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Targeting Effective Analgesia in Clinics for HIV - Intervention (TEACH)

19 novembre 2018 mis à jour par: Jeffrey Samet, Boston Medical Center

Collaborative Care Intervention to Improve Providers' Opioid Prescribing for HIV-infected Patients - Intervention Component

The TEACH randomized controlled trial will test the effectiveness of a collaborative care intervention directed towards physicians who provide care for HIV-infected persons to improve the quality of care for prescribing chronic opioid therapy (COT) for pain and reduce the misuse of prescription opioids among HIV-infected persons.

Aperçu de l'étude

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

41

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

    • Georgia
      • Atlanta, Georgia, États-Unis, 30322
        • Emory University
    • Massachusetts
      • Boston, Massachusetts, États-Unis, 02118
        • Boston Medical Center

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Recherche sur les services de santé
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Aucune intervention: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Délai
Patient receipt of ≥2 UDT (Electronic Medical Record (EMR) extraction)
Délai: 12 Months
12 Months
% of patients who have ≥1 early refill (i.e., any early refills) (EMR extraction)
Délai: 12 Months
12 Months
Physician satisfaction managing HIV-infected patients on COT for pain (Physician self-report)
Délai: 12 Months
12 Months

Mesures de résultats secondaires

Mesure des résultats
Délai
≥3 primary care visits in infectious disease clinic (EMR extraction)
Délai: 12 Months
12 Months
% of patients who had a discontinuation of their narcotic prescriptions (EMR extraction)
Délai: 12 Months
12 Months
Opioid treatment agreement (EMR extraction)
Délai: 12 Months
12 Months
% of physicians who self-report consulting the state Prescription Monitoring Program (Physician self-report)
Délai: 12 Months
12 Months
Number (continuous measure) of early refills at 12 months (EMR extraction)
Délai: 12 Months
12 Months
Patient aberrant use (Patient self-report)
Délai: 12 Months
12 Months
Number of patients who have visited the emergency department to seek opioids (EMR extraction and patient self-report)
Délai: 12 Months
12 Months
Patient pain severity and interference (Patient self-report)
Délai: 12 Months
12 Months
Patient addiction severity (Patient self-report)
Délai: 12 Months
12 Months
Physician confidence in prescribing COT (Physician self-report)
Délai: 12 Months
12 Months
Patient satisfaction with COT (Patient self-report)
Délai: 12 Months
12 Months
Patient trust in physician (Patient self-report)
Délai: 12 Months
12 Months

Autres mesures de résultats

Mesure des résultats
Délai
Undetectable HIV viral load (EMR extraction)
Délai: 12 Months
12 Months
Cluster of differentiation 4 (CD4) cell count (EMR extraction)
Délai: 12 Months
12 Months

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

  • Chercheur principal: Jeffrey Samet, MD, MA, MPH, Boston Medical Center
  • Chercheur principal: Carlos del Rio, MD, Emory University

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 septembre 2015

Achèvement primaire (Réel)

1 novembre 2018

Achèvement de l'étude (Réel)

1 novembre 2018

Dates d'inscription aux études

Première soumission

28 septembre 2015

Première soumission répondant aux critères de contrôle qualité

29 septembre 2015

Première publication (Estimation)

30 septembre 2015

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

20 novembre 2018

Dernière mise à jour soumise répondant aux critères de contrôle qualité

19 novembre 2018

Dernière vérification

1 novembre 2018

Plus d'information

Termes liés à cette étude

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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