Chronic Non-malignant PainPPACTNCT02113592
Pain Program for Active Coping & Training
A study testing Interdisciplinary pain program in people with Chronic Non-malignant Pain, run by Kaiser Permanente at 3 sites in United States.
Trial summary
The overall aim of this study is to adopt an integrative rehabilitation approach for helping patients adopt self-management skills for managing chronic pain, limiting use of opioid medications, and identifying exacerbating factors amenable to treatment (e.g., depression, sleep problems) that is feasible and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Non-malignant Pain
- What is being tested?
- Interdisciplinary pain program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 850 participants
- Where
- 3 sitesUnited States
- Study dates
- 10 Apr 2014to Feb 2018
- 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
Patient inclusion criteria are:
- Adult (18 years of age or older) Kaiser Permanente (KP) health plan members from the KP Northwest, KP Georgia, and KP Hawaii regions who receive their primary care services from participating primary care providers
- Kaiser Permanente health plan membership of at least 180 days duration
- Long term opioid use defined by: 90+ day supply of short acting opioid spanning at least 120 days or 2 or more long acting opioid dispense in the past 180 days
- Pain diagnosis within the past year (based on ICD-9 or ICD-10 diagnostic codes)
- English speaking
Patient exclusion criteria are:
- Currently enrolled in intensive addiction medicine services or evidence of active substance dependence
- Cognitive impairment severe enough to preclude patient's participation in a behavioral/lifestyle change program
- Current malignant cancer diagnosis
- Having received hospice or other end-of-life palliative care within past year
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Kaiser Permanente Center for Health Research
Atlanta, Georgia, 30305
Kaiser Permanente Center for Health Research
Honolulu, Hawaii, 96817
Kaiser Permanente Center for Health Research
Portland, Oregon, 97227
About this study
Official title: Collaborative Care for Chronic Pain in Primary Care
The overall aim of this study is to adopt an integrative rehabilitation approach for helping patients adopt self-management skills for managing chronic pain, limiting use of opioid medications, and identifying exacerbating factors amenable to treatment (e.g., depression, sleep problems) that is feasible and sustainable within the primary care setting.
Read the detailed description
Pain is a common and very costly public health problem. Common chronic pain conditions are expensive and pervasive, affecting at least 116 million American adults at an annual cost of $560 billion in direct medical treatment costs and lost productivity, and disproportionally affect vulnerable populations. Pain is the primary reason patients seek medical care and, as the first point of contact, primary care providers (PCPs) deliver the majority of that care. Unfortunately, PCPs face many challenges in managing these patients' care and often have little specific training in pain medicine. Yet with proper system support, PCPs are in the best position to coordinate pain management longitudinally. While pharmacotherapy is the predominant treatment approach for many PCPs, this limits the patient's role to taking medication, and he or she can become a passive recipient of care-leading to poor outcomes, potential overmedication, and possible disillusionment with the medical system. Further, increases in opiate prescribing for pain treatment-amidst increasing awareness of adverse outcomes, including addiction-and limited efficacy suggest the importance of broader treatment approaches that focus on patients' improvement of functioning. Although opiates may reduce pain symptoms while prescribed, patients are unlikely to experience significant and sustained improvements without the use of other nonpharmacologic pain management approaches. Medical management of patients with persistent pain and complex problems is often fragmented, which leads patients to seek a wide variety of primary and specialty care services in an effort to manage their pain and related conditions. Such fragmented care leads to poorer outcomes and significantly increases health care costs as patients often receive unneeded diagnostic and medical procedures. While research has identified evidence-based multidisciplinary behavioral treatment approaches that are effective for such patients and can even prevent the disability associated with persistent pain when offered earlier in the course of care, these interventions are rarely available in everyday practice settings and will require data from pragmatic clinical trials to change the care paradigm.
