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A Nurse-led Patient-centred Intervention to Increase Written Advance Care Planning (anticip@imad)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04065685
Recruitment Status : Suspended (Covid-19: participants is a population at risk)
First Posted : August 22, 2019
Last Update Posted : March 25, 2020
Sponsor:
Collaborators:
School of Health Sciences Geneva
University Hospital, Geneva
Institution genevoise de maintien à domicile
High School for Social Work and Health, Lausanne
Swiss Academy of Medical Sciences (SAMS)
Information provided by (Responsible Party):
Katia Iglesias, University of Applied Sciences of Western Switzerland

Brief Summary:

Background and rationale: Since 2013, with the new Swiss Adult Protection Law, Anticipated Directives (ADs) have been used to identify patients' wills in case they cannot express them later. This instrument is considered to improve care quality, reduce conflicts in decisions between patients, relatives and healthcare teams and utilisation of health resources. Despite their perceived utility, political and institutional campaigns have failed to make ADs common among the population. Discussing life threatening diseases evolution and end-of-life (EOL) issues remains difficult for patients, relatives and professionals. Several interventions were developed to improve advance care planning (ACP) and lead to ADs. However, most of them are cognitively demanding or requiring high levels of literacy. People in 'early stage palliative care' (i.e. with chronic degenerative conditions) could benefit from a simple, adjusted, and acceptable intervention to address the problem outside the hospital setting before the crisis and the appearance of other complications. For a dialogue about EOL to take place, it is necessary to engage in a trustful therapeutic relationship constructed on favourable care conditions. The intervention with a serious card game (Go Wish) is a patient-centred approach developed to help people discuss their wishes of EOL care and to formalize them in ADs. Compared to previous interventions, it has some major advantages: it is accessible (no literacy barriers), it is specific (it is centred on the needs and wishes about care priorities), and it is adaptable depending on how patients feel ready to engage in such discussions. And most important of all, it is compatible with the Terror Management theory (TMT) that provides explanations on reluctance to write ADs and how to work around this problem. The TMT is a theoretical rationale that posits that death thoughts, occurring during EOL care discussions, operates as barriers by creating an existential anxiety and defence mechanisms. From the TMT perspective, it is possible to reduce the perceived health-related anxiety by helping people to become aware of their own death. This can be achieved by facilitating discussions about EOL preferences and on psychosocial, cultural, and spiritual values of life. The Go Wish intervention focuses on these individual's important life dimensions which could reduce anxiety in the process of ACP and ADs completion and alleviate defensive behaviours present in EOL care.

Primary objective: To test the efficacy of the Go Wish intervention for increasing the proportion of ADs completed in outpatients receiving early stage of palliative care services compared to usual care (i.e. standardized information on ADs).

Secondary objectives: To explore the role that TMT defence mechanisms plays in the process of end-of-life discussions in nurses, patients and relatives (mixed method).


Condition or disease Intervention/treatment Phase
Advance Care Planning Outpatients Palliative Care Other: serious game named Go Wish Other: usual care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 135 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: a randomised controlled trial with three parallel arms (with a waiting list for the control group)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Nurse-led Patient-centred Intervention to Increase Written Advance Care Planning for Outpatients With Progressive Chronic Illnesses: a Randomized Controlled Trial With an Embedded Explanatory Qualitative Study
Actual Study Start Date : October 1, 2019
Actual Primary Completion Date : October 1, 2019
Estimated Study Completion Date : October 31, 2021

Arm Intervention/treatment
Active Comparator: CG
control group receiving the usual care, the standardized information on anticipated directives
Other: usual care
Standardized information on anticipated directives (ADs): the imad nurse are trained to promote AD to clients to help nurses to describe and explain ADs, to identify and to mobilize the required interview condition to promote ADs to clients to facilitate and initiate discussion on ADs

Active Comparator: IG p+r
intervention group with patients and her/his relative
Other: serious game named Go Wish

The nurse led intervention Go Wish is composed of 36 cards presenting statements of personal needs, values, and beliefs about end-of-life care. The aim is to decide about what to put into the patient's file as care options and the subsequent appointments to name a potential surrogate or to elaborate ADs.

Patient and relative (if participating) will meet their nurse twice:

Session 1: patient the cards in three piles and to rank the ten most important. Session 2 without relative: the nurse reiterates the wishes of care and treatments previously expressed and links them to the state of health and symptoms of the patient and the current treatments and their possible evolution.

Session 2 with a relative: the relative sort the cards based on his/her beliefs about the patient's expectation.

Session 3 with a relative: the nurse bring together the patient and his/her relative to discuss the priorities selected independently, identify, and explore the similarities and differences.


Active Comparator: IG p
intervention group with patients without relative
Other: serious game named Go Wish

The nurse led intervention Go Wish is composed of 36 cards presenting statements of personal needs, values, and beliefs about end-of-life care. The aim is to decide about what to put into the patient's file as care options and the subsequent appointments to name a potential surrogate or to elaborate ADs.

Patient and relative (if participating) will meet their nurse twice:

Session 1: patient the cards in three piles and to rank the ten most important. Session 2 without relative: the nurse reiterates the wishes of care and treatments previously expressed and links them to the state of health and symptoms of the patient and the current treatments and their possible evolution.

