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Table 2 Primary and secondary outcomes overview

From: Comparing the clinical and cost-effectiveness of remote (telehealth and online) cognitive behavioral therapy-based treatments for high-impact chronic pain relative to usual care: study protocol for the RESOLVE multisite randomized control trial

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 12 months