- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01299974
Project PARIS: Parents and Residents in Session (PARIS)
December 22, 2015 updated by: Icahn School of Medicine at Mount Sinai
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
83
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10029
- Mount Sinai Kravis Children's Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Resident's knowledge
Time Frame: The difference between values obtained at baseline (upon recruitment) and values obtained within 24 hours after completion of the interview
|
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
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Residents' attitude towards family-centered care as measured by a questionnaire
Time Frame: The difference between values obtained at baseline (upon recruitment) and values obtained within 24 hours after completion of the interview
|
The difference between values obtained at baseline (upon recruitment) and values obtained within 24 hours after completion of the interview
|
Parents' acceptance of family-centered care as measured by a questionnaire
Time Frame: The difference between values obtained at baseline (upon recruitment) and values obtained within 24 hours after completion of the interview
|
The difference between values obtained at baseline (upon recruitment) and values obtained within 24 hours after completion of the interview
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Joel Forman, MD, Icahn School of Medicine at Mount Sinai
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2011
Primary Completion (ACTUAL)
June 1, 2012
Study Completion (ACTUAL)
June 1, 2012
Study Registration Dates
First Submitted
February 8, 2011
First Submitted That Met QC Criteria
February 18, 2011
First Posted (ESTIMATE)
February 21, 2011
Study Record Updates
Last Update Posted (ESTIMATE)
December 23, 2015
Last Update Submitted That Met QC Criteria
December 22, 2015
Last Verified
December 1, 2015
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- GCO 10-1621
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Family-centered Care
-
University of GiessenUniversity of UlmRecruitingFamily Centered CareGermany
-
Nagano Children's HospitalActive, not recruiting
-
Lady Davis InstituteJewish General HospitalRecruitingCritical Care | Patient-centered Care | Family EngagementCanada
-
Children's Hospital of PhiladelphiaYale UniversityActive, not recruitingFamily-centered Care in Pediatric ResuscitationUnited States
-
Nagano Children's HospitalRecruitingDecision Making | Family Centered CareJapan
-
Nagano Children's HospitalRecruiting
-
Bagcilar Training and Research HospitalUnknown
-
University of California, DavisCompleted
-
Selcuk UniversityCompletedAnxiety | Children | Parents | Education | Day Surgery | Family-centered CareTurkey
-
Hunan Children's HospitalNot yet recruitingInfant ALL | Parents | Emotional Stress | Neonatal Intensive Care | Family Centered Care | Family Separation | Parents Support
Clinical Trials on Parents and Residents in Session
-
University of IcelandCompletedAttention Deficit Hyperactivity Disorder CombinedIceland
-
Northwestern UniversityNational Institutes of Health (NIH); Alzheimer's Association; Illinois Department... and other collaboratorsCompletedFrontotemporal Dementia | Primary Progressive AphasiaUnited States
-
Nagano Children's HospitalActive, not recruiting
-
University Hospital Inselspital, BerneCompleted
-
Hospices Civils de LyonCompleted
-
University of California, Los AngelesBodiMojo, Inc.CompletedChronic Pain | Parents | Pediatric DisorderUnited States
-
Kanuni Sultan Suleyman Training and Research HospitalCompleted
-
Assistance Publique - Hôpitaux de ParisCompletedType1diabetes
-
University of California, San FranciscoNational Institute on Alcohol Abuse and Alcoholism (NIAAA); Syracuse University and other collaboratorsCompletedHIV/AIDS | Alcohol Use, UnspecifiedUganda
-
jasvinder singhCompletedKnee ArthroplastyUnited States