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De-Implementing Opioid Use and Implementing Optimal Pain Management Following Dental Extractions (DIODE): Protocol for a Cluster Randomized Trial

BACKGROUND: Overdose deaths from prescription opioid analgesics are a continuing crisis in the United States. Opioid analgesics are among the most frequently prescribed drugs by dentists. An estimated 5 million people undergo third-molar extractions in the United States each year, resulting in posto...

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Autores principales: Rindal, D Brad, Asche, Stephen E, Gryczynski, Jan, Kane, Sheryl M, Truitt, Anjali R, Shea, Tracy L, Ziegenfuss, Jeanette Y, Schwartz, Robert P, Worley, Donald C, Mitchell, Shannon G
Formato: Online Artículo Texto
Lenguaje:English
Publicado: JMIR Publications 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8076983/
https://www.ncbi.nlm.nih.gov/pubmed/33843594
http://dx.doi.org/10.2196/24342
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author Rindal, D Brad
Asche, Stephen E
Gryczynski, Jan
Kane, Sheryl M
Truitt, Anjali R
Shea, Tracy L
Ziegenfuss, Jeanette Y
Schwartz, Robert P
Worley, Donald C
Mitchell, Shannon G
author_facet Rindal, D Brad
Asche, Stephen E
Gryczynski, Jan
Kane, Sheryl M
Truitt, Anjali R
Shea, Tracy L
Ziegenfuss, Jeanette Y
Schwartz, Robert P
Worley, Donald C
Mitchell, Shannon G
author_sort Rindal, D Brad
collection PubMed
description BACKGROUND: Overdose deaths from prescription opioid analgesics are a continuing crisis in the United States. Opioid analgesics are among the most frequently prescribed drugs by dentists. An estimated 5 million people undergo third-molar extractions in the United States each year, resulting in postoperative pain. Studies show that, in most cases, the combination of ibuprofen and acetaminophen is an effective alternative to commonly prescribed opioid analgesics for the management of postextraction pain. Nevertheless, many dentists routinely prescribe opioids after dental extractions. OBJECTIVE: We describe the rationale, design, and methods for a randomized trial of interventions designed to de-implement opioid prescribing by dentists while implementing effective nonopioid analgesics following dental extractions. METHODS: Using a prospective, 3-arm, cluster randomized trial design with dentists as the unit randomized and patient-level prescribing data as the primary outcome, we will compare different strategies to reduce the reliance on opioids and increase the use of alternative pain management approaches utilizing information support tools aimed at both providers and their patients. The study will test the efficacy of 2 interventions to decrease opioid prescribing following dental extractions: clinical decision support with (CDS-E) and without patient education (CDS). Providers will be randomized to CDS, CDS-E, or standard practice. Patient-level outcomes will be determined via review of comprehensive electronic health records. We will compare study arms on differential change in prescribing patterns from pre- to postimplementation of the intervention. The primary outcome of interest is a binary indicator of whether or not the patient received an opioid prescription on the day of the extraction encounter. We will also examine recommendations or prescriptions for nonopioid analgesics, patients’ perceptions of shared decision making, and patients’ pain experiences following the extraction. RESULTS: The HealthPartners Institutional Review Board approved the study. All study materials including the CDS and patient education materials have been developed and pilot tested, and the protocol has been approved by the National Institute of Dental and Craniofacial Research. The intervention was implemented in February 2020, with 51 dentists who were randomized to 1 of the 3 arms. CONCLUSIONS: If the intervention strategies are shown to be effective, they could be implemented more broadly in dental settings with high levels of opioid prescribing. TRIAL REGISTRATION: ClinicalTrials.gov NCT03584789, https://clinicaltrials.gov/ct2/show/NCT03584789 INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/24342
