An interventional study of Timely Care, in Multimorbidity, Integrated Care and Primary Care Patients With Chronic Conditions, sponsored by Linnaeus University. Enrolling by invitation at 1 site in Sweden. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by Linnaeus University · Not applicable, Interventional, and Other
Healthcare systems face persistent challenges in providing coordinated, proactive care for individuals with complex health needs, resulting in high vulnerability to fragmented care, acute clinical deterioration, and frequent emergency hospital admissions. TimelyCare is a proactive, multimodal primary care intervention designed to improve care continuity, optimize hospital-to-home transitions, and reduce unplanned acute healthcare dependency among high-risk individuals. This study evaluates the TimelyCare model using a pragmatic, stepped-wedge matched cluster-controlled trial (SW-CRT) with an open dynamic cohort across 12-15 primary healthcare centers in Region Kalmar, Sweden.
The intervention targets individuals identified through an innovative combined risk algorithm integrating high morbidity (Resource Utilization Bands [RUB] levels 4-5) and sociodemographic vulnerability (Demographic Statistical Areas [DeSO]). The primary hypothesis is that exposure to the TimelyCare intervention will significantly reduce unplanned hospital admission rates over an 18-month follow-up period compared with usual care, while improving patient-experienced continuity, health-related quality of life, and healthcare cost-effectiveness.
The TimelyCare study comprises a pre-implementation risk-modeling phase and three integrated work packages combining trial evaluation, co-design, and process evaluation: Target Population \& Identification Algorithm: Eligible participants are community-dwelling adults classified at RUB/DeSO levels 4 or 5 within participating primary healthcare centers
. The algorithm combines Adjusted Clinical Groups (ACG) morbidity levels (RUB 4-5) with localized socio-geographic disadvantage (DeSO) to target individuals facing a compounded risk of fragmented care and high emergency care utilization.
Intervention Components: The TimelyCare model integrates four synergistic clinical components:
Component A (Coordinated Care Transitions): Standardized, cross-boundary transition protocols and communication pathways (e.g., Cosmic LINK®) between specialized hospital care, primary care, and municipal home care to eliminate discharge information gaps . Component B (Designated GP / Care Contact): Assignment of a named General Practitioner (GP) and/or fixed care-contact nurse to guarantee relational and informational stability . Component C (Proactive Serious Illness Conversations): Structured, values-based care-planning conversations conducted with patients and family carers using the Swedish-adapted Serious Illness Conversation Guide (SICG)
. Component D (Emergency Decision Support \& Fast-Track Pathways): Interprofessional decision-support routines and direct-access escalation protocols for ambulance staff, municipal nurses, and primary care clinicians during acute home deteriorations, bypassing unnecessary emergency department delays
.
Study Design \& Methodological Framework:
Stepped-Wedge Cluster Trial: 12-15 primary healthcare center clusters will be sequentially rolled out into the intervention phase in stepped steps over an 18-month period, ensuring all clusters receive the intervention while allowing both within- and between-cluster comparisons . Open Dynamic Cohort: Reflecting routine clinical practice, an open cohort of approximately 6,000-9,000 eligible high-risk patients will be followed over an 18-month post-implementation window
.
Outcome Measures:
Primary Outcome: Rate of unplanned hospital admissions per 1,000 person-years, evaluated quarterly using regional healthcare registers via Interrupted Time Series (ITS) with segmented regression
. Secondary Utilization Outcomes: Quarterly rates of emergency department visits, 30-day unplanned readmissions, average length of stay (ALOS), ambulance transport frequency, specialist outpatient visits, and all-cause mortality
. Patient-Reported Endpoints (PROMs/PREMs): Patient-experienced continuity evaluated via the Patient-Experienced Continuity of Care Questionnaire (PECQ; short version) and health-related quality of life via EQ-5D-5L (and QALYs), surveyed at baseline, 6, 12, and 18 months and analyzed using multilevel regression.
