Skip to main content
OpenTrials
Completed

NCT Number: NCT04867005

Advance Care Planning in Primary Care: 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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eap Arenys de Mar, Arenys de Mar, Barcelona, Spain

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Impact of a training program

Behavioral

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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...

  3. 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

Sponsors and collaborators

Lead sponsor

University of Vic - Central University of Catalonia

Other

Registry information

Official study title

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

Acronym: PDA_CAT

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 30, 2021
Registry last updated
Apr 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.