Background
The population of frail older people dying in nursing homes is rising [
1‐
3]. In Belgium, the proportion of hospital deaths in people aged 65 and older decreased from 54.3 to 50.5 percent and care home deaths increased from 25.4 to 30.3 percent between 1998 and 2007 [
3]. In the United States, 25 percent of the population aged 65 and over dies in a care home [
4]. This percentage is expected to double by 2020 [
4,
5]. Subsequently, nursing homes are playing an increasing role in caring for older adults with palliative care needs [
1,
2].
Optimal palliative care in long-term care facilities requires a comprehensive evaluation of the different care needs of nursing home residents [
6,
7]. A comprehensive geriatric assessment (CGA) is defined as ‘a multidimensional, interdisciplinary diagnostic process to determine the medical, psychological and functional capabilities of a frail older person in order to develop a coordinated and integrated plan for treatment and long-term follow-up’ [
8]. The main objectives of a CGA are to improve diagnostic accuracy and treatment, optimize functioning and quality of life, extend community tenure, reduce use of unnecessary formal services and improve long-term care management [
8,
9].
In 2005, the multinational consortium interRAI released the interRAI suite of Instruments [
10]. The interRAI suite of instruments contains comprehensive geriatric assessment instruments, developed for different healthcare settings (interRAI Home Care, interRAI Acute Care, interRAI Long-term Care, interRAI Palliative Care, etc.) [
11]. These instruments provide a comprehensive picture of the complex care problems of older people and allow the exchange of data between different care settings [
12]. In Belgium, the interRAI-instruments were translated into Dutch, French and German during the BelRAI project [
13,
14]. Furthermore, the instruments can be linked and filled out on a secured online web-application (belrai.org). Every interRAI-instrument includes a holistic questionnaire about the health condition of the patient and results that are calculated by means of internationally validated algorithms [
15]. Based on these outcomes, care plans can be developed, evaluated and adjusted [
15]. Examples of results are Scales, Quality Indicators (QIs) and Client Assessment Protocols (CAPs).
The interRAI Palliative Care instrument (interRAI PC) was developed as part of the interRAI suite of instruments [
16]. To improve the continuity of care across settings, the interRAI PC is compatible with the other interRAI instruments [
17]. The interRAI PC is a CGA that evaluates the diverse needs and preferences of adults nearing the end of life in all healthcare settings [
16‐
18]. The aims of the instrument are to improve symptoms, enhance comfort, ameliorate quality of life and assist in coming to terms with death [
18]. Outcomes of the interRAI PC are CAPs and Scales. The CAPs of the interRAI PC instrument are results that inform caregivers to which extent the client’s condition still can improve. The CAPs also inform whether improvement potential is lacking. The goals of care of different CAPs vary and contain the possibility to solve problems, to reduce decline or to create an atmosphere of improvement [
13,
14]. The Scales of the interRAI PC are coherent calculations of client characteristics. These scales are conform to internationally validated scales (Depression Rating Scale, Cognitive Performance Scale, etc.) [
13,
14].
The interRAI suite of instruments is tested and implemented in more than 30 countries and regions worldwide [
10]. Reliability studies on the interRAI PC instrument have already been conducted in six countries [
16,
17]. A systematic review also showed the interRAI PC instrument to be the most comprehensive geriatric assessment instrument that has been partially validated for nursing home residents with palliative care needs [
19]. However, the review also identified that research on the effectiveness and a further validation of the instrument was needed [
19].
This article describes the methods of a phase 0-I-II intervention that was conceived to best address our main research aims:
1)
to evaluate the effect of the interRAI PC on the quality of palliative care in nursing homes;
2)
to evaluate the feasibility of using the interRAI PC in nursing homes;
3)
and to evaluate the face validity of the instrument (as research on the validation of the interRAI PC instrument in nursing homes is deficient).
The study has two additional research objectives:
4)
to evaluate the predictive validity of the Palliative Index for Mortality (PIM) of the interRAI PC instrument (The PIM predicts the absolute and relative mortality risk within six months. If predictive validity is judged as high this index can internationally be used to detect the need for palliative care [
20]);
5)
to assess the convergent validity of the CAP ‘Mood’ of the interRAI PC instrument. (This CAP refers to depression, sadness and fear. These are psychological characteristics that regularly occur in persons with palliative care needs. These characteristics contribute to a diminished quality of life of the person and his or her family [
21]).
The described study protocol will address the following specific research questions:
Effect
Question 1. Does the use of the interRAI PC instrument improve the quality of spiritual, physical, psychosocial and emotional care for nursing home residents near the end of life?
Feasibility
Question 2. Is the use of the interRAI PC instrument feasible for care professionals in nursing homes?
