Advance Care Planning in Primary Care: a Cluster Randomized Clinical Trial

Self Efficacy Clinical Trial

— PDA_CAT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04867005
• Other study ID #: PDA001
• Status: Completed
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: April 1, 2020

Study information

• Verified date: April 2021
• Source: University of Vic - Central University of Catalonia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: April 1, 2020
• Est. primary completion date: January 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Self Efficacy

Intervention

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.

Locations

Country	Name	City	State
Spain	Eap Arenys de Mar	Arenys de Mar	Barcelona
Spain	Eap Gatassa - Mataró 6	Mataró	Barcelona
Spain	Eap La Riera - Mataró-1	Mataró	Barcelona
Spain	Eap Rocafonda-El Palau - Mataró 3	Mataró	Barcelona
Spain	Eap Ronda Cerdanya - Mataró 5	Mataró	Barcelona
Spain	Eap Ronda Prim - Mataró 7	Mataró	Barcelona
Spain	Eap Premià de Mar	Premià de Mar	Barcelona
Spain	Eap Sant Andreu de Llavaneres	Sant andreu de llavaneres	Barcelona
Spain	Eap Vilassar de Dalt	Vilassar de Dalt	Barcelona
Spain	Eap Vilassar de Mar	Vilassar De Mar	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
University of Vic - Central University of Catalonia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Knowledge acquired	An ad-hoc 12 items test was created. This outcome was measure before and after training . Correct answers were compared	4 months