JMIR Publications

ABSTRACT

Background:

Chronic non-cancer pain is a frequent reason for counselling in general practice. Current German guidelines emphasize its biopsychosocial etiology and the importance of self-care and non-pharmacological treatment strategies such as education, physical and social activity and psychological approaches. Comprehensive assessments are necessary to individualize treatment as far as possible and monitor appropriate use of pain medication. General practitioners face many challenges in implementing holistic pain management which considers biological, psychological and social aspects. In the project RELIEF, a case management program was developed to facilitate implementation of guideline recommendations on pain management regarding 1) medical assessment and monitoring, 2) patient and practice team education, 3) promotion of self-care strategies and 4) rational pharmacotherapy.

Objective:

Primary objective is to evaluate feasibility of the intervention and study procedures before they will be applied in a larger cluster-randomized controlled trial. A secondary objective is to estimate potential effects of the complex intervention.

Methods:

A one-armed trial with general practices and patients with chronic non-cancer pain (CNCP) and analgesics use will be conducted, accompanied by a process evaluation. The intervention comprises five components: Software-supported medical pain history; three scheduled structured appointments; e-learning on CNCP for General practitioners and medical assistants; educational material for patients; toolbox with information on (regional) resources for patients and practice teams. Participating practices will be located in the federal state of Baden-Württemberg, Germany, and will recruit eligible patients (adults with CNCP for more than 3 months, with at least moderate pain-related disability, permanent or on-demand use of analgesics or co-analgesics in the previous 4 weeks, and practice team assessed ability to participate actively in the trial). A questionnaire given to the first 150 adult patients entering the practice from a defined date on will be used to screen for patients who meet the inclusion criteria. Feasibility of intervention and study procedures will be measured by a set of newly developed indicators. The key secondary outcome is pain-related disability measured by the Pain Disability Index. All participants will be asked to participate in the process evaluation. Data for the outcome evaluation will be gathered by paper-based questionnaires to be completed by participants. Data for the process evaluation will be gathered in surveys and a qualitative study.

Results:

Targeted sample size is n=6 practices and n=50 patients. It is expected that eligible patients will benefit from the intervention and that improved medication management and intensified use of non-medical treatment strategies will result in a reduction of pain-related disabilities and other patient-reported outcomes.

Conclusions:

This study will provide valuable information regarding feasibility and potential effects before testing the intervention in a confirmatory cluster-randomized controlled trial. Clinical Trial: https://www.drks.de/DRKS00034831