Improved adherence to clinical guidelines for low back pain after implementation of the BetterBack model of care: A stepped cluster randomized controlled trial within a hybrid type 2 trial

Figures & data

Table 1. The stepped cluster structure (dog-leg design) of the trial.

2017											2018
Mar	Apr	May		Jun	Jul	Aug	Sep	Oct	Nov	Dec	Jan	Feb	Mar
PT Cluster random allocation	Patient recruitment during internal pilot phase			Patient recruitment during main trial phase
Cluster 1 West	MoC	MoC		MoC	MoC	MoC	MoC	MoC	MoC	MoC	MoC	MoC	MoC
MoC implementation
Cluster 2 Central	Routine	Routine		Routine	Routine	Routine	MoC	MoC	MoC	MoC	MoC	MoC	MoC
						MoC implementation
Cluster 3 East	Routine	Routine		Routine	Routine	Routine	Routine	Routine	Routine	Routine	Routine	Routine	Routine

PT = physiotherapist, MoC model of care = intervention group, Routine = control group.

Table 2. CPG assessment- and treatment-related quality indicator variables, definitions, source of data and target behaviors.

	CPG related indicator variables	Definition	Source of data	CPG related target behavior
Assessment interventions	1. Proportion of patients receiving referral to specialist consultation	Referral to pain clinic, orthopedic or neurosurgical care during PT treatment period	Public health care regional registry	Reduce referral for benign non-complex LBP
	2. Proportion of patients receiving medical imaging	X-ray, MRI, CT scan during PT treatment period	Public health care regional registry	Reduce imaging for benign non-complex LBP
Treatment interventions	1. Proportion of patients receiving stratified number of PT visits	The number of visits to PT within actual treatment period for patients sub-grouped in low or medium/high-risk of persistent symptoms	Public health care regional registry	Fewer visits in the SBT low risk subgroup (1–3 visits) and more in the SBT medium/high-risk subgroup (≥4 visits)
	2. Proportion of patients receiving educational interventions	Reassuring information/education on pain, pain management and relapse prevention applying behavioral medicine approaches	CRPE	Increase overall use and stratified use with higher proportions in higher risk groups
	3. Proportion of patients receiving exercise interventions	Supervised/monitored individualized home or group-based exercise program	CRPE	Increase overall use
	4. Proportion of patients receiving manual therapy	Joint and/or soft-tissue mobilization/manipulation	CRPE	Short-term use as a part of †multimodal treatment when LBP with segmental movement impairments are found
	5. Proportion of patients receiving acupuncture	Acupuncture	CRPE	Short-term use as an adjunct to treatment intervention 2&3 when additional short-term analgesic effect as goal
	6. Proportion of patients receiving non-evidence-based treatments	Passive physical modalities e.g. corset, static traction, electrotherapy, ultrasound, *non-evidence-based manual therapy, **non-evidence-based acupuncture	CRPE	Decrease use

CPG Clinical practice guideline, PT physiotherapy, LBP Low Back Pain, MRI Magnetic Resonance Imaging, CT Computerized Tomography, CRPE clinical reasoning and process evaluation data from physiotherapists. SBT STarT Back Screening Tool, † multimodal treatment = exercise and/or educational interventions, *non-evidence manual therapy = manual therapy without reported segmental movement impairments or used as unimodal intervention not combined with exercise and/or educational interventions, **non-evidence acupuncture = acupuncture used as unimodal intervention not combined with exercise and educational interventions.

Table 3. PT clinical practice quality index for benign LBP.

	PT clinical practice quality indicators forming the clinical practice quality index
Assessment quality index	Cohort with registry data 1. No referral to specialist consultation during PT treatment period
	2. No imaging during PT treatment period
Treatment quality index	Cohort with CRPE data 1. Use of patient education interventions
	2. Use of exercise interventions
	3. No use of non-evidence-based interventions
Overall adherence	Cohort with CRPE data All 5 quality indicators fulfilled

PT physiotherapy, LBP Low Back Pain, CRPE data clinical reasoning and process evaluation data from physiotherapists.

Figure 1. CONSORT flow diagram.

* 12 PTs in cluster 2 crossed over from control to intervention phase after implementation of the BetterBack☺ MoC and therefore treated patients in both phases of the study

Table 4. Characteristics of PTs treating patients during control and intervention phases of the trial.

	PTs in intervention† n = 44	PTs in control† n = 54	P values
Age, mean (SD)	35.4 (11.8)	36.1 (11.1)	0.776§
Sex: female, n (%)	30 (68.2)	37 (68.5)	1.0#
Clinical experience, years, n (%)			0.681#
1–5	27 (61.4)	25 (48.1)
6–10	5 (11.4)	10 (19.2)
11–15	3 (6.8)	3 (5.8)
16–20	4 (9.1)	4 (7.7)
21–25	3 (6.8)	4 (7.7)
> 25	2 (4.5)	6 (11.5)
Clinical specialist qualification*, n (%)	3 (6.8)	1 (1.9)	0.330#
Highest educational level**, n (%)			0.937#
Bachelor’s degree	35 (85.4)	44 (86.3)
Post graduate major	4 (9.8)	5 (9.8)
Post graduate master	1 (2.4)	2 (3.9)
PhD	1 (2.4)	0 (0)

PT physiotherapist, †12 PTs treated patients in both intervention and control group, SD Standard deviation, n number of observations, PhD Doctor of Philosophy, *Clinical specialist qualification by the Swedish association of registered physiotherapists, **Education levels with European Tertiary Credit system, §Independent T-test, #Fisher's Exact Test.

Table 5. Baseline characteristics of the included patients.

