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

NCT04867005 | Completed

• 1 other identifier: PDA001
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 10

Brief 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

Conditions

Self Efficacy

Keywords

Advance Care Planning; Cluster Randomized clinical trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Clinical records on Advance care planning

  5 months

• Satisfaction with the training process

  1 month

• Knowledge acquired

  4 months

Study Arms (2)

Online traininig group. A

ACTIVE COMPARATOR

This arm included 5 primary care teams, that carried out a 10 hours online course.

Behavioral: Impact of a training program

online and face-to-face training group. B

EXPERIMENTAL

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

Interventions

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.

Also known as: Self-efficacy improvement on Advance Care Planning

Online traininig group. A; online and face-to-face training group. B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Being teams that share Primary Care Center, in order to avoid contamination between clusters as long as they share patient assignment.
• Professionals who refuse to be part of the study.

Sponsors & Collaborators

• University of Vic - Central University of Catalonia: lead

Study Sites (10)

Eap Arenys de Mar

Arenys de Mar, Barcelona, 08031, Spain

Location

Eap Gatassa - Mataró 6

Mataró, Barcelona, 08031, Spain

Location

Eap La Riera - Mataró-1

Mataró, Barcelona, 08031, Spain

Location

Eap Rocafonda-El Palau - Mataró 3

Mataró, Barcelona, 08031, Spain

Location

Eap Ronda Cerdanya - Mataró 5

Mataró, Barcelona, 08031, Spain

Location

Eap Ronda Prim - Mataró 7

Mataró, Barcelona, Spain

Location

Eap Premià de Mar

Premià de Mar, Barcelona, 08031, Spain

Location

Eap Sant Andreu de Llavaneres

Sant Andreu de Llavaneres, Barcelona, 08031, Spain

Location

Eap Vilassar de Dalt

Vilassar de Dalt, Barcelona, 08031, Spain

Location

Eap Vilassar de Mar

Vilassar de Mar, Barcelona, 08031, Spain

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: April 19, 2021
• First Posted: April 30, 2021
• Study Start: September 1, 2019
• Primary Completion: January 10, 2020
• Study Completion: April 1, 2020
• Last Updated: April 30, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (10)