Table 2.

Study design and schedule of enrolment, interventions and assessments

Timeline		June 2016–February 2017	March 2017	April 2017	May 2017	June 2017	July 2017	August 2017	September 2017	October 2017	November 2017	December 2017	January 2018	Final clinic visit	Follow-up 3 months after baseline	Follow-up 6 months after baseline	Follow-up 12 months after baseline
Enrolment schedule			HCP cluster random allocation	Patient recruitment during internal pilot phase		Patient recruitment during main trial phase
Intervention schedule		MOC and protocol development	Cluster 1 west	1	1	1	1	1	1	1	1	1	1
			Cluster 2 central	0	0	0	0	0	1	1	1	1	1
			Cluster 3 east	0	0	0	0	0	0	0	0	0	0
Assessment schedule				Baseline data Internal pilot (T=0)		Baseline data Main trial (T=0)								Longitudinal repeated measures in cohorts (T=1), (T=2), (T=3) and (T=4)
Implementation process	PCS		Cluster 1 before and after MOC implementation					Cluster 2 before and after MOC implementation					Cluster 3 before and after MOC implementation		x		x
	PABS-PT		Cluster 1 before MOC implementation					Cluster 2 before MOC implementation					Cluster 3 before MOC implementation		x		x
	DIBQ		Cluster 1 after MOC implementation					Cluster 2 after MOC implementation					Cluster 3 after MOC implementation		x		x
PROMS	NRS back pain and leg pain			x	x	x	x	x	x	x	x	x	x		x	x	x
	ODI			x	x	x	x	x	x	x	x	x	x		x	x	x
	EQ-5D			x	x	x	x	x	x	x	x	x	x		x	x	x
	BIPQ			x	x	x	x	x	x	x	x	x	x		x	x	x
	PEI														x	x	x
	Satisfaction														x	x	x
	PGIC														x	x	x
Implementation outcomes	HCP assessment, diagnosis and treatment codes			x	x	x	x	x	x	x	x	x	x	x
	Referrals to specialist care																x

0, control condition; 1, intervention condition; grey-shaded cells, internal pilot; T, assessment time. Period where 2-week crossover from control to intervention can occur dependent on patient recruitment rates identified in the internal pilot study.

BIPQ, Brief Illness Perception Questionnaire; DIBQ, Determinants of Implementation Behaviour Questionnaire; EQ-5D, EuroQoL 5-Dimension Questionnaire; HCP, healthcare practitioner; MOC, model of care; NRS, Numeric Rating Scale; ODI, Oswestry Disability Index; PABS-PT, Pain Attitudes and Beliefs Scale for physical therapists; PCS, Practitioner Confidence Scale; PEI, Patient Enablement Index; PGIC, Patient Global Rating of Change; PROMS, patient-reported outcome measures.