitative methods will be used to study the context and processes that influence PRB adoption and fidelity and to understand and develop a deeper understanding of how the PRB influences recruitment beyond the existing study variables.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –This arm will include 35 organizations who receive access to the Prescriber Recruitment Bundle (PRB) materials online via a secure website. |
| PRB: organizations implementing the PRB | Experimental | Behavioral: Prescriber Recruitment Bundle (PRB)This arm will include 35 organizations that will implement the intervention, the Prescriber Recruitment Bundle (PRB) using the NIATx Organizational Change Model (a model developed by our center research team). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Organizations that are publicly funded through the Substance Abuse and Prevention Treatment (SAPT) block grant, and had more than 100 admissions/annum about their interest in greater buprenorphine prescribing capacity.
- Organizations in the states of Florida, Ohio, and Wisconsin.
Key exclusion criteria (1 listed)
- Organizations that are not publicly funded through the SAPT block grant, or do not have interest in expanding their buprenorphine prescribing capacity.
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 |
|---|---|---|
| Prescriber Recruitment Bundle (PRB)Also: PRBThe Prescriber Recruitment Bundle (PRB) is a bundle pharmacotherapy capacity building practices. The PRB to be implemented contains the following elements, a) candidate identification strategies, b) prescriber education forums, c) prescriber-friendly workflow and risk-reduction strategies, d) academic detailing to recruit OUD prescribers, e) telemedicine, and f) organizational leadership and culture to support building OUD pharmacotherapy capacity. | Behavioural | PRB: organizations implementing the PRB |
Primary outcome
Buprenorphine slots and extended naltrexone capacity survey
Time frame: Monthly; beginning in Month 13 (April 2017) and continuing up to Month 50.
Monthly number of assigned and open buprenorphine slots as well as extended-release naltrexone capacity and administrations over the past month.
3 secondary outcomes
Organizational survey
Time frame: Annual data collection, starting in Month 13 (April 2017) and continuing to Month 38.
Physician Satisfaction
Time frame: Annual data collection; starting in Month 13 (April 2017) and continuing up to Month 38.
Qualitative surveys
Time frame: Twice; first in Month 22 (January 2018) and again in Month 43.
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 13 Aug 2024.
- Background: PubMed 25228059Chen LH, Hedegaard H, Warner M. Drug-poisoning Deaths Involving Opioid Analgesics: United States, 1999-2011. NCHS Data Brief. 2014 Sep;(166):1-8.
- Background: PubMed 15918803Berglund M. A better widget? Three lessons for improving addiction treatment from a meta-analytical study. Addiction. 2005 Jun;100(6):742-50. doi: 10.1111/j.1360-0443.2005.01106.x.
- Background: PubMed 24500948Mattick RP, Breen C, Kimber J, Davoli M. Buprenorphine maintenance versus placebo or methadone maintenance for opioid dependence. Cochrane Database Syst Rev. 2014 Feb 6;2014(2):CD002207. doi: 10.1002/14651858.CD002207.pub4.
- Background: PubMed 26066931Jones CM, Campopiano M, Baldwin G, McCance-Katz E. National and State Treatment Need and Capacity for Opioid Agonist Medication-Assisted Treatment. Am J Public Health. 2015 Aug;105(8):e55-63. doi: 10.2105/AJPH.2015.302664. Epub 2015 Jun 11.
- Background: PubMed 23663749Molfenter T, Kim JS, Quanbeck A, Patel-Porter T, Starr S, McCarty D. Testing use of payers to facilitate evidence-based practice adoption: protocol for a cluster-randomized trial. Implement Sci. 2013 May 10;8:50. doi: 10.1186/1748-5908-8-50.
- Background: PubMed 26380328Molfenter T, Sherbeck C, Zehner M, Starr S. Buprenorphine Prescribing Availability in a Sample of Ohio Specialty Treatment Organizations. J Addict Behav Ther Rehabil. 2015;4(2):1000140. doi: 10.4172/2324-9005.1000140.
- Background: PubMed 25218919Stein BD, Gordon AJ, Dick AW, Burns RM, Pacula RL, Farmer CM, Leslie DL, Sorbero M. Supply of buprenorphine waivered physicians: the influence of state policies. J Subst Abuse Treat. 2015 Jan;48(1):104-11. doi: 10.1016/j.jsat.2014.07.010. Epub 2014 Aug 2.
- Background: PubMed 11596799Klein KJ, Conn AB, Sorra JS. Implementing computerized technology: an organizational analysis. J Appl Psychol. 2001 Oct;86(5):811-24. doi: 10.1037/0021-9010.86.5.811.
- BackgroundTremblay MA, Blanchard CM, Taylor S, Pelletier LG, Villeneuve M. Work Extrinsic and Intrinsic Motivation Scale: Its value for organizational psychology research. Canadian Journal of Behavioural Science/Revue canadienne des sciences du comportement. 2009;41(4):213-226.
- Background: PubMed 10549616Williams ES, Konrad TR, Linzer M, McMurray J, Pathman DE, Gerrity M, Schwartz MD, Scheckler WE, Van Kirk J, Rhodes E, Douglas J. Refining the measurement of physician job satisfaction: results from the Physician Worklife Survey. SGIM Career Satisfaction Study Group. Society of General Internal Medicine. Med Care. 1999 Nov;37(11):1140-54. doi: 10.1097/00005650-199911000-00006.
- BackgroundCenters for Disease Control and Prevention (CDC). Vital Signs: Opioid painkiller prescribing. 2014.
- Background: PubMed 2104640Soumerai SB, Avorn J. Principles of educational outreach ('academic detailing') to improve clinical decision making. JAMA. 1990 Jan 26;263(4):549-56.
- 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.
Todd Molfenter principal investigator
Center for Health Enhancement Systems Studies, University of Wisconsin-Madison
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prescriber Recruitment Bundle (PRB) in people with Opioid-use Disorder, run by University of Wisconsin, Madison at 3 sites 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 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Buprenorphine slots and extended naltrexone capacity survey (time frame: Monthly; beginning in Month 13 (April 2017) and continuing up to Month 50.). 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 NCT02926482, which also lists 31 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 13 Aug 2024.