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Phase III randomized controlled cluster trial to study the impact of a palliative care intervention

PACE will perform a randomized controlled cluster trial comparing the health service intervention ‘PACE Steps to Success’ with care as usual. The intervention aims to enhance palliative care through facilitating organisational change and supporting staff to develop their roles concerning palliative care, and thereby strives to ensure all residents receive high-quality palliative care. The intervention runs for 12 months in the facilities of the intervention group. In the control group care is delivered ‘as usual’, which in some countries involves palliative care services and in other countries does not (see study I).

The objectives of this study are:

1. To compare the impact of the intervention “Pace Steps to Success” with traditional care in long term care facilities in terms of patient and family outcomes, quality of dying, quality of palliative care, cost-effectiveness, and staff knowledge and attitudes
2. To evaluate the implementation process of the intervention in long term care facilities and identify national or international facilitators and barriers

Important outcome measures are quality of dying, quality of palliative care, costs-effectiveness and staff knowledge and attitudes.

Data collection and instruments for objective (1): instruments from study I will be used. A baseline measurement (i.e. month 1) will be performed in all participating long term care facilities, i.e. intervention and control group. In both groups, researchers perform a second cross-sectional study of deaths after 13 and 17 months.

Data collection for objective (2): In order to collect information concerning barriers and facilitators, researchers will perform focus groups at month 15 with family and care staff separately, and interviews with residents in each intervention facility.

After the intervention, researchers perform semi-structured interviews with facility managers who have an overview of the facility, PACE coordinators of the facility, and Country Trainers to evaluate experiences.