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Transforming the patient pathway through a cross-sectoral, short-stay hospital model focused on general medicine (STATAMED)

Organizational Data

DRKS-ID:
DRKS00033096
Recruitment Status:
Recruiting planned
Date of registration in DRKS:
2023-11-27
Last update in DRKS:
2023-11-27
Registration type:
Prospective

Acronym/abbreviation of the study

STATAMED

URL of the study

https://www.aok.de/gp/statamed

Brief summary in lay language

This new model of care involves transforming an existing hospital into a new STATAMED site, including the creation of a general medicine ward with approximately 15 to 25 beds alongside a gradual reduction in the total number of hospital beds, the scaling back of specialist departments, and the eventual closure of the emergency department. Concurrently, cross-sectoral networks will be established among various health professions and specialist doctors, who will provide their services via telemedicine or in cooperation with STATAMED. The Associations of Statutory Health Insurance Physicians will be involved in this process to ensure needs-based referral of patients to STATAMED, as well as collaborative treatment planning and seamless ongoing care after hospital discharge. Joint quality circles (training/case discussions) will ensure continued collaboration, interdisciplinary exchange, and development of the cross-sectoral networks according to regional specifics. STATAMED integrates ambulatory and inpatient care through (i) mandatory communication among sectors and professional groups, (ii) involvement of a care navigator to coordinate care across sectors and providers, including a four-week follow-up after discharge from hospital, (iii) interdisciplinary and cross-sector treatment planning, (iv) involvement of regional expertise through telemedicine consultations by ambulatory physicians participating in the health provider network and STATAMED, and (v) deployment of mobile community nurses at nearby long-term care facilities and for patient follow-up care at home. The goal of the new model of care is to protect the growing number of older adults from overtreatment and inappropriate care through a new intermediary form of cross-sectoral care close to home, providing them with better medical and social care by transforming the patient pathway.

Brief summary in scientific language

STATAMED will undergo scientific evaluation in a series of sub-studies. The sub-study registered here focuses on the quantitative assessment of outcomes and investigates the effectiveness of the new model of care compared to usual care. The central hypothesis is that the implementation of STATAMED will lead to a reduction in the hospital re-admission rate within 30 days post-discharge and the average length of hospital stay (combined primary outcome). In addition, the sub-study will analyse whether STATAMED leads to a reduction in the use of ambulatory emergency care and hospital emergency departments. It will also examine if employing a care navigator increases the use of ambulatory care services. Post-hospital care will also be analysed, with a focus on whether patients are able to return home directly after discharge or if they are transferred to a nursing home. Furthermore, a health economic evaluation will assess whether STATAMED is cost-effective compared to usual care from the perspective of statutory health insurers. The evaluation will rely on claims data and thus on secondary data analysis. The evaluation in this sub-study will be conducted as a prospective cluster-randomised controlled trial (C-RCT) using a stepped-wedge design. All referring entities in the catchment area of a STATAMED site (including general practitioners, specialists, nursing homes, ambulatory care services, and emergency services) will be potential candidates for cluster formation. These catchment areas will subsequently be divided into clusters. The stepped-wedge design entails each cluster beginning in a control phase and transitioning to the intervention phase sequentially, in staggered steps. Each cluster undergoes a three-month transition phase to practice the intervention before moving on to the intervention phase. The shift from control to transition phase is structured in four distinct steps, occurring at three-month intervals, with one quarter of the clusters moving to the transition phase at each step. This staggered approach to introducing the intervention permits the recording and comparison of effects over time. Once a cluster enters the intervention phase, it will remain in this phase for the remainder of the study. The intervention group consists of all eligible patients treated in STATAMED sites. All individuals who are covered by one of the participating statutory health insurers and fulfil the participation requirements are eligible to take part in the study. Claims data will be provided only for individuals who are insured with one of the participating insurers (i.e., AOK Rheinland-Hamburg and AOK Niedersachsen). Furthermore, two control groups are planned. Control group 1 consists of patients who fulfil the inclusion criteria for being treated in STATAMED and live in the catchment area of a STATAMED site but receive usual hospital care because their respective regional cluster is assigned to the control phase at the time of treatment. Control group 2 consists of patients who fulfil the above-mentioned inclusion criteria for being treated in STATAMED and do not live in the catchment area of a STATAMED site and thus are treated at a non-STATAMED hospital.

