Nursing Home Residents With Palliative Care NeedsinterRAI PCNCT02281032
Informed Palliative Care in Nursing Homes Through the interRAI Palliative Care Instrument
A study testing interRAI PC in people with Nursing Home Residents With Palliative Care Needs, run by KU Leuven at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Nursing Home Residents With Palliative Care Needs
- What is being tested?
- interRAI PC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 1 siteBelgium
- Study dates
- Nov 2013to Feb 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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)
Who cannot join
- 65-
- not residing in a nursing home
- no palliative care needs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- interRAI PC
- Keywords
- Palliative Care, Nursing Homes, interRAI Palliative Care instrument, Older adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interRAI PCOther
Also called FLIECE-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
| Study group | Role | What they receive |
|---|---|---|
| interRAI Palliative Care | Other | 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. Receives: Other: interRAI PC |
| No interRAI Palliative Care | No intervention | 15 control nursing homes: - Caregivers of control nursing homes do not receive the intervention and provide care as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 1 year
Secondary outcomes (2)
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
Measured: 1 year
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2014 (estimated)
- Study startNov 2013
- Primary completionFeb 2015 (estimated)
- Study completionFeb 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Nursing Home Residents With Palliative Care NeedsStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 172 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Amsterdam UMC, location VUmc, University Ghent, Vrije Universiteit Brussel, Agentschap voor Innovatie door Wetenschap en Technologie
- Responsible party
- Principal investigator, Kirsten Hermans, KU Leuven
- Investigators
- Kirsten Hermans, Principal investigator, KU Leuven, LUCASNele Spruytte, Principal investigator, KU Leuven, LUCASJoachim Cohen, Principal investigator, End-of-Life Care Research Group, Vrije Universiteit Brussel (VUB) & Ghent UniversityChantal Van Audenhove, Principal investigator, KU Leuven, LUCASAnja Declercq, Principal investigator, KU Leuven, LUCAS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02281032
- Sponsor's protocol ID
- SBO-IWT 100036
- Other IDs
- S56798
- Acronym
- interRAI PC
- Status last verified
- Oct 2014
- First submitted
- 30 Oct 2014
- Last updated
- 3 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 24569081Hermans 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.
PubMed 25479633
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Informed Palliative Care in Nursing Homes Through the interRAI Palliative Care Instrument: A Study Protocol Based on the Medical Research Council Framework
- ClinicalTrials.gov ID
- NCT02281032
- Acronym / sponsor ID
- interRAI PC / SBO-IWT 100036
- Keywords
- Palliative Care, Nursing Homes, interRAI Palliative Care instrument, Older adults
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 172 participants (estimated)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Collaborators
- Amsterdam UMC, location VUmc, University Ghent, Vrije Universiteit Brussel, Agentschap voor Innovatie door Wetenschap en Technologie
- Study start
- Nov 2013
- Primary completion
- Feb 2015 (estimated)
- Study completion
- Feb 2015 (estimated)
- First posted
- 3 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| interRAI Palliative Care | Other | Other: interRAI PC15 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. |
| No interRAI Palliative Care | No intervention | –15 control nursing homes: - Caregivers of control nursing homes do not receive the intervention and provide care as usual |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- 65-
- not residing in a nursing home
- no palliative care needs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| interRAI PCAlso: FLIECE-interRAI PCPREPARATORY 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 | interRAI Palliative Care |
Primary outcome
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)
2 secondary outcomes
The validity of the interRAI PC for use in nursing homes assessed by Psychometric analysis
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2014.
- Background: PubMed 24569081Hermans 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.
- Derived from this study: PubMed 25479633Hermans 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kirsten Hermans principal investigator
KU Leuven, LUCAS
Nele Spruytte principal investigator
KU Leuven, LUCAS
Joachim Cohen principal investigator
End-of-Life Care Research Group, Vrije Universiteit Brussel (VUB) & Ghent University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing interRAI PC in people with Nursing Home Residents With Palliative Care Needs, run by KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02281032, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2014.