Cooperation for Primary Care Patients on Sick Leave for CMD: Care Manager and Workplace Intervention - CO-WORK-CARE

Study Overview
=================
Brief Summary
-----------------
This study aims to evaluate whether a convergence dialogue during sick leave, between the employee and the employer, with the Primary Care Centre Rehab Coordinator as discussion leader, leads to reduced sick leave time compared to those individuals who only have contact with a Care Manager during the period of sick leave. The study will be performed as a randomised controlled trial with randomisation at the PCC level where intervention PCCs offers a convergence dialogue meeting with the work place representative during sick leave in addition to Care Manager contact.

Detailed Description
-----------------
In Sweden sick leave time and frequency are increasing. This is primarily in the area of common mental disorders (CMD), and CMD is now the most common single cause of sickness absence. Primary care is the area in which most individuals with mental illness seek care and also receive care. A Care Manager function at the primary care centre (PCC) where the Care Manager is responsible for the support and close contact with patients with CMD and act as the spider in the web and combine patient support with other measures, have been shown to have beneficial effects for depression course. In Region Västra Götaland an implementation of the Care Manager function at the PCC has been set out, and the function is now available in nearly 100 PCCs in the region. The present study aims to evaluate whether a convergence dialogue during sick leave, between the employee and the employer, with the PCCs Rehab Coordinator as discussion leader, leads to reduced sick leave time compared to those individuals who only have contact with the Care Manager during the period of sick leave. The study will be performed as pragmatic randomised controlled trial with randomisation at the PCC level. Around 20 PCCs with a Care Manager function for patients on sick-leave with CMD diagnosis will be recruited and randomized to intervention where patients in addition to a Care Manager contact (12 weeks) will have one convergence dialogue meeting with the work place representative during sick leave. Control PCCs will give Care Manager contact 12 weeks only.

Official Title
-----------------
Cooperation for Patients With Common Mental Disorders: Care Manager Function at the Primary Care Centre and Intervention at the Workplace - CO-WORK-CARE

Conditions
-----------------
Depressive Disorder, Anxiety Disorders

Intervention / Treatment
-----------------
* Behavioral: Workplace convergence dialogue
* Behavioral: Care Manager


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients attending primary care centers with care manager function aged >=18 to 67 years diagnosed with a new (< 1 month) depression diagnose (F32, F33), anxiety syndrome (F41, F48) or stress related adjustment disorder (F43) on sick-leave > 14 days Exclusion Criteria: Bipolar disorder psychosis addiction other serious mental disorder suicidal ideation or earlier suicide attempt cognitive impairment or not speaking/understanding Swedish

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

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Pragmatic randomised controlled trial; randomisation on primary care centre level
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention (Workplace dialogue)<br>Intervention: Work place convergence dialogue contact | Behavioral: Workplace convergence dialogue<br>* Work place contact as a convergence dialogue between the employer and employee with the Rehab Coordinator as a guide<br>Behavioral: Care Manager<br>* Regular contact Care Manager during around 12 weeks<br>|
| Active Comparator: Care Manager<br>Intervention: Care Manager contact 12 weeks (Care as usual) | Behavioral: Care Manager<br>* Regular contact Care Manager during around 12 weeks<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Net and gross sick-leave days | number of net and gross sick-leave days during 12 months | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depressive symptoms | Change of depressive symptoms Montgomery-Asberg Depression Rating Scale - Self rating version (MADRS-S) Range 0-60 (Total score) Low score better outcome | 6 and 12 months | 
| Anxiety symptoms | Change of anxiety symptoms Generalized Anxiety Disorder 7-item (GAD-7) scale Range 0-15 (total score) low score better outcome | 6 and 12 months | 
| Quality-of-life questionnaire score | Change of quality of life EuroQoL-5 Dimension Questionnaire(EQ-5D) Range 0-1.0(total score) low score worst outcome | 6 and 12 months | 
| Work ability | Change of work ability Work Ability Index (WAI) Range 7-49 (total score) low score worst outcome | 6 and 12 months | 
| Exhaustion | Change of Exhaustion Karolinska Exhaustion Disorder Scale (KEDS) Range 0-54 (total score) low score better outcome | 6 and 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
primary care, convergence dialogue, sick leave, care manager