Table 1 Administrative information

2a and 2b

Trial registration

2a: Registry: DRKS00026172 on DRKS (German Clinical Trials Register)

2b: Data Set:

Data category

Information

Primary registry and trial identifying number

DRKS00026172 on DRKS

Date of registration in primary registry

2021/09/06

Secondary identifying numbers

n/a

Source(s) of monetary or material support

German Innovation Fund of the Federal Joint Committee

Primary sponsor

German Innovation Fund of the Federal Joint Committee

Secondary sponsor(s)

n/a

Contact for public queries

Catholic University of Applied Sciences Mainz

Prof. Dr. Renate Stemmer

Saarstr. 3

55122 Mainz

Germany

Telephone: + 496131 28944 520

stemmer@kh-mz.de

Contact for scientific queries

Catholic University of Applied Sciences Mainz

Prof. Dr. Renate Stemmer

Saarstr. 3

55122 Mainz

Germany

Telephone: + 496131 28944 520

stemmer@kh-mz.de

Public title

Case-based care of multimorbid patients in general practice by advanced practice nurses (APNs)

Scientific title

Effects of care of multimorbid patients in general practices by advanced practice nurses (FAMOUS): study protocol for a nonrandomized controlled trial

Country of recruitment

Germany

Health condition(s) or problem(s) studied

Multimorbidity

Intervention(s)

Intervention group: GP-oriented care of multimorbid patients by APNs. Qualification profile of APNs: professional nursing licence, at least 2 years of professional experience in nursing, academic degree at master’s level, 500 hours project-specific advanced training.

Task profile: in-depth assessment, preparation, monitoring and evaluation of a person-centred and evidence-based care plan.

Control group: multimorbid patients receiving standard care.

Key inclusion and exclusion criteria

Gender: all genders

Minimum age: ≥ 18 years

Maximum age: no maximum age

Further inclusion criteria: medical diagnosis of at least three chronic diseases, which in the past 12 months in at least three out of four quarters have given rise to general practitioners’ treatment;being in general practitioners’ treatment; insurance with a statutory health insurance company.

Exclusion criteria: not fulfilling the inclusion criteria; being in the dying phase according to the assessment of the general practitioner.

Study type

Interventional, nonrandomized, nonblinded controlled trial

Date of first enrolment

2021/10/01

Target sample size

n=2451

Recruitment status

Recruiting

Primary outcome(s)

Number of emergency contacts

Key secondary outcomes

Use of other health care facilities (e.g. hospital, nursing home), hospital readmission and visits by general practitioners

3 Protocol version

Issue Date: 2021/10/01

4 Funding

There was financial support only, provided by the  German Innovation Fund of the Federal Joint Committee. The Innovation Fund uses funds from the statutory health insurance (SHI) to support innovative, cross-sectoral new forms of care and patient-oriented care research projects in order to further develop and improve SHI-financed care in Germany

5a Author details

RS and EG initiated the study design; CDS is responsible for the project management; JK developed the concept of the internal evaluation and will conduct it. EG and MB developed the concept of the external evaluation; BB and MB together with a statistician are planning and will conduct the statistical analysis. BB is responsible for the implementation of the qualitative interviews. All authors contributed to the development and refinement of the study protocol and approved the final manuscript.

5b Name and contact information for the trial sponsor

Trial Sponsor: Catholic University of Applied Sciences Mainz (CUAS)

Contact name: Prof. Dr. Renate Stemmer

Address: 55122 Mainz, Saarstr. 3, Germany

Telephone: + 49613128944520

Email: stemmer@kh-mz.de

5c Role of funder

This funding source had no role in the design of this study and will not have any role during its execution, analyses, interpretation of the data, or decision to submit results.