Funding for this research was provided by:
Innovation Fund of Federal Joint Committee (01VSF16029)
Universität zu Lübeck
Received: 21 January 2022
Accepted: 10 June 2022
First Online: 8 July 2022
: The <i>interprof</i> ACT trial received ethical approval from the ethical committee of the Medical Faculty, Georg-August-University, Göttingen (no. 31/7/17), the ethical committee of the University of Lübeck (no. 18-051), and the Ethics Committee of the Medical Association of Hamburg-Eppendorf (no. MC-304/17).First, the facility director of the nursing home must sign written consent to participate in the <i>interprof</i> ACT trial after being informed orally and in written form about the study.Second, NHRs or their legal guardians must give their written consent to participate in the <i>interprof</i> ACT trial. NHRs and/or their legal guardians receive oral and written information about the study and its procedure as well as about benefits for residents’ health and potential risks. The information is written in language that is easy to understand and contains information about the data to be collected from/about the NHR, either via data extraction from the patient chart (main trial only) or structured oral face-to-face interviews (main trial and process evaluation). NHRs and/or their legal guardians subsequently provide informed consent. Immediately before each face-to-face interview, a member of the research team will repeat this oral information, confirming the NHRs’ willingness to participate. Similar to the data extracted from the NHRs’ charts, the interview data will be collected in a pseudonymized manner based on a separate code list.For all target populations, informed consent will be necessary for participation in any quantitative inquiry for the process evaluation if data will not be collected anonymously (RN, GP and IPAV questionnaires). Written information about scheduled surveys is included on the cover page of each questionnaire (except for the NHRs’ questionnaire), and completion of these questionnaires will be regarded as written informed consent. At each kick-off meeting, all attendees will be asked to confirm their participation in person on a list. These participant lists will be saved electronically at the local study center separately from all of the other trial documents and will be accessible only to the members of the local study team.All target groups of the qualitative part of the process evaluation must provide written consent to participate after they receive detailed information about the qualitative process evaluation and data collection methods. Before each follow-up interview or observation, the study will again be explained, and participants will be given the opportunity to reconsider their consent.Participation in the <i>interprof</i> ACT trial and in the integrated process evaluation is voluntary and can be withdrawn at any measurement point in the study without providing a reason as well as without consequences for medical/nursing care. If individuals withdraw their consent to participate, they will be asked to give consent to analyses of their collected data. If a person refuses to consent to the analyses, the collected data will be deleted immediately. An exception is data that were collected anonymously and that have already been aggregated and published.
: Not applicable
: The authors declare they have no competing interests.