To address these issues, we are conducting a large-scale, mixed-methods, cluster-randomized pragmatic clinical trial throughout three regions of Kaiser Permanente - Northwest, Georgia, and Hawaii. This trial will evaluate the integration of multidisciplinary services within the primary care environment as compared to usual care in these settings. This project embeds an intervention into everyday clinical practice flow utilizing assessment measures and intervention staff directly from the clinical care system rather than utilizing a research-developed and administered structure. The intervention is an integrated, interdisciplinary program that guides all pain-related care for intervention patients. This study compares this primary care-based intervention to usual care using systematic, clinic-based assessments. The trial will include up to 1,000 patients and 500 primary care providers (half of each receiving active treatment) with intervention care being delivered by behavioral specialists, nurses, physical therapists, pharmacists, and other affiliated staff. Patients include those selected by their primary care providers who have non-malignant chronic pain (pain persisting for ≥ 3 months) and who are on long-term opiate therapy for the treatment of their condition. This intervention brings together elements often available in health plans but organized in a less integrated fashion, and it will ensure flexibility in implementation to best fit individual clinic environments and the needs of chronic pain patients on long-term opiate therapy.
- Conditions
- Chronic Non-malignant Pain
- Being tested
- Interdisciplinary pain program
- Keywords
- Pain management, Opioid use, Pragmatic, Collaborative care, Primary care
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interdisciplinary pain programBehavioural
Interdisciplinary pain program, which includes behavioral health, nurse case management, physical therapy, and pharmacy embedded in primary care.
| Study group | Role | What they receive |
|---|---|---|
| Interdisciplinary pain program | Experimental | Interdisciplinary pain program, which includes behavioral health, nurse case management, physical therapy, and pharmacy embedded in primary care. Receives: Behavioral: Interdisciplinary pain program |
| Treatment as usual | No intervention | Patients in this arm will receive care as usual and utilize services as they currently exist in the health plan system. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Impact Assessed Using the 4-Item Version of Brief Pain Inventory-Short Form ("PEGS")
Reliable and valid tool that measures patients' pain intensity and functional interference. The primary outcome of pain impact is assessed with the 4-item PEGS scale, a composite of pain intensity, and interference with enjoyment of life, general activity, and sleep (range, 0-10, higher score = worse pain impact).
Measured: Collected every 3 months for 1 year
Secondary outcomes (7)
Pain-related Disability
Pain-related disability will be assessed using the 24-item Roland Morris Disability Questionnaire (range, 0-1, higher score = worse function)
Measured: Collected every 3 months for 1 year
Average Daily Dose of Opioids
Average daily dose of opioids per 3-month quarter measured in morphine milligram equivalents (MME)
Measured: Collected every 3 months for 1 year
Patient Satisfaction
Patient satisfaction with health care services will be assessed using two distinct items:
- [Satisfaction with primary care services]: In the past 3 months, how satisfied have you been with your primary care services? (1, Very dissatisfied; 2, Mildly dissatisfied; 3, Indifferent; 4, Mostly satisfied; 5, Very satisfied)
- [Satisfaction with pain services]: In the past 3 months, how satisfied have you been with the pain services you have received? (1, Very dissatisfied; 2, Mildly dissatisfied; 3, Indifferent; 4, Mostly satisfied; 5, Very satisfied)
Each item is scored individually; (range=1-5, higher score = greater satisfaction)
Measured: Collected at baseline and 6 months (post-treatment)
Health Care Costs
Costs were measured based on patient utilization of health care services and all prescription/medication costs. The costs of health care encounters during the 1-year follow-up were estimated using the standardized relative resource cost algorithm (SRRCA).
Pain-related health care costs were based on the pain-related health care encounters identified using diagnostic and procedure coding.
Measured: Collected for 1 year post-randomization
Count of Health Care Encounters by Type (Health Care Utilization)
Total Ambulatory Encounters includes encounters in the following health care service categories: Primary care; Physical therapy; Pain clinic; Other specialty medical care; Mental health; Complementary and alternative medicine; ED, urgent care, and observation beds; Hospital ambulatory visits; Same day surgeries; and Home health.
Total Pain-Related Ambulatory Encounters are a subset of Total Ambulatory Encounters and were identified using CPT, HCPCS, and ICD-9-PCS or ICD-10-PCS codes
Measured: Collected for 1 year post-randomization
Inpatient Hospital Days (Health Care Utilization)
Inpatient hospital days is the average number of days that patients stayed in hospital (total number of days spent by inpatients during the 1 year post-randomization divided by the total number of inpatient admissions)
Measured: Collected for 1 year post-randomization
Total Pharmacy Dispenses (Health Care Utilization)
Total Pharmacy Dispenses is a count of the unique medication prescriptions dispensed.
