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Table 3 Process evaluation: data collection methods

From: Evaluation of a multi-component, non-pharmacological intervention to prevent and reduce sleep disturbances in people with dementia living in nursing homes (MoNoPol-sleep): study protocol for a cluster-randomized exploratory trial

Parameter

Material

Measurement points

Elements of process evaluation

Recruitment description

▪ Documentation of the recruitment process

▪ Survey of reasons for participation (nursing home management/nursing service management)

▪ Survey of reasons for non-participation/withdrawal (nursing home management/nursing service management)

T0

Recruitment

Description of the context factors of the nursing homes

▪ Existence of concepts or standards for dealing with sleep or promoting sleep (structured survey, nursing service management)

T0,

T2 (only control group)

Description of the cluster (Context)

▪ Culture in the nursing homes (Organizational Readiness for Implementing Change (ORIC)) [49].

▪ Person-centered care (Person-centered climate questionnaire (staff version) (PCQ-S)) [50].

▪ Team effort (Assessment of Interprofessional Team Collaboration Scale (AITCS)) [51].

▪ Sample: nursing services and residential area managers, as well as 20% of all nursing staff per cluster

T0, T2

Implementation of the intervention components

▪ Information about the needs assessment for each cluster (e.g. number of stakeholders involved, content)

▪ Number, frequency and content of the different components delivered to each cluster (including duration, number and function of participants, topics, necessary adjustments (type, reasons), deviations from the protocol), i.e.:

▪ Educational courses (basic and advanced) offered per cluster

▪ Workshops offered per cluster

▪ Training and support delivered to the change agents

▪ Other components offered

Implementation phase, T1, T2

(only intervention group)

Implementation of the intervention (Delivery)

Adoption of the intervention components in the nursing homes

▪ Content of the sleep-related care concept (document analysis)

T1, T2

Implementation of the intervention (Response)

▪ Number (rate) of participants attending the workshops per cluster (documentation)

Implementation phase

▪ Number of workshops and internal training planned and carried out in the context of the intervention

T1, T2

▪ Changes in procedures and processes as a result of the interventions’ implementation (e.g. assessments)

T1, T2

Change processes in the nursing homes

▪ Changes in procedures and processes due to the implementation of the sleep concept in each cluster (planned vs. implemented)

T1, T2 (only intervention group

▪ Changes regarding sleep promotion in the care plans of people with dementia (document analysis, n = 5 residents with sleep problems per cluster)

T2 (only intervention group)

▪ Performance of care plans for sleep promotion (participating observations, 2 residents with sleep problems from selected nurses (2 per cluster))

T2 (only intervention group)

▪ Perception of changes in sleep promotion from people with dementia or their representatives, relatives or legal guardians (interviews, 4 per cluster)

T2 (only intervention group)

Inhibiting / promoting factors and contextual conditions

▪ Perspective of the target groups (managers, nurses actively involved in the intervention; interviews)

T2 (only intervention group)

  1. T0 = baseline before randomization, T1 = follow-up after 8 weeks, T2 = follow-up after 16 weeks