Background
Objectives
Methods/Design
Study design
Preparatory work
Participants and recruitment
Inclusion and exclusion criteria
Interventions
Updated original programme
Concise updated programme
Control group
Components of the interventions | Arms | ||
---|---|---|---|
Intervention group 1 (updated original programme) | Intervention group 2 (concise version) | Control group | |
Educational programme for all nurses | ✓ | - | - |
Training and structured support for nominated key nurses | ✓ | ✓ | - |
Facultative train-the-trainer module for key nurses | - | ✓ | - |
Printed study material | ✓ | ✓ | ✓ |
Supportive material (poster, mugs and pencils) | ✓ | ✓ | - |
Randomisation
Outcome measures
Process evaluation
Focus | Documentation/Assessment | Measurement point |
---|---|---|
Comprehensibility/usability of information material | 3 Focus groups: nurses, legal guardians, relatives | pre-test, prior to t0 |
Feasibility of the intervention | Piloting in 2 nursing homes: | Piloting, prior to t0 |
1/intervention arm | t0 | |
Recruitment procedure | Protocol/region | t0 |
Information of clusters on study sequence | Protocol/cluster | t0 |
Information material: flyers, leaflets for leaders, nurses, residents | t0 | |
Reasons for non-participation or drop-out | Structured inquiry and documentation of reasons | t0-t2 |
Description of crucial structure- and process-related factors on cluster-level (e.g. size of the institution, nurse-to-resident-ratio, regulations for approaching to behavioral and psychological symptoms of dementia (BPSD), architectural features, motivation/reasons for participation) | CRF-Baseline data/cluster | t0 |
Social-demographic data, self-efficacy and knowledge about physical restraints | 10 % nurses/cluster: | |
Questionnaire 1: Baseline-data nurses | t0 | |
Questionnaire 2: Self-efficacy | t0, t1, t2 | |
Questionnaire 3: Knowledge about physical restraints | t0, t1, t2 | |
Organisational culture | 1 leader + 10 % nurses/cluster: | |
Questionnaire 4: D-OCAI (German version of the “Organizational Culture Assessment Instrument” derived from the “Competing Values Framework”) | t0, t2 | |
Conveyance of the intervention (intervention fidelity) | Trainer/educational session (all trainers, including key nurses): | t0 (immediately after the educational intervention) |
Structured protocol of each educational session | ||
Need for the intervention and application of training content | All Participants of the educational program: | |
Questionnaire → evaluation of the program | t0 (immediately after the educational intervention) | |
-Self-efficacy | ||
-Knowledge | ||
-Satisfaction | ||
Study Nurse: | ||
Protocols of all key nurses´ contacts and conversations, in relation to the study nurse supervision; content of conversations (e.g. barriers/facilitators) + frequency/intensity of supervision | t0 first 3 months | |
Key nurses: | ||
Diary → To what extent was the intervention implemented?/How many training sessions were held?/How often did key nurses meet each other? | t0,-t2 | |
3 randomly selected nurses/cluster: | ||
Short Survey → awareness of the intervention | t2 | |
Structural changes/modifications on cluster level (e.g. architectural modifications; new regulations for approaching BPSD; introduction of specific strategies to reduce physical restraints; new equipment) | 1 leader/cluster: | |
Short Survey → “structural modifications” | t1, t2 | |
Staff fluctuation | 1 leader/cluster: | |
Questionnaire → staff-fluctuation | t1, t2 | |
Barriers and facilitators (How/To what extent was the intervention implemented? Changes in daily nursing routine? Attitude towards the intervention? Influence of key nurses and other nurses on the reduction of physical restraints? Use of/Demand for information material?) | Leaders/key nurses: | |
8 Focus groups; 1/region/intervention arm | t2 | |
Relatives, legal guardians, home advisory board: | ||
8 Focus groups; 1/measurement point/region | t1, t2 | |
Key nurses + 1 leader/cluster: | ||
Structured final interview (including focus on unintended consequences/adverse effects: Delay of procedures? Uncertainty/Fear? Additional strains?) | t2 | |
Attitude of nurses towards the intervention (Changes in daily nursing routine? Delay of procedures? Changes of the working atmosphere/climate? Uncertainty/Fear? Additional strains?) | 1 nurse/cluster: | |
Focus group interviews in all 3 intervention arms | t2 | |
Attitude of legal guardians toward physical restraints | Subgroup of residents’ legal guardians/cluster: | |
Maastricht Attitude Questionnaire (MAQ) | t0, t2 | |
Changes in residents’ behaviors | Proxy-assessment by nurses/all residents: | |
CRF – cognition (DSS), challenging behavior (CMAI) | t0, t2 | |
Proxy-assessment by nurses/10 % of residents/cluster: | ||
Quality of Life (QoL-AD) | t0, t2 | |
Use of/Demand for material (information material, incentives/image material) | Observation by members of the research team: How/To what extent are materials present and used? | t1, t2 |
Documentation: Use of material/additional demand | t1, t2 | |
Falls, fall-related fractures | CRF-documentation/resident | t0, t1, t2 |
Physical restraints (prevalence) | CRF-documentation of prevalence/resident | t0, t1, t2 |
Confidence of residents (How secure/insecure do residents feel in case of reduction of physical restraints?) | Additional Multiple Case Study |