A Structured Framework for Assessment of Rehabilitation and Sicklisting in Primary Care - a Multicenter Study

NCT05655962 | Unknown

• 1 other identifier: 2021-04412
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

In a controlled pragmatic multicenter primary care study, centers working according to a newly constructed structured framework for assessment of rehabilitation and sicklisting (STARS) will be investigated. Nine intervention centers working according to STARS will be compared to matched control centers not working according to STARS. The design of this study includes qualitative as well as quantitative measures, with the aim to evaluate the effects of STARS at patient, staff, and organization levels.

Conditions

Public Health

Outcome Measures

Primary Outcomes (2)

• Qualitative measures regarding the patients' perception of STARS, assessed by interviews.

  The patients' perceptions and experiences of their sick listing process at STARS centers, as described in individual interviews with the study participants.

  Through study completion, an average of 2 years.

• Length of sick leave in days.

  Number of days on the sick leave for patients receiving care at a STARS center compared to control centers.

  Through study completion, an average of 2 years.

Secondary Outcomes (1)

• Qualitative measures regarding the healthcare professionals' perception of STARS, assessed by interviews.

  Through study completion, an average of 2 years.

Study Arms (2)

STARS center

EXPERIMENTAL

Centers in the southeast region of Sweden working according to STARS.

Other: STARS

Control center

NO INTERVENTION

Centers in the southeast region of Sweden not working according to STARS.

Interventions

STARS OTHER

STARS is a structured framework for assessment of rehabilitation and sicklisting, applied by primarily the rehabilitation coordinators working at the primary health care centers.

STARS center

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients:
• age ≥18 years;
• sick-listed due to ICD-diagnoses: F00-F99 (mental/behavioral disorders), M00-99 (musculoskeletal pain), R52 (non-specified pain), U08.9, U09.9 or U10.9 (codes related to COVID19);
• have received rehabilitation coordination performed by a RECO
• Health care professionals:
• \- Health care professionals involved in the sick-listing process of the patients at the health care center.

You may not qualify if:

• Patients:
• inability to understand Swedish;
• incapacity to give informed consent;
• protected identity
• Health care professionals:
• \- Health care professionals not involved in the sick-listing process of the patients at the health care center.

Sponsors & Collaborators

• Region Östergötland: lead
• Region Jönköping County: collaborator
• Kalmar County Hospital: collaborator

Study Sites (1)

Region Östergötland

Norrköping, Sweden

RECRUITING

Study Officials

• Hanna I Larsen

  Region Östergötland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hanna I Larsen, PhD, MD

CONTACT

0046 73 8317008; hanna.israelsson.larsen@regionostergotland.se

Emma Linder, Nurse

CONTACT

emma.linder@regionostergotland.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, MD, Adjunct senior lecturer

Model Details: 9 centers implement the STARS framwork, and are compared to control centers that do not work according to STARS.

Study Record Dates

• First Submitted: November 30, 2022
• First Posted: December 19, 2022
• Study Start: September 1, 2022
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)