InTherAKT - Initiative for safety of prescribed medications in elderly care by means of cooperation and team work

• Register: German Clinical Trials Register
• Last refreshed on: 8 April 2024
• Main ID: DRKS00007900
• Date of registration: 02/09/2015
• Prospective Registration: No
• Primary sponsor: Grünenthal GmbH
• Public title: InTherAKT - Initiative for safety of prescribed medications in elderly care by means of cooperation and team work
• Scientific title: InTherAKT - Initiative for safety of prescribed medications in elderly care by means of cooperation and team work - InTherAKT
• Date of first enrolment: 23/06/2015
• Target sample size: 300
• Recruitment status: Complete
• URL: http://drks.de/search/en/trial/DRKS00007900
• Study type: interventional
• Study design: Allocation: N/A: single arm study; Masking: Open (masking not used); Control: uncontrolled; Assignment: single; Study design purpose: other
• Phase: N/A

Countries of recruitment

Germany

Contacts

• Name: Jürgen Osterbrink
• Affiliation: Paracelsus Medizinische PrivatuniversitätInstitut für Pflegewissenschaft und -praxis

• Name: Nadja Nestler
• Affiliation: Paracelsus Medizinische PrivatuniversitätInstitut für Pflegewissenschaft und -praxis

Key inclusion & exclusion criteria

Inclusion criteria: Residents: Participation consent, age > 64 years, drug therapy.

Professional groups: GPs, geriatric nurses with three years of training, occupational health nurses with three years of training, pharmacists, trained pharmaceutical technicians, trained medical assistants.
Exclusion criteria: Residents: Missing declaration of consent of the resident, missing declaration of consent of the legal guardian, insufficient cognitive performance for making independent decisions and no legal guardian, age < 65 years, acute life-threatening situation, isolation due to acute infections or multiresistant germs.
Professional groups: care workers with no three-year training in nursing.

Age minimum: 65 Years
Age maximum: None
Gender: All

Health Condition(s) or Problem(s) studied

Appropriateness of the medication Tendency of developing a delirium Cognitive skills Agitation Mobility

Intervention(s)

Group 1: The Intervention InTherAKT comprises two components:
- Transprofessional expansion of knowledge by means of a three-part training program on drug therapy safety in elderly people for care staff, GPs, pharmacists, medical assistants and pharmaceutical technicians. The training sessions developed in a multiprofessional setting by experts in care, pharmacy and medicine are guided by the individual challenges of the professional groups but also by the obstacles and risks arising from their cooperation.
The expansion of knowledge makes use of three main elements:
a. Joint face-to-face event for all professional groups involved
b. Individual online training sessions for each professional group with problem-oriented case management
c. Final joint face-to-face event, in which the solutions developed for all professional groups will be brought together and the aspects of improving cooperation will be specifically developed based on the results of the group interviews (cf. endpoints).

- Therapy Check via the InTherAKT – online platform (I-oP)
A communication tool especially developed for this project (InTherAKT online platform I-oP) forms the central part of optimized cooperation between the professional groups involved. It is an online communication platform for all persons involved in the medication process with an online medication plan, from which version 2.0 of the national medication plan can be built. The I-oP is used on the basis of the following steps: (1) The care staff enter the medication in a resident data sheet; (2) The GP reviews the medication plan and shares it with the care staff; (3) The pharmacist carries out the type 1 medication analysis (Grundsatzpapier zur Medikationsanalyse [policy paper on medication analysis], ABDA, 2014); (4) The GP makes ano

Primary Outcome(s)

- Quantitative part: Appropriateness of the recorded drug therapy of the residents at t0 (baseline, i.e. before the intervention), t1 (after 7 months) and t2 (after 13 months), measured by means of the Medication Appropriateness Index (MAI) (Hanlon, 1992).

- Qualitative part: Changes in interprofessional communication and cooperation between the participating professional groups, qualitatively collected by means of group interviews at t0 and t2.

Secondary Outcome(s)

- Cognitive abilities of the included residents, measured by means of the Mini-Mental State Examination (MMSE) (Folstein, 1975; Tombaugh, 1992; Kaiser, 2009) and the Dementia Screening Scale (DSS) (Köhler, 2007) at t0, t1 and t2
- Probability of the included residents of developing a delirium, measured by means of the Delirium Observation Screening Scale (DOS) (Schuurmans, 2003) at t0, t1 and t2
- Agitation in people with cognitive impairments (MMST < 18) (Rösler, 2003), measured by means of the Cohen Mansfield Agitation Inventory (CMAI-D) (Stoffel, 2010) at t0, t1 and t2
- Mobility and tendency of falling of the included residents, measured by means of the Timed Up and Go (TUG) Test (Podsiadlo, 1991) at t0, t1 and t2
- Total number of medicines prescribed for the study participants at t0, t1 and t2
- Number of potentially dangerous drug interactions, measured by means of the ABDA database at t0, t1 and t2
- Appropriateness of the recorded analgesics, measured by means of the Medication Appropriateness Index (MAI) at t0, t1 and t2

Start of data collection t0: 20 July – 30 September 2015
Data collection t1: after 7 months
Data collection t2: after 13 months

Source(s) of Monetary Support

Paracelsus Medizinische Privatuniversität, Institut für Pflegewissenschaft und -praxis

Grünenthal GmbH

Ethics review

Status: Approved
Approval date: 30/03/2015
Contact:

[e-mail]

Ethikkommission der Ärztekammer Westfalen-Lippe und der Westfälischen Wilhelms-Universität Münster

[phone]

[e-mail]

Results

• Date Completed: 13/01/2017
• URL: http://drks.de/search/en/trial/DRKS00007900#studyResults