Health condition or problem studied

Free text:
Patients are eligible if they have: health insurance from one of the participating statutory health insurers, a general medical condition and inpatient treatment needs according to the criteria of the German Appropriate Evaluation Protocol (G-AEP), a diagnosis according to a project-specific ICD-10 code, and a foreseeable uncomplicated course of disease (Patient Clinical Complexity Level(PCCL) 0-2). The subsequent list of ICD-10 codes comprises exemplary diagnoses and is not exhaustive: I10.01 (Benign essential hypertension: With mention of hypertensive urgency), I48.1 (Persistent atrial fibrillation), E86 (Volume depletion), K59.09 (Other and unspecified constipation), I50.14 (Left ventricular failure: With symptoms at rest), I20.8 (Other forms of angina pectoris), I48.0 (Paroxysmal atrial fibrillation), R55 (Syncope and collapse), R07.3 (Other chest pain), K29.6 (Other gastritis), N39.0 (Urinary tract infection, site not specified), I50.13 (Left ventricular failure: With symptoms under mild strain), J20.9 (Acute bronchitis, unspecified), J18.9 (Pneumonia, unspecified), I50.01 (Secondary congestive heart failure), K57.32 (Diverticulitis of large intestine without perforation, abscess or bleeding), E11.91(Type 2 diabetes mellitus: Without complications, Uncontrolled), R10.3 (Pain localized to other parts of lower abdomen), A09.9 (Gastroenteritis and colitis of unspecified origin), K29.1 (Other acute gastritis).
Healthy volunteers:
No

Interventions, Observational Groups

Arm 1:
Treatment at a STATAMED site, including a pre-admission interview to determine a patient’s eligibility, followed by the formulation of a treatment plan if eligibility is confirmed, multidisciplinary team rounds throughout the inpatient stay, coordination of follow-up care by a care navigator, and, as required, the involvement of a community nurse to ensure ongoing care post-discharge
Arm 2:
usual care

Endpoints

Primary outcome:
Combined primary outcome: hospital re-admission rate (within 30 days post-discharge) and length of hospital stay
Secondary outcome:
Utilisation of ambulatory care services Utilisation of ambulatory care emergency services Utilisation of hospital emergency department Cost (ambulatory care, inpatient care, pharmaceuticals, medical and assistive devices, rehabilitation, and prospective actual cost of the intervention) Post-hospital care (especially the location of post-hospital care, such as at home or in a nursing care facility)

Study Design

Purpose:
Health care system
Allocation:
Randomized controlled study
Control:
  • Active control (effective treatment of control group)
Phase:
N/A
Study type:
Interventional
Mechanism of allocation concealment:
No Entry
Blinding:
No
Assignment:
Crossover
Sequence generation:
No Entry
Who is blinded:
No Entry

Recruitment

Recruitment Status:
Recruiting planned
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Germany
Number of study centers:
Multicenter study
Recruitment location(s):
  • Medical center Stadtteilklinik Hamburg Hamburg
  • Medical center Stadtteilklinik Essen-Stoppenberg Essen
  • Medical center Krankenhaus Bad Gandersheim Bad Gandersheim
  • Medical center Klinik-Sulingen Sulingen
  • Medical center Ubbo-EmmiusKlinik Norden Norden
  • Medical center Krankenhaus Groß-Sand Hamburg

Recruitment period and number of participants

Planned study start date:
2024-04-01
Actual study start date:
No Entry
Planned study completion date:
No Entry
Actual Study Completion Date:
No Entry
Target Sample Size:
4481
Final Sample Size:
No Entry

