Family-centered CarePARISNCT01299974
Project PARIS: Parents and Residents in Session
A study testing Parents and Residents in Session in people with Family-centered Care, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Family-centered Care
- What is being tested?
- Parents and Residents in Session
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to Jun 2012
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Residents in good standing in a pediatric residency at Mount Sinai Medical
- Center who agree to participate in the study
Who cannot join
- Residents who did not agree to participate
- Residents who have less than 3 months to complete their residency
Trial locations and contacts
1 site in 1 country.
United States1 site
Mount Sinai Kravis Children's Hospital
New York, New York, 10029
About this study
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.
Read the 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.
- Conditions
- Family-centered Care
- Being tested
- Parents and Residents in Session
- Keywords
- Family-centered, teaching, residents, family faculty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parents and Residents in SessionOther
Also called Parents and Residents in Session to improve family-centered care
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.
| Study group | Role | What they receive |
|---|---|---|
| Parents and Residents in Session | Other | Parents and Residents in Session Receives: Other: Parents and Residents in Session |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resident's knowledge
Residents' knowledge about family-centered care as measured by a questionnaire
Measured: The difference between values obtained at baseline (upon recruitment) and values obtained within 24 hours after completion of the interview
Secondary outcomes (2)
Residents' attitude towards family-centered care as measured by a questionnaire
Measured: 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
Measured: The difference between values obtained at baseline (upon recruitment) and values obtained within 24 hours after completion of the interview
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Family-centered CareStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- Picker Institute, The Arnold P. Gold Foundation
- Responsible party
- Sponsor
- Investigators
- Joel Forman, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01299974
- Sponsor's protocol ID
- GCO 10-1621
- Acronym
- PARIS
- Status last verified
- Dec 2015
- First submitted
- 8 Feb 2011
- Last updated
- 23 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project PARIS: Parents and Residents in Session
- ClinicalTrials.gov ID
- NCT01299974
- Acronym / sponsor ID
- PARIS / GCO 10-1621
- Conditions
- Family-centered Care
- Keywords
- Family-centered, teaching, residents, family faculty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- Picker Institute, The Arnold P. Gold Foundation
- Study start
- Feb 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 21 Feb 2011 (estimated)
- 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 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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parents and Residents in Session | Other | Other: Parents and Residents in SessionParents and Residents in Session |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Residents in good standing in a pediatric residency at Mount Sinai Medical
- Center who agree to participate in the study
Key exclusion criteria (2 listed)
- Residents who did not agree to participate
- Residents who have less than 3 months to complete their residency
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 |
|---|---|---|
| Parents and Residents in SessionAlso: Parents and Residents in Session to improve family-centered careFamily 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 | Parents and Residents in Session |
Primary outcome
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
2 secondary outcomes
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
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
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 23 Dec 2015.
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Parent-Facilitated Early Oral-Sensory Experience in the NICU for Feeding Outcomes
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EFFECT OF A ONLINE NUTRITION EDUCATION PROGRAM IN PRESCHOOLER'S FAMILIES ON THEIR ADHERENCE TO THE MEDITERRANEAN DIET
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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.
Joel Forman, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parents and Residents in Session in people with Family-centered Care, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
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 2 inclusion and 2 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 23 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
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). 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 23 Dec 2015.