The effects of a structured communication tool in patients with medically unexplained physical symptoms : a clusterrandomized trial

Background: Medically Unexplained Physical Symptoms (MUPS) are prevalent among primary care patients andfrequently lead to diminished quality of life, increased healthcare costs, and decreased work participation. We aimedto examine the effects of a work-focused structured communication tool based on cognitive-behavioral therapy inpatients with MUPS.

Methods: In a Norwegian two-arm cluster randomized trial, the effectiveness of the structured communication toolIndividual Challenge Inventory Tool (ICIT) was compared to usual care for patients with MUPS using a two-armcluster randomized design. Enrollment period was between March 7 and April 1, 2022. Ten groups (clusters) of103 General Practitioners (GPs) were randomized to provide the ICIT or usual care for 11 weeks. Patientsreceived two or more sessions with their GP, and outcomes were assessed individually. Primary outcome waspatient-reported change in function, symptoms, and quality of life measured by the Patient Global Impression ofChange (PGIC). Secondary outcomes included sick leave, work-related self-efficacy (RTW-SE), health-relatedquality of life (RAND-36), and patient experiences with consultants (PEQ). The trial was registered onClinicalTrials.gov(NCT05128019).

Findings: A total of 541 patients with MUPS were enrolled in the study. In the intervention group 76% (n = 223)showed a significant overall improvement in function, symptoms, and quality of life as measured by the PGIC,compared to 38% (n = 236) in the usual care group (mean difference−0.8 ([95% CI−1.0 to−0.6]; p < 0.0001). At 11weeks, the intervention group had a 27-percentage point decrease in sick leave (from 52.0 to 25.2), compared to 4-percentage point decrease (from 49.7 to 45.7) in the usual care group. Furthermore, compared to usual care, theintervention group reported significant improvements in work-related self-efficacy, health-related quality of life,and greater satisfaction with the communication during the consultations. No adverse events were reported.

Interpretation: The implementation of the structured communication tool ICIT in primary care significantly improvedpatient outcomes and reduced sick leave among patients with MUPS.