Measured: Collected for 1 year post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2014 (estimated)
- Study start10 Apr 2014
- Primary completionFeb 2018
- Study completionFeb 2018
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 (6)Papers the sponsor has linked to this study.
- Other trials for Chronic Non-malignant PainStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 850 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), Duke University, Oregon Health and Science University
- Responsible party
- Sponsor
- Investigators
- Lynn DeBar, PhD, MPH, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02113592
- Sponsor's protocol ID
- Pro00004169
- Other IDs
- UH3NS088731
- Acronym
- PPACT
- Status last verified
- Apr 2022
- First submitted
- 7 Apr 2014
- Last updated
- 28 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Smith DH, O'Keeffe-Rosetti M, Leo MC, Mayhew M, Benes L, Bonifay A, Deyo RA, Elder CR, Keefe FJ, McMullen C, Owen-Smith A, Trinacty CM, Vollmer WM, DeBar L. Economic Evaluation: A Randomized Pragmatic Trial of a Primary Care-based Cognitive Behavioral Intervention for Adults Receiving Long-term Opioids for Chronic Pain. Med Care. 2022 Jun 1;60(6):423-431. doi: 10.1097/MLR.0000000000001713. Epub 2022 Mar 30.
PubMed 35352703DeBar L, Mayhew M, Benes L, Bonifay A, Deyo RA, Elder CR, Keefe FJ, Leo MC, McMullen C, Owen-Smith A, Smith DH, Trinacty CM, Vollmer WM. A Primary Care-Based Cognitive Behavioral Therapy Intervention for Long-Term Opioid Users With Chronic Pain : A Randomized Pragmatic Trial. Ann Intern Med. 2022 Jan;175(1):46-55. doi: 10.7326/M21-1436. Epub 2021 Nov 2.
PubMed 34724405Mayhew M, Leo MC, Vollmer WM, DeBar LL, Kiernan M. Interactive group-based orientation sessions: A method to improve adherence and retention in pragmatic clinical trials. Contemp Clin Trials Commun. 2020 Jan 21;17:100527. doi: 10.1016/j.conctc.2020.100527. eCollection 2020 Mar.
PubMed 32083219Owen-Smith A, Mayhew M, Leo MC, Varga A, Benes L, Bonifay A, DeBar L. Automating Collection of Pain-Related Patient-Reported Outcomes to Enhance Clinical Care and Research. J Gen Intern Med. 2018 May;33(Suppl 1):31-37. doi: 10.1007/s11606-018-4326-9.
PubMed 29633139DeBar L, Benes L, Bonifay A, Deyo RA, Elder CR, Keefe FJ, Leo MC, McMullen C, Mayhew M, Owen-Smith A, Smith DH, Trinacty CM, Vollmer WM. Interdisciplinary team-based care for patients with chronic pain on long-term opioid treatment in primary care (PPACT) - Protocol for a pragmatic cluster randomized trial. Contemp Clin Trials. 2018 Apr;67:91-99. doi: 10.1016/j.cct.2018.02.015. Epub 2018 Mar 6.
PubMed 29522897Johnson KE, Neta G, Dember LM, Coronado GD, Suls J, Chambers DA, Rundell S, Smith DH, Liu B, Taplin S, Stoney CM, Farrell MM, Glasgow RE. Use of PRECIS ratings in the National Institutes of Health (NIH) Health Care Systems Research Collaboratory. Trials. 2016 Jan 16;17:32. doi: 10.1186/s13063-016-1158-y.
PubMed 26772801
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collaborative Care for Chronic Pain in Primary Care
- ClinicalTrials.gov ID
- NCT02113592
- Acronym / sponsor ID
- PPACT / Pro00004169
- Conditions
- Chronic Non-malignant Pain
- Keywords
- Pain management, Opioid use, Pragmatic, Collaborative care, Primary care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 850 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), Duke University, Oregon Health and Science University
- Study start
- 10 Apr 2014 (actual)
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 14 Apr 2014 (estimated)
- Results
- Posted 18 May 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall aim of this study is to adopt an integrative rehabilitation approach for helping patients adopt self-management skills for managing chronic pain, limiting use of opioid medications, and identifying exacerbating factors amenable to treatment (e.g., depression, sleep problems) that is feasible and sustainable within the primary care setting.
