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

NCT ID: NCT05216861

Last Updated: 2024-05-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-15
• Study Completion Date: 2025-12-21

Brief Summary

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.

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?

Conditions

Pain, Chronic; Mental Disorder

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Experimental

The rehabilitation coordinators are trained in the intervention (0,5 day).

Group Type: EXPERIMENTAL

Demand and ability protocol

Intervention Type: OTHER

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.

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.

Group Type: OTHER

Collaborative interventions as usual

Intervention Type: OTHER

The rehabilitation coordinator conduct collaborative interventions as usual with patient and employer. This might be through phone calls are unstructured meetings.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Uppsala University Hospital

OTHER

Sponsor Role: collaborator

Uppsala University

OTHER

Sponsor Role: lead

Responsible Party

Therese Hellman

PhD, Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Therese Hellman, PhD

Role: PRINCIPAL_INVESTIGATOR

Uppsala University

Locations

Region Uppsala

Uppsala, Uppsala County, Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

Therese Hellman, PhD

Role: CONTACT

therese.hellman@medsci.uu.se

+46706539504

Facility Contacts

Therese Hellman, PhD

Role: primary

therese.hellman@medsci.uu.se

+46706539504

Other Identifiers

RFR-968570

Identifier Type: -

Identifier Source: org_study_id