Clinical trial NCT03669939: Toward Safer Opioid Prescribing for Chronic Pain in High Risk Populations
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Disease
Chronic Pain
Keywords: Center for Disease Control Guidelines
Opioids for chronic pain
communication strategies
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: The New York Academy of Medicine
First posted: 2018-09-13
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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

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.

Eligibility criteria: 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

Exclusion Criteria:

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

Primary outcomes:
measure: Proportion of eligible PCPs who successfully complete randomization
timeFrame: 18 months
Secondary outcomes:
measure: Percentage of items in the CDCG intervention which were adhered to
timeFrame: 18 months
Other outcomes:
measure: Standard of Care
timeFrame: 18 months
measure: Primary Outcome Measure determination
timeFrame: 18 months
measure: CDCG Adherence Assessment Tool
timeFrame: 18 months
measure: Current Opioid Misuse Measure (COMM)
timeFrame: 18 months
measure: Self-Reported Misuse, Abuse, and Diversion (SR-MAD)
timeFrame: 18 months
measure: Brief Pain Inventory (BPI)
timeFrame: 18 months
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 18 months
measure: Trust in Provider Scale (TIPS)
timeFrame: 18 months
measure: HIV Stigma Scale (HSS)
timeFrame: 18 months
measure: Brief Perceived Ethnic Discrimination Questionnaire-Community Version (BPEDQ-CV)
timeFrame: 18 months
measure: Internalized Stigma of Chronic Pain (ISCP)
timeFrame: 18 months
measure: Consumer Assessment of Healthcare Providers and System (CAHPS®) Clinician & Group Survey (CG-CAHPS)
timeFrame: 18 months
measure: Opioid Therapy PROVIDER Survey
timeFrame: 18 months
measure: Intervention provider post- survey
timeFrame: 18 months
measure: Modified ACTG Adherence
timeFrame: 18 months
measure: Quantitative Analgesic Questionnaire (QAQ)
timeFrame: 18 months
measure: TOWER Post Clinic Visit Interview
timeFrame: 18 months
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Jessica Robinson-Papp, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.