Effects of nurse-led motivational interviewing of patients with chronic musculoskeletal pain in preparation of rehabilitation treatment (PREPARE) on societal participation, attendance level, and cost-effectiveness: study protocol for a randomized controlled trial.

BACKGROUND: Non-adherence and drop-out are major problems in pain rehabilitation. For patients with various health problems, motivational interviewing (MI) has shown promising effects to tackle these problems. In chronic pain patients, the effectiveness of MI is however unknown. Therefore, a MI-based pre-pain rehabilitation intervention (MIP) addressing motivation, expectations, and beliefs has been developed to prepare eligible patients for rehabilitation treatment.

METHODS/DESIGN: A parallel randomized controlled trial including two interventions: a motivational interviewing pre-pain rehabilitation intervention (MIP) and a usual care (UC) control arm. Follow-up will be 6 months after completion of rehabilitation treatment.

STUDY POPULATION: One hundred and sixty (n = 80 per arm) patients with chronic non-specific musculoskeletal pain visiting an outpatient rehabilitation department, who are eligible to participate in an outpatient cognitive behavioral pain rehabilitation program.

INTERVENTION: MIP consists of two sessions to prepare and motivate the patient for pain rehabilitation treatment and its bio psychosocial approach. UC consists of information and education about the etiology and the general rehabilitation approach of chronic pain. Both the MIP and UC contain two sessions of 45 to 60 minutes each.

OBJECTIVE: The aim of the current study is to evaluate the effectiveness of MIP compared to UC in terms of an increase in the long-term level of societal participation and decrease of drop-out during rehabilitation treatment.Main study endpoints: Primary outcome is the change in level of participation (according to the ICF-definition: 'involvement in a life situation') 6 months after completion of rehabilitation treatment. Secondary outcomes are adherence and treatment drop-out, disability, pain intensity, self-reported main complaints, (pain-specific) self-efficacy, motivation, and quality of life. Costs are calculated including the costs of the pre-treatment intervention, productivity losses, and healthcare utilization. Potential moderators and active ingredients of MI are explored. For the process evaluation, parameters such as MI fidelity, feasibility, and experiences are explored.

DISCUSSION: The results of this study will provide evidence on the effectiveness of this MI-based pre-treatment in pain rehabilitation. Furthermore, a cost-effectiveness analysis and exploration of moderating and working mechanisms of MI and an extensive process evaluation takes place.

TRIAL REGISTRATION: Nederlands trial register NTR3065.