Objective | Outcome | Time frame (s) | ||
---|---|---|---|---|
Description | Source | Type | ||
To determine whether the active interventions result in a higher proportion of patients achieving a reduction in pain severity that is a minimal clinically important difference (MCID) relative to those receiving usual care at 3 months (T1) post-allocation |  ≥ 30% decrease in score on 11-item version of the Brief Pain Inventory – Short Form (BPI-SF) [69,70,71] | Participant self-report | Binary | T0 to T1 |
Secondary Objective 1  To determine whether the active interventions result in a higher proportion of patients achieving a MCID in pain severity relative to those receiving usual care at 6 (T2) and 12 months (T3) post-allocation | Same as above | Participant self-report | Binary | T0 to T2 T0 to T3 |
Secondary Objective 2  To determine whether the active interventions result in a higher proportion of patients achieving a MCID in pain intensity relative to those receiving usual care at 3 (T1), 6 (T2), and 12 months (T3) post-allocation |  ≥ 30% decrease in score on 4-item pain intensity subscale of the BPI-SF | Participant self-report | Binary | T0 to T1 T0 to T2 T0 to T3 |
Secondary Objective 3  To determine whether the active interventions result in a higher proportion of patients achieving a MCID in pain-related interference relative to those receiving usual care at 3 (T1), 6 (T2), and 12 months (T3) post-allocation |  ≥ 30% decrease in score on 7-item pain-related interference subscale of the BPI-SF | Participant self-report | Binary | T0 to T1 T0 to T2 T0 to T3 |
Secondary Objective 4  To examine the impact of the active interventions on pain severity at 3 (T1), 6 (T2), and 12 months (T3) post-allocation | Score on modified 11-item BPI-SF | Participant self-report | Continuous | T0, T1, T2, and T3 |
Secondary Objective 5  To examine the impact of the active interventions on pain intensity at 3 (T1), 6 (T2), and 12 months (T3) post-allocation | Score on 4-item pain intensity subscale of the BPI-SF | Participant self-report | Continuous | T0, T1, T2, and T3 |
Secondary Objective 6  To examine the impact of the active interventions on pain-related interference at 3 (T1), 6 (T2), and 12 months (T3) post-allocation | Score on 7-item pain-related interference subscale of the BPI-SF | Participant self-report | Continuous | T0, T1, T2, and T3 |
Secondary Objective 7  To examine the impact of the active interventions on social role functioning at 3 (T1), 6 (T2), and 12 months (T3) post-allocation | PROMIS Ability to Participate in Social Roles 4A [72] (4 items) | Participant self-report | Continuous | T0, T1, T2, and T3 |
Secondary Objective 8  To examine the impact of the active interventions on physical functioning at 3 (T1), 6 (T2), and 12 months (T3) post-allocation | PROMIS Physical Functioning Short Form 6b (6 items) | Participant self-report | Continuous | T0, T1, T2, and T3 |
Secondary Objective 9  To examine the impact of the active interventions on patient global impression of change (PGIC) in pain status and overall status | Modified Guy/Farrar Patient Global Impression of Change (1 item for pain status and 1 item for overall status) | Participant self-report | Continuous | T0, T1, T2, and T3 |
To assess the costs and cost-effectiveness of the active interventions compared to each other and usual care | EuroQuol-5D-5L [73] to construct cost per quality-adjusted life year (QALY) Healthcare utilization: Electronic health records data costed using standard costing algorithms [74, 75] and Medicare fee schedules | Participant self-report and electronic health records | Continuous | T0,T1, T2 and T3 T0 minus 12Â months |