CClinicalTrials.gg
CompletedNCT01806038Updated Nov 13, 2014

Drug-Related Problems and Healthcare Utilization Post-Hospital Discharge

An interventional study of RPh Counseling + Outpatient Med Dispensing at Discharge and Discharge Med Dispensing Plus Counseling - Current Practice in Drug Related Problems Post Hospital Discharge, Healthcare Utilization and Discharge Medication Counseling, sponsored by Duke University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-11-13.

Sponsored by Duke University · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
44
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Drug Related Problems Post Hospital Discharge
  • Healthcare Utilization
  • Discharge Medication Counseling

Keywords

  • Adverse events
  • Drug interactions
  • Healthcare utilization
  • Discharge medication counseling
03

In context

Lead sponsor

Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.

Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Adult patients age 18 years or older scheduled for discharge to self-care from a Duke University Hospital Adult General Medicine Service that does not have a rounding pharmacist
  • Able to be contacted via phone within 30 days post-discharge
  • Able to speak and understand English
  • (For intervention patients) Have at least one prescription filled by Duke Outpatient Pharmacy and receive medication counseling by a pharmacist at the time of discharge
  • Of sufficient physical or mental capacity to provide informed consent, understand the medication counseling, manage their own medications, and answer the telephone questionnaire

Exclusion criteria

Exclusion Criteria:

  • Patients receiving medication-related counseling from other pharmacists (e.g., transplant patients or new start warfarin patients) or other healthcare providers (e.g., diabetes educators) during their hospital stay and/or at