A Nurse-led Patient-centred Intervention to Increase Written Advance Directives

NCT04065685 | Suspended DMC

• 1 other identifier: anticip@imad_PC_12/18
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

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).

Conditions

Advance Care Planning; Outpatients; Palliative Care

Outcome Measures

Primary Outcomes (1)

• Number of completed anticipated directives

  Completion of anticipated directives will be coded "yes" when anticipated directives are written and signed, otherwise it will be coded "no"

  6 months after inclusion

Secondary Outcomes (6)

• Level of anxiety

  for patients and relatives: baseline; at three months; for nurses: baseline; at 1, 3 and 12 months

• Attitudes towards ADs

  baseline; at 1, 3 and 12 months

• Quality of end of life communication

  baseline; at three months

• Patient Empowerment

  baseline; at three months

• Quality of life patients

  baseline; at three months

Study Arms (3)

CG

ACTIVE COMPARATOR

control group receiving the usual care, the standardized information on anticipated directives

Other: usual care

IG p+r

ACTIVE COMPARATOR

intervention group with patients and her/his relative

Other: serious game named Go Wish

IG p

ACTIVE COMPARATOR

intervention group with patients without relative

Other: serious game named Go Wish

Interventions

serious game named Go Wish OTHER

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.

IG p; IG p+r

usual care OTHER

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

CG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Katia Iglesias: lead
• School of Health Sciences Geneva: collaborator
• University Hospital, Geneva: collaborator
• Institution genevoise de maintien à domicile: collaborator
• High School for Social Work and Health, Lausanne: collaborator
• Swiss Academy of Medical Sciences (SAMS): collaborator

Study Sites (1)

IMAD

Geneva, 1227, Switzerland

Location

Related Publications (1)

• Iglesias K, Busnel C, Dufour F, Pautex S, Sechaud L. Nurse-led patient-centred intervention to increase written advance directives for outpatients in early-stage palliative care: study protocol for a randomised controlled trial with an embedded explanatory qualitative study. BMJ Open. 2020 Sep 20;10(9):e037144. doi: 10.1136/bmjopen-2020-037144.

  PMID: 32958487 DERIVED

Study Officials

• Katia Iglesias, PhD

  HES-SO University of Applied Sciences and Arts of Western Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor HES

Model Details: a randomised controlled trial with three parallel arms (with a waiting list for the control group)

Study Record Dates

• First Submitted: June 27, 2019
• First Posted: August 22, 2019
• Study Start: October 1, 2019
• Primary Completion: October 1, 2019
• Study Completion: December 31, 2022
• Last Updated: November 4, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)