Session 2 with a relative: the relative sort the cards based on his/her beliefs about the patient's expectation.

Session 3 with a relative: the nurse bring together the patient and his/her relative to discuss the priorities selected independently, identify, and explore the similarities and differences.





Primary Outcome Measures :
  1. Number of completed anticipated directives [ Time Frame: 6 months after inclusion ]
    Completion of anticipated directives will be coded "yes" when anticipated directives are written and signed, otherwise it will be coded "no"


Secondary Outcome Measures :
  1. Level of anxiety [ Time Frame: for patients and relatives: baseline; at three months; for nurses: baseline; at 1, 3 and 12 months ]

    Level of anxiety will be measured using the validated French version of the Positive and Negative Affect Scale (PANAS). It consists of two 10-item scales to measure mood: positive and negative affect (with two sub-scales: afraid and upset). Items are rated on a 5-points Likert scale.

    A high score on the positive affect scale denotes an optimal state of energy, concentration, and pleasurable engagement whereas a low score reflects sadness and lethargy. A high score on the negative affect scale indicates distress and unpleasant engagement whereas a low score denotes calmness and serenity.


  2. Attitudes towards ADs [ Time Frame: baseline; at 1, 3 and 12 months ]
    For nurses: It will be measured using the validated Knowledge Attitudes and Practice Behaviors Questionnaire (KAP), translated-back translated in French. KAP is 53-item scale composed of five dimensions: (a) demographic and practical characteristics (11 items), (b) knowledge about ADs cares (12 items), (c) attitudes face with ADs (18 items) split up into -beliefs (8 items) - subjective norms (6 items) - control perception (4 items), (d) practices during discussions (4 items), (e) other information on practice (8 items). The questions related to knowledge about ADs cares (12 items) were excluded (not relevant for the research questions). Items are rated on a 5-points Likert scale.

  3. Quality of end of life communication [ Time Frame: baseline; at three months ]
    For patients: Quality of end of life communication between patient and nurse will be measured using the validated "Quality of patient-clinician communication about end-of-life care" (QOC). It is a 19-item scale composed of two subscales: a) global communication competencies of the clinician (7 items) and b) specific competencies determining the quality of the communication about end-of-life care (12 items). Items are rated on a 10-points Likert scale. Translation and back translation procedure will be run.

  4. Patient Empowerment [ Time Frame: baseline; at three months ]
    For patients: Patient empowerment will be measured using the validated French version of the "Health care empowerment questionnaire (HCEQ)". A 10-item scale that evaluates the degree of "empowerment" perceived by the patient with the care received and health services on a 4-point Likert scale.

  5. Quality of life patients [ Time Frame: baseline; at three months ]
    For patients: Quality of life will be measured using the French validated version of the "McGill quality of life revised (MQOL-R)". It is a 14-item scale composed of a four sub scales (plus a general quality of life question (1 item)): physical (3 items), existential (4 items), psychological (4 items) and social (3 items). Items are measured on an 11-points Likert scale.

  6. Quality of life of relatives [ Time Frame: baseline; at three months ]
    For the relatives: quality of life will be measured using the validated French version of World Health Organization Quality of Life (WHOQOL) brief. It is a 26-item scale based on satisfaction questions across four domains of quality of life: physical health (7 items), psychological health (6 items), social relationships (3 items), environment (8 items), and two general questions. Items are rated on a 5-points Likert scale in reference to the last 2 weeks. A percentage rating within each domain was computed with scores ranging from 0 (lowest quality of life) to 100 (highest quality of life) as defined by the instrument use.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Nurses: stable contract, with a diploma in nursing, fluent in French, being able to provide informed consent;
  • Patients: at least 18 years old, chronic progressive disease impacting life expectancy, being able to speak, read and understand French, followed by nurses of imad a least once a week, capacity of discernment, being able to provide informed consent;
  • Relatives: designed by the patient, at least 18 years old, being able to speak, read and understand French, capacity of discernment, being able to provide informed consent

Exclusion Criteria:

  • Nurses: temporary work, refusal to provide informed consent
  • Patients: existing ADs, terminal care, existing diagnosis of cognitive disorders or sensory motor impairment documented in the patient file related to memory loss or disturbances of speech that would not allow for a constructive exchange, refusal to provide informed consent;
  • Relatives: imad's professional, refusal to provide informed consent

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): NCT04065685


Locations
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Switzerland
IMAD
Geneva, Switzerland, 1227
Sponsors and Collaborators
Katia Iglesias
School of Health Sciences Geneva
University Hospital, Geneva
Institution genevoise de maintien à domicile
High School for Social Work and Health, Lausanne
Swiss Academy of Medical Sciences (SAMS)
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Responsible Party: Katia Iglesias, Professor HES, University of Applied Sciences of Western Switzerland
ClinicalTrials.gov Identifier: NCT04065685    
Other Study ID Numbers: anticip@imad_PC_12/18
First Posted: August 22, 2019    Key Record Dates
Last Update Posted: March 25, 2020
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No