- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT02564341
Targeting Effective Analgesia in Clinics for HIV - Intervention (TEACH)
Collaborative Care Intervention to Improve Providers' Opioid Prescribing for HIV-infected Patients - Intervention Component
Přehled studie
Postavení
Podmínky
Detailní popis
The "Targeting Effective Analgesia in Clinics for HIV" (TEACH) Study will test the effectiveness of a collaborative care intervention directed toward HIV physicians to improve the management of chronic opioid therapy (COT) and reduce the misuse of prescription opioids among HIV-infected persons.
The intervention is composed of the following elements: 1) collaboration with an IT enabled nurse care manager; 2) physician education and academic detailing; and 3) facilitated access to a specialist in addictions to help manage the most challenging HIV-infected patients on COT. The nurse care manager will utilize an electronic registry to assist physicians in implementing guideline-driven care including opioid treatment agreements, urine drug testing (UDT), random pill counts and checking of online Prescription Monitoring Programs (PMPs). Physicians in the control group will receive information summarizing guidelines for COT but will not have access to the support of the TEACH intervention. This study is multi-site and will be conducted at Boston Medical Center and Grady Hospital (teaching hospital of Emory University). The 2-site study will use a cluster randomized trial design, randomized at the level of the physician, and compare primary outcomes over one year. The Specific Aims are to test the effectiveness of the TEACH collaborative care program to achieve the following: Aim 1 - to test whether the TEACH collaborative care program improves HIV physicians' adherence to guidelines for prescribing COT compared to standard practice; Aim 2 - to assess whether patient level outcomes improve as a result of the TEACH intervention; Aim 3 - to test whether the intervention increases HIV physicians' satisfaction with prescribing COT; and Aim 4 - to assess whether the intervention improves virologic control among HIV-infected patients who are on COT. If effective, implementation of the intervention in HIV clinics will enable physicians in clinical teams to deliver chronic opioid therapy according to established guidelines with more confidence, potentially resulting in less prescription drug abuse and improved HIV outcomes.
There are two distinct components to the study. The intervention, outlined in this Clinical Trials Protocol Registration and Results System (PRS) summary, involves consenting physicians as participants in a randomized controlled trial of an intervention and, via a waiver of informed consent, extracting patient level data on the physicians' patients from the electronic medical record. The patient cohort component, which is outlined in a separate Clinical Trials PRS summary, will involve recruiting and consenting patients in the HIV clinic on COT to be participants in an observational study, which will involve interviewing them to collect self-reported data and conducting medical chart reviews.
If effective, implementation of the TEACH intervention in clinics will enable physicians who provide primary care to HIV-infected patients in clinical teams to deliver chronic opioid therapy according to established guidelines with more confidence, potentially resulting in less prescription drug abuse and improved HIV outcomes.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
Georgia
-
Atlanta, Georgia, Spojené státy, 30322
- Emory University
-
-
Massachusetts
-
Boston, Massachusetts, Spojené státy, 02118
- Boston Medical Center
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Physician Inclusion Criteria:
- Physician (i.e. MD, DO) or Advanced Practice Provider (i.e., Nurse Practitioner or Physicians Assistant) at enrollment sites.
- Main provider for ≥ 1 HIV-infected patient on COT (defined as having received ≥ 3 opioid prescriptions at least 21 days apart within a 6 month period).
Physician Exclusion Criteria:
- Investigator on this study.
- Planning to leave clinic < 9 months from enrollment.
Patient Inclusion Criteria:
- COT patient ages ≥ 18 who are patients of physicians enrolled in the TEACH study.
Patient Exclusion Criteria:
- None
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Výzkum zdravotnických služeb
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: TEACH Collaborative Care Intervention
Physicians randomized to the intervention will receive: 1) collaboration with an IT enabled nurse care manager; 2) physician education and academic detailing; and 3) facilitated access to a specialist in addictions to help manage the most challenging HIV-infected patients on COT.
|
The nurse care manager at each site will collaborate with intervention physicians to implement key essential elements of guideline driven care, namely opioid treatment agreements, urine drug testing, random pill counts and periodic checking of on-line Prescription Monitoring Programs.
The nurse care manager will use an electronic registry to retrieve pain medication information from the electronic medical record (EMR).
Registry data will be collected on the patients of the intervention group providers.
The nurse care manager will be able to use the registry to generate reports that will allow him/her to monitor those patients who are receiving opioids for chronic pain.
All intervention participants will receive a 60 minute group didactic session by a national expert on opioid prescribing for pain.
Physicians will receive two academic detailing sessions, and will be given the option of having a third, booster academic detailing session if desired.
