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

NCT ID: NCT05128019

Last Updated: 2023-05-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 459 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-07
• Study Completion Date: 2023-02-28

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.

Conditions

Medical Unexplained Physical Symptoms (MUPS); Subjective Health Complaint

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Intervention

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

Group Type: EXPERIMENTAL

ICIT

Intervention Type: BEHAVIORAL

Patients in the intervention group will receive a number of consultations with their GP based on the ICIT

Control

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

ICIT

Patients in the intervention group will receive a number of consultations with their GP based on the ICIT

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 67 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Oslo

OTHER

Sponsor Role: lead

Responsible Party

Erik L Werner

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Oslo

Oslo, , Norway

Countries

Norway

References

Abrahamsen C, Reme SE, Wangen KR, Lindbaek M, Werner EL. The effects of a structured communication tool in patients with medically unexplained physical symptoms: a cluster randomized trial. EClinicalMedicine. 2023 Oct 6;65:102262. doi: 10.1016/j.eclinm.2023.102262. eCollection 2023 Nov.

Reference Type: DERIVED

PMID: 37855023 (View on PubMed)

Other Identifiers

NSD368367

Identifier Type: -

Identifier Source: org_study_id