Project PARIS: Parents and Residents in Session

Family-centered Care Clinical Trial

— PARIS  

Official title:

Project PARIS: Parents and Residents in Session

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01299974
• Other study ID #: GCO 10-1621
• Status: Completed
• Phase: N/A
• First received: February 8, 2011
• Last updated: December 22, 2015
• Start date: February 2011
• Est. completion date: June 2012

Study information

• Verified date: December 2015
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: None
• Study type: Interventional

Clinical Trial Summary

The study seeks to implement and test a novel approach to teach pediatric residents about patient and family-centered care (PFCC). The approach calls for a supervised meeting between a family member of a previously hospitalized child and a resident in the context of a pediatric residency rotation.

Description:

A specific patient and family centered care module will be implemented in the context of an existing training rotation. This module includes a meeting between resident physicians (trainees) and parents of previously hospitalized children (members of the Family Faculty in our institution), monitored by a senior faculty member. Patient and family centered care will be discussed using predefined, manual-driven guidance. This meeting is followed by a discussion with the faculty member to identify core components of family-centered care as exemplified in the parent interview.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Residents in good standing in a pediatric residency at Mount Sinai Medical

• Center who agree to participate in the study

Exclusion Criteria:

• Residents who did not agree to participate

• Residents who have less than 3 months to complete their residency

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Family-centered Care

Intervention

Other:
• Parents and Residents in Session
Family Faculty members agreed to participate in meetings with pediatric residents who agree to participate. Standardized meetings include discussions of the following: 1. Impact of hospitalization on the behavior and development of each participating parent's child. 2. Effective communication with a parent 3. How to gain trust 4. The family meeting: who participates, the agenda 5. Troubleshooting: how to deal with difficult situations (the parents will present a few instances, from their own experience, which they think might be challenging to the clinicians who treated their children). Other core components will be added (or existing ones deleted) based on participants' feedback. The meeting will be attended by two residents, a family council member, and a senior faculty who will serve as monitor. Following the meeting, the residents will have an opportunity to ask questions and offer comments about the experience in a dedicated feedback interview with a senior faculty member.

Locations

Country	Name	City	State
United States	Mount Sinai Kravis Children's Hospital	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	Picker Institute, The Arnold P. Gold Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resident's knowledge	Residents' knowledge about family-centered care as measured by a questionnaire	The difference between values obtained at baseline (upon recruitment) and values obtained within 24 hours after completion of the interview	No
Secondary	Residents' attitude towards family-centered care as measured by a questionnaire		The difference between values obtained at baseline (upon recruitment) and values obtained within 24 hours after completion of the interview	No
Secondary	Parents' acceptance of family-centered care as measured by a questionnaire		The difference between values obtained at baseline (upon recruitment) and values obtained within 24 hours after completion of the interview	No