Inclusion Criteria

Sex:
All
Minimum Age:
18 Years
Maximum Age:
no maximum age
Additional Inclusion Criteria:
Patients are eligible if they have: health insurance from one of the participating statutory health insurers, a general medical condition and inpatient treatment needs according to the criteria of the German Appropriate Evaluation Protocol (G-AEP), a diagnosis according to a project-specific ICD-10 code, and a foreseeable uncomplicated course of disease (Patient Clinical Complexity Level(PCCL) 0-2). The subsequent list of ICD-10 codes comprises exemplary diagnoses and is not exhaustive: I10.01 (Benign essential hypertension: With mention of hypertensive urgency), I48.1 (Persistent atrial fibrillation), E86 (Volume depletion), K59.09 (Other and unspecified constipation), I50.14 (Left ventricular failure: With symptoms at rest), I20.8 (Other forms of angina pectoris), I48.0 (Paroxysmal atrial fibrillation), R55 (Syncope and collapse), R07.3 (Other chest pain), K29.6 (Other gastritis), N39.0 (Urinary tract infection, site not specified), I50.13 (Left ventricular failure: With symptoms under mild strain), J20.9 (Acute bronchitis, unspecified), J18.9 (Pneumonia, unspecified), I50.01 (Secondary congestive heart failure), K57.32 (Diverticulitis of large intestine without perforation, abscess or bleeding), E11.91(Type 2 diabetes mellitus: Without complications, Uncontrolled), R10.3 (Pain localized to other parts of lower abdomen), A09.9 (Gastroenteritis and colitis of unspecified origin), K29.1 (Other acute gastritis).

Exclusion Criteria

Exclusion criteria are: highly technical diagnostic needs, the need for inpatient surgery, or transfers from other hospitals.

Addresses

Primary Sponsor

AOK Rheinland/Hamburg – Die Gesundheitskasse
Torben Bergemann
Kasernenstr. 61
40213 Düsseldorf
Germany
Telephone:
+49 211 81950000
Fax:
No Entry
Contact per E-Mail
URL:
No Entry
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Universität Hamburg (Hamburg Center for Health Economics)
Eva Wild
Esplanade 36
20354 Hamburg
Germany
Telephone:
+49 40 428 38 8048
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Contact for Public Queries

AOK Rheinland/Hamburg – Die Gesundheitskasse
Kasernenstr. 61
40213 Düsseldorf
Germany
Telephone:
+49 211 81950000
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Principal Investigator

Universität Hamburg (Hamburg Center for Health Economics)
Eva Wild
Esplanade 36
20354 Hamburg
Germany
Telephone:
+49 40 428 38 8048
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Other contact for public queries

AOK – Die Gesundheitskasse für Niedersachsen
Hildesheimer Straße 273
30519 Hannover
Telephone:
+49 0511 8701 0
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Sources of Monetary or Material Support

Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)

Innovationsausschuss beim Gemeinsamen Bundesausschuss
Postfach 12 06 06
10596 Berlin
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Ethics Committee

Address Ethics Committee

Universität Hamburg, Fakultät Betriebswirtschaftslehre, Forschungsdekanat
Moorweidenstraße 18
20148 Hamburg
Germany
Telephone:
+49 40 42838-3551
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Date of ethics committee application:
2023-10-02
Ethics committee number:
No Entry
Vote of the Ethics Committee:
Approved
Date of the vote:
2023-10-05

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
No
IPD Sharing Plan:
No Entry

Study protocol and other study documents

Study protocols:
No Entry
Study abstract:
No Entry
Other study documents:
No Entry
Background literature:
No Entry
Related DRKS studies:
No Entry

Publication of study results

Planned publication:
No Entry
Publikationen/Studienergebnisse:
No Entry
Date of first publication of study results:
No Entry
DRKS entry published for the first time with results:
No Entry

Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry