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HIOPP-3-iTBX: Appropriate and safe medication for nursing home residents using an interdisciplinary toolbox (AMTS-Toolbox)

Organizational Data

DRKS-ID:
DRKS00013588
Recruitment Status:
Recruiting complete, study complete
Date of registration in DRKS:
2018-01-25
Last update in DRKS:
2023-02-07
Registration type:
Prospective

Acronym/abbreviation of the study

HIOPP-3-iTBX: General practitioners' initiative for the optimisation of patients' safety in polypharmacy

URL of the study

http://www.hiopp3.de

Brief summary in lay language

Nursing home residents commonly take 5 or more long-term medications; this is referred to as polypharmacy. Certain medications are considered potentially inappropriate medication (PIM), because they may bear health risks for older adults. Beyond the type of medication, elderly people may experience harm due to duplicate prescription, the dosage of medication or the interaction of medications. Additionally, so-called psychotropic drugs, especially antipsychotics, are commonly prescribed to nursing home residents. Among the elderly, these may lead to drowsiness and therefore falls, for example. It is the goal of the HIOPP-3-iTBX study to help optimise the medication of nursing home residents. To achieve this, we developed an intervention aimed at improving the cooperation of pharmacists, general practitioners (GPs) and nursing home staff concerning the medication management. We hypothesise that the intervention will improve the medication of nursing homes residents, particularly that PIM and antipsychotics will be prescribed less. Moreover we expect that communication between nursing staff, pharmacists and GPs in the intervention-homes will improve, also leading to an overall enhancement of medication management. In order to test this hypothesis we will conduct our intervention in at least four nursing homes in Rostock, Hannover, Düsseldorf and Tübingen (intervention group), while we will observe usual care in at least four additional homes in each city (control group). Residents eligible to participate in our study need to be at least 65 years old and long-term residents in a nursing home (short-term care excluded). We will measure the medication and health status in both residents of intervention and control group once at the beginning of the study and once again 6 months later. After this, all data will be analysed and compared.

Brief summary in scientific language

HIOPP-iTBX is an intervention study aiming to optimise the medication among nursing home residents. The co-operation of nursing home staff, general practitioners (GPs) and pharmacists is crucial for this. The study's objective is to achieve, by means of an interprofessionell intervention, 1. an improved and more efficient pharmacotherapy by reducing the number of nursing home residents receiving potentially inadequate medications (PIM) and/or antipsychotic drugs, and 2. a sustainable optimisation of the medication process by raising awareness for polypharmacy and improving co-operation of nursing home staff, GPs and pharmacists. For this, a cluster-randomised controlled trial will be conducted, e.g. we will randomise at the level of nursing homes, not individuals. Participating nursing home residents have to be 65 years or older, long-term nursing home residents and consent, either themselves or via their custodian, to take part in the study. We want to recruit a total of at least 32 nursing homes and 760 nursing home residents into our study. The follow-up period is 6 months. In preparation of the study, pharmacists in the intervention group will receive a special training (e.g. geriatric pharmacology) provided by the pharmacist chamber. A multimodal education intervention will be conducted in the intervention group that consists of three core elements: 1. the standardised intervention comprising a medication review including transfer of results (from pharamcist to GP to nursing home) and Change Management Support, 2. further education sessions for pharmacists, GPs and nursing home staff and 3. need-adjusted tools (some of which are adapted to specific professional groups).

Health condition or problem studied

Free text:
Polypharmacy, antipsychotics, PIM.
Healthy volunteers:
No Entry

Interventions, Observational Groups

Arm 1:
Participating nursing home residents in the intervention group receive a medication review by a specially trained pharamacist. The parttaking professions receive a multimodal interprofessional intervention consisting of change management measures, trainings and a toolbox aimed to improve and support their co-operation surrounding the medication management in nursing homes.
Arm 2:
Among the control group usual care will be observed, no intervention will be conducted.

Endpoints

Primary outcome:
The rate of nursing home residents with PIM and/or two antipsychotic drugs. This will be measured by a study Nurse at T0 and T1 using the nursing home documentation or medication documentation.
Secondary outcome:
Number of active pharmaceutical components, PIM, neuroleptics, falls, hospitalisations and their duration, emergency medical services, unplanned/unscheduled GP contacts, quality of life, cognition, healtheconomic outcomes, health care utilisation and patient care based on routine health data. Information on sociodemographic background, social contacts, general health status, quality of life, affectivity and pain is measured as part of a questionnaire by a study nurse. If the NHR has given seperate consent, the nursing home will administer a memory test (Mini Mental State Test). All other parameters are collected by the study Nurse via the nursing home documentation. If a NHR cannot be interviewed in person, relatives, nursing staff or nursing documentation will be used as data sources. All secondary endpoints will be collected twice, once at T0 and once at T1.

