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

Study Overview
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Brief Summary
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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

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

Conditions
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Self Efficacy

Intervention / Treatment
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* Behavioral: Impact of a training program


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Online traininig group. A<br>This arm included 5 primary care teams, that carried out a 10 hours online course. | Behavioral: Impact of a training program<br>* 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.<br>* Other names: Self-efficacy improvement on Advance Care Planning;|
| Experimental: online and face-to-face training group. B<br>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<br>* 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.<br>* Other names: Self-efficacy improvement on Advance Care Planning;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Advance Care Planning, Cluster Randomized clinical trial