Evaluation of a Collaborative Intervention to Promote Employer Contact and RTW Among People With CMD or Chronic Pain

Evaluation of a Collaborative Intervention to Promote Early Employer Contact and Return to Work Among People With Common Mental Disorders or Long-term Pain

The overall aim of this cluster ranomized controlled trial is to investigate whether an intervention for collaboration between patient with CMD or chronic pain and employer (the Demand and Ability Protocol) can contribute to reduced sick leave and to increased health, work ability and trust in the managers. The intervention is delivered by rehabiliation coordinators at primary health care centres.

Study Overview

• Status: Recruiting
• Conditions: Pain, Chronic; Mental Disorder
• Intervention / Treatment: Other: Demand and ability protocol; Other: Collaborative interventions as usual

Detailed Description

The overall aim of this cluster ranomized controlled trial is to investigate whether an intervention for collaboration between patient with CMD or chronic pain and employer (the Demand and Ability Protocol) can contribute to reduced sick leave and to increased health, work ability and trust in the managers. The intervention is delivered by rehabilitation coordinators at primary health care centres.

Furthermore, the aim is to identify hindering and facilitating factors for feasibility, usability and implementation of the Demand and Ability Protocol intervention (DAP) in primary health care.

Research questions:

1. What is the effect of DAP for patients regarding sick leave, health, work ability, and trust in the manager compared to matched controls who do not recieve DAP?
2. How do patients and managers experience their participation in the intervention and how do they experience the usability of the DAP?
3. What facilitating and hindering factors exist for the introduction and implementation of DAP in primary health care, and how do rehabilitation coordinators (REKO) and medical doctors experience the feasibility and usability of the intervention?

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Therese Hellman, PhD; Phone Number: +46706539504; Email: therese.hellman@medsci.uu.se

Study Locations

• Sweden
  • Uppsala Lan
    • Uppsala, Uppsala Lan, Sweden, 75652
      • Recruiting
      • Region Uppsala
      • Contact: Therese Hellman, PhD; Phone Number: +46706539504; Email: therese.hellman@medsci.uu.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• have a diagnosis of CMD and/or chronic pain
• have a job
• be on full-time or part time sick leave
• accept the manager's involvement.

Exclusion Criteria:

• been on full-time sick leave for more than 6 months before the first contact with REKO

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; The rehabilitation coordinators are trained in the intervention (0,5 day).	Other: Demand and ability protocol; The intervention consists of a structured conversation between the patient and his immediate manager under the guidance of licensed medical staff (in this case REKO) with knowledge of the requirements of the patient's work and his/her current functional ability. The intervention takes about 90 minutes excluding preparation time for REKO. DAP consider the following domains; 1) mental and cognitive ability, 2) basic skills and social ability, 3) tolerance for physical conditions, 4) ability to work dynamically, 5) ability to work statically and 6) to be able to work certain times. Based on the above domains, a structured review is made of the balance between requirements and function in current work in order to identify possible adaptations and measures at the workplace. During the intervention, the work requirements and the patient's function/ability are identified on a three-point scale and in domains where there is thus an imbalance adjustments or changed tasks are identified.
Other: Active comparator; Participants in the experimental arm will be matched with controls from the Micro Data for the Analysis of Social Insurance register (MiDAS) from the Social Insurance Agency, Sweden.	Other: Collaborative interventions as usual; The rehabilitation coordinator conduct collaborative interventions as usual with patient and employer. This might be through phone calls are unstructured meetings.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sick leave	The total number of days on sick leave due to CMDs or chronic pain during the 12 month follow-up period	From baseline until 12 months

Collaborators and Investigators

• Sponsor: Uppsala University
• Collaborators: Uppsala University Hospital
• Investigators: Principal Investigator: Therese Hellman, PhD, Uppsala University

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2022
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 21, 2025

Study Registration Dates

• First Submitted: January 17, 2022
• First Submitted That Met QC Criteria: January 31, 2022
• First Posted (Actual): February 1, 2022

Study Record Updates

• Last Update Posted (Actual): May 8, 2024
• Last Update Submitted That Met QC Criteria: May 7, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Schizophrenia Spectrum and Other Psychotic Disorders; Psychotic Disorders; Chronic Pain; Mental Disorders
• Other Study ID Numbers: RFR-968570

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