Toward Safer Opioid Prescribing for Chronic Pain in High Risk Populations

NCT03669939 | Completed

• 1 other identifier: GCO 17-0154
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

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).

Conditions

HIV Disease; Chronic Pain

Keywords

Center for Disease Control Guidelines; Opioids for chronic pain; communication strategies

Outcome Measures

Primary Outcomes (1)

• Proportion of eligible PCPs who successfully complete randomization

  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).

  18 months

Secondary Outcomes (1)

• Percentage of items in the CDCG intervention which were adhered to

  18 months

Other Outcomes (17)

• Standard of Care

  18 months

• Primary Outcome Measure determination

  18 months

• CDCG Adherence Assessment Tool

  18 months

Study Arms (2)

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

Other: Communication Strategy

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

Other: Standard of Care

Interventions

Communication Strategy OTHER

Communication Strategy The intervention consists of a handbook that refers to the CDC Guidelines with tools and communication strategies that the PCP can use when assessing their patients who are on opioids. The Handbook will have a description of the Ohm-app and the information the PCP can retrieve from the dashboard in their medical record. They will also be provided a template to use when seeing the patient to use as guide and as documentation.

Communication strategy

Standard of Care OTHER

The standard information about the CDC Guidelines and no other information that is available through the study.

Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primary Care Providers who treat HIV patients in the Institute of Advanced Medicine Institute at Mount Sinai Health System

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• The New York Academy of Medicine: collaborator

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 11101, United States

Location

Related Publications (1)

• Cedillo G, George MC, Deshpande R, Benn EKT, Navis A, Nmashie A, Siddiqui A, Mueller BR, Chikamoto Y, Weiss L, Scherer M, Kamler A, Aberg JA, Vickrey BG, Bryan A, Horn B, Starkweather A, Fisher J, Robinson-Papp J. Toward Safer Opioid Prescribing in HIV care (TOWER): a mixed-methods, cluster-randomized trial. Addict Sci Clin Pract. 2022 May 16;17(1):28. doi: 10.1186/s13722-022-00311-8.

  PMID: 35578356 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Chronic Pain

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Jessica Robinson-Papp, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 22, 2018
• First Posted: September 13, 2018
• Study Start: October 5, 2018
• Primary Completion: September 30, 2020
• Study Completion: September 30, 2020
• Last Updated: October 9, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will share

Locations

US (1)