Study Design

Purpose:
Health care system
Allocation:
Randomized controlled study
Control:
  • Control group receives no treatment
Phase:
N/A
Study type:
Interventional
Mechanism of allocation concealment:
No Entry
Blinding:
No
Assignment:
Parallel
Sequence generation:
No Entry
Who is blinded:
No Entry

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):
  • Other Institut für Allgemeinmedizin und Palliativmedizin, Medizinische Hochschule Hannover Hannover
  • Other Institut für Allgemeinmedizin, Universitätsmedizin Rostock Rostock
  • Other Institut für Allgemeinmedizin (ifam), Universitätsklinik Düsseldorf Düsseldorf
  • Other Institut für Allgemeinmedizin und Interprofessionelle Versorgungsforschung, Universitätsklinikum Tübingen Tübingen

Recruitment period and number of participants

Planned study start date:
2018-04-02
Actual study start date:
2018-05-02
Planned study completion date:
No Entry
Actual Study Completion Date:
2019-07-23
Target Sample Size:
760
Final Sample Size:
871

Inclusion Criteria

Sex:
All
Minimum Age:
65 Years
Maximum Age:
no maximum age
Additional Inclusion Criteria:
Nursing homes: size at least 30 residents and nursing home status with a provision contract in accordance with §72 SGB XI. Nursing home residents: at least 65 years old and in long-term residential care. GPs: serving a nursing home participating in the study, willing to provide participants' health data (current diagnoses, laboratory parameters), willing to participate in the intervention if randomised to the intervention group (take note of/check pharmacist's medication review and if necessary adjust presciption), willing to participate in training (peer-education outreach visits). Pharmacists: serving a nursing home participating in the study (i.e. member of staff in a pharmacy which has a provision contract with a participating nursing home), willing to participate in the ATHINA and HIOPP-3 training if randomised to the intervention group.

Exclusion Criteria

Nursing home: specialised homes/wards (psychiatric nursing home, nursing homes for patients requiring mechanical ventilation or with addictions), patients in short-term care. Nursing home residents: residents without written consent, residents with a life expectancy less than 6 months based on GP assessment. GPs: currently participating in a so called polymedication contract (HzV) with the AOK (a German statutory health insurance Company) and/or take part in a current study about medication of nursing home rsidents, GPs who concurrently serve intervention and controll homes, GPs without written consent. Pharmacists: without willingness to participate in the ATHINA and HIOPP-3 trainings, pharmacists who concurrently serve intervention and control group nursing homes, pharmacists without written consent.

Addresses

Primary Sponsor

Medizinische Hochschule Hannover
Carl-Neuberg-Str. 1
30625 Hannover
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Medizinische Hochschule Hannover, Institut für Allgemeinmedizin, OE 5440,
Dr. med. Olaf Krause
Carl-Neuberg-Str. 1
30625 Hannover
Germany
Telephone:
0049-511-532-2744
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Contact for Public Queries

Medizinische Hochschule Hannover, Institut für Allgemeinmedizin, OE 5440,
MA Claudia Kirsch
Carl-Neuberg-Str. 1
30625 Hannover
Germany
Telephone:
0049-511-532-4987
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Principal Investigator

Medizinische Hochschule Hannover, Institut für Allgemeinmedizin, OE 5440,
Dr. med. Olaf Krause
Carl-Neuberg-Str. 1
30625 Hannover
Germany
Telephone:
0049-511-532-2744
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
Wegelystraße 8
10623 Berlin
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Ethics Committee

Address Ethics Committee

Ethikkommission der Medizinischen Hochschule Hannover
Carl-Neuberg-Str. 1
30625 Hannover
Germany
Telephone:
+49-511-5323443
Fax:
+49-511-5325423
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Date of ethics committee application:
2017-10-27
Ethics committee number:
7655
Vote of the Ethics Committee:
Approved
Date of the vote:
2017-12-04

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:
Junius-Walker U, Krause O, Thürmann P, Bernhard S, Fuchs A, Sparenberg L, Wollny A, Stolz R, Haumann H, Freytag A, Kirsch C, Usacheva S, Wilm S, Wiese B, on behalf of the HIOPP-3-iTBX study group: Drug safety for nursing-home residents—findings of a pragmatic, cluster-randomized, controlled intervention trial in 44 nursing homes. Dtsch Arztebl Int 2021; 118: 705–12. DOI: 10.3238/arztebl.m2021.0297
Study abstract:
Unter dem Link gelangen Sie direkt zur veröffentlichten Studie im Deutschen Ärzteblatt (Deutsch und Englisch verfügbar). Ebenso haben wir für Sie das PDF der Originalarbeit in Deutsch hochgeladen. Es ist frei verfügbar als Open Access Publikation und kann somit geteilt werden.
Other study documents:
No Entry
Background literature:
No Entry
Related DRKS studies:
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Publication of study results

Planned publication:
No Entry
Publikationen/Studienergebnisse:
Multidisciplinary intervention to improve medication safety in nursing home residents: protocol of a cluster randomised controlled trial (HIOPP-3-iTBX study)
Date of first publication of study results:
2019-01-25
DRKS entry published for the first time with results:
2023-02-07

Basic reporting

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