Use of the Individual Challenge Inventory Tool (ICIT) by General Practitioners

Study Overview
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Brief Summary
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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
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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.

Official Title
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Can the Use of the Conversation Tool Individual Challenge Inventory Tool (ICIT) by General Practitioners Increase Coping of the Patients?

Conditions
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Medical Unexplained Physical Symptoms (MUPS), Subjective Health Complaint

Intervention / Treatment
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* Behavioral: ICIT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 67 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Cluster Randomized Controlled Trial with an intervention group and a control group
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>50 GPs will recruit 10 patients each from their daily practice, to take part in the study. They will offer the patients a session of unspecified length or number of consultations, to follow the conversation tool ICIT | Behavioral: ICIT<br>* Patients in the intervention group will receive a number of consultations with their GP based on the ICIT<br>|
| No Intervention: Control<br>50 GPs will recruit 10 patients each from their daily practice, to take part in the study. They will however, only receive standard routine care and follow-up by their GP. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients' assessment of personal quality of life | Patients Global Impression of Change (PGIC) | One year | 
| Patients' experiences at the encounter | Mean change on score at the Patient Experiences Questionnaire (PEQ) | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome is any change in patient's coping strategies | Mean change on score at the Patient Activation Measure (PAM) in both groups | One year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MUPS, SHC, sick leave, Communication tool, General practice