HYPERION-TransCare (Heading to ContinuitY of Prescribing in EldeRly with MultImOrbidity iN Transitional Care) - a clusterrandomized and controlled feasibility study to test the practicability and implementability of a complex intervention and study design
Organizational Data
- DRKS-ID:
- DRKS00027649
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2022-01-19
- Last update in DRKS:
- 2024-01-08
- Registration type:
- Prospective
Acronym/abbreviation of the study
HYPERION-TransCare
URL of the study
https://www.saxoforn.net/laufendes-projekt/hyperion-transcare
Brief summary in lay language
With a small group of participants, the project investigates the feasibility and practicability of the study and the study design for testing an improvement measure at the interface between outpatient and inpatient care. The effect of the measure is to be examined in a follow-up study with a larger number of participants. The availability of health-related information at this interface is still often insufficient, which can have a negative impact on patient care. The aim of the project is to test a referral management system that, on the one hand, targets older patients (over 65 years of age) who regularly take several medications and have several illnesses. The patients should be more involved and their health-related information situation improved. On the other hand, the coordination function of GP practices is to be further strengthened and contributed to an improvement in the availability and timeliness of patient information. Through these measures, we expect that the availability of health-related information will be improved and that up-to-date information will be available completely and promptly in the event of hospitalisation.
Brief summary in scientific language
Despite existing approaches to improving the intersectoral information situation, there are still difficulties here. The aim of the project is therefore to start at this point and to improve the exchange of information at the interface between outpatient and inpatient care. In the present research project, a "hospital referral management" system is being tested in a multicenter, cluster-randomized, controlled pilot study. It is designed to help improve care for older patients* (≥65 years of age) with multimorbidity and multimedication. The intervention was developed participatively with different stakeholders in sub-study 1. On the one hand, it starts with the patients. The aim is to support them by improving their health-related information situation. On the other hand, the coordination function of GP practices is to be further strengthened and an improvement in the availability and timeliness of patient information is to be contributed to. The effect of the complex intervention will be exploratory tested in two study arms (experimental and control group). The study-accompanying process evaluation examines the feasibility and implementability of the intervention and the study design and should provide important information for the design and implementation of a subsequent main study.
Health condition or problem studied
- Free text:
- multimorbidity
- Free text:
- Multimedication
- Healthy volunteers:
- No
Interventions, Observational Groups
- Arm 1:
- In the intervention group, the testing and implementation of the participatory developed "hospital referral management" takes place in the 6-month intervention phase. Prospective data collection. Due to blinding, the intervention is not described in more detail.
- Arm 2:
- For the participants (GP practices and patients) who were randomly assigned to the control group, treatment during the 6-month intervention phase will be as before ("care-as-usual"). Care-as-usual means that the treatment follows the guidelines. After completion of the study, the participants of the control group will be presented with the information of the intervention and materials will be made available. Prospective data collection.
Endpoints
- Primary outcome:
- Combined primary endpoint (testing for the main study): health-related patient outcomes: Hospitalisation (FIMA), falls (standardised documentation) and mortality (standardised documentation) at t0 (baseline) and t1 (follow-up after 6 months) in the intervention group compared to the control group. The combined primary endpoint is recorded by information from patients or enquiries in the general practitioner's office.
- Secondary outcome:
- Exploratory examination of the effect of the complex intervention on: a) Improvement of the medication- and treatment-relevant information situation as well as increase of health literacy among patients b) Improvement of the medication-related information situation in the general practice. Target parameters: a) Improvement of health literacy and satisfaction with the information situation among patients* between the survey times t0 and t1 in the intervention group compared to the control group. The following measures will be collected: - Health literacy: Health Literacy Questionnaire - German (HLQ-G) - Satisfaction with medication-related information: Satisfaction with Information about Medicines Scale (SIMS-D), questions about the medication plan (survey) b) Improvement of the information situation in GP practices between t0 and t1 in the intervention group compared to the control group. - Information on the care situation: questionnaire on the use of medical and non-medical care services in old age (FIMA) Comparison of the information provided by patients with that provided by the GP practice. - Information on medication: Checking the completeness of the medication information by comparing the information provided by patients (survey) and the information in the GP practice (medication plan). Process evaluation: A process evaluation accompanying the entire study assesses the feasibility and implementability of the intervention and the study design. On the other hand, parameters are collected and analysed that could have an influence on the results. The process evaluation is conducted with a mix of methods including interviews, questionnaires and standardised project documentation. The methodology of the process evaluation follows the framework for designing and reporting on process evaluations of cluster randomized trials (Grant et al 2013) and the Consolidated Framework of Implementation Research (CFIR, Damschroder et al 2009).
Study Design
- Purpose:
- Other
- Allocation:
- Randomized controlled study
- Control:
-
- Control group receives no treatment
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- Yes
- Assignment:
- Parallel
- Sequence generation:
- No Entry
- Who is blinded:
-
- Data analyst
- Investigator/therapist
- Patient/subject
Recruitment
- Recruitment Status:
- Recruiting complete, study complete
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Multicenter study
- Recruitment location(s):
-
- Doctor's practice Hessen
- Doctor's practice Sachsen
Recruitment period and number of participants
- Planned study start date:
- 2022-02-15
- Actual study start date:
- 2022-03-26
- Planned study completion date:
- 2023-12-31
- Actual Study Completion Date:
- 2023-12-31
- Target Sample Size:
- 200
- Final Sample Size:
- 98
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 65 Years
- Maximum Age:
- no maximum age
- Additional Inclusion Criteria:
- Age: 65+ years, ≥ 2 long-term diagnoses, Taking ≥ 5 long-term medication, ≥ 1 previous hospital stay in the last 12 months, The patient must be able to take part in written and telephone surveys (the patient can be supported by relatives, acquaintances ..)
