Self EfficacyPDA_CATNCT04867005
Advance Care Planning in Primary Care: a Cluster Randomized Clinical Trial
A study testing Impact of a training program in people with Self Efficacy, run by University of Vic - Central University of Catalonia at 10 sites in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Self Efficacy
- What is being tested?
- Impact of a training program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 10 sitesSpain
- Study dates
- 1 Sep 2019to 1 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Spain10 sites
Eap Arenys de Mar
Arenys de Mar, Barcelona, 08031
Eap Gatassa - Mataró 6
Mataró, Barcelona, 08031
Eap La Riera - Mataró-1
Mataró, Barcelona, 08031
Eap Rocafonda-El Palau - Mataró 3
Mataró, Barcelona, 08031
Eap Ronda Cerdanya - Mataró 5
Mataró, Barcelona, 08031
Eap Ronda Prim - Mataró 7
Mataró, Barcelona
Eap Premià de Mar
Premià de Mar, Barcelona, 08031
Eap Sant Andreu de Llavaneres
Sant Andreu de Llavaneres, Barcelona, 08031
Eap Vilassar de Dalt
Vilassar de Dalt, Barcelona, 08031
Eap Vilassar de Mar
Vilassar de Mar, Barcelona, 08031
About this study
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
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
- Being tested
- Impact of a training program
- Keywords
- Advance Care Planning, Cluster Randomized clinical trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Impact of a training programBehavioural
Also called Self-efficacy improvement on Advance Care Planning
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.
| Study group | Role | What they receive |
|---|---|---|
| Online traininig group. A | Active comparator | This arm included 5 primary care teams, that carried out a 10 hours online course. Receives: 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 Receives: Behavioral: Impact of a training program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 months
Secondary outcomes (3)
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
Measured: 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...
Measured: 1 month
Knowledge acquired
An ad-hoc 12 items test was created. This outcome was measure before and after training . Correct answers were compared
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2021
- Study start1 Sep 2019
- Primary completion10 Jan 2020
- Study completion1 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Self EfficacyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vic - Central University of Catalonia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cristina Lasmarias, University of Vic - Central University of Catalonia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04867005
- Sponsor's protocol ID
- PDA001
- Acronym
- PDA_CAT
- Status last verified
- Apr 2021
- First submitted
- 19 Apr 2021
- Last updated
- 30 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04867005
- Acronym / sponsor ID
- PDA_CAT / PDA001
- Conditions
- Self Efficacy
- Keywords
- Advance Care Planning, Cluster Randomized clinical trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of Vic - Central University of CataloniaUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 10 Jan 2020 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 30 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Online traininig group. A | Active comparator | Behavioral: Impact of a training programThis arm included 5 primary care teams, that carried out a 10 hours online course. |
| online and face-to-face training group. B | Experimental | Behavioral: Impact of a training programThis arm included 5 primary care teams, that carried out a 10 hours online course plus a 6h hours face-to-face course |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Cluster inclusion criteria:
- Individuals inclusion criteria:
Key exclusion criteria (4 listed)
- Cluster inclusion criteria:
- Individuals inclusion criteria:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Impact of a training programAlso: Self-efficacy improvement on Advance Care PlanningMeasurement 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. | Behavioural | Online traininig group. A, online and face-to-face training group. B |
Primary outcome
Advance care planning self-efficacy (ACP-SEs)
Time frame: 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
3 secondary outcomes
Clinical records on Advance care planning
Time frame: 5 months
Satisfaction with the training process
Time frame: 1 month
Knowledge acquired
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Impact of a training program in people with Self Efficacy, run by University of Vic - Central University of Catalonia at 10 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Advance care planning self-efficacy (ACP-SEs) (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2021.