Parental AnxietyNCT01883739
Randomised Controlled Trial to Investigate the Effect of Parental Presence at Intensive Care Unit to Ward Transfer Bedside Rounds on Parental Anxiety and Children's Safety
A study testing Parental Presence at Handover Rounds in people with Parental Anxiety and Children's Safety, run by University of Alberta at 1 site in Canada.
Trial summary
The investigators shall conduct a randomized controlled trial to investigate the effect of parental presence at transfer rounds on parental anxiety and patient safety following transfer from the Pediatric Cardiac Intensive Care Unit (PCICU) to the ward. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Parental Anxiety, Children's Safety
- What is being tested?
- Parental Presence at Handover Rounds
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2013to Jul 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 cardiac children aged 1 day to 17 years admitted to PCICU
- Written informed consent and assent when appropriate
- Planned discharge from the PCICU to the ward.
Who cannot join
- Parents with less than grade 6 reading skills as they will not be able to independently take the Spielberger's State -Trait Anxiety Inventory (STAI).
- Parents who are not willing to be randomized to the control group in which they cannot be present for transfer rounds.
- Neonates being discharged from PCICU to NICU or neonates being discharged from NICU to wards.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Pediatric Cardiac ICU, Stollery Children's Hospital
Edmonton, Alberta, T6G 2B7
About this study
The investigators shall conduct a randomized controlled trial to investigate the effect of parental presence at transfer rounds on parental anxiety and patient safety following transfer from the Pediatric Cardiac Intensive Care Unit (PCICU) to the ward. The investigators plan to test the hypothesis that parental involvement in the child's transfer, with the option of peer support, will result in measurable reductions in medication errors, unplanned nutritional and feeding management, and parental anxiety after transfer as compared to the control group. The investigators goal is to improve continuity of care by implementing multidisciplinary transfer rounds at the child's bedside in which patients and family share in the control of the management plan when a cardiac child is discharged from PCICU to the ward.
- Conditions
- Parental Anxiety, Children's Safety
- Being tested
- Parental Presence at Handover Rounds
- Keywords
- Parental anxiety, Children's safety, Family Centered Care, Bedside Transfer Rounds, Pediatric Cardiac Intensive Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parental Presence at Handover RoundsOther
| Study group | Role | What they receive |
|---|---|---|
| Parental Presence at Handover Rounds | Experimental | Subjects will receive an educational document prior to transfer rounds introducing the concept of Patient and Family Centered Care and the role of a parent in transfer rounds. These parents will have the option of meeting with a parental peer support person for a "coaching" or training session prior to their participation in transfer rounds. During the transfer rounds parents will be actively included in discussion of their child's medical management plan upon discharge to the wards. Receives: Other: Parental Presence at Handover Rounds |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in parental STAI score
Speilberger State-Trait Anxiety Inventory will be administered to participating parents both prior to and post transfer of their child out of the pediatric cardiac ICU.
Measured: 2 to 4 hours post transfer
Secondary outcomes (1)
Rate of unplanned changes in medication and nutrition management
Medication and nutritional order reconciliation will occur 48 hours after transfer from the PCICU. The pharmacist, dietician and physician who review the patient charts and order sheets will be blinded to the randomization. Differences between pre and post transfer orders will be discussed to detect omissions and/or deviation from standard of care.
Measured: 48 hours post transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parental AnxietyStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Medical Protective Association
- Responsible party
- Sponsor
- Investigators
- Ian Adatia, MBChB, MRCP, FRCP(C), Principal investigator, Stollery Children's Hospital, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01883739
- Sponsor's protocol ID
- Pro 00037475
- Status last verified
- Dec 2014
- First submitted
- 17 Jun 2013
- Last updated
- 19 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Trial to Investigate the Effect of Parental Presence at Intensive Care Unit to Ward Transfer Bedside Rounds on Parental Anxiety and Children's Safety
- ClinicalTrials.gov ID
- NCT01883739
- Acronym / sponsor ID
- Pro 00037475
- Conditions
- Parental Anxiety, Children's Safety
- Keywords
- Parental anxiety, Children's safety, Family Centered Care, Bedside Transfer Rounds, Pediatric Cardiac Intensive Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Canadian Medical Protective Association
- Study start
- Jun 2013
- Primary completion
- Jul 2014 (actual)
- First posted
- 21 Jun 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.
The investigators shall conduct a randomized controlled trial to investigate the effect of parental presence at transfer rounds on parental anxiety and patient safety following transfer from the Pediatric Cardiac Intensive Care Unit (PCICU) to the ward. The investigators plan to test the hypothesis that parental involvement in the child's transfer, with the option of peer support, will result in measurable reductions in medication errors, unplanned nutritional and feeding management, and parental anxiety after transfer as compared to the control group. The investigators goal is to improve continuity of care by implementing multidisciplinary transfer rounds at the child's bedside in which patients and family share in the control of the management plan when a cardiac child is discharged from PCICU to the ward.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parental Presence at Handover Rounds | Experimental | Other: Parental Presence at Handover RoundsSubjects will receive an educational document prior to transfer rounds introducing the concept of Patient and Family Centered Care and the role of a parent in transfer rounds. These parents will have the option of meeting with a parental peer support person for a "coaching" or training session prior to their participation in transfer rounds. During the transfer rounds parents will be actively included in discussion of their child's medical management plan upon discharge to the wards. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Parents of cardiac children aged 1 day to 17 years admitted to PCICU
- Written informed consent and assent when appropriate
- Planned discharge from the PCICU to the ward.
Key exclusion criteria (3 listed)
- Parents with less than grade 6 reading skills as they will not be able to independently take the Spielberger's State -Trait Anxiety Inventory (STAI).
- Parents who are not willing to be randomized to the control group in which they cannot be present for transfer rounds.
- Neonates being discharged from PCICU to NICU or neonates being discharged from NICU to wards.
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 |
|---|---|---|
| Parental Presence at Handover Rounds | Other | Parental Presence at Handover Rounds |
Primary outcome
Change from baseline in parental STAI score
Time frame: 2 to 4 hours post transfer
Speilberger State-Trait Anxiety Inventory will be administered to participating parents both prior to and post transfer of their child out of the pediatric cardiac ICU.
1 secondary outcome
Rate of unplanned changes in medication and nutrition management
Time frame: 48 hours post transfer
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 19 Dec 2014.
Related trials for Parental Anxiety
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Parent-Based Intervention for Childhood Avoidant/Restrictive Food Intake Disorder (ARFID)
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Internet-Delivered Cognitive Behaviour Therapy for Depression and Anxiety in Perinatal Parents
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e-Perinatal Butterfly: An Embedded Study for Parents Experiencing Perinatal Loss
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Preoperative Anxiety Experienced by the Pediatric Patient, Dental Anxiety in Children
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.
Ian Adatia, MBChB, MRCP, FRCP(C) principal investigator
Stollery Children's Hospital, University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parental Presence at Handover Rounds in people with Parental Anxiety and Children's Safety, run by University of Alberta at 1 site in Canada.
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 3 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 19 Dec 2014. 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 Canada. 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?
Change from baseline in parental STAI score (time frame: 2 to 4 hours post transfer). 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 19 Dec 2014.