Advance Care Planning in Primary Care: a Cluster Randomized Clinical Trial (PDA_CAT)

April 26, 2021 updated by: Cristina Lasmarias, University of Vic - Central University of Catalonia

Measuring the Effectiveness of a Training Program for the Implementation of Advance Care Planning in Primary Care Teams: a Cluster Randomized Clinical Trial

The study on the effectiveness of a training program in Advance Care Planning (ACP) with primary care professionals has been designed as a cluster-randomized clinical trial.

Aim: To measure the effectiveness of a training program on ACP in Primary healthcare professionals in a population area of Catalonia. Design: Cluster Randomized clinical trial with a measure of pre-post effectiveness between groups of intervention based on the measurement of self-efficacy in advance care planning. Scope: Barcelona Nord and Maresme (BNM). Population: Primary care doctors and nurses. Sample: doctors and nurses from the Primary Care Service (SAP) of the BNM. The study is divided into 3 phases: 1) Planning: training design, randomization and parallel assignment in 2 arms, online training versus online and face-to-face training; 2) Implementation: data collection pre-intervention and training; 3) Evaluation: post data collection (1 follow-up 4 months after recruitment/ after training) and data analysis. Intervention: both arms (A and B) will carry out the online training which consists of a 10 hours course. Arm B will also do the 6-hour face-to-face workshop, divided into two sessions of 3 hours. Primary outcome: ACP Self-efficacy (using a validated scale Advance Care Planning-Self Efficacy Spanish (ACP_SEs). Secondary outcomes: Socio-demographic: age, gender, years of professional experience and in the professional field, previous knowledge in ACP, previous training in ACP; training Satisfaction; ACP Registration Variables in the medical records of patients identified as chronic advanced patients:% clinical records with ACP processes registration, identification of the surrogate decision-maker, values, preferences, and specific decisions records, identification of the place of care and of death preferred, adequacy of the place of death in case of death. Analysis: calculation of the sample applying correction values for the cluster effect; mean, median, range, confidence interval, and standard deviation of quantitative variables and absolute and relative frequency of qualitative variables. Pre- and post-comparison for the measurement of variance (ANOVA) resulting between the intervention groups from the chi-square test; multivariate logistic regression model and 5% significance level

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Barcelona
      • Arenys de Mar, Barcelona, Spain, 08031
        • Eap Arenys de Mar
      • Mataró, Barcelona, Spain, 08031
        • Eap Gatassa - Mataró 6
      • Mataró, Barcelona, Spain, 08031
        • Eap La Riera - Mataró-1
      • Mataró, Barcelona, Spain, 08031
        • Eap Rocafonda-El Palau - Mataró 3
      • Mataró, Barcelona, Spain, 08031
        • Eap Ronda Cerdanya - Mataró 5
      • Mataró, Barcelona, Spain
        • Eap Ronda Prim - Mataró 7
      • Premià de Mar, Barcelona, Spain, 08031
        • Eap Premià de Mar
      • Sant andreu de llavaneres, Barcelona, Spain, 08031
        • Eap Sant Andreu de Llavaneres
      • Vilassar De Mar, Barcelona, Spain, 08031
        • EAP Vilassar de Mar
      • Vilassar de Dalt, Barcelona, Spain, 08031
        • Eap Vilassar de Dalt

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Cluster inclusion criteria:

    • Being a primary care team belonging to SAP BNM.

  • Individuals inclusion criteria:

    • Being a doctor or a nurse working at the primary care teams recruited.
    • 280 will take part in the study, belonging to the 10 primary care teams recruited.

Exclusion Criteria:

  • Cluster inclusion criteria:

    • Being teams that share Primary Care Center, in order to avoid contamination between clusters as long as they share patient assignment.

  • Individuals inclusion criteria:

    • Professionals who refuse to be part of the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Online traininig group. A
This arm included 5 primary care teams, that carried out a 10 hours online course.
Behavioral: Impact of a training program
Measurement of the effectiveness of a training program based on the skills and knowledge learning on advance care planning. A 10 hours online course was administered to both arms through an online platform; the 6 hours face-to-face course was administered to each primary care team (5) included in this arm. The 6 hours course was split into 2 sessions of 3 hours each.
Other Names:
  • Self-efficacy improvement on Advance Care Planning
Experimental: online and face-to-face training group. B
This arm included 5 primary care teams, that carried out a 10 hours online course plus a 6h hours face-to-face course
Behavioral: Impact of a training program
Measurement of the effectiveness of a training program based on the skills and knowledge learning on advance care planning. A 10 hours online course was administered to both arms through an online platform; the 6 hours face-to-face course was administered to each primary care team (5) included in this arm. The 6 hours course was split into 2 sessions of 3 hours each.
Other Names:
  • Self-efficacy improvement on Advance Care Planning

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Advance care planning self-efficacy (ACP-SEs)
Time Frame: 4 months
Self-efficacy on Advance care planing was measured through a recently validated scale into spanish. This scale includes 19 items and it is a 5-point likert scale (1 not at all capable/ 5 completely capable). Due to self-efficacy is a subjective item, no worse o better score is considered. Measurements were collected before training and immediately after training
4 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Clinical records on Advance care planning
Time Frame: 5 months
The clinical records of advanced chronic patients were measured in order to evaluate how ACP were registered before and after the intervention
5 months
Satisfaction with the training process
Time Frame: 1 month
Satisfaction was measured after training on both arms. An ad-hoc 6 point likert ad questionaire was created, including 20 items: satisfaction with contents, organization, teacher, among others...
1 month
Knowledge acquired
Time Frame: 4 months
An ad-hoc 12 items test was created. This outcome was measure before and after training . Correct answers were compared
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Vic - Central University of Catalonia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 10, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 19, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 26, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 30, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 30, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 26, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PDA001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Self Efficacy

Clinical Trials on Impact of a training program

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings