Clinical trial NCT04867005: Advance Care Planning in Primary Care: a Cluster Randomized Clinical Trial
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Self Efficacy
Keywords: Advance Care Planning
Cluster Randomized clinical trial
Lead sponsor: University of Vic - Central University of Catalonia
Sponsor class: OTHER
First posted: 2021-04-30
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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


Eligibility criteria: 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.

Primary outcomes:
measure: Advance care planning self-efficacy (ACP-SEs)
timeFrame: 4 months
Secondary outcomes:
measure: Clinical records on Advance care planning
timeFrame: 5 months
measure: Satisfaction with the training process
timeFrame: 1 month
measure: Knowledge acquired
timeFrame: 4 months
Other outcomes:
Locations:
city: Arenys de Mar
country: Spain
facility: Eap Arenys de Mar
state: Barcelona
city: Mataró
country: Spain
facility: Eap Gatassa - Mataró 6
state: Barcelona
city: Mataró
country: Spain
facility: Eap La Riera - Mataró-1
state: Barcelona
city: Mataró
country: Spain
facility: Eap Rocafonda-El Palau - Mataró 3
state: Barcelona
city: Mataró
country: Spain
facility: Eap Ronda Cerdanya - Mataró 5
state: Barcelona
city: Mataró
country: Spain
facility: Eap Ronda Prim - Mataró 7
state: Barcelona
city: Premià de Mar
country: Spain
facility: Eap Premià de Mar
state: Barcelona
city: Sant andreu de llavaneres
country: Spain
facility: Eap Sant Andreu de Llavaneres
state: Barcelona
city: Vilassar de Dalt
country: Spain
facility: Eap Vilassar de Dalt
state: Barcelona
city: Vilassar De Mar
country: Spain
facility: Eap Vilassar de Mar
state: Barcelona
Study officials:
References: