Clinical trial NCT02336490: Randomized Pilot Trial of the Impact of Bedside Delivery of Discharge Medications to Pediatric Patients With Asthma
Official title: Randomized Pilot Trial of the Impact of Bedside Delivery of Discharge Medications
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
First posted: 2015-01-13
Enrollment: 23
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* admission includes treatment for asthma exacerbation
* discharge medications will require a new prescription
* primary care taker speaks english or spanish

Exclusion Criteria:

* patients being discharge outside of the operating hours of the delivery service

Primary outcomes:
measure: Patient Experience measured by phone call followup interview
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston Medical Center
name: Jonathan Hatoun, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: