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

19. November 2018 aktualisiert von: 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.

Studienübersicht

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

41

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

    • Georgia
      • Atlanta, Georgia, Vereinigte Staaten, 30322
        • Emory University
    • Massachusetts
      • Boston, Massachusetts, Vereinigte Staaten, 02118
        • Boston Medical Center

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Versorgungsforschung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Kein Eingriff: 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.

Was misst die Studie?

Primäre Ergebnismessungen

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

Sekundäre Ergebnismessungen

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

Andere Ergebnismessungen

Ergebnis Maßnahme
Zeitfenster
Undetectable HIV viral load (EMR extraction)
Zeitfenster: 12 Months
12 Months
Cluster of differentiation 4 (CD4) cell count (EMR extraction)
Zeitfenster: 12 Months
12 Months

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Ermittler

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

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. September 2015

Primärer Abschluss (Tatsächlich)

1. November 2018

Studienabschluss (Tatsächlich)

1. November 2018

Studienanmeldedaten

Zuerst eingereicht

28. September 2015

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

29. September 2015

Zuerst gepostet (Schätzen)

30. September 2015

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

20. November 2018

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

19. November 2018

Zuletzt verifiziert

1. November 2018

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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