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

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

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.

Study Overview

• Status: Completed
• Conditions: Medical Unexplained Physical Symptoms (MUPS); Subjective Health Complaint
• Intervention / Treatment: Behavioral: 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.

• Study Type: Interventional
• Enrollment (Actual): 459
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cathrine Abrahamsen, MD; Phone Number: +4745868340; Email: drcatha@gmail.com
• Study Contact Backup: Name: Morten Lindbekk, PhD; Phone Number: +92454850; Email: morten.lindbak@medisin.uio.no

Study Locations

• Norway
  • Oslo, Norway
    • University of Oslo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 67 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Behavioral: ICIT; Patients in the intervention group will receive a number of consultations with their GP based on the ICIT
No Intervention: 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Single question	Patients will be asked about their own anticipation of return to work	One year

Collaborators and Investigators

• Sponsor: University of Oslo

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2022
• Primary Completion (Actual): May 21, 2022
• Study Completion (Actual): February 28, 2023

Study Registration Dates

• First Submitted: October 19, 2021
• First Submitted That Met QC Criteria: November 8, 2021
• First Posted (Actual): November 19, 2021

Study Record Updates

• Last Update Posted (Actual): May 17, 2023
• Last Update Submitted That Met QC Criteria: May 16, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: MUPS, SHC, sick leave, Communication tool, General practice
• Other Study ID Numbers: NSD368367

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No