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

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: Completed
• Conditions: Self Efficacy
• Intervention / Treatment: Behavioral: Impact of a training program

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Advance care planning self-efficacy (ACP-SEs)	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

Outcome Measure	Measure Description	Time Frame
Clinical records on Advance care planning	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	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	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

• Sponsor: University of Vic - Central University of Catalonia

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2019
• Primary Completion (Actual): January 10, 2020
• Study Completion (Actual): April 1, 2020

Study Registration Dates

• First Submitted: April 19, 2021
• First Submitted That Met QC Criteria: April 26, 2021
• First Posted (Actual): April 30, 2021

Study Record Updates

• Last Update Posted (Actual): April 30, 2021
• Last Update Submitted That Met QC Criteria: April 26, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Advance Care Planning; Cluster Randomized clinical trial
• Other Study ID 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