Toward Safer Opioid Prescribing for Chronic Pain in High Risk Populations — TOWER  

Chronic Pain Clinical Trial

Official title: Toward Safer Opioid Prescribing for Chronic Pain in High Risk Populations: Implementing the Centers for Disease Control Guideline (CDC) Guideline in the Primary Care HIV Clinic.

Status Completed

Clinical Trial Summary

The overarching plan for TOWER is to develop and test an algorithmic version of the Center for Disease Control Guidelines (CDCG) tailored for a specific primary care setting, the HIV primary care clinic. This CDCG intervention incorporates communication and implementation strategies tailored for the HIV primary care setting, and enabled with technology (an app for use by patients and EMR tools for providers).

Clinical Trial Description

However, according to a 2014 AHRQ report, there have been no studies evaluating the effectiveness of any prescription opioid risk mitigation strategies. Furthermore, due to ambiguity in some of the CDCG recommendations and the challenging nature of the patient-provider opioid conversation, the success of the CDCG may hinge on the manner in which it is implemented in individual care settings. Thus it is unclear what the true effect of the CDCG will be. The investigators believe that for the CDCG to have the greatest likelihood of achieving its goals of improving prescription opioid safety without causing unintended effects (e.g. exacerbation of pain, disruption of other aspects of care), its recommendations will need to be skillfully communicated. Furthermore, because of this "human element"and other sources of variability, documenting the effectiveness of the CDCG will require standardization of implementation. The overarching plan for TOWER is to develop and test an algorithmic version of the CDCG tailored for a specific primary care setting, the HIV primary care clinic. This CDCG intervention incorporates communication and implementation strategies tailored for the HIV primary care setting, and enabled with technology (an app for use by patients and EMR tools for providers). Achieving this goal has involved soliciting input from the HIV community using the method of Public Deliberation (PD) in the setting of two Citizen' s Panels, each with ~22 HIV-infected participants and lasting one day; and using the information obtained from the deliberative process to inform the development of the CDCG intervention. The investigators now plan to test the CDCG intervention for feasibility. ;

Related Conditions & MeSH terms

• Chronic Pain
• HIV Disease

• NCT number: NCT03669939
• Study type: Observational
• Source: Icahn School of Medicine at Mount Sinai
• Status: Completed
• Start date: October 5, 2018
• Completion date: September 30, 2020