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

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ClinicalTrials.gov Identifier: NCT03669939
Recruitment Status : Completed
First Posted : September 13, 2018
Last Update Posted : October 9, 2020
Sponsor:
Collaborator:
The New York Academy of Medicine
Information provided by (Responsible Party):
Jessica Robinson-Papp, Icahn School of Medicine at Mount Sinai

Tracking Information
First Submitted Date August 22, 2018
First Posted Date September 13, 2018
Last Update Posted Date October 9, 2020
Actual Study Start Date October 5, 2018
Actual Primary Completion Date September 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 11, 2018)
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).
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: September 11, 2018)
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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: September 11, 2018)
  • 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.
  • Primary Outcome Measure determination [ Time Frame: 18 months ]
    The best choice of a primary outcome measure for future studies.
  • 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.
  • 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
  • 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.
  • 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.
  • 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.
  • 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.
  • 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
  • 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.
  • 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.
  • 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.
  • 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)
  • 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.
  • 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..
  • 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.
  • 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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title 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.
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.
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition
  • HIV Disease
  • Chronic Pain
Intervention
  • 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.
  • Other: Standard of Care
    The standard information about the CDC Guidelines and no other information that is available through the study.
Study Groups/Cohorts
  • 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
    Intervention: 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
    Intervention: Other: Standard of Care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 8, 2020)
42
Original Estimated Enrollment
 (submitted: September 11, 2018)
60
Actual Study Completion Date September 30, 2020
Actual Primary Completion Date September 30, 2020   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03669939
Other Study ID Numbers GCO 17-0154
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: Clinical information that is relevant to the provider or patient
Responsible Party Jessica Robinson-Papp, Icahn School of Medicine at Mount Sinai
Study Sponsor Icahn School of Medicine at Mount Sinai
Collaborators The New York Academy of Medicine
Investigators
Principal Investigator: Jessica Robinson-Papp, MD Icahn School of Medicine at Mount Sinai
PRS Account Icahn School of Medicine at Mount Sinai
Verification Date October 2020