Advanced Directives in Palliative Care (DAVPAL)

NCT05090072 | Completed

• 1 other identifier: DAVPAL Study
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief Summary

A prospective, single-blinded, controlled, and randomized trial to find if physician's use of the Portuguese Advance Directives, in palliative care, as a communication tool between patients and caregivers, improves the agreement and reliability between patients and their health surrogates, in their decisions about end-of-life care.

Conditions

End-of-life

Keywords

palliative care; Advance Directives; caregivers; End-of-life decision-making

Outcome Measures

Primary Outcomes (2)

• Agreement between patients´ and caregivers´ answers in the Advance Directives´ document

  Agreement between patients and their caregivers was accessed with the Overall Proportion of Agreement (Overall PA) and Proportion of Specific Agreement (Yes PA and No PA), for the 12 questions of the Portuguese Advance Directives, on the Advance Directives and Control group

  1 month

• Reliability of the results of agreement between patients´ and caregivers' answers in the Advance Directives´ document

  Reliability was accessed with Cohen's kappa (k). (Cohen, 1960). We assumed Landis and Koch's (1977) interpretation of κ value. According to these authors, a κ value of 0.20 represents slight reliability, a value between 0.21 and 0.40 fair reliability, a value between 0.41 and 0.60 moderate reliability, a value between 0.61 and 0.80 substantial reliability, and a value of 0.81-1.00 indicates almost perfect reliability

  1 month

Secondary Outcomes (1)

• Agreement between caregivers' answers as patients' surrogates and caregivers' answers about their own end-of-life preferences

  1 month

Study Arms (2)

- Advance Directives Group

ACTIVE COMPARATOR

The group that will receive the principal physician intervention, using Advance Directives document as a communication tool between patients and caregivers, to find its efficacy on the promotion of better-prepared surrogates

Behavioral: Advance Directives

Control Group

PLACEBO COMPARATOR

The group that will receive the Placebo Intervention, consisting of a clinical evaluation of patients' clinical status, by the physician

Behavioral: Control

Interventions

Advance Directives BEHAVIORAL

The palliative care physician engaged patients and their caregivers in an open discussion about patients' answers to the Advance Directives document, to explore and clarify all doubts and questions prompted by the document

- Advance Directives Group

Control BEHAVIORAL

The palliative care physician undergone a conference with both patients and caregivers and evaluated patients' symptoms using the the Edmonton Frail Scale (Bruera, 1991), adapted to the Portuguese population. The Advance Directives theme wasn't approached during this conference.

Control Group

Eligibility Criteria

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

You may qualify if:

• Adult patients with 18 years or more
• Patients referenced to the palliative care service with a chronic, progressive, and incurable disease
• Patients with the ability to comprehend, write and speak the Portuguese language
• Patients with an absence of major cognitive disorders (Portuguese validated Mini-Mental State Test score superior to 22, 25, or 27, according to patients' scholarly)
• Patients that accepted to participate in the trial
• Patients who were capable of nominate a caregiver as their surrogate in decision making
• Adult caregivers with 18 years or more
• Caregivers who were nominated by patients as their surrogate decision-maker
• Caregivers with the ability to comprehend, write and speak the Portuguese language
• Caregivers that accepted to participate in the trial

You may not qualify if:

• Patients or caregivers that refused to participate
• Patients with cognitive impairment
• Patients with incapacity to dialogue
• Patients who were too sick to cooperate
• Patients without a caregiver

Sponsors & Collaborators

• Universidade do Porto: lead

Study Sites (1)

Tràs-os-Montes and Alto Douro Hospital Centre

Vila Real, 5000-508, Portugal

Location

Related Publications (3)

• Martins CS, Nunes R. Portuguese Advance Directives-a twist against futility? A cross sectional study. Sao Paulo Med J. 2024 Mar 25;142(3):e2022537. doi: 10.1590/1516-3180.2022.0537.R2.201023. eCollection 2024.

  PMID: 38536997 DERIVED

• Martins CS, Nunes R. Advanced directives' knowledge among Portuguese palliative patients and caregivers: do the sociodemographic factors influence it? A cross-sectional survey. BMC Palliat Care. 2023 Jul 1;22(1):84. doi: 10.1186/s12904-023-01203-7.

  PMID: 37393243 DERIVED

• Martins CS, Sousa I, Barros C, Pires A, Castro L, da Costa Santos C, Nunes R. Do surrogates predict patient preferences more accurately after a physician-led discussion about advance directives? A randomized controlled trial. BMC Palliat Care. 2022 Jul 12;21(1):122. doi: 10.1186/s12904-022-01013-3.

  PMID: 35820845 DERIVED

MeSH Terms

Conditions

Death

Interventions

Advance Directives

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Jurisprudence; Social Control, Formal; Health Care Economics and Organizations; Advance Care Planning; Patient Care Planning; Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: All participants were blinded to the allocated intervention, from the beginning to the end of the trial. Investigator only had access to the allocation group after participants enrollment on the trial, sociodemographic data collected, and phase 1 Advance Directives fulfilled. Preliminary data analysis was made without knowledge of the participants' allocated group
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: After enrollment and some sociodemographic data were collected, participants were asked to, separately, fulfill the Advance Directives document, concerning patients' last wishes. Caregivers also fulfill one document with their own end-of-life preferences. The pair was then randomly assigned to one of the two parallel groups (Advance Directives or Control Group). Both groups had a conference meeting with the same palliative care physician, in the same room, with the same average duration (40 to 50 minutes). The Advance Directives Group discussed patients' answers to the Advance Directive document, and the Control Group talked about patients' clinical status. Two months later, caregivers only, were asked to fulfill another Advance Directive document as patients' surrogates.

Study Record Dates

• First Submitted: September 28, 2021
• First Posted: October 22, 2021
• Study Start: September 10, 2018
• Primary Completion: August 23, 2019
• Study Completion: April 30, 2021
• Last Updated: March 17, 2022

Record last verified: 2022-03

Locations

PT (1)