Toward Safer Opioid Prescribing for Chronic Pain in High Risk Populations

Completed

• Conditions: HIV Disease; Chronic Pain
• Interventions: Other: Communication Strategy; Other: Standard of Care

• Registration Number: NCT03669939
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

Brief 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).

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-08-22
• Study First Submitted QC: 2018-09-11
• Study First Posted: 2018-09-13
• Study Start: 2018-10-05
• Primary Completion: 2020-09-30
• Study Completion: 2020-09-30
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-08
• Last Update Posted: 2020-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

• Attending physician or advance practice provider in one of the Institute of Advanced Medicine (IAM) clinics
• Designated PCP for at least 5 patients to whom he/she prescribes opioids
• Willing and able to adhere to study procedures including randomization, and refraining from discussion of study procedures with other clinical staff or patients

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Exclusion Criteria

• Unwillingness to undergo randomization
• Plans to leave IAM within the study period.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Communication strategy	Communication Strategy	Primary Care providers who see HIV patients and follow them on opiates for chronic pain to receive communication strategies developed by the study team wit the guidance from the HV community and providers
Standard of Care	Standard of Care	Primary Care Providers - who see HIV patients and follow them on opiates for chronic pain will receive education on the the standard information about the CDC Guidelines

Primary Outcome Measures

Name	Time	Method
Proportion of eligible PCPs who successfully complete randomization	18 months	Feasibility of recruitment and randomization of PCPs, reflected by the proportion of eligible PCPs who successfully complete randomization (where the denominator is the total number of PCPs offered participation).

Secondary Outcome Measures

Name	Time	Method
Percentage of items in the CDCG intervention which were adhered to	18 months	Maintenance of intervention fidelity will be ascertained using the audiotaped data from the clinic visits, and will be described as the percentage of items in the CDCG intervention which were adhered to.

Trial Locations

Locations (1)

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States