Ignite Creation Date:
2025-12-25 @ 3:08 AM
Ignite Modification Date:
2025-12-31 @ 8:18 PM
Study NCT ID:
NCT04867005
Status:
COMPLETED
Last Update Posted:
2021-04-30
First Post:
2021-04-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Advance Care Planning in Primary Care: a Cluster Randomized Clinical Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-26', 'studyFirstSubmitDate': '2021-04-19', 'studyFirstSubmitQcDate': '2021-04-26', 'lastUpdatePostDateStruct': {'date': '2021-04-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Advance care planning self-efficacy (ACP-SEs)', 'timeFrame': '4 months', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'Clinical records on Advance care planning', 'timeFrame': '5 months', 'description': 'The clinical records of advanced chronic patients were measured in order to evaluate how ACP were registered before and after the intervention'}, {'measure': 'Satisfaction with the training process', 'timeFrame': '1 month', 'description': '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...'}, {'measure': 'Knowledge acquired', 'timeFrame': '4 months', 'description': 'An ad-hoc 12 items test was created. This outcome was measure before and after training . Correct answers were compared'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Advance Care Planning', 'Cluster Randomized clinical trial'], 'conditions': ['Self Efficacy']}, 'descriptionModule': {'briefSummary': '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.\n\nAim: 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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Cluster inclusion criteria:\n\n • Being a primary care team belonging to SAP BNM.\n* Individuals inclusion criteria:\n\n * Being a doctor or a nurse working at the primary care teams recruited.\n * 280 will take part in the study, belonging to the 10 primary care teams recruited.\n\nExclusion Criteria:\n\n* Cluster inclusion criteria:\n\n • Being teams that share Primary Care Center, in order to avoid contamination between clusters as long as they share patient assignment.\n* Individuals inclusion criteria:\n\n * Professionals who refuse to be part of the study.'}, 'identificationModule': {'nctId': 'NCT04867005', 'acronym': 'PDA_CAT', 'briefTitle': 'Advance Care Planning in Primary Care: a Cluster Randomized Clinical Trial', 'organization': {'class': 'OTHER', 'fullName': 'University of Vic - Central University of Catalonia'}, 'officialTitle': 'Measuring the Effectiveness of a Training Program for the Implementation of Advance Care Planning in Primary Care Teams: a Cluster Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'PDA001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Online traininig group. A', 'description': 'This arm included 5 primary care teams, that carried out a 10 hours online course.', 'interventionNames': ['Behavioral: Impact of a training program']}, {'type': 'EXPERIMENTAL', 'label': 'online and face-to-face training group. B', 'description': 'This arm included 5 primary care teams, that carried out a 10 hours online course plus a 6h hours face-to-face course', 'interventionNames': ['Behavioral: Impact of a training program']}], 'interventions': [{'name': 'Impact of a training program', 'type': 'BEHAVIORAL', 'otherNames': ['Self-efficacy improvement on Advance Care Planning'], 'description': '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.', 'armGroupLabels': ['Online traininig group. A', 'online and face-to-face training group. B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08031', 'city': 'Arenys de Mar', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Eap Arenys de Mar', 'geoPoint': {'lat': 41.5819, 'lon': 2.54936}}, {'zip': '08031', 'city': 'Mataró', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Eap Gatassa - Mataró 6', 'geoPoint': {'lat': 41.54211, 'lon': 2.4445}}, {'zip': '08031', 'city': 'Mataró', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Eap La Riera - Mataró-1', 'geoPoint': {'lat': 41.54211, 'lon': 2.4445}}, {'zip': '08031', 'city': 'Mataró', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Eap Rocafonda-El Palau - Mataró 3', 'geoPoint': {'lat': 41.54211, 'lon': 2.4445}}, {'zip': '08031', 'city': 'Mataró', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Eap Ronda Cerdanya - Mataró 5', 'geoPoint': {'lat': 41.54211, 'lon': 2.4445}}, {'city': 'Mataró', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Eap Ronda Prim - Mataró 7', 'geoPoint': {'lat': 41.54211, 'lon': 2.4445}}, {'zip': '08031', 'city': 'Premià de Mar', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Eap Premià de Mar', 'geoPoint': {'lat': 41.49206, 'lon': 2.36524}}, {'zip': '08031', 'city': 'Sant Andreu de Llavaneres', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Eap Sant Andreu de Llavaneres', 'geoPoint': {'lat': 41.56667, 'lon': 2.48333}}, {'zip': '08031', 'city': 'Vilassar de Dalt', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Eap Vilassar de Dalt', 'geoPoint': {'lat': 41.51667, 'lon': 2.36667}}, {'zip': '08031', 'city': 'Vilassar de Mar', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Eap Vilassar de Mar', 'geoPoint': {'lat': 41.50507, 'lon': 2.39227}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Vic - Central University of Catalonia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Cristina Lasmarias', 'investigatorAffiliation': 'University of Vic - Central University of Catalonia'}}}}