Clinical trial NCT02281032: Informed Palliative Care in Nursing Homes Through the interRAI Palliative Care Instrument
Official title: Informed Palliative Care in Nursing Homes Through the interRAI Palliative Care Instrument: A Study Protocol Based on the Medical Research Council Framework
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nursing Home Residents With Palliative Care Needs
Keywords: Palliative Care
Nursing Homes
interRAI Palliative Care instrument
Older adults
Lead sponsor: KU Leuven
Sponsor class: OTHER
Collaborators: name: Amsterdam UMC, location VUmc
name: University Ghent
name: Vrije Universiteit Brussel
name: Agentschap voor Innovatie door Wetenschap en Technologie
First posted: 2014-11-02
Enrollment: 172
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: BACKGROUND Nursing homes are important locations for palliative care. Through comprehensive geriatric assessments (CGAs), evaluations can be made of the palliative care needs of nursing home residents. The interRAI Palliative Care instrument (interRAI PC) is a CGA that evaluates diverse palliative care needs of adults in all healthcare settings. The evaluation results in Client Assessment Protocols (CAPs: indications of problems that need addressing) and Scales (e.g. Palliative Index for Mortality (PIM)) which can be used to design, evaluate and adjust care plans. This study aims to examine the effect of using the interRAI PC on the quality of palliative care in nursing homes. Additionally, it aims to evaluate the feasibility and validity of the interRAI PC.

METHODS This study covers phases 0, I and II of the Medical Research Council (MRC) framework for designing and evaluating complex interventions, with a longitudinal, quasi-experimental pretest-posttest design and with mixed methods of evaluation. In phase 0, a systematic literature search is conducted. In phase I, the interRAI PC instrument is adapted for use in Belgium and implemented on the BelRAI-website and a practical training is developed. In phase II, the intervention is tested in fifteen nursing homes. Participating nursing homes fill out the interRAI PC during one year for all residents receiving palliative care. Using a pretest-posttest design with quasi-random assignment to the intervention or control group, the effect of the interRAI PC on the quality of palliative care is evaluated with the Palliative care Outcome Scale (POS). Psychometric analysis is conducted to evaluate the predictive validity of the PIM and the convergent validity of the CAP 'Mood' of the interRAI PC. Qualitative data regarding the usability and face validity of the instrument are collected.

DISCUSSION This is the first study to evaluate the validity and effect of the interRAI PC in nursing homes, following a methodology based on the MRC framework. This approach improves the study design and implementation and will contribute to a higher generalizability of results. The final result will be a psychometrically evaluated CGA for nursing home residents receiving palliative care.


Eligibility criteria: Inclusion Criteria:

* 65+
* residing in a nursing home
* having palliative care needs (based on the 'surprise question': 'would you be surprised if this person was to die within 6 to 12 months?') (Hubard G, 2011)

Exclusion Criteria:

* 65-
* not residing in a nursing home
* no palliative care needs

Primary outcomes:
measure: The effect of using the interRAI PC instrument on the quality of palliative care in nursing homes evaluated by the Palliative care Outcome Scale (POS)
timeFrame: 1 year
Secondary outcomes:
measure: The validity of the interRAI PC for use in nursing homes assessed by Psychometric analysis
timeFrame: 1 year
measure: The feasibility of the interRAI C for use in nursing homes assessed through focus groups, interviews and field notes
timeFrame: 1 year
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: KU Leuven, LUCAS
state: Vlaams-Brabant
Study officials:
affiliation: KU Leuven, LUCAS
name: Kirsten Hermans
role: PRINCIPAL_INVESTIGATOR
affiliation: KU Leuven, LUCAS
name: Nele Spruytte
role: PRINCIPAL_INVESTIGATOR
affiliation: End-of-Life Care Research Group, Vrije Universiteit Brussel (VUB) & Ghent University
name: Joachim Cohen
role: PRINCIPAL_INVESTIGATOR
affiliation: KU Leuven, LUCAS
name: Chantal Van Audenhove
role: PRINCIPAL_INVESTIGATOR
affiliation: KU Leuven, LUCAS
name: Anja Declercq
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hermans K, De Almeida Mello J, Spruytte N, Cohen J, Van Audenhove C, Declercq A. A comparative analysis of comprehensive geriatric assessments for nursing home residents receiving palliative care: a systematic review. J Am Med Dir Assoc. 2014 Jul;15(7):467-476. doi: 10.1016/j.jamda.2014.01.002. Epub 2014 Feb 22.
citation: Hermans K, Spruytte N, Cohen J, Van Audenhove C, Declercq A. Informed palliative care in nursing homes through the interRAI Palliative Care instrument: a study protocol based on the Medical Research Council framework. BMC Geriatr. 2014 Dec 5;14:132. doi: 10.1186/1471-2318-14-132.