Exclusion Criteria
Prefinal disease state, Patient in the nursing home, Severe mental illness (spectrum ICD-10-F diagnoses), Planned long-term admission in the nursing home Patient with legal guardian
Addresses
Primary Sponsor
- Address:
- Medizinische Fakultät Carl Gustav Carus an der TU Dresden Bereich Allgemeinmedizin/ Medizinische Klinik und Poliklinik IIIFetscherstraße 7401307 DresdenGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.tu-dresden.de/med/mf/ame
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Institut für Allgemeinmedizin Goethe Universität Frankfurt am MainTruc Sophia DinhTheodor-Stern-Kai 760590 Frankfurt/M.Germany
- Telephone:
- (0) 69-6301-84483
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.allgemeinmedizin.uni-frankfurt.de
Contact for Public Queries
- Address:
- Medizinische Fakultät Carl Gustav Carus an der TU DresdenBereich Allgemeinmedizin/ Medizinische Klinik und Poliklinik IIIFranziska BrosseFetscherstraße 7401307 DresdenGermany
- Telephone:
- 0351 458 89-234
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.tu-dresden.de/med/mf/ame
Principal Investigator
- Address:
- Institut für Allgemeinmedizin Goethe Universität Frankfurt am MainFrau Prof. Dr. Marjan van den AkkerTheodor-Stern-Kai 760590 Frankfurt/M.Germany
- Telephone:
- (0)69-6301-80454/-5930
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.allgemeinmedizin.uni-frankfurt.de
Other principal investigator
- Address:
- Medizinische Fakultät Carl Gustav Carus an der TU Dresden Bereich Allgemeinmedizin/ Medizinische Klinik und Poliklinik IIIFrau Dr. rer. Karen VoigtFetscherstraße 7401307 DresdenGermany
- Telephone:
- +49 351 458 89-230
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.tu-dresden.de/med/mf/ame
Other contact for scientific queries
- Address:
- Institut für Allgemeinmedizin Goethe Universität Frankfurt am MainMaria HanfTheodor-Stern-Kai 760590 Frankfurt/M.Germany
- Telephone:
- (0)69-6301-84124
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.allgemeinmedizin.uni-frankfurt.de
Other contact for scientific queries
- Address:
- Medizinische Fakultät Carl Gustav Carus an der TU Dresden Bereich Allgemeinmedizin/ Medizinische Klinik und Poliklinik IIIAstrid-Alexandra KleinFetscherstraße 7401307 Dresden
- Telephone:
- +49 351 458 89-248
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.tu-dresden.de/med/mf/ame
Other contact for public queries
- Address:
- Institut für Allgemeinmedizin Goethe Universität Frankfurt am MainSylvia Schulz-RotheTheodor-Stern-Kai 760590 Frankfurt/M.
- Telephone:
- (0)69-6301-5930
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.allgemeinmedizin.uni-frankfurt.de
Other contact for public queries
- Address:
- Klinikum der Johann Wolfgang Goethe-Universität Frankfurt am MainTheodor-Stern-Kai 760590 Frankfurt/M.Germany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.allgemeinmedizin.uni-frankfurt.de
Other contact for public queries
- Address:
- Abteilung Klinische Pharmakologie & Pharmakoepidemiologie Universitätsklinikum HeidelbergProf. Dr. sc. hum. Hanna SeidlingIm Neuenheimer Feld 41069120 HeidelbergGermany
- Telephone:
- 06221 56-38736
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.klinikum.uni-heidelberg.de
Other contact for public queries
- Address:
- Abteilung für Medizinische Informatik, Biometrie und EpidemiologieRuhr-Universität BochumProf. Dr. Nina TimmesfeldUniversitätsstraße 10544789 BochumGermany
- Telephone:
- +49 234 32 27790
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.amib.ruhr-uni-bochum.de/
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.)
- Address:
- Bundesministerium für Bildung und Forschung Dienstsitz BerlinFriedrichstraße 130 B10117 BerlinGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission an der TU DresdenFetscherstr. 7401307 DresdenGermany
- Telephone:
- +49-351-4582992
- Fax:
- +49-351-4584369
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2021-11-30
- Ethics committee number:
- AZ: SR-EK-550112021
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2021-12-15
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
- Other secondary IDs:
- Förderkennz.: 01GK1906A/01GK1906B als Teilproje... - sponsor-id
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- Yes
- IPD Sharing Plan:
- Anonymised patient data sets can be requested after completion of the study. The data will only be passed on if certain rules are observed (e.g. approval by an independent ethics committee, scientific medical research purposes, application for use). The management of the two coordinating study sites carefully examine and decide, according to standardised criteria, whether the research purpose and the applying research group justify disclosure.
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