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

October 31, 2014 updated by: Kirsten Hermans, KU Leuven

Informed Palliative Care in Nursing Homes Through the interRAI Palliative Care Instrument: A Study Protocol Based on the Medical Research Council Framework

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

172

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • KU Leuven, LUCAS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 year
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
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

KU Leuven

Collaborators

Amsterdam UMC, location VUmc
Agentschap voor Innovatie door Wetenschap en Technologie
University Ghent
Vrije Universiteit Brussel

Investigators

  • 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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Anticipated)

February 1, 2015

Study Completion (Anticipated)

February 1, 2015

Study Registration Dates

First Submitted

October 30, 2014

First Submitted That Met QC Criteria

October 31, 2014

First Posted (Estimate)

November 2, 2014

Study Record Updates

Last Update Posted (Estimate)

November 2, 2014

Last Update Submitted That Met QC Criteria

October 31, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SBO-IWT 100036
  • S56798 (Registry Identifier: Medical Ethics Committee UZ KU Leuven)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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