Table 3 Primary and secondary analysis overview

To determine if CBT reduces the prevalence of moderate to severe persistent post-surgical pain over 12 months post-fracture

Persistent post-surgical pain as defined by the WHO, and of ≥ 4/10 severity

Binary

The prevalence of persistent post-surgical pain over 12 months post-fracture will be lower in the CBT treatment group compared to the usual care group

Logistic regression

Secondary Objective 1

 To determine if CBT improves physical and mental functioning over 12 months post-fracture

SF-36 PCS

Continuous

Participants receiving CBT will have higher SF-36 PCS scores over 12 months compared to participants who do not receive CBT

GEE

SF-36 MCS

Continuous

Participants receiving CBT will have higher SF-36 MCS scores over 12 months compared to participants who do not receive CBT

GEE

Secondary Objective 2

 To determine if CBT improves return to function over 12 months post-fracture

Return to ≥ 80% of pre-injury functioning

Binary

The proportion of participants who report ≥ 80% of pre-injury functioning will be greater in the CBT group than the usual care group over 12 months post-fracture

Logistic regression

Return to full function with respect to work, leisure activities, and responsibilities around the home

Binary

The proportion of participants who have returned, without limitations, to: (1) work, (2) leisure activities, and (3) responsibilities around the home will be higher among participants in the CBT group than participants in the usual care group

Logistic regression

Secondary Objective 3

 To determine if CBT reduces pain over 12 months post-fracture

BPI-SF Average Pain Severity Score

Continuous

Participants receiving CBT will have lower pain severity scores over 12 months compared to participants who do not receive CBT

GEE

BPI-SF Pain Interference Score

Continuous

Participants receiving CBT will have lower pain interference scores over 12 months compared to participants who do not receive CBT

GEE

Secondary Objective 4

 To determine if CBT reduces the proportion of participants prescribed opioid class medications at 6 and 12 months

Taking an opioid class medication

Binary

The proportion of participants prescribed opioids at 6 and 12 months will be lower in participants receiving the CBT compared to participants who do not receive CBT

Logistic regression

Amount of opioid class medication consumed

Continuous

Participants receiving CBT will be prescribed less opioids (morphine equivalent dose per day) compared to participants who do not receive CBT

GEE