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Randomized Controlled Trial
. 2024 Dec 18;25(1):831.
doi: 10.1186/s13063-024-08652-2.

Process evaluation of an individually tailored complex intervention to improve activities and participation of older nursing home residents with joint contractures (JointConEval): a mixed-methods study

Affiliations
Randomized Controlled Trial

Process evaluation of an individually tailored complex intervention to improve activities and participation of older nursing home residents with joint contractures (JointConEval): a mixed-methods study

Regina Thalhammer et al. Trials. .

Abstract

Background: Older people with joint contractures in nursing homes often experience severe restrictions in their activities and participation. The effectiveness of an individually tailored complex intervention to improve residents' activities and participation by incorporating the biopsychosocial perspective into nursing care using a structured facilitator approach could not be established in the JointConEval cluster-randomised controlled trial. This process evaluation aimed to systematically identify factors influencing implementation and effectiveness.

Methods: The mixed-methods process evaluation analysed recruitment, implementation, mechanisms of impact, and context. Qualitative data was generated in semi-structured focus groups and in individual interviews with facilitators, nursing and social care staff, residents, relatives and guardians. Quantitative data was recorded with facilitators and 20% of nursing and social care staff using standardised documentation forms and questionnaires. Qualitative data was analysed using qualitative thematic content analysis, while the quantitative data was analysed descriptively. An interpretation was performed by combining and comparing the qualitative and quantitative results after the separate analyses.

Results: The implementation was realised as planned, but the intervention did not always reach the nursing home staff, which hindered the planned change in attitude and behaviour. The attitude of the facilitators was mainly in line with the intervention. However, the intervention reached only half the residents. We identified various key influencing factors related to the context, setting and implementation agents. Nursing homes lacking facilitator support from staff or management or experiencing staff shortages and facing organisational weaknesses had difficulties in achieving the desired behavioural changes and positive primary outcomes.

Conclusions: The complex intervention was delivered as planned with several factors affecting the implementation. A key influencing factor was the organisational structure and leadership of the nursing homes, which had an impact on the behaviour and motivation of the implementation agents. The findings highlight challenges in achieving behavioural changes among nursing staff in the context of long-term care in Germany. We recommend a systematic organisational context analysis for similar complex interventions in long-term care, involving stakeholders and improving leadership participation for more effective implementation.

Trial registration: DRKS (German Clinical Trials Register), number DRKS00015185. Registered on 1 August 2018, https://drks.de/search/en/trial/DRKS00015185 . Universal Trial Number U1111-1218-1555.

Keywords: Complex intervention; Contracture; Human activities; Individually tailored intervention; International Classification of Functioning, Disability, and Health; Nursing Homes; Participation; Process evaluation; Randomised Controlled Trials.

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Conflict of interest statement

Declarations. Ethics approval and consent to participate: Ethical approval was granted by the ethics committees of the Martin Luther University of Halle-Wittenberg in June 2018 (Reference No. 2018–63) and the Ludwig-Maximilians-University of Munich in July 2018 (Reference No. 18–356). Each participant signed a written informed consent form before enrolment. Consent for publication: All the participants gave their written consent for the publication of anonymised data. Competing interests: The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Logic model of the PECAN concept
Fig. 2
Fig. 2
Overview of the PECAN implementation approach. ‘a’ indicates PECAN = Participation Enabling Care in Nursing. ‘b’ indicates hand-out of supporting materials
Fig. 3
Fig. 3
Short overview of the delivery in the clusters. Colour gradient from green, yellow to red: good delivery = green; fair delivery = yellow; poor delivery = red. ‘a’ indicates rating: participation of at least one manager; the number of nominated facilitators; declaration was signed by leaders; meeting conducted according to protocol; satisfaction with the delivery. ‘b’ indicates rating: number of trained facilitators in relation to total number of facilitators nominated; achievement of learning objectives; agenda and content according to protocol; satisfaction with delivery. ‘c’ indicates rating of peer mentor visit: adequate preparation of the cluster at the individual level and at the organisational level; agenda and content according to protocol; satisfaction with delivery; rating of peer counselling via telephone: number of telephone consultations with facilitators and with managers; number of facilitators counselled in relation to total number of facilitators. ‘d’ indicates rating: invited groups and type of invitation; achievement of learning objectives; session conducted according to the protocol; satisfaction with delivery. ‘e’ indicates rating: invited groups and type of invitation; information event conducted according to the protocol; satisfaction with delivery. ‘f’ indicates rating: achievement of learning objectives; agenda and content according to protocol; satisfaction with delivery
Fig. 4
Fig. 4
Delivery to residents per cluster
Fig. 5
Fig. 5
Changes of context in the intervention group and control group. Abbreviations: IG, intervention group; CG, control group; SOP, standard operating procedure
Fig. 6
Fig. 6
Overview of the context analysis adapted from Pfadenhauer et al. [18]

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