Validity
Question 3. To what extent is the content of the interRAI PC experienced as complete, accurate and clear according to care professionals in nursing homes? (face validity).
Question 4. Is the Palliative Index for Mortality (PIM) of the interRAI PC instrument a good predictor of the risk of mortality within six months of nursing home residents? (predictive validity).
Question 5. Is the Client Assessment Protocol ‘Mood’ of the interRAI PC instrument a valid screening tool for depressive symptoms in nursing home residents with palliative care needs? (convergent validity).
Discussion
This article describes the research protocol of a mixed methods study with a longitudinal, quasi-experimental pretest-posttest design. The study is based on phases 0, I and II of the Medical Research Council (MRC) Framework [
22,
23]. The main aims of the study are to evaluate (1) the effect of the interRAI PC on the quality of palliative care in nursing homes; (2) the feasibility of the interRAI PC; (3) the face validity of the interRAI PC; (4) the predictive validity of the Palliative Index for Mortality (PIM) of the interRAI PC; (5) and the convergent validity of the CAP ‘Mood’ of the interRAI PC.
Previous research has shown a need for well-validated CGAs in clinical practice to evaluate an older person’s medical, psychosocial and functional condition [
46]. Based on a systematic review, the authors found the interRAI PC to be the most comprehensive geriatric assessment for palliative care in nursing homes. However, insufficient data are available on the validity and the effectiveness of the instrument in a nursing home population [
19]. Therefore, this research is conducted on the effect, the feasibility and the validity of the interRAI PC instrument in a population of nursing home residents with palliative care needs.
The interRAI PC consists of various components and the introduction of the interRAI PC in clinical practice requires several steps at different stages [
47]. Interventions ‘comprising a number of separate elements which seem essential to the proper functioning of the interventions although the ‘active ingredient’ of the intervention that is effective is difficult to specify’ are considered as complex interventions [
48]. For trials of such complex interventions, Campbell et al. recommended the MRC framework [
22,
23].
The phased MRC approach, which combines qualitative and quantitative methods, improves the study design and implementation and will contribute to a higher generalizability of the results [
23]. A supplementary strength of the study lies in the fact that it is longitudinal. Several observations of the same variables will be conducted over a period of time. In addition, changes, developments and learning processes over time can be detected. Because of the pretest-posttest design and the use of a control group, expected improvements in the quality of palliative care can be examined.
Limitations of the study also need to be acknowledged. Because of time restrictions, the interRAI PC instrument will only be filled out during one year. Therefore, the maximum amount of longitudinal measures is limited to four. Furthermore, the experimental group consists of all nursing home residents with palliative care needs of fifteen nursing homes (public, private, profit and private commercial nursing homes). However, this sample might not be representative of the general Flemish nursing home population. Additionally, due to ethical and practical constraints, participants will not be randomly assigned to the intervention or control group. Because of the strong commitment requirements, nursing homes which volunteer in the experimental group are all included. Moreover, it is impossible to refuse caregivers to fill out the interRAI PC since the instrument is made accessible through the online webapplication BelRAI. Nursing homes are thus included in the experimental group if they are interested in filling out the interRAI PC.
The final result of the study will be a psychometrically evaluated CGA for nursing home residents with palliative care needs, with outcomes that can be used for care planning. If the validity and the effect of the use of the interRAI PC instrument are evaluated positive, this study protocol can form the basis for a larger-scale phase III randomized controlled trial and a broader implementation of the interRAI PC in nursing homes (phase IV). This can further enhance and stimulate optimal palliative care for nursing home residents and eventually also for adults living in other settings. Finally, the international relevance of this study protocol needs to be acknowledged. While the interRAI suite of instruments -and more specifically the interRAI PC instrument- is tested and implemented worldwide, this study protocol can provide guidelines to evaluate the effect, the validity and the usability of interRAI PC in other countries.
1. KH – MSPsy, PhD Student*
2. NS – MSPsy, PhD, Postdoctoral researcher*
3. JC – MSSoc, PhD, ProfessorƗ
4. CVA – MSPsy, PhD, Professor*
5. AD – MSSoc, PhD, Professor*
*KU Leuven, LUCAS, Center for Healthcare and Consultancy, Kapucijnenvoer 39/5310 B-3000 Leuven, BELGIUM
ƗVrije Universiteit Brussel (VUB) & Ghent University, Laarbeeklaan 103 B-1090 Brussels, BELGIUM.
Competing interests
The authors declare that they have no competing interests.
Authors’ contributions
Substantial contributions to conception and design: KH, NS, JC, AD. Drafting the manuscript: KH. Critical revision of the manuscript for important intellectual content: KH, NS, JC, CVA, AD. Final approval of the manuscript: KH, NS, JC, CVA, AD.