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Randomized Pilot Trial of the Impact of Bedside Delivery of Discharge Medications to Pediatric Patients With Asthma

NCT ID: NCT02336490

Last Updated: 2015-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2015-07-31

Brief Summary

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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

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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

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Usual Care

discharge medication prescriptions are printed or sent electronically to a patient's pharmacy of choice

Group Type NO_INTERVENTION

No interventions assigned to this group

Meds-in-Hand

discharge medication delivery service: discharge prescriptions are filled at the hospital pharmacy and delivered to patients before they leave the hospital

Group Type ACTIVE_COMPARATOR

Discharge Medication Delivery Service

Intervention Type OTHER

hospital-owned outpatient pharmacy fills and delivers discharge medications to patients in their rooms prior to discharge

Interventions

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Discharge Medication Delivery Service

hospital-owned outpatient pharmacy fills and delivers discharge medications to patients in their rooms prior to discharge

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Jonathan Hatoun

General Academic Pediatric Fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jonathan Hatoun, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Boston Medical Center

Locations

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Boston Medical Center

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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BostonMC

Identifier Type: -

Identifier Source: org_study_id