Study on advance care planning in care dependent community-dwelling older persons in Germany (STADPLAN): protocol of a cluster-randomised controlled trial

Table 2 Study outcomes/variables, measurement tools and data collection schedule

Outcome/ variable	Measured by	Validated version*	Baseline	6 months (t1)	12 months (t2)	Assessed by
Patient activation (primary outcome)	Patient activation Measure (PAM-13) [42]	German version [36]	✓	✓	✓	RA – at home visit
ACP behaviour	Patient engagement survey [41]	English version [41]	✓		✓	RA – at home visit
Anxiety and depression	Hospital anxiety and depression scale (HADS) [40]	German version [43]	✓		✓	RA – at home visit
Self-reported, health-related quality of life	Veterans Health Administration (VR-12) [38, 39]	German version [44]	✓		✓	RA – at home visit
Deaths, hospitalization, institutionalisation	Own questions	n.a.	✓	✓	✓	RA – at home care service & home visit
Proxy/Family involvement**	Audit of ACP discussion	n.a.	✓			Nurse facilitator
Sociodemographic & clinical data, hearing capacity by RAI-NH [45] & vision	Own questions	n.a.	✓			RA- at home care service & home visit
GPs involvement	Own questions	n.a.	✓	✓	✓
Physician visits, formal & informal care	Own questions	n.a.	✓		✓	RA – at home visit
Healthcare preferences	Hypothetical scenarios	Adapted German version [46]***	✓		✓	RA – at home visit

*all instruments were pretested in a German version in the pilot study; **intervention group only; *** adapted version of the Life-Support Preferences Questionnaires and Emanuel Medical Directive, which will be validated in the STADPLAN study within a limited subgroup (n = 120); RA Research assistant, RAI-NH Resident Assessment Instrument for Nursing Homes

ISSN: 1471-2318