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Clinical Trials/NCT05655962
NCT05655962RecruitingNot Applicable

A Structured Framework for Assessment of Rehabilitation and Sicklisting (STARS) in Primary Care - Evaluating Effects, Professionals' and Patient Experiences of STARS

Region Östergötland1 site in 1 country200 target enrollmentStarted: September 1, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
200
Locations
1
Primary Endpoint
Length of sick leave in days.

Study Overview

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.

Detailed Description

Common mental disorders and musculoskeletal pain are the most frequent causes for sick leave. Despite frequent appearance, the sick listing process is often perceived as uncertain and unclear, both among sick listed patients and health care professionals. In addition, the follow-up of patients on sick leave is sometimes lacking, leading to protracted processes and suffering for the patients. In three healthcare regions in the Southeast of Sweden, a structured framework regarding the sick listing and rehabilitation process has been developed in close collaboration between researchers and clinicians: STructured Assessment of Rehabilitation and Sick listing in primary care (henceforth referred to as STARS), to meet the needs among patients and professionals within health care, as well as to meet the statutory demands regarding coordination efforts for sick-listed patients. The comprehensive design of this study includes qualitative as well as quantitative studies, with the aim to evaluate the effects of STARS at patient, staff, and organization levels.

In a controlled pragmatic multicenter primary care study, nine centers (three from each region) working according to STARS will be compared with control centers with care as usual. The STARS framework has seven detailed method supports for health care professionals, each to be applied at different times during the first 90 days of the patients´ sick listing. Potential study participants are a) patients aged 18-65 that are sick listed due to common mental disorders, musculoskeletal pain or residual symptoms from Covid-19 and; b) medical staff involved in the sick listing- and rehabilitation process. Data will be collected through focus group interviews (health care professionals), individual interviews (patients), questionnaires (patients and health care professionals) as well as national registries regarding length and extent of sick listing. Primary outcome measures are length and extent of sick listing up until 90 days (quantitative) and the medical staffs´ experiences and perceptions regarding following the guidelines of the STARS framework (i.e. both qualitative and quantitative data). Secondary outcome measures at the included STARS centers are i) the patients' experiences regarding their sick listing process, ii) the medical staffs´ experiences of their organizational work environment , iii) causes for sick listing >90 days, and iv) health economic studies to investigate the cost-effectiveness of STARS.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
None

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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.

Exclusion Criteria

  • •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.

Arms & Interventions

STARS center

Experimental

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

Intervention: STARS (Other)

Control center

No Intervention

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

Outcomes

Primary Outcomes

Length of sick leave in days.

Time Frame: Through study completion, an average of 2 years.

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

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

Time Frame: Through study completion, an average of 2 years.

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

Secondary Outcomes

  • Qualitative measures regarding the healthcare professionals' perception of STARS, assessed by interviews.(Through study completion, an average of 2 years.)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Hanna Israelsson Larsen

PhD, MD, Adjunct senior lecturer

Region Östergötland

Study Sites (1)

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