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

October 8, 2020 updated by: Jessica Robinson-Papp, Icahn School of Medicine at Mount Sinai

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.

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
42

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 11101
        • ICAHN School of Medicine at Mount Sinai

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
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.
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
The standard information about the CDC Guidelines and no other information that is available through the study.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Proportion of eligible PCPs who successfully complete randomization
Time Frame: 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).
18 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of items in the CDCG intervention which were adhered to
Time Frame: 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.
18 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Standard of Care
Time Frame: 18 months
Per the CDC guideline (CDCG) for prescribing opioids in general primary care settings, there are 12 recommendations providers must follow in order to reduce prescription opioid-related harms while maintaining pain control and function. In order to monitor providers' adherence to the guideline and to establish appropriateness of "usual care", within the control arm, we will implement the CDCG Adherence Assessment Tool. The CDCG Adherence tool will score patients' EMR notes and will consist of 10-items relevant to the 12 recommendations outlined in the CDCG. If the CDCG recommendations have been denoted in the EMR note, each item will receive points based on a 1-2 numeric scale (max of 16 points). All clinical visits completed during the duration of the study will be scored. A higher number indicating a favorable outcome of adherence to the CDCG guideline.
18 months
Primary Outcome Measure determination
Time Frame: 18 months
The best choice of a primary outcome measure for future studies.
18 months
CDCG Adherence Assessment Tool
Time Frame: 18 months
Two tools will be provided to Intervention providers, an Opioid Managing-app (OM-app) and an EMR note template. The acceptability of the OM-app and EMR tool within the clinical setting will be measured. The OM-app was designed to help collect data needed by the PCP to follow the CDC guideline. The OM-app will contact patients once daily with a link which will take them to a series of questions relevant to their pain management. The app will be responsible for aggregating this data into a report form that the PCP can utilize to facilitate a discussion with the patient and to populate an EMR progress note. The EMR note template will be provided to intervention providers in order to import data collected from the app into a patient's EMR during clinic visits. As with the control arm, the CDCG Adherence Assessment Tool will be implemented which will score patients' EMR notes on a 1-2 numeric scale (max of 16 points). A higher number indicating a favorable outcome.
18 months
Current Opioid Misuse Measure (COMM)
Time Frame: 18 months
17-item, each scored 0 (never) to 4 (very often) with total scale from 0 - 68, higher score indicating more opioid misuse
18 months
Self-Reported Misuse, Abuse, and Diversion (SR-MAD)
Time Frame: 18 months
Self-Reported Misuse, Abuse and Diversion of Prescription Opioids (SR-MAD) instrument consists of 18 self-report items 0-10 numerical rating scale. Total scale from 0 to 180, with higher score indicating worse outcomes.
18 months
Brief Pain Inventory (BPI)
Time Frame: 18 months
Brief Pain Inventory (BPI) is a 9-item instrument with total score from 0 to 10, with higher score indicating worse outcomes.
18 months
Hospital Anxiety and Depression Scale (HADS)
Time Frame: 18 months
14-items scale with responses scored from 0-3, scores for each subscale from 0 (normal) to 21 (severe symptoms). Scores for the entire scale is 0 to 42, with higher score indicating more distress.
18 months
Trust in Provider Scale (TIPS)
Time Frame: 18 months
11-items scale scored on a 5-point likert scale from 1 (strongly disagree) to 5 (strongly agree). A 52 Freburger et al summary measure of trust is obtained by taking the unweighted mean of the responses to the 11 questions and transforming that value to a 0-100 scale. Higher scores reflect greater trust.
18 months
HIV Stigma Scale (HSS)
Time Frame: 18 months
40-items using a 4 point likert scale 1 (strongly disagree) to 4 (strongly agree), with full scale from 40 to 160. Higher score indicates poorer outcomes
18 months
Brief Perceived Ethnic Discrimination Questionnaire-Community Version (BPEDQ-CV)
Time Frame: 18 months
17-item scale on a summed average likert-type scale from 1 (never happened) to 5 (happened very often). Higher score indicated perception of discrimination.
18 months
Internalized Stigma of Chronic Pain (ISCP)
Time Frame: 18 months
Sum average score on 4-point Likert-type scale (1 = strongly disagree, 2 = disagree, 3 = agree, 4 = strongly agree). Higher score indicates more stigma of chronic pain.
18 months
Consumer Assessment of Healthcare Providers and System (CAHPS®) Clinician & Group Survey (CG-CAHPS)
Time Frame: 18 months
Composite score converted to numerical scale from 0 (never) to 100 (always). and one overall rating of the doctor on a scale from 0 to 10, with higher score showing a more favorable outcome.
18 months
Opioid Therapy PROVIDER Survey
Time Frame: 18 months
10 question survey, sum average score on a 5-point likert scale 1 (strongly agree) to 5 (strongly disagree)
18 months
Intervention provider post- survey
Time Frame: 18 months
6 question survey, intended for provider participants who have been randomized into the intervention arm. The survey includes a 5-point Likert-scale (5=strongly agree, 4=agree, 3=neutral, 2=disagree, 1=strongly disagree) with a high sum average indicating a satisfactory outcome.
18 months
Modified ACTG Adherence
Time Frame: 18 months
A self-reported questionnaire comprised of 8 items. Only item #4 will be used as a percentage of their HIV medication intake, on a scale from 0-100%. . A higher percentage indicating a favorable outcome..
18 months
Quantitative Analgesic Questionnaire (QAQ)
Time Frame: 18 months
Tool for quantifying how much pain meds a patient is taking, by calculating the total weekly doses, the QAQ ("as reported"), and comparing them to the regimen score previously established by physicians who actively treat chronic pain. Regimens are rated on scale from 1 (small amount of meds) to 5 (large amt of meds). 1 QAQ point is assign for taking any opioids at all, & an additional point assign for every equivalent of 100 mg of oral morphine used per week (1-99 mg = 1 pt; 100-199 = 2 pts, etc.). For all other oral meds, 1 point for taking the meds at all, & an additional point for each 25% of the maximum dose taken (1-24% = 1 pt; 25-49% = 2 points, etc.). For topicals, 1 point for each topical reports using regardless of dose or frequency. No upper limit to the amt of QAQ points a patient may accrue. The lowest number of QAQ is 0=no medication. A higher discrepancy between the sum average of QAQ points and "as prescribed" points will indicate a lower adherence rate.
18 months
TOWER Post Clinic Visit Interview
Time Frame: 18 months
This is an 18 item questionnaire of the patients experience after a clinical session with their provider. There are 2 scores, one score will be a sum average on a scale from 0-6 for questions 1-6. The second score will be a sum average on a scale from 0-50 for questions 8-12. A higher scored indicating a favorable outcome.
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Icahn School of Medicine at Mount Sinai

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The New York Academy of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 5, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 22, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 11, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 13, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 9, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 8, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GCO 17-0154

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Clinical information that is relevant to the provider or patient

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Pain

Clinical Trials on Communication Strategy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings