End-of-lifeDAVPALNCT05090072
Advanced Directives in Palliative Care (DAVPAL)
A study testing Advance Directives in people with End-of-life, run by Universidade do Porto at 1 site in Portugal.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End-of-life
- What is being tested?
- Advance Directives
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 116 participants
- Where
- 1 sitePortugal
- Study dates
- 10 Sep 2018to 30 Apr 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Tràs-os-Montes and Alto Douro Hospital Centre
Vila Real, 5000-508
About this study
Official title: Advanced Directives in Palliative Care: Physician's Role on Caregiver's Empowerment as Patient's Surrogates
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.
Read the detailed description
This trial was a prospective, single-blinded, controlled, and randomized study analyzing if Advance Directives' discussion between patients and caregivers, promoted by a palliative care physician, improves concordance between them, concerning to patients' last wishes, therefore improving surrogates' accuracy when caregivers decide and act on behalf of the patients. This trial was conducted in a central hospital of Portugal's north inland, serving an estimated population of 465.000 habitants. Patients referenced to all three units of the palliative care service from September 2018 to September 2019, and caregivers, were sequentially approached and recruited on the first consult.
All participants gave written consent to enroll in the trial. This study occurred in two phases, within a 1-month interval. At baseline (phase 1) participants separately fulfilled the Advance Directives' document considering patients' preferences for end-of-life care. Caregivers also fulfill a similar document with their own end-of-life preferences.
Dyads were then randomly assigned to two different groups - The Advance Directives and the Control groups.
Simple individual randomization was previously informatically achieved and the randomization sequence was disclosed by a sealed envelope only after trial enrollment of the dyad, to ensure proper investigator concealment. Both patients and caregivers were blinded to the assigned group until the end of the trial. In both groups (Advance Directives and Control), dyads were engaged in a conference meeting, in the same room, with the same average duration, with the same investigator.
In the Advance Directives group, the palliative care physician promoted an open discussion between patients and caregivers, about patients' answers to the Advance Directives document. In the Control group, the palliative care physician underwent a conference with both patients and caregivers to evaluate patients' clinical symptoms.
At phase 2, one month after the first interview, caregivers were asked to fill in another Advance Directives document, as patients´ surrogates.
Each participant had the choice to drop out at any moment of the trial, and the pair was excluded from data analysis.
Portuguese official Advance Directives was the central instrument used in this trial. Participants were asked to choose 1 to 3 different scenarios, to apply the following 12 questions regarding end-of-life preferences. Each question in each scenario was informatically registered as a Yes or No item, respectively corresponding to items selected or not by all participants. For each participant, the investigators expected 36 possible answers for concordance analysis.
Categorical variables were described by absolute and relative frequencies. Age was described by the mean and standard deviation (mean ± SD), as its distribution was not deviated from normality in each group, according to visual analysis of histograms and confirmed with the Shapiro-Wilk's test of normality.
Agreement between patients and caregivers was assessed (in each question) with the Overall Proportions of Agreement (Overall PA) and Proportions of Specific Agreement (for Yes and No), with respective 95% confidence intervals. Reliability was accessed with Cohen's kappa (k).
Descriptive data analysis was performed using SPSS® Statistics. Proportions of agreement and Cohen's κ with respective confidence intervals were computed using packages "obs. agree" and "psych" from R software, v 3.4.0.
- Conditions
- End-of-life
- Being tested
- Advance Directives, Control
- Keywords
- palliative care, Advance Directives, caregivers, End-of-life decision-making
- Medical subject headings
- Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advance DirectivesBehavioural
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
ControlBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| - 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 Receives: 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 Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 1 month
Secondary outcomes (1)
Agreement between caregivers' answers as patients' surrogates and caregivers' answers about their own end-of-life preferences
Agreement between caregivers as surrogates and their own preferences 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
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2021
- Study start10 Sep 2018
- Primary completion23 Aug 2019
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for End-of-lifeStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade do Porto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Catarina Sampaio Martins, Universidade do Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05090072
- Sponsor's protocol ID
- DAVPAL Study
- Acronym
- DAVPAL
- Status last verified
- Mar 2022
- First submitted
- 28 Sep 2021
- Last updated
- 17 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38536997Martins 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.
PubMed 37393243Martins 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.
