Toward Safer Opioid Prescribing for Chronic Pain in High Risk Populations

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).

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.

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.

The best choice of a primary outcome measure for future studies.

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.

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 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) is a 9-item instrument with total score from 0 to 10, with higher score indicating worse outcomes.

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.

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.

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

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.

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.

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.

10 question survey, sum average score on a 5-point likert scale 1 (strongly agree) to 5 (strongly disagree)

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.

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..

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.

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.