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

Sponsor

Göteborg University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03250026

Collaborator

Vastra Gotaland Region (Other)

349

Enrollment

Location

Arms

72.8

Anticipated Duration (Months)

4.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Depressive Disorder Anxiety Disorders	Behavioral: Workplace convergence dialogue Behavioral: Care Manager	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

349 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Pragmatic randomised controlled trial; randomisation on primary care centre levelPragmatic randomised controlled trial; randomisation on primary care centre level

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Dec 5, 2017

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Intervention (Workplace dialogue)

Intervention: Work place convergence dialogue contact

Behavioral: Workplace convergence dialogue

Work place contact as a convergence dialogue between the employer and employee with the Rehab Coordinator as a guide

Behavioral: Care Manager

Regular contact Care Manager during around 12 weeks

Active Comparator: Care Manager

Intervention: Care Manager contact 12 weeks (Care as usual)

Behavioral: Care Manager

Regular contact Care Manager during around 12 weeks

Outcome Measures

Primary Outcome Measures

Net and gross sick-leave days [12 months]
number of net and gross sick-leave days during 12 months

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 67 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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