	Original cohort with registry data		P values	Cohort with complete data		P values
	Intervention n = 278	Control n = 223		Intervention n = 223	Control n = 165
Age, mean (SD)	45.0 (12.1)	45.3 (12.4)	0.779§	45.2 (12.2)	45.1 (12.6)	0.962§
Sex: female, n (%)	157 (56.5)	122 (55.0)	0.734#	121 (54.3)	89 (53.9)	0.950#
Pain Duration, n (%)			0.562#			0.742#
< 12 weeks	149 (56.4)	120 (59.1)		118 (56.5)	85 (58.2)
> 12 weeks	115 (43.6)	83 (40.9)		91 (43.5)	61 (41.8)
NRS back pain, mean (SD)	6.4 (2.2)	6.1 (2.3)	0.135§	6.5 (2.2)	6.1 (2.3)	0.093§
NRS leg pain, mean (SD)	3.7 (3.3)	3.7 (3.3)	0.986§	3.8 (3.3)	3.4 (3.2)	0.277§
ODI, mean (SD)	30.8 (15.2)	31.3 (16.7)	0.714§	30.4 (15.0)	31.5 (17.1)	0.556§
EQ-5D index, mean (SD)	0.525 (0.303)	0.548 (0.299)	0.430§	0.532 (0.303)	0.557 (0.297)	0.451§
General health, mean (SD)	6.4 (2.1)	6.4 (2.1)	0.788§	6.4 (2.1)	6.5 (2.1)	0.707§
STB risk groups, n (%)			0.990#			0.914#
Low risk group	97 (36.7)	75 (36.9)		76 (36.4)	54 (37.0)
Medium risk group	132 (50.0)	102 (50.2)		104 (49.8)	74 (50.7)
High risk group	35 (13.3)	26 (12.8)		29 (13.9)	18 (12.3)

SD Standard deviation, n number of observations, NRS Numeric Rating Scale (0–10) higher score indicates higher pain intensity, SBT STarT Back Screening Tool, ODI Oswestry Disability Index (1–100) higher score indicates higher disability, EQ-5D index EuroQol (−0.594–1) higher score indicates better health, General health (0–10) higher score indicates better health. §Independent Student T-test, #Persons Chi-Square.

Table 6. Strength of associations between interventions and adherence to CPG recommendations.

	CPG related indicator variables	Intervention group, n (%)	Control group, n (%)	Between-group comparison OR (95% CI); p-value; ICC
Assessment intervention	1. Proportion of patients receiving referral to specialist consultation Cohort with registry data	6/278 (2.2)	12/221 (5.4)	0.6 (0.3 to 1.4); p = .257; ICC = 0
	2. Proportion of patients receiving medical imaging Cohort with registry data	23/278(8.3)	36/221 (16.3)	0.5 (0.3 to 0.8); p = .011: ICC < 0.001
Treatment intervention	1. Proportion of patients receiving stratified number of PT visits Cohort with registry data	152/278 (54.7)	99/222 (44.6)	1.5 (1.0 to 2.3): p = .040; ICC = 0.010
	2. Proportion of patients receiving educational interventions Cohort with CRPE data	164/223 (73.5)	58/165 (35.2)	5.1 (3.3 to 8.0); p < .001; ICC = 0.148
	- SBT low risk subgroup	49/76 (64.5)	20/54 (37.0)	3.1 (1.1 to 8.6); p = .026; ICC = 0.091
	- SBT medium/high risk subgroup	107/133 (80.5)	31/92 (33.7)	8.1 (4.4 to 14.9); p < .001; ICC = 0.228
	3. Proportion of patients receiving exercise interventions Cohort with CRPE data	203/223 (91.0)	146/165 (88.5)	1.3 (0.7 to 2.6); p = .411; ICC < 0.001
	4. Proportion of patients receiving short-term use of manual therapy as a part of multimodal treatment when LBP with segmental movement impairments is found. Cohort with CRPE data	25/223 (11.2)	27/165 (16.4)	0.7 (0.4 to 1.2); p = .154; ICC < 0.001
	5. Proportion of patients receiving acupuncture as an adjunct to treatment interventions 2 & 3 Cohort with CRPE data	1/223 (0.4)	3/165 (1.8)	0.8 (0.3 to 2.4); p = .682; ICC < 0.001
	6. Proportion of patients receiving non-evidence-based treatments Cohort with CRPE data	25/223 (11.2)	36/165 (21.8)	0.4 (0.2 to 0.8); p = .015; ICC = 0.042

CPG Clinical Practice Guidelines, n number of observations, OR Odds ratio, CI Confidence Interval, CRPE data clinical reasoning and process evaluation data from physiotherapists, SBT STarT Back Screening Tool, ICC intracluster correlation coefficient, Bold text p < 0.05.

Table 7. The proportion of clinical practice quality index fulfillment.

	Number of criteria for adherence	Intervention group, n (%)	Control group, n (%)	Between group comparison OR (95% CI); p-value; ICC
Assessment quality index	Both criteria fulfilled Cohort with registry data	253/278 (91.0)	184/222 (82.9)	2.0 (1.2 to 3.4); p = .011; ICC < 0.001
Treatment quality index	All 3 criteria fulfilled Cohort with CRPE data	148/223 (66.4)	47/165 (28.5)	3.5 (1.7 to 7.2); p < .001; ICC = 0.182
Overall adherence	All 5 criteria fulfilled Cohort with CRPE data	131/223 (58.7)	42/165 (25.5)	3.5 (1.9 to 6.6); p < .001; ICC = 0.077

n number of observations, OR Odds ratio, CI Confidence Interval, CRPE data clinical reasoning and process evaluation data from physiotherapists, ICC intracluster correlation coefficient, Bold text p < 0.05.