Detailed description
Pain is a common and very costly public health problem. Common chronic pain conditions are expensive and pervasive, affecting at least 116 million American adults at an annual cost of $560 billion in direct medical treatment costs and lost productivity, and disproportionally affect vulnerable populations. Pain is the primary reason patients seek medical care and, as the first point of contact, primary care providers (PCPs) deliver the majority of that care. Unfortunately, PCPs face many challenges in managing these patients' care and often have little specific training in pain medicine. Yet with proper system support, PCPs are in the best position to coordinate pain management longitudinally. While pharmacotherapy is the predominant treatment approach for many PCPs, this limits the patient's role to taking medication, and he or she can become a passive recipient of care-leading to poor outcomes, potential overmedication, and possible disillusionment with the medical system. Further, increases in opiate prescribing for pain treatment-amidst increasing awareness of adverse outcomes, including addiction-and limited efficacy suggest the importance of broader treatment approaches that focus on patients' improvement of functioning. Although opiates may reduce pain symptoms while prescribed, patients are unlikely to experience significant and sustained improvements without the use of other nonpharmacologic pain management approaches. Medical management of patients with persistent pain and complex problems is often fragmented, which leads patients to seek a wide variety of primary and specialty care services in an effort to manage their pain and related conditions. Such fragmented care leads to poorer outcomes and significantly increases health care costs as patients often receive unneeded diagnostic and medical procedures. While research has identified evidence-based multidisciplinary behavioral treatment approaches that are effective for such patients and can even prevent the disability associated with persistent pain when offered earlier in the course of care, these interventions are rarely available in everyday practice settings and will require data from pragmatic clinical trials to change the care paradigm.
To address these issues, we are conducting a large-scale, mixed-methods, cluster-randomized pragmatic clinical trial throughout three regions of Kaiser Permanente - Northwest, Georgia, and Hawaii. This trial will evaluate the integration of multidisciplinary services within the primary care environment as compared to usual care in these settings. This project embeds an intervention into everyday clinical practice flow utilizing assessment measures and intervention staff directly from the clinical care system rather than utilizing a research-developed and administered structure. The intervention is an integrated, interdisciplinary program that guides all pain-related care for intervention patients. This study compares this primary care-based intervention to usual care using systematic, clinic-based assessments. The trial will include up to 1,000 patients and 500 primary care providers (half of each receiving active treatment) with intervention care being delivered by behavioral specialists, nurses, physical therapists, pharmacists, and other affiliated staff. Patients include those selected by their primary care providers who have non-malignant chronic pain (pain persisting for ≥ 3 months) and who are on long-term opiate therapy for the treatment of their condition. This intervention brings together elements often available in health plans but organized in a less integrated fashion, and it will ensure flexibility in implementation to best fit individual clinic environments and the needs of chronic pain patients on long-term opiate therapy.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interdisciplinary pain program | Experimental | Behavioral: Interdisciplinary pain programInterdisciplinary pain program, which includes behavioral health, nurse case management, physical therapy, and pharmacy embedded in primary care. |
| Treatment as usual | No intervention | –Patients in this arm will receive care as usual and utilize services as they currently exist in the health plan system. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interdisciplinary pain programInterdisciplinary pain program, which includes behavioral health, nurse case management, physical therapy, and pharmacy embedded in primary care. | Behavioural | Interdisciplinary pain program |
Primary outcome
Pain Impact Assessed Using the 4-Item Version of Brief Pain Inventory-Short Form ("PEGS")
Time frame: Collected every 3 months for 1 year
Reliable and valid tool that measures patients' pain intensity and functional interference. The primary outcome of pain impact is assessed with the 4-item PEGS scale, a composite of pain intensity, and interference with enjoyment of life, general activity, and sleep (range, 0-10, higher score = worse pain impact).
