The effectiveness of shared decision-making followed by positive reinforcement on physical disability in the long-term follow-up of patients with nonspecific low back pain in primary care : A clustered randomised controlled trial

Background: Although the recovery of patients suffering from low back pain is highly context dependent, patient preferences about treatment options are seldom incorporated into the therapeutic plan. Shared decision-making (SDM) offers a tool to overcome this deficiency. The reinforcement by the general practitioner (GP) of a 'shared' chosen therapy might increase patients' expectations of favourable outcomes and thus contribute to recovery. Methods: In the Netherlands, a clustered randomised controlled trial was performed to assess the effectiveness of shared decision-making followed by positive reinforcement of the chosen therapy (SDM&PR) on patient-related clinical outcomes. Overall, 68 GPs included 226 patients visiting their GP for a new episode of non-chronic low back pain. GPs in the intervention group were trained in implementing SDM&PR using a structured training programme with a focus on patient preferences in reaching treatment decisions. GPs in the control group provided care as usual. The primary outcome was the change in physical disability measured with the Roland-Morris disability questionnaire (RMD) during the six-month follow-up after the first consultation. Physical disability (RMD), pain, adequate relief, absenteeism and healthcare consumption at 2, 6, 12 and 26 weeks were secondary outcomes. A multivariate analysis with a mixed model was used to estimate the differences in outcomes. Results: Of the patients in the intervention and the control groups, 66 and 62%, respectively, completed the follow-up. Most patients (77%) recovered to no functional restrictions due to back pain within 26 weeks. No significant differences in the mean scores for any outcome were observed between intervention patients and controls during the follow-up, and in multivariate analysis, there was no significant difference in the main outcome during the six-month follow-up. Patients in the intervention group reported more involvement in decision-making. Conclusion: This study did not detect any improvement in clinical outcome or in health care consumption of patients with non-chronic low back pain after the training of GPs in SDM&PR. The implementation of SDM merely introduces task-oriented communication. The training of the GPs may have been more effective if it had focused more on patient-oriented communication techniques and on stressing the expectation of favourable outcomes. Trial registration: The Netherlands National Trial Register (NTR) number: NTR1960. The trial was registered in the NTR on August 20, 2009