Training Program for residents in breaking bad news in perinatology using standardized patients

• Register: REBEC
• Last refreshed on: 29 May 2023
• Main ID: RBR-8k3cyk
• Date of registration: 05/11/2014
• Prospective Registration: No
• Primary sponsor: Hospital da Mulher Prof. Dr. José Aristodemo Pinotti - CAISM
• Public title: Training Program for residents in breaking bad news in perinatology using standardized patients
• Scientific title: Evaluation of a training program efficacy for residents in breaking bad news in perinatology using standardized patients
• Date of first enrolment: 15/03/2014
• Recruitment status: Recruiting
• URL: http://ensaiosclinicos.gov.br/rg/RBR-8k3cyk
• Study type: Intervention
• Study design: Educational intervention trial, uni-blinded, with two parallel arms
• Phase: N/A

Countries of recruitment

Brazil

Contacts

• Name: Maria Silvia V Setubal
• Affiliation: Hospital da Mulher Prof. Dr. José Aristodemo Pinotti - CAISM

• Name: Maria Silvia V Setubal
• Affiliation: Hospital da Mulher Prof. Dr. José Aristodemo Pinotti - CAISM

Key inclusion & exclusion criteria

Inclusion criteria: First to fourth year residents in the gynecology and obstetrics program at FCM Unicamp; first and second year residents from pediatrics; third and fourth year residents from the Neonatal program.
Exclusion criteria: Third and fourth year pediatric residents from areas other than Neonatology.

Age minimum:
Age maximum:
Gender: -

Health Condition(s) or Problem(s) studied

Ability to break bad news in perinatology

F53.8

Intervention(s)

H02.403.670.400

SP8.946.819.955.866

Experimental Group: 30 residents (15 from pediatrics and 15 from gynecology and obstetrics) who participated in the first standardized patient encounter to break bad news to a mother about her baby's conditions will be randomly assigned to participate in the SPIKES training program for breaking bad news. The training program will be in small groups of 5 to 6 residents each, will last 2 hours, will be based on the videos from the first simulated encounter and will be coordinated by the project's Principal Investigator. It will happen before the second standardized patient's encounter. Control Group: 30 residents (15 from pediatrics and 15 from gynecology e obstetrics) who participated in the first simulated encounter won't have any training program before the second encounter. All 60 residents will participate in a second simulated encounter structured just as the first one after the experimental group finishes the training program. The standardized patients will be blind to the resident's participation in the training program.

H02.403.810.450

SP5.001.047.138

Behavioural

I02.399

Primary Outcome(s)

Increase of empathic skills in residents at the end of the study.

Metric: Mean scores from the standardized patient evaluation checklist, from residents' self-evaluation checklist, and from the satisfaction questionnaire filled up by residents. These checklists and questionnaire will be adapted from the WEB OSCE SP checklist from Drexel University College of Medicine. The mean scores post intervention will be compared between both groups: intervention and control

Secondary Outcome(s)

no secondary outcomes are expected.

Source(s) of Monetary Support

Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)

Secondary Sponsor(s)

Hospital da Mulher Prof. Dr. José Aristodemo Pinotti - CAISM