7 secondary outcomes
Pain-related Disability
Time frame: Collected every 3 months for 1 year
Average Daily Dose of Opioids
Time frame: Collected every 3 months for 1 year
Patient Satisfaction
Time frame: Collected at baseline and 6 months (post-treatment)
Health Care Costs
Time frame: Collected for 1 year post-randomization
Count of Health Care Encounters by Type (Health Care Utilization)
Time frame: Collected for 1 year post-randomization
Inpatient Hospital Days (Health Care Utilization)
Time frame: Collected for 1 year post-randomization
Total Pharmacy Dispenses (Health Care Utilization)
Time frame: Collected for 1 year post-randomization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 35352703Smith DH, O'Keeffe-Rosetti M, Leo MC, Mayhew M, Benes L, Bonifay A, Deyo RA, Elder CR, Keefe FJ, McMullen C, Owen-Smith A, Trinacty CM, Vollmer WM, DeBar L. Economic Evaluation: A Randomized Pragmatic Trial of a Primary Care-based Cognitive Behavioral Intervention for Adults Receiving Long-term Opioids for Chronic Pain. Med Care. 2022 Jun 1;60(6):423-431. doi: 10.1097/MLR.0000000000001713. Epub 2022 Mar 30.
- Results publication: PubMed 34724405DeBar L, Mayhew M, Benes L, Bonifay A, Deyo RA, Elder CR, Keefe FJ, Leo MC, McMullen C, Owen-Smith A, Smith DH, Trinacty CM, Vollmer WM. A Primary Care-Based Cognitive Behavioral Therapy Intervention for Long-Term Opioid Users With Chronic Pain : A Randomized Pragmatic Trial. Ann Intern Med. 2022 Jan;175(1):46-55. doi: 10.7326/M21-1436. Epub 2021 Nov 2.
- Derived from this study: PubMed 32083219Mayhew M, Leo MC, Vollmer WM, DeBar LL, Kiernan M. Interactive group-based orientation sessions: A method to improve adherence and retention in pragmatic clinical trials. Contemp Clin Trials Commun. 2020 Jan 21;17:100527. doi: 10.1016/j.conctc.2020.100527. eCollection 2020 Mar.
- Derived from this study: PubMed 29633139Owen-Smith A, Mayhew M, Leo MC, Varga A, Benes L, Bonifay A, DeBar L. Automating Collection of Pain-Related Patient-Reported Outcomes to Enhance Clinical Care and Research. J Gen Intern Med. 2018 May;33(Suppl 1):31-37. doi: 10.1007/s11606-018-4326-9.
- Derived from this study: PubMed 29522897DeBar L, Benes L, Bonifay A, Deyo RA, Elder CR, Keefe FJ, Leo MC, McMullen C, Mayhew M, Owen-Smith A, Smith DH, Trinacty CM, Vollmer WM. Interdisciplinary team-based care for patients with chronic pain on long-term opioid treatment in primary care (PPACT) - Protocol for a pragmatic cluster randomized trial. Contemp Clin Trials. 2018 Apr;67:91-99. doi: 10.1016/j.cct.2018.02.015. Epub 2018 Mar 6.
- Derived from this study: PubMed 26772801Johnson KE, Neta G, Dember LM, Coronado GD, Suls J, Chambers DA, Rundell S, Smith DH, Liu B, Taplin S, Stoney CM, Farrell MM, Glasgow RE. Use of PRECIS ratings in the National Institutes of Health (NIH) Health Care Systems Research Collaboratory. Trials. 2016 Jan 16;17:32. doi: 10.1186/s13063-016-1158-y.
- 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.
Lynn DeBar, PhD, MPH principal investigator
Kaiser Permanente
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interdisciplinary pain program in people with Chronic Non-malignant Pain, run by Kaiser Permanente 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?
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 28 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 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?
Yes. Results are posted in the registry (first posted 18 May 2022). 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?
Pain Impact Assessed Using the 4-Item Version of Brief Pain Inventory-Short Form ("PEGS") (time frame: Collected every 3 months for 1 year). 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 NCT02113592, which also lists 6 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 28 Aug 2023.