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

Not Applicable

Completed

• Conditions: Self Efficacy
• Interventions: Behavioral: Impact of a training program

• Registration Number: NCT04867005
• Lead Sponsor: University of Vic - Central University of Catalonia

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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-01
• Primary Completion: 2020-01-10
• Study Completion: 2020-04-01
• Status Verified: 2021-04
• Study First Submitted: 2021-04-19
• Study First Submitted QC: 2021-04-26
• Last Update Submitted: 2021-04-26
• Study First Posted: 2021-04-30
• Last Update Posted: 2021-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
online and face-to-face training group. B	Impact of a training program	This arm included 5 primary care teams, that carried out a 10 hours online course plus a 6h hours face-to-face course
Online traininig group. A	Impact of a training program	This arm included 5 primary care teams, that carried out a 10 hours online course.

Primary Outcome Measures

Name	Time	Method
Advance care planning self-efficacy (ACP-SEs)	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 Outcome Measures

Name	Time	Method
Satisfaction with the training process	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...
Knowledge acquired	4 months	An ad-hoc 12 items test was created. This outcome was measure before and after training . Correct answers were compared
Clinical records on Advance care planning	5 months	The clinical records of advanced chronic patients were measured in order to evaluate how ACP were registered before and after the intervention

Trial Locations

Locations (10)

Eap Gatassa - Mataró 6; 🇪🇸 Mataró, Barcelona, Spain

Eap Arenys de Mar; 🇪🇸 Arenys de Mar, 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 Mar; 🇪🇸 Vilassar De Mar, Barcelona, Spain

Eap Vilassar de Dalt; 🇪🇸 Vilassar de Dalt, Barcelona, Spain