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Informed Palliative Care in Nursing Homes Through the interRAI Palliative Care Instrument (interRAI PC)

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ClinicalTrials.gov Identifier: NCT02281032
Recruitment Status : Unknown
Verified October 2014 by Kirsten Hermans, KU Leuven.
Recruitment status was:  Enrolling by invitation
First Posted : November 3, 2014
Last Update Posted : November 3, 2014
Sponsor:
Collaborators:
VU University Medical Center
University Ghent
Vrije Universiteit Brussel
Agentschap voor Innovatie door Wetenschap en Technologie
Information provided by (Responsible Party):
Kirsten Hermans, KU Leuven

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.


Condition or disease Intervention/treatment Phase
Nursing Home Residents With Palliative Care Needs Other: interRAI PC Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 172 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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 Start Date : November 2013
Estimated Primary Completion Date : February 2015
Estimated Study Completion Date : February 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
interRAI Palliative Care

15 experimental nursing homes:

  • Caregivers of 15 participating nursing homes receive a training about the interRAI PC and the BelRAI webapplication
  • Caregivers of 15 experimental nursing homes fill out the interRAI PC multidisciplinary every three months during one year for all nursing home residents with palliative care needs. Based on the results (Client Assessment Protocols and Scales) of the interRAI PC instrument, care plans are being evaluated, adapted and designed.
Other: interRAI PC

PREPARATORY PHASE

  • Step 0: Introductory information
  • Step 1: Training on the interRAI PC and the BelRAI webapplication
  • Step 2: Introduction on the interRAI PC and the BelRAI webapplication in the organization

IMPLEMENTATION PHASE

  • Step 3: Identification of residents with palliative care needs, based on the surprise question
  • Step 4: Informed consent signature requirements
  • Step 5: Login to the BelRAI webapplication
  • Step 6: Definitions of roles and functions
  • Step 7: Completion of the interRAI PC
  • Step 8: Interpretation of results
  • Step 9: Use of results
Other Name: FLIECE-interRAI PC

No Intervention: No interRAI Palliative Care

15 control nursing homes:

- Caregivers of control nursing homes do not receive the intervention and provide care as usual




Primary Outcome Measures :
  1. 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) [ Time Frame: 1 year ]
    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)


Secondary Outcome Measures :
  1. The validity of the interRAI PC for use in nursing homes assessed by Psychometric analysis [ Time Frame: 1 year ]
    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

  2. The feasibility of the interRAI C for use in nursing homes assessed through focus groups, interviews and field notes [ Time Frame: 1 year ]
    Qualitative data regarding the feasibility of the instrument are collected through focus groups, interviews and field notes



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02281032


Locations
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Belgium
KU Leuven, LUCAS
Leuven, Vlaams-Brabant, Belgium, 3000
Sponsors and Collaborators
KU Leuven
VU University Medical Center
University Ghent
Vrije Universiteit Brussel
Agentschap voor Innovatie door Wetenschap en Technologie
Investigators
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Principal Investigator: Kirsten Hermans KU Leuven, LUCAS
Principal Investigator: Nele Spruytte KU Leuven, LUCAS
Principal Investigator: Joachim Cohen End-of-Life Care Research Group, Vrije Universiteit Brussel (VUB) & Ghent University
Principal Investigator: Chantal Van Audenhove KU Leuven, LUCAS
Principal Investigator: Anja Declercq KU Leuven, LUCAS
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Kirsten Hermans, KU Leuven, LUCAS, KU Leuven
ClinicalTrials.gov Identifier: NCT02281032    
Other Study ID Numbers: SBO-IWT 100036
S56798 ( Registry Identifier: Medical Ethics Committee UZ KU Leuven )
First Posted: November 3, 2014    Key Record Dates
Last Update Posted: November 3, 2014
Last Verified: October 2014
Keywords provided by Kirsten Hermans, KU Leuven:
Palliative Care
Nursing Homes
interRAI Palliative Care instrument
Older adults