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spelling pubmed-80769832021-05-06 De-Implementing Opioid Use and Implementing Optimal Pain Management Following Dental Extractions (DIODE): Protocol for a Cluster Randomized Trial Rindal, D Brad Asche, Stephen E Gryczynski, Jan Kane, Sheryl M Truitt, Anjali R Shea, Tracy L Ziegenfuss, Jeanette Y Schwartz, Robert P Worley, Donald C Mitchell, Shannon G JMIR Res Protoc Protocol BACKGROUND: Overdose deaths from prescription opioid analgesics are a continuing crisis in the United States. Opioid analgesics are among the most frequently prescribed drugs by dentists. An estimated 5 million people undergo third-molar extractions in the United States each year, resulting in postoperative pain. Studies show that, in most cases, the combination of ibuprofen and acetaminophen is an effective alternative to commonly prescribed opioid analgesics for the management of postextraction pain. Nevertheless, many dentists routinely prescribe opioids after dental extractions. OBJECTIVE: We describe the rationale, design, and methods for a randomized trial of interventions designed to de-implement opioid prescribing by dentists while implementing effective nonopioid analgesics following dental extractions. METHODS: Using a prospective, 3-arm, cluster randomized trial design with dentists as the unit randomized and patient-level prescribing data as the primary outcome, we will compare different strategies to reduce the reliance on opioids and increase the use of alternative pain management approaches utilizing information support tools aimed at both providers and their patients. The study will test the efficacy of 2 interventions to decrease opioid prescribing following dental extractions: clinical decision support with (CDS-E) and without patient education (CDS). Providers will be randomized to CDS, CDS-E, or standard practice. Patient-level outcomes will be determined via review of comprehensive electronic health records. We will compare study arms on differential change in prescribing patterns from pre- to postimplementation of the intervention. The primary outcome of interest is a binary indicator of whether or not the patient received an opioid prescription on the day of the extraction encounter. We will also examine recommendations or prescriptions for nonopioid analgesics, patients’ perceptions of shared decision making, and patients’ pain experiences following the extraction. RESULTS: The HealthPartners Institutional Review Board approved the study. All study materials including the CDS and patient education materials have been developed and pilot tested, and the protocol has been approved by the National Institute of Dental and Craniofacial Research. The intervention was implemented in February 2020, with 51 dentists who were randomized to 1 of the 3 arms. CONCLUSIONS: If the intervention strategies are shown to be effective, they could be implemented more broadly in dental settings with high levels of opioid prescribing. TRIAL REGISTRATION: ClinicalTrials.gov NCT03584789, https://clinicaltrials.gov/ct2/show/NCT03584789 INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/24342 JMIR Publications 2021-04-12 /pmc/articles/PMC8076983/ /pubmed/33843594 http://dx.doi.org/10.2196/24342 Text en ©D Brad Rindal, Stephen E Asche, Jan Gryczynski, Sheryl M Kane, Anjali R Truitt, Tracy L Shea, Jeanette Y Ziegenfuss, Robert P Schwartz, Donald C Worley, Shannon G Mitchell. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 12.04.2021. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on http://www.researchprotocols.org, as well as this copyright and license information must be included.
spellingShingle Protocol
Rindal, D Brad
Asche, Stephen E
Gryczynski, Jan
Kane, Sheryl M
Truitt, Anjali R
Shea, Tracy L
Ziegenfuss, Jeanette Y
Schwartz, Robert P
Worley, Donald C
Mitchell, Shannon G
De-Implementing Opioid Use and Implementing Optimal Pain Management Following Dental Extractions (DIODE): Protocol for a Cluster Randomized Trial
title De-Implementing Opioid Use and Implementing Optimal Pain Management Following Dental Extractions (DIODE): Protocol for a Cluster Randomized Trial
title_full De-Implementing Opioid Use and Implementing Optimal Pain Management Following Dental Extractions (DIODE): Protocol for a Cluster Randomized Trial
title_fullStr De-Implementing Opioid Use and Implementing Optimal Pain Management Following Dental Extractions (DIODE): Protocol for a Cluster Randomized Trial
title_full_unstemmed De-Implementing Opioid Use and Implementing Optimal Pain Management Following Dental Extractions (DIODE): Protocol for a Cluster Randomized Trial
title_short De-Implementing Opioid Use and Implementing Optimal Pain Management Following Dental Extractions (DIODE): Protocol for a Cluster Randomized Trial
title_sort de-implementing opioid use and implementing optimal pain management following dental extractions (diode): protocol for a cluster randomized trial
topic Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8076983/
https://www.ncbi.nlm.nih.gov/pubmed/33843594
http://dx.doi.org/10.2196/24342
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