AsthmaNCT01895478
Adaptation of the Pediatric Asthma Control & Communication Instrument (PACCI) in a Pediatric Emergency Department
A study testing PACCI-ED use in people with Asthma, run by Rhode Island Hospital at 1 site in United States.
Trial summary
This study examined whether the Pediatric Asthma Control and Communication Instrument for the Emergency Department (PACCI-ED), a 12-item questionnaire, can help doctors in the emergency department accurately assess a child's asthma control. Read more about this study
- Who is it for?
- Ages 1 year to 17 years
- Conditions the study is for
- Asthma
- What is being tested?
- PACCI-ED use
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to May 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 1 year to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Child presented to study institution emergency department during study period
- Child was 1 - 17 years-old
- Child has physician-diagnosed asthma by parent report
- Attending physician for child believed emergency department visit was due to asthma
- Attending physician for child completed informed consent and was randomized to PACCI-ED or control group at beginning of study
Who cannot join
- Child has major pulmonary or cardiac co-morbid illness
- Family of child was non-English speaking
- Child was triaged to the med-trauma bay for severe respiratory distress
Trial locations and contacts
1 site in 1 country.
United States1 site
Rhode Island Hospital / Hasbro Children's Hospital
Providence, Rhode Island, 02906
About this study
This study examined whether the Pediatric Asthma Control and Communication Instrument for the Emergency Department (PACCI-ED), a 12-item questionnaire, can help doctors in the emergency department accurately assess a child's asthma control.
This study involved an intervention with the doctors in the emergency department of an urban pediatric hospital. The intervention was done when one of the doctors involved in the study treated a child aged 1-17 years for an asthma exacerbation. Parents answered questions on the PACCI-ED about their children's asthma. Half of the doctors were allowed to see the PACCI-ED results and half were not. The two groups of doctors were compared on their ability to correctly identify asthma control categories, whether a child's asthma was worsening or improving, whether the family was administering controller medications as often as they should, and how much burden the child's asthma was for the family.
- Conditions
- Asthma
- Being tested
- PACCI-ED use
- Keywords
- asthma, pediatrics, control, medication adherence
- Medical subject headings
- Asthma, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PACCI-ED useBehavioural
Attending physicians were allowed to view the patient's PACCI-ED prior to completing the assessment form. Attendings were told at the time of the child's ED visit that the PACCI-ED is used to assess a child's asthma control and medication adherence, and that they could use it to complete the outcomes assessment form.
| Study group | Role | What they receive |
|---|---|---|
| PACCI-ED | Experimental | PACCI-ED attendings were given the PACCI-ED use intervention. Receives: Behavioral: PACCI-ED use |
| Control | No intervention | Control attendings were not given the PACCI-ED use intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma Control
Attending physician answered "Which of the following best describes this patient's asthma control over the past 12 months?" (RESPONSES: Controlled, partly controlled, mildly uncontrolled, moderately uncontrolled, severely uncontrolled). Responses were compared to equivalent categories of control based on PACCI algorithm.
Measured: 1 day (Assessment occurs at a single time during emergency department visit)
Secondary outcomes (3)
Asthma Trajectory
Attending physician answered "Which of the following best describes the changes in this patient's asthma status over the past 12 months?" (RESPONSES: No change, getting worse, getting better). Responses were compared to equivalent categories of trajectory based on PACCI algorithm.
Measured: 1 day (Assessment occurs at a single time during emergency department visit)
Medication Adherence
Attending physician answered "In your clinical judgment, during the past week, how often does this patient use his/her daily controller asthma medicine?" (RESPONSES: Not at all (0 days/week), sometimes (1-3 days/week), most of the time (4-6 days/week), all of the time (7 days/week)). Responses were compared to equivalent categories of medication adherence based on PACCI algorithm.
Measured: 1 day (Assessment occurs at a single time during emergency department visit)
Asthma burden to family
Attending physician answered "Which of the following best describes how burdensome to the caregiver this patient's asthma has been over the past 12 months?" (RESPONSES: Not at all burdensome, somewhat burdensome, very burdensome). Responses were compared to equivalent categories of asthma burden based on PACCI algorithm.
Measured: 1 day (Assessment occurs at a single time during emergency department visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2013 (estimated)
- Study startApr 2011
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rhode Island Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aris Garro, Rhode Island Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01895478
- Sponsor's protocol ID
- 210394
- Status last verified
- Jul 2013
- First submitted
- 1 Jul 2013
- Last updated
- 10 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptation of the Pediatric Asthma Control & Communication Instrument (PACCI) in a Pediatric Emergency Department
- ClinicalTrials.gov ID
- NCT01895478
- Acronym / sponsor ID
- 210394
- Conditions
- Asthma
- Keywords
- asthma, pediatrics, control, medication adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Rhode Island HospitalUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 10 Jul 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 examined whether the Pediatric Asthma Control and Communication Instrument for the Emergency Department (PACCI-ED), a 12-item questionnaire, can help doctors in the emergency department accurately assess a child's asthma control.
This study involved an intervention with the doctors in the emergency department of an urban pediatric hospital. The intervention was done when one of the doctors involved in the study treated a child aged 1-17 years for an asthma exacerbation. Parents answered questions on the PACCI-ED about their children's asthma. Half of the doctors were allowed to see the PACCI-ED results and half were not. The two groups of doctors were compared on their ability to correctly identify asthma control categories, whether a child's asthma was worsening or improving, whether the family was administering controller medications as often as they should, and how much burden the child's asthma was for the family.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PACCI-ED | Experimental | Behavioral: PACCI-ED usePACCI-ED attendings were given the PACCI-ED use intervention. |
| Control | No intervention | –Control attendings were not given the PACCI-ED use intervention. |
Who may qualify
- Ages
- 1 year to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Child presented to study institution emergency department during study period
- Child was 1 - 17 years-old
- Child has physician-diagnosed asthma by parent report
- Attending physician for child believed emergency department visit was due to asthma
- Attending physician for child completed informed consent and was randomized to PACCI-ED or control group at beginning of study
Key exclusion criteria (3 listed)
- Child has major pulmonary or cardiac co-morbid illness
- Family of child was non-English speaking
- Child was triaged to the med-trauma bay for severe respiratory distress
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 |
|---|---|---|
| PACCI-ED useAttending physicians were allowed to view the patient's PACCI-ED prior to completing the assessment form. Attendings were told at the time of the child's ED visit that the PACCI-ED is used to assess a child's asthma control and medication adherence, and that they could use it to complete the outcomes assessment form. | Behavioural | PACCI-ED |
Primary outcome
Asthma Control
Time frame: 1 day (Assessment occurs at a single time during emergency department visit)
Attending physician answered "Which of the following best describes this patient's asthma control over the past 12 months?" (RESPONSES: Controlled, partly controlled, mildly uncontrolled, moderately uncontrolled, severely uncontrolled). Responses were compared to equivalent categories of control based on PACCI algorithm.
3 secondary outcomes
Asthma Trajectory
Time frame: 1 day (Assessment occurs at a single time during emergency department visit)
Medication Adherence
Time frame: 1 day (Assessment occurs at a single time during emergency department visit)
Asthma burden to family
Time frame: 1 day (Assessment occurs at a single time during emergency department visit)
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 10 Jul 2013.
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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 PACCI-ED use in people with Asthma, run by Rhode Island 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 5 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 10 Jul 2013. 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?
Asthma Control (time frame: 1 day (Assessment occurs at a single time during emergency department visit)). 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 10 Jul 2013.