Clinical trial NCT05128019: Use of the Individual Challenge Inventory Tool (ICIT) by General Practitioners
Official title: Can the Use of the Conversation Tool Individual Challenge Inventory Tool (ICIT) by General Practitioners Increase Coping of the Patients?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medical Unexplained Physical Symptoms (MUPS)
Subjective Health Complaint
Keywords: MUPS, SHC, sick leave, Communication tool, General practice
Lead sponsor: University of Oslo
Sponsor class: OTHER
First posted: 2021-11-19
Enrollment: 459
Sex: ALL
Minimum age (years): 18
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Cluster Randomized Controlled Trial with an intervention group and a control group
Primary purpose: SUPPORTIVE_CARE

Brief summary: Many patients in general practice present symptoms that do not refer to specific pathology. We refer to these patients at Medical Unexplained Physical Symptoms (MUPS). Practice and research have well documented that these patients frustrate most General Practitioners (GPs). They also produce a lot of unnecessary investigations and are overrepresented on sick-listing. The conversational tool Individual Challenge Inventory Tool (ICIT) offers an aid for the GPS to the consultation and aims to increase the patients' coping abilities with their health challenges. The aim of the study is to investigate whether patients experience such increased coping following a session of consultations with their GP based on ICIT.

Detailed description: The study is a Cluster Randomized Controlled Trial (cRCT) with GPs as clusters. We plan to includ 50 GPs to participate as intervention group and 50 GPs as controls. Each cluster will include 10 patients. GPs in the intervention group will be trained in the use of ICIT through a 30 hours course, partly digital and partly in presence. The participants will receive lectures on the background for the conversation tool, and the study, and will practice on each other. At the end of the study, also the 50 GPs of the control group will be invited to an identical course.

The outcome of the study is any changes of the patients coping abilities. If the symptoms cannot be healed, a goal for the patients will be to reduce the impact of the symptoms. In practice, this is to reuptake normal activities, including work, in spite of pain, fatigue or mood disturbances. Through the ICIT, the patients will be challenged to look at themselves in a broader spectrum and decide for themselves which activities are possible to reuptake and making a thorough plan for doing so.

The patients will be treated by their regular GP across several meetings and they will agree on a specific plan across weeks or months to achieve their individual goal.

The patients of the GPs in the control group will represent identical medical symptoms and will be treated and followed by their GP as usual. They will, however, be informed and asked to consign to participate in the study, and will respond to the same questionnaires as the patients in the intervention group.

Eligibility criteria: Inclusion Criteria:

* Patients must have a condition the GP deems as MUPS (unspecific og generalized pain, fatigue or mood disturbances without being depressed)
* Patients must be deemed satisfactory clinical examined without specific findings
* Patients must be able to speak and understand Norwegian language without interpreter
* Patients must sign on a consignment form

Exclusion Criteria:

* Patients must not have any well defined psychiatric diagnosis
* Patients must not have any alcohol or drug abuse
* Patients must not be using more than 10 mg Benzodiasepine per day

Primary outcomes:
measure: Patients' assessment of personal quality of life
timeFrame: One year
measure: Patients' experiences at the encounter
timeFrame: One year
Secondary outcomes:
measure: The primary outcome is any change in patient's coping strategies
timeFrame: One year
Other outcomes:
measure: Single question
timeFrame: One year
Locations:
city: Oslo
country: Norway
facility: University of Oslo
Study officials:
References: