Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Number of participants on a TCM panel that achieve BUP stabilization |
Number of eligible participants on a TCM panel achieving BUP stabilization defined as using BUP at least 70 of the final 90 days of the 12-month period following TCM intake assessed by the electronic pharmacy record review. |
12 months |
|
| Primary |
Change in the number of participants that initiate COPES |
Change in the number of participants initiating COPES among patients randomized to COPES. Ongoing COPES engagement will be tracked by the COPES system. |
16 weeks and 10 months |
|
| Primary |
Number of participants achieving improvement in pain interference |
The number of participants achieving improvement in pain interference by using the PEG-3 scale. Assessment of all participants. The PEG-3 is a 3 question survey with each having a scale ranging from 0-10. It is scored by averaging the three numbers with lower scores indicating less pain. |
16 weeks and 10 months |
|
| Secondary |
Mean change in anxiety using the Generalized Anxiety Disorder-2 (GAD-2) questionnaire |
Mean change in anxiety post intervention using GAD-2 will be assessed at Day 0 and 6 months. Generalized Anxiety Disorder-2 questionnaire is a 2-item validated questionnaire used to screen for anxiety with a range of scores from 0-3. A score of 3 is considered positive for anxiety with lower scores indicating no or mild anxiety. |
16 weeks and 10 months |
|
| Secondary |
Mean change in depression assessed using Patient Health Questionnaire-2 (PHQ-2) |
Mean change in depression post intervention using PHQ-2 will be assessed at Day 0 and 6 months. The PHQ-2 consists of the first two questions of the Patient Health Questionnaire-9 and asks about the frequency of depressed mood and anhedonia over the past two weeks. Each question is answered on a scale of 0-3 as follows: 0 = Not at all, 1 = Several days, 2 = More than half the days, 3 = Nearly every day. Score ranges from 0-6, with a score of 0-2 being negative for potential major depressive disorder and a score of 3 or more being positive for potential major depressive disorder. |
16 weeks and 10 months |
|
| Secondary |
Mean change in alcohol use assessed using Alcohol Use Disorders Identification Test-C (AUDIT-C) |
Mean change in alcohol use post intervention using AUDIT-C will be assessed at Day 0 and 6 months. The AUDIT-C consists of 3 questions posed to participants about consumption habits that quantifies alcohol misuse. Each question is answered on a scale of 0-4 and scores range from 0-8 with higher scores correlating with greater severity of alcohol misuse. |
16 weeks and 10 months |
|
| Secondary |
Mean change in sleep assessed using Brief Pain Inventory (BPI) -sleep item |
Mean change in sleep post intervention using BPI sleep item will be assessed at Day 0 and 6 months. The BPI rapidly assesses the severity of pain and its impact on functioning. BPI asks the participant to rate how pain interferes with daily activities. The sleep item to be used asks, "Circle the one number that describes how, during the past week, pain has interfered with your sleep", with a scale of 1 to 10, where "0" indicates "does not interfere and "10" indicates "completely interferes". |
16 weeks and 10 months |
|
| Secondary |
Number of PCP at each site eligible to prescribe buprenorphine |
Number of PCP at each site eligible to prescribe buprenorphine to assess adoptability of intervention |
End of TCM implementation (approximately 30 months after start) |
|
| Secondary |
Number of PCP at each site that prescribed buprenorphine during the study period |
Number of PCP at each site that prescribed buprenorphine during the study period assessed by the electronic pharmacy record review. |
End of TCM implementation (approximately 30 months after start) |
|
| Secondary |
Number of patient encounters in which =1 TCM components were implemented by providers to assess implementation of intervention |
Number of patient encounters in which =1 TCM components were implemented by providers over the intervention using the participants electronic health record period to assess implementation. |
End of TCM implementation (approximately 30 months after start) |
|
| Secondary |
Number of patient encounters in which individual TCM components were implemented over the intervention period |
Number of patient encounters in which individual TCM components were implemented by providers over the intervention using the participants electronic health record period to assess implementation. |
End of TCM implementation (approximately 30 months after start) |
|
| Secondary |
Maintenance of medication management for =1 patients post-implementation |
Number of sites in which the TCM team maintained medication management for =1 patients post-implementation using the electronic pharmacy record. |
6 months post TCM implementation |
|
| Secondary |
Maintenance of referral to COPES post-implementation |
Number of COPES-assigned sites in which =1 patients were referred to COPES post-implementation using the participants electronic health record. |
6 months post TCM implementation |
|
| Secondary |
Change in the number of participants on a TCM panel experiencing resolution of TAPS-2 Assessment positivity score |
Change in the number of eligible participants on a TCM panel experiencing resolution of TAPS-2 positivity score. The TAPS-2 assesses use in the past three months of tobacco, alcohol, six different classes of illicit drugs, and 'other' drugs using a yes/no format with "Yes"=1 and "No"=0. Resolution is indicated by a score of 0 on TAPS-2 opioid items. |
Baseline, 16 weeks and 10 months |
|
