Healthcare Utilization Clinical Trial
Official title:
The Effect of Pharmacist-Provided Counseling Combined With Outpatient Dispensing at Hospital Discharge on the Incidence of Post-Discharge Drug-Related Problems and Healthcare Utilization
The goal of this study is to investigate whether pharmacist provided counseling and medication dispensing at the patient's bedside can provide better outcomes than the current discharge process at Duke University Hospital. This study will be single-site, prospective, randomized, cohort study. Patients who meet the inclusion and exclusion criteria, and provide consent will be included in this study.
Two Adult General Medicine Services, which do not have a rounding pharmacist (RPh), will be
identified by the investigators. Permission to approach the patients on each service will be
obtained from the attending physician of each respective General Medicine Service at the
beginning of each attending physician's time on service. The attending physician will be
asked to communicate to the study personnel of situations in which patients should not be
approached (i.e., patient has communicated disinterested in being approached about study
participation opportunities and/or, in the opinion of the attending physician, the patient
should not be approached).
Patients who will be recruited from pre-specified medical services will be screened for
eligibility and, if deemed eligible, then will be approached by study personnel and asked if
they would like to enroll in this study. If the patient accepts, written informed consent
will be obtained and the patient will enter the study. Patients will be randomly assigned to
either the intervention or control arm. Patients randomized to the intervention arm will
receive discharge medications and pharmacist-provided discharge medication counseling prior
to hospital discharge, and patients randomized to the control group will receive standard
discharge procedures and obtain discharge medications per their usual process. After the
patient has been enrolled in the study, study personnel will collect patient demographic
data for study purposes, utilizing patient medical records and/or patient interviews. At
discharge, patients will receive either the intervention or standard of care defined by the
arm of the study to which each patient has been randomly assigned. After discharge, a
maximum of seven attempts will be made via phone to contact all patients in both arms for
follow up at 30 (+/- 7) days after discharge. During the follow phone call, a blinded
pharmacist will conduct a structured interview to collect data for the study endpoints. The
pharmacist conducting the interview will have the most recent discharge medication list (the
list the patient received at his/her hospital discharge) from the patient's medication
record to be used for comparison to the information gathered from the patient's interview 30
days post discharge.
Intervention Arm - After enrollment, a pharmacy technician not associated with the study
will collect information necessary to process and fill the patient's discharge prescriptions
by the Duke Outpatient Pharmacy. On the day of discharge, a pharmacist will perform a chart
review and medication reconciliation on all patients' discharge medications (for patients
randomized to the intervention arm). Any medication discrepancies will be addressed with the
patient's primary care team. At the time of discharge, the patient will receive his/her
discharge medications dispensed from the Duke Outpatient Pharmacy, along with medication
counseling by a licensed pharmacist.
Control Arm - Patients will receive the standard discharge process provided by nurses and/or
physicians. Patients will obtain outpatient medications per usual care.
Data Evaluation - After a patient has completed the phone follow up interview, two
pharmacist co-investigators who have not been involved in the inpatient care of the patients
will review the collected data to assess for adverse drug reactions and drug-drug
interactions. When there is a disagreement between the pharmacists concerning the occurrence
of an adverse reaction (including causality or severity), or a drug interaction (including
severity), a third pharmacist co-investigator who was not involved in the inpatient care of
the patient will review the patient's data to make a final decision concerning the
disagreement. All patients who complete the follow up survey will be evaluated in this
manner.
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
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