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

NCT ID: NCT05655962

Last Updated: 2023-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-01

Study Completion Date

2025-03-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Public Health

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

9 centers implement the STARS framwork, and are compared to control centers that do not work according to STARS.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

STARS center

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

Group Type EXPERIMENTAL

STARS

Intervention Type 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.

Control center

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

STARS

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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.

Exclusion Criteria

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Region Jönköping County

OTHER_GOV

Sponsor Role collaborator

Kalmar County Hospital

OTHER

Sponsor Role collaborator

Region Östergötland

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Hanna Israelsson Larsen

PhD, MD, Adjunct senior lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Hanna I Larsen

Role: PRINCIPAL_INVESTIGATOR

Region Östergötland

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Region Östergötland

Norrköping, , Sweden

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Sweden

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Hanna I Larsen, PhD, MD

Role: CONTACT

0046 73 8317008

Emma Linder, Nurse

Role: CONTACT

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Hanna Israelsson Larsen, PhD

Role: primary

0046 73 8317008

Emma Linder, Nurse

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2021-04412

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Performance Feedback in Health Care
NCT04579614 COMPLETED NA