Randomized Pilot Trial of the Impact of Bedside Delivery of Discharge Medications to Pediatric Patients With Asthma
Primary Purpose
Asthma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Discharge Medication Delivery Service
Sponsored by
About this trial
This is an interventional health services research trial for Asthma
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
Sites / Locations
- Boston Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Usual Care
Meds-in-Hand
Arm Description
discharge medication prescriptions are printed or sent electronically to a patient's pharmacy of choice
discharge medication delivery service: discharge prescriptions are filled at the hospital pharmacy and delivered to patients before they leave the hospital
Outcomes
Primary Outcome Measures
Patient Experience measured by phone call followup interview
phone call followup interview to assess the patient experience
Secondary Outcome Measures
Full Information
NCT ID
NCT02336490
First Posted
January 8, 2015
Last Updated
October 28, 2015
Sponsor
Boston Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02336490
Brief Title
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
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
July 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
discharge medication prescriptions are printed or sent electronically to a patient's pharmacy of choice
Arm Title
Meds-in-Hand
Arm Type
Active Comparator
Arm Description
discharge medication delivery service: discharge prescriptions are filled at the hospital pharmacy and delivered to patients before they leave the hospital
Intervention Type
Other
Intervention Name(s)
Discharge Medication Delivery Service
Intervention Description
hospital-owned outpatient pharmacy fills and delivers discharge medications to patients in their rooms prior to discharge
Primary Outcome Measure Information:
Title
Patient Experience measured by phone call followup interview
Description
phone call followup interview to assess the patient experience
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Hatoun, MD, MPH
Organizational Affiliation
Boston Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Randomized Pilot Trial of the Impact of Bedside Delivery of Discharge Medications to Pediatric Patients With Asthma
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