PubMed 35820845
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advanced Directives in Palliative Care: Physician's Role on Caregiver's Empowerment as Patient's Surrogates
- ClinicalTrials.gov ID
- NCT05090072
- Acronym / sponsor ID
- DAVPAL / DAVPAL Study
- Conditions
- End-of-life
- Keywords
- palliative care, Advance Directives, caregivers, End-of-life decision-making
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Universidade do PortoUniversity, hospital or other
- Study start
- 10 Sep 2018 (actual)
- Primary completion
- 23 Aug 2019 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 22 Oct 2021 (actual)
- 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.
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.
Detailed description
This trial was a prospective, single-blinded, controlled, and randomized study analyzing if Advance Directives' discussion between patients and caregivers, promoted by a palliative care physician, improves concordance between them, concerning to patients' last wishes, therefore improving surrogates' accuracy when caregivers decide and act on behalf of the patients. This trial was conducted in a central hospital of Portugal's north inland, serving an estimated population of 465.000 habitants. Patients referenced to all three units of the palliative care service from September 2018 to September 2019, and caregivers, were sequentially approached and recruited on the first consult.
All participants gave written consent to enroll in the trial. This study occurred in two phases, within a 1-month interval. At baseline (phase 1) participants separately fulfilled the Advance Directives' document considering patients' preferences for end-of-life care. Caregivers also fulfill a similar document with their own end-of-life preferences.
Dyads were then randomly assigned to two different groups - The Advance Directives and the Control groups.
Simple individual randomization was previously informatically achieved and the randomization sequence was disclosed by a sealed envelope only after trial enrollment of the dyad, to ensure proper investigator concealment. Both patients and caregivers were blinded to the assigned group until the end of the trial. In both groups (Advance Directives and Control), dyads were engaged in a conference meeting, in the same room, with the same average duration, with the same investigator.
In the Advance Directives group, the palliative care physician promoted an open discussion between patients and caregivers, about patients' answers to the Advance Directives document. In the Control group, the palliative care physician underwent a conference with both patients and caregivers to evaluate patients' clinical symptoms.
At phase 2, one month after the first interview, caregivers were asked to fill in another Advance Directives document, as patients´ surrogates.
Each participant had the choice to drop out at any moment of the trial, and the pair was excluded from data analysis.
Portuguese official Advance Directives was the central instrument used in this trial. Participants were asked to choose 1 to 3 different scenarios, to apply the following 12 questions regarding end-of-life preferences. Each question in each scenario was informatically registered as a Yes or No item, respectively corresponding to items selected or not by all participants. For each participant, the investigators expected 36 possible answers for concordance analysis.
Categorical variables were described by absolute and relative frequencies. Age was described by the mean and standard deviation (mean ± SD), as its distribution was not deviated from normality in each group, according to visual analysis of histograms and confirmed with the Shapiro-Wilk's test of normality.
Agreement between patients and caregivers was assessed (in each question) with the Overall Proportions of Agreement (Overall PA) and Proportions of Specific Agreement (for Yes and No), with respective 95% confidence intervals. Reliability was accessed with Cohen's kappa (k).
Descriptive data analysis was performed using SPSS® Statistics. Proportions of agreement and Cohen's κ with respective confidence intervals were computed using packages "obs. agree" and "psych" from R software, v 3.4.0.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| - Advance Directives Group | Active comparator | Behavioral: Advance DirectivesThe 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 |
| Control Group | Placebo comparator | Behavioral: ControlThe group that will receive the Placebo Intervention, consisting of a clinical evaluation of patients' clinical status, by the physician |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Advance DirectivesThe 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 | Behavioural | - Advance Directives Group |
| ControlThe 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. | Behavioural | Control Group |
Primary outcome
Agreement between patients´ and caregivers´ answers in the Advance Directives´ document
Time frame: 1 month
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
Reliability of the results of agreement between patients´ and caregivers' answers in the Advance Directives´ document
Time frame: 1 month
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 secondary outcome
Agreement between caregivers' answers as patients' surrogates and caregivers' answers about their own end-of-life preferences
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2022.
- Derived from this study: PubMed 38536997Martins 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.
- Derived from this study: PubMed 37393243Martins 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.
- Derived from this study: PubMed 35820845Martins 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Advance Directives in people with End-of-life, run by Universidade do Porto at 1 site in Portugal.
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 10 inclusion and 5 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: finished, as of the sponsor's last update on 17 Mar 2022. 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 Portugal. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Agreement between patients´ and caregivers´ answers in the Advance Directives´ document (time frame: 1 month). The study lists 2 primary outcomes in all. 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 NCT05090072, which also lists 3 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 17 Mar 2022.