The nurse care manager will encourage and arrange referral of challenging patients with potential abuse or dependence to prescription opioids to an addiction specialist.
|
|
Žádný zásah: Standard of Care Control
Physicians in the control group will receive information summarizing guidelines for COT but will not have access to the support of the TEACH intervention.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
|
Patient receipt of ≥2 UDT (Electronic Medical Record (EMR) extraction)
Časové okno: 12 Months
|
12 Months
|
|
% of patients who have ≥1 early refill (i.e., any early refills) (EMR extraction)
Časové okno: 12 Months
|
12 Months
|
|
Physician satisfaction managing HIV-infected patients on COT for pain (Physician self-report)
Časové okno: 12 Months
|
12 Months
|
Sekundární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
|
≥3 primary care visits in infectious disease clinic (EMR extraction)
Časové okno: 12 Months
|
12 Months
|
|
% of patients who had a discontinuation of their narcotic prescriptions (EMR extraction)
Časové okno: 12 Months
|
12 Months
|
|
Opioid treatment agreement (EMR extraction)
Časové okno: 12 Months
|
12 Months
|
|
% of physicians who self-report consulting the state Prescription Monitoring Program (Physician self-report)
Časové okno: 12 Months
|
12 Months
|
|
Number (continuous measure) of early refills at 12 months (EMR extraction)
Časové okno: 12 Months
|
12 Months
|
|
Patient aberrant use (Patient self-report)
Časové okno: 12 Months
|
12 Months
|
|
Number of patients who have visited the emergency department to seek opioids (EMR extraction and patient self-report)
Časové okno: 12 Months
|
12 Months
|
|
Patient pain severity and interference (Patient self-report)
Časové okno: 12 Months
|
12 Months
|
|
Patient addiction severity (Patient self-report)
Časové okno: 12 Months
|
12 Months
|
|
Physician confidence in prescribing COT (Physician self-report)
Časové okno: 12 Months
|
12 Months
|
|
Patient satisfaction with COT (Patient self-report)
Časové okno: 12 Months
|
12 Months
|
|
Patient trust in physician (Patient self-report)
Časové okno: 12 Months
|
12 Months
|
Další výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
|
Undetectable HIV viral load (EMR extraction)
Časové okno: 12 Months
|
12 Months
|
|
Cluster of differentiation 4 (CD4) cell count (EMR extraction)
Časové okno: 12 Months
|
12 Months
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Jeffrey Samet, MD, MA, MPH, Boston Medical Center
- Vrchní vyšetřovatel: Carlos del Rio, MD, Emory University
Publikace a užitečné odkazy
Obecné publikace
- Ngo B, Liebschutz JM, Cheng DM, Colasanti JA, Merlin JS, Armstrong WS, Forman LS, Lira MC, Samet JH, Del Rio C, Tsui JI. Hazardous alcohol use is associated with greater pain interference and prescription opioid misuse among persons living with HIV and chronic pain. BMC Public Health. 2021 Mar 22;21(1):564. doi: 10.1186/s12889-021-10566-6.
- Lira MC, Tsui JI, Liebschutz JM, Colasanti J, Root C, Cheng DM, Walley AY, Sullivan M, Shanahan C, O'Connor K, Abrams C, Forman LS, Chaisson C, Bridden C, Podolsky MC, Outlaw K, Harris CE, Armstrong WS, Del Rio C, Samet JH. Study protocol for the targeting effective analgesia in clinics for HIV (TEACH) study - a cluster randomized controlled trial and parallel cohort to increase guideline concordant care for long-term opioid therapy among people living with HIV. HIV Res Clin Pract. 2019 Apr;20(2):48-63. doi: 10.1080/15284336.2019.1627509.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Duševní poruchy
- Chemicky indukované poruchy
- RNA virové infekce
- Virová onemocnění
- Infekce
- Infekce přenášené krví
- Přenosné nemoci
- Pohlavně přenosné choroby, virové
- Pohlavně přenosné nemoci
- Lentivirové infekce
- Retroviridae infekce
- Syndromy imunologické nedostatečnosti
- Onemocnění imunitního systému
- Poruchy související s látkami
- HIV infekce
Další identifikační čísla studie
- H-33269
- R01DA037768 (Grant/smlouva NIH USA)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na HIV infekce
-
Jianfeng XieNáborCLABSI - Central Line Associated Bloodstream InfectionČína
-
Assiut UniversityZatím nenabírámeCLABSI - Central Line Associated Bloodstream Infection | Periferně zavedený centrální katétr | Pupeční žilní katétr
-
Helsinki University Central HospitalUniversity of Turku; Oulu University Hospital; Kuopio University Hospital; Tampere... a další spolupracovníciNáborHysterektomie | Antibiotika | Infection Post Op | ProfylaktickýFinsko
-
Fundacion Clinic per a la Recerca BiomédicaDokončenoProtheses infectionŠpanělsko
-
Duke UniversityDokončenoCentral Line-associated Bloodstream Infection (CLABSI)Spojené státy
-
Catholic University of the Sacred HeartDokončenoCentral Line-associated Bloodstream Infection (CLABSI)
-
Sinocelltech Ltd.NáborHPV Infection Vaccine Safety SCT1000Čína
-
University of MalayaTeleflexDokončenoCLABSI - Central Line Associated Bloodstream InfectionMalajsie
-
Burdenko Neurosurgery InstituteDokončenoHyperglykémie | Kraniotomie | Infection Post OpItálie, Ruská Federace
-
Princess Maxima Center for Pediatric OncologyUMC Utrecht; Dutch Cancer SocietyNáborCentral Line-associated Bloodstream Infection (CLABSI)Holandsko