CommunicationNCT01836601
Nighttime Communication Study
A study testing Family-centered nighttime communication bundle in people with Communication, run by Boston Children's Hospital at 1 site in United States.
Trial summary
This study seeks to determine whether a family-centered nighttime communication intervention improves: 1) shared understanding by parents, residents, and nurses of hospitalized pediatric patient's medical plans, 2) parent-reported errors, 3) parent and provider experience of nighttime medical care. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Communication
- What is being tested?
- Family-centered nighttime communication bundle
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,334 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Nov 2014
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Parents of patients admitted to the general pediatrics inpatient units
- Overnight nurses working on the general pediatrics inpatient units
- Overnight residents working on the general pediatrics inpatient units
Who cannot join
- Non-English speaking parents
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Children's Hospital
Boston, Massachusetts, 02115
About this study
Official title: The Effect of a Family-Centered Nighttime Communication Bundle on Shared Mental-Model Building, Safety, and Patient Experience
This study seeks to determine whether a family-centered nighttime communication intervention improves: 1) shared understanding by parents, residents, and nurses of hospitalized pediatric patient's medical plans, 2) parent-reported errors, 3) parent and provider experience of nighttime medical care.
- Conditions
- Communication
- Being tested
- Family-centered nighttime communication bundle
- Keywords
- safety, patient experience, family-centered rounds
- Medical subject headings
- Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family-centered nighttime communication bundleBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Pre-nighttime communication intervention arm | No intervention | This arm is the pre-intervention arm of parents, nurses, and residents before the nighttime communication bundle has been enacted. |
| Post-nighttime communication intervention arm | Experimental | This arm is the post-intervention arm of parents, nurses, and residents after the nighttime communication bundle has been enacted. Receives: Behavioral: Family-centered nighttime communication bundle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordance between parent, resident, and nurse reported elements of the patient action plan and overall plan
This will be assessed through surveys administered to parents, residents, and nurses for a subset of patients every evening. Parent, resident, and nurse responses will be compared pre and post-intervention.
Measured: 18 months
Secondary outcomes (1)
Parent-reported medical errors
This will be assessed through surveys administered to parents for a subset of patients every evening. Parent error reporting will be compared pre and post-intervention.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CommunicationStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,334 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Program for Patient Safety and Quality
- Responsible party
- Principal investigator, Alisa Khan, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01836601
- Sponsor's protocol ID
- IRB-P00006501
- Status last verified
- Jul 2015
- First submitted
- 10 Apr 2013
- Last updated
- 29 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Khan A, Rogers JE, Forster CS, Furtak SL, Schuster MA, Landrigan CP. Communication and Shared Understanding Between Parents and Resident-Physicians at Night. Hosp Pediatr. 2016 Jun;6(6):319-29. doi: 10.1542/hpeds.2015-0224.
PubMed 27188189
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Family-Centered Nighttime Communication Bundle on Shared Mental-Model Building, Safety, and Patient Experience
- ClinicalTrials.gov ID
- NCT01836601
- Acronym / sponsor ID
- IRB-P00006501
- Conditions
- Communication
- Keywords
- safety, patient experience, family-centered rounds
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,334 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- Program for Patient Safety and Quality
- Study start
- Apr 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 22 Apr 2013 (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.
This study seeks to determine whether a family-centered nighttime communication intervention improves: 1) shared understanding by parents, residents, and nurses of hospitalized pediatric patient's medical plans, 2) parent-reported errors, 3) parent and provider experience of nighttime medical care.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-nighttime communication intervention arm | No intervention | –This arm is the pre-intervention arm of parents, nurses, and residents before the nighttime communication bundle has been enacted. |
| Post-nighttime communication intervention arm | Experimental | Behavioral: Family-centered nighttime communication bundleThis arm is the post-intervention arm of parents, nurses, and residents after the nighttime communication bundle has been enacted. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Parents of patients admitted to the general pediatrics inpatient units
- Overnight nurses working on the general pediatrics inpatient units
- Overnight residents working on the general pediatrics inpatient units
Key exclusion criteria (1 listed)
- Non-English speaking parents
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 |
|---|---|---|
| Family-centered nighttime communication bundle | Behavioural | Post-nighttime communication intervention arm |
Primary outcome
Concordance between parent, resident, and nurse reported elements of the patient action plan and overall plan
Time frame: 18 months
This will be assessed through surveys administered to parents, residents, and nurses for a subset of patients every evening. Parent, resident, and nurse responses will be compared pre and post-intervention.
1 secondary outcome
Parent-reported medical errors
Time frame: 18 months
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 29 Jul 2015.
- Derived from this study: PubMed 27188189Khan A, Rogers JE, Forster CS, Furtak SL, Schuster MA, Landrigan CP. Communication and Shared Understanding Between Parents and Resident-Physicians at Night. Hosp Pediatr. 2016 Jun;6(6):319-29. doi: 10.1542/hpeds.2015-0224.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family-centered nighttime communication bundle in people with Communication, run by Boston Children's Hospital 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 3 inclusion and 1 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 29 Jul 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?
Concordance between parent, resident, and nurse reported elements of the patient action plan and overall plan (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01836601, which also lists 1 linked publication.
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 29 Jul 2015.