Nursing Home Residents With Palliative Care Needs Clinical Trial
— interRAI PCOfficial title:
Informed Palliative Care in Nursing Homes Through the interRAI Palliative Care Instrument: A Study Protocol Based on the Medical Research Council Framework
| Verified date | October 2014 |
| Source | Katholieke Universiteit Leuven |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Belgium: Ethics Committee |
| Study type | Interventional |
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.
| Status | Enrolling by invitation |
| Enrollment | 172 |
| Est. completion date | February 2015 |
| Est. primary completion date | February 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 65 Years and older |
| Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
| Country | Name | City | State |
|---|---|---|---|
| Belgium | KU Leuven, LUCAS | Leuven | Vlaams-Brabant |
| Lead Sponsor | Collaborator |
|---|---|
| Katholieke Universiteit Leuven | Agentschap voor Innovatie door Wetenschap en Technologie, University Ghent, Vrije Universiteit Brussel, VU University Medical Center |
Belgium,
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):467-76. doi: 10.1016/j.jamda.2014.01.002. Epub 2014 Feb 22. Review. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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) | 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) | 1 year | No |
| Secondary | The validity of the interRAI PC for use in nursing homes assessed by Psychometric analysis | Psychometric analysis is conducted to evaluate the predictive validity of the Palliative Index for Mortality (PIM) of the interRAI PC and the convergent validity of the CAP 'Mood' of the interRAI PC. Qualitative data regarding the face validity of the instrument are collected through focus groups, interviews and field notes | 1 year | No |
| Secondary | The feasibility of the interRAI C for use in nursing homes assessed through focus groups, interviews and field notes | Qualitative data regarding the feasibility of the instrument are collected through focus groups, interviews and field notes | 1 year | No |