Toward Safer Opioid Prescribing for Chronic Pain in High Risk Populations

Chronic Pain Clinical Trial

— TOWER  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03669939
• Other study ID #: GCO 17-0154
• Status: Completed
• Start date: October 5, 2018
• Est. completion date: September 30, 2020

Study information

• Verified date: October 2020
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: September 30, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain
• HIV Disease

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

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	The New York Academy of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Standard of Care	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
Other	Primary Outcome Measure determination	The best choice of a primary outcome measure for future studies.	18 months
Other	CDCG Adherence Assessment Tool	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
Other	Current Opioid Misuse Measure (COMM)	17-item, each scored 0 (never) to 4 (very often) with total scale from 0 - 68, higher score indicating more opioid misuse	18 months
Other	Self-Reported Misuse, Abuse, and Diversion (SR-MAD)	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
Other	Brief Pain Inventory (BPI)	Brief Pain Inventory (BPI) is a 9-item instrument with total score from 0 to 10, with higher score indicating worse outcomes.	18 months
Other	Hospital Anxiety and Depression Scale (HADS)	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
Other	Trust in Provider Scale (TIPS)	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
Other	HIV Stigma Scale (HSS)	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
Other	Brief Perceived Ethnic Discrimination Questionnaire-Community Version (BPEDQ-CV)	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
Other	Internalized Stigma of Chronic Pain (ISCP)	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
Other	Consumer Assessment of Healthcare Providers and System (CAHPS®) Clinician & Group Survey (CG-CAHPS)	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
Other	Opioid Therapy PROVIDER Survey	10 question survey, sum average score on a 5-point likert scale 1 (strongly agree) to 5 (strongly disagree)	18 months
Other	Intervention provider post- survey	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
Other	Modified ACTG Adherence	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
Other	Quantitative Analgesic Questionnaire (QAQ)	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
Other	TOWER Post Clinic Visit Interview	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
Primary	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	Percentage of items in the CDCG intervention which were adhered to	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