Public HealthSTARSNCT05655962
A Structured Framework for Assessment of Rehabilitation and Sicklisting in Primary Care - a Multicenter Study
A study testing STARS in people with Public Health, run by Region Östergötland at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Public Health
- What is being tested?
- STARS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSweden
- Study dates
- 1 Sep 2022to 1 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Emma Linder, Nurse contact
Sweden1 site, 1 recruiting
- Recruiting
Region Östergötland
Norrköping
Hanna Israelsson Larsen, PhD, 0046 73 8317008, hanna.israelsson.larsen@regionostergotland.se
Emma Linder, Nurse, emma.linder@regionostergotland.se
About this study
Official title: A Structured Framework for Assessment of Rehabilitation and Sicklisting (STARS) in Primary Care - Evaluating Effects, Professionals' and Patient Experiences of STARS
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.
Read the 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.
- Conditions
- Public Health
- Being tested
- STARS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STARSOther
STARS is a structured framework for assessment of rehabilitation and sicklisting, applied by primarily the rehabilitation coordinators working at the primary health care centers.
| Study group | Role | What they receive |
|---|---|---|
| STARS center | Experimental | Centers in the southeast region of Sweden working according to STARS. Receives: Other: STARS |
| Control center | No intervention | Centers in the southeast region of Sweden not working according to STARS. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Through study completion, an average of 2 years.
Secondary outcomes (1)
Qualitative measures regarding the healthcare professionals' perception of STARS, assessed by interviews.
The health care professionals' perceptions and experiences of the sick listingprocess at STARS centers.
Measured: Through study completion, an average of 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2022
- Study start1 Sep 2022
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Public HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 9 centers implement the STARS framwork, and are compared to control centers that do not work according to STARS.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Östergötland
- Sponsor type
- University, hospital or other
- Collaborators
- Region Jönköping County, Kalmar County Hospital
- Responsible party
- Principal investigator, Hanna Israelsson Larsen, Region Östergötland
- Investigators
- Hanna I Larsen, Principal investigator, Region Östergötland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05655962
- Sponsor's protocol ID
- 2021-04412
- Acronym
- STARS
- Status last verified
- Sep 2023
- First submitted
- 30 Nov 2022
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sundkvist EM, Jansson I, Sverker A, Karlsson E, Rosenberg L, Israelsson Larsen H. A structured framework for assessment of rehabilitation and sick-listing (STARS) - experiences among healthcare professionals. Scand J Prim Health Care. 2027 Dec;45(1):2748807. doi: 10.1080/02813432.2026.2748807. Epub 2026 Oct 20.
PubMed 42900467
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Structured Framework for Assessment of Rehabilitation and Sicklisting (STARS) in Primary Care - Evaluating Effects, Professionals' and Patient Experiences of STARS
- ClinicalTrials.gov ID
- NCT05655962
- Acronym / sponsor ID
- STARS / 2021-04412
- Conditions
- Public Health
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Region ÖstergötlandUniversity, hospital or other
- Collaborators
- Region Jönköping County, Kalmar County Hospital
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 19 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 9 centers implement the STARS framwork, and are compared to control centers that do not work according to STARS.
| Arm | Type | Receives |
|---|---|---|
| STARS center | Experimental | Other: STARSCenters in the southeast region of Sweden working according to STARS. |
| Control center | No intervention | –Centers in the southeast region of Sweden not working according to STARS. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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 involved in the sick-listing process of the patients at the health care center.
Key exclusion criteria (6 listed)
- inability to understand Swedish;
- incapacity to give informed consent;
- protected identity
- Health care professionals not involved in the sick-listing process of the patients at the health care center.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STARSSTARS is a structured framework for assessment of rehabilitation and sicklisting, applied by primarily the rehabilitation coordinators working at the primary health care centers. | Other | STARS center |
Primary outcome
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.
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.
1 secondary outcome
Qualitative measures regarding the healthcare professionals' perception of STARS, assessed by interviews.
Time frame: Through study completion, an average of 2 years.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Derived from this study: PubMed 42900467Sundkvist EM, Jansson I, Sverker A, Karlsson E, Rosenberg L, Israelsson Larsen H. A structured framework for assessment of rehabilitation and sick-listing (STARS) - experiences among healthcare professionals. Scand J Prim Health Care. 2027 Dec;45(1):2748807. doi: 10.1080/02813432.2026.2748807. Epub 2026 Oct 20.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emma Linder, Nurse contact
Hanna I Larsen principal investigator
Region Östergötland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STARS in people with Public Health, run by Region Östergötland at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hanna I Larsen, PhD, MD (0046 73 8317008, hanna.israelsson.larsen@regionostergotland.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Qualitative measures regarding the patients' perception of STARS, assessed by interviews. (time frame: Through study completion, an average of 2 years.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05655962, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.