Health Economic Endpoints: Direct healthcare costs (Cost per Patient database, Prescribed Drug Register) and municipal care expenditure, evaluated via Cost-Consequence Analysis (CCA) and Cost-Effectiveness Analysis (CEA) calculating the Incremental Cost-Effectiveness Ratio (ICER) per avoided hospital admission.
Process Evaluation: A Consolidated Framework for Implementation Research (CFIR 2.0)-guided mixed-methods evaluation assessing staff implementation capacity (IPAT questionnaire at baseline, 6, 12, 18 months), qualitative stakeholder interviews, fidelity, reach, and contextual adaptations mapped via the Implementation Research Logic Model (IRLM).
Linnaeus University is the lead sponsor of 29 studies on the registry; 14 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Standard primary care, municipal home care, and hospital discharge routines prior to intervention rollout at each participating primary healthcare center cluster
Implementation of the multimodal TimelyCare model, comprising four core components
Behavioral: Timely Care,
The TimelyCare intervention combines four synergistic clinical components administered through interprofessional collaboration across regional primary healthcare centers (PHCCs), hospital wards, municipal home care, and emergency medical services: Component A: Coordinated Care Transitions Intervention Administered: Standardized transition protocols and digital communication pathways to bridge information gaps during hospital-to-home discharges Component B: Designated GP / Care Contact. Intervention Administered: Formal assignment of a named General Practitioner (GP) and/or a designated care-contact nurse Component C: Proactive Serious Illness Conversations Intervention Administered: Structured, proactive care-planning discussions using the Swedish-adapted Serious Illness Conversation Guide Component D: Emergency Decision Support \& Fast-Track Pathways Intervention Administered: Decision-support tools and fast-track escalation protocols for managing acute home-based deteriorations
Unplanned Hospital Admission Rate
Rate of unplanned emergency hospital admissions per 1,000 person-years. Evaluated using quarterly regional healthcare register data via Interrupted Time Series (ITS) with segmented regression analysis to assess post-implementation changes compared to the baseline trajectory
Time frame: Baseline (pre-intervention retrospective trajectory, 2014-2025) through 18-month post-implementation follow-up (September 2025-March 2027)
Emergency Department (ED) Visit Rate
Rate of emergency department visits and emergency admissions per 1,000 person-years
Time frame: Quarterly from baseline up to 18 months post-implementation
30-Day Unplanned Hospital Readmissions
Proportion of patients experiencing an unplanned hospital readmission within 30 days of discharge
Time frame: Quarterly over the 18-month follow-up period
Average Length of Hospital Stay
Average duration of unplanned hospital stay measured in days
Time frame: Quarterly over the 18-month follow-up period
Patient-Experienced Continuity of Care Score
Evaluated using the validated Patient-Experienced Continuity of Care Questionnaire (PECQ; short version), measuring four dimensions: informational, relational, management, and knowledge continuity
Time frame: Baseline, 6, 12, and 18 months post-enrolment
Health-Related Quality of Life (HRQoL) and QALYs
Evaluated using the EQ-5D-5L index score and Visual Analogue Scale (VAS), converted to Quality-Adjusted Life Years (QALYs) for health economic utility analysis
Time frame: Baseline, 6, 12, and 18 months post-enrolment
Incremental Cost-Effectiveness Ratio (ICER)
Incremental cost per avoided unplanned hospital admission, integrating direct healthcare costs (DRG/Cost per Patient database, Prescribed Drug Register) and municipal home care expenditures
Time frame: Baseline to 18-month post-implementation horizon
Implementation Capacity Score (IPAT)
Measured among healthcare staff using the Implementation Process Assessment Tool (IPAT) to evaluate organizational readiness, implementation capacity, and sustainment over time
Time frame: Baseline, 6, 12, and 18 months
Plan to share: Undecided — No individual participant data (IPD) will be shared. The data contain confidential participant information, and consent for external sharing of individual-level data was not obtained from participants. To protect participant privacy and comply with ethical and legal requirements, IPD will not be made available. Non-confidential information, such as study protocols, aggregate results, and summary data, may be shared upon reasonable request.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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