Table 2.

Summary study endpoints, operationalisation and data collection timepoints

Study endpoints	Operationalisation	Data collection timepoint
		T1	T2	T3	T4
Implementation process
Process indicators	Small group interviews*	x		x
	NoMAD*†‡			x	x
	Implementation rating tool*	x		x
Implementation outcomes
Fidelity: delivery
Relative frequency	Intervention fidelity log*§	x	x	x	x
Absolute dose	Intervention fidelity log*§	x	x	x	x
Consistency	Intervention fidelity log*§	x	x	x	x
Availability	Intervention capacity assessment*	x
	Focus group interviews†				x
Fidelity: receipt
Attendance at case conferences	Case conferences*¶	x	x	x	x
Comprehension and skills	FNPS***	x	x		x
	Focus group interviews†				x
Fidelity: enactment
Engagement and performance	Fidelity Self-Rating Tool*		x		x
	Semi-structured observation*		x
	Focus group interviews†				x
Feasibility	FIM*†††	x		x	x
	Focus group interviews†				x
Acceptability	AIM*†‡‡	x		x	x
	Focus group interviews				x
Appropriateness	IAM*†§§	x		x	x
	Focus group interviews†				x
Sustainability/sustainment	Sustainability implementation survey¶¶				x
	Focus group interviews†				x
Contextual determinants	Small group interviews*	x		x
	Focus group interviews†				x

*Part of the process evaluation.

†Part of the summative evaluation.

‡German Version of the Normalisation Measure Development questionnaire (NoMAD).⁶⁸

§Case report forms embedded in REDCap⁶⁵ and completed throughout the study by family nurses.

¶Monthly case conferences throughout the 18-month active implementation and delivery phase.

**German version of the Family Nursing Practice Scale (FNPS).⁶⁶

††German version of the Feasibility Intervention Measure (FIM).⁶⁷

‡‡German version of the Acceptability Intervention Measure (AIM).⁶⁷

§§German version of the Intervention Appropriateness Measure.⁶⁷

¶¶Data collection occurs 6 and 12 months after active implementation and intervention delivery/family intensive care units study end.

CFIR, Consolidated Framework for Implementation Research; FN, family nurses; HP, healthcare professionals; ICU, intensive care unit; KP, key clinical partners; LI, local implementers; LoS, length of stay; NPT, Normalisation Process Theory.