AsthmaNCT02336490
Randomized Pilot Trial of the Impact of Bedside Delivery of Discharge Medications to Pediatric Patients With Asthma
A study testing Discharge Medication Delivery Service in people with Asthma, run by Boston Medical Center at 1 site in United States.
Trial summary
This randomized pilot study proposes to field-test key logistical aspects of studying an intervention already available to patients on the pediatric ward, namely a discharge medication delivery service, called "Meds-in-Hand," which has been refined via a quality improvement process, but not rigorously studied nor… Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Asthma
- What is being tested?
- Discharge Medication Delivery Service
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Jul 2015
- 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 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- admission includes treatment for asthma exacerbation
- discharge medications will require a new prescription
- primary care taker speaks english or spanish
Who cannot join
- patients being discharge outside of the operating hours of the delivery service
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Pilot Trial of the Impact of Bedside Delivery of Discharge Medications
This randomized pilot study proposes to field-test key logistical aspects of studying an intervention already available to patients on the pediatric ward, namely a discharge medication delivery service, called "Meds-in-Hand," which has been refined via a quality improvement process, but not rigorously studied nor fully implemented.
Read the detailed description
At this time, Meds-in-Hand is not currently utilized for approximately 40% of patients admitted to the pediatric ward at Boston Medical Center. Currently patients do not receive their discharge medications via the delivery service for a variety of reasons, however they continue to receive the usual care standard employed by most hospitals, where prescriptions are sent to their home pharmacy for pickup after discharge. This study does not change the actual medications patients receive, but how and when they get them. Rigorous study of the relationship between Meds-in-Hand and patient satisfaction and clinical outcomes has not been performed to date, so there is equipoise about the value of the intervention, however observational data in the population in question, namely children admitted for an asthma exacerbation, suggest that patients who receive Meds-in-Hand prior to discharge have a reduced likelihood of a return visit to the Emergency Department in 30 days. The study will focus on parent-patient dyads admitted with an asthma exacerbation where the child is aged 2-17 years, however parents will be the exclusive study subjects. Parents of the patients will be asked a baseline, in-hospital survey as well as participate in phone follow-up interviews to report on the patient experience and parent-reported child health outcomes at approximately 3 and 30 days after leaving the hospital. 60 total parents will be enrolled, 30 in each arm of the study. This pilot study will also obtain empiric estimates of key study parameters to inform future study design and begin to examine trends between the groups of patients who are randomized to the Meds-in-Hand intervention and those randomized to usual care.
- Conditions
- Asthma
- Being tested
- Discharge Medication Delivery Service
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Discharge Medication Delivery ServiceOther
hospital-owned outpatient pharmacy fills and delivers discharge medications to patients in their rooms prior to discharge
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | discharge medication prescriptions are printed or sent electronically to a patient's pharmacy of choice |
| Meds-in-Hand | Active comparator | discharge medication delivery service: discharge prescriptions are filled at the hospital pharmacy and delivered to patients before they leave the hospital Receives: Other: Discharge Medication Delivery Service |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Experience measured by phone call followup interview
phone call followup interview to assess the patient experience
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionMay 2015
- Study completionJul 2015
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.
- More trials run by Boston Medical CenterThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan Hatoun, Boston Medical Center
- Investigators
- Jonathan Hatoun, MD, MPH, Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02336490
- Sponsor's protocol ID
- BostonMC
- Status last verified
- Oct 2015
- First submitted
- 8 Jan 2015
- Last updated
- 30 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Pilot Trial of the Impact of Bedside Delivery of Discharge Medications
- ClinicalTrials.gov ID
- NCT02336490
- Acronym / sponsor ID
- BostonMC
- Conditions
- Asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- May 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 13 Jan 2015 (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 randomized pilot study proposes to field-test key logistical aspects of studying an intervention already available to patients on the pediatric ward, namely a discharge medication delivery service, called "Meds-in-Hand," which has been refined via a quality improvement process, but not rigorously studied nor fully implemented.
Detailed description
At this time, Meds-in-Hand is not currently utilized for approximately 40% of patients admitted to the pediatric ward at Boston Medical Center. Currently patients do not receive their discharge medications via the delivery service for a variety of reasons, however they continue to receive the usual care standard employed by most hospitals, where prescriptions are sent to their home pharmacy for pickup after discharge. This study does not change the actual medications patients receive, but how and when they get them. Rigorous study of the relationship between Meds-in-Hand and patient satisfaction and clinical outcomes has not been performed to date, so there is equipoise about the value of the intervention, however observational data in the population in question, namely children admitted for an asthma exacerbation, suggest that patients who receive Meds-in-Hand prior to discharge have a reduced likelihood of a return visit to the Emergency Department in 30 days. The study will focus on parent-patient dyads admitted with an asthma exacerbation where the child is aged 2-17 years, however parents will be the exclusive study subjects. Parents of the patients will be asked a baseline, in-hospital survey as well as participate in phone follow-up interviews to report on the patient experience and parent-reported child health outcomes at approximately 3 and 30 days after leaving the hospital. 60 total parents will be enrolled, 30 in each arm of the study. This pilot study will also obtain empiric estimates of key study parameters to inform future study design and begin to examine trends between the groups of patients who are randomized to the Meds-in-Hand intervention and those randomized to usual care.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –discharge medication prescriptions are printed or sent electronically to a patient's pharmacy of choice |
| Meds-in-Hand | Active comparator | Other: Discharge Medication Delivery Servicedischarge medication delivery service: discharge prescriptions are filled at the hospital pharmacy and delivered to patients before they leave the hospital |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- admission includes treatment for asthma exacerbation
- discharge medications will require a new prescription
- primary care taker speaks english or spanish
Key exclusion criteria (1 listed)
- patients being discharge outside of the operating hours of the delivery service
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 |
|---|---|---|
| Discharge Medication Delivery Servicehospital-owned outpatient pharmacy fills and delivers discharge medications to patients in their rooms prior to discharge | Other | Meds-in-Hand |
Primary outcome
Patient Experience measured by phone call followup interview
Time frame: 30 days
phone call followup interview to assess the patient experience
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 30 Oct 2015.
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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.
Jonathan Hatoun, MD, MPH principal investigator
Boston Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Discharge Medication Delivery Service in people with Asthma, run by Boston Medical Center 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 30 Oct 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?
Patient Experience measured by phone call followup interview (time frame: 30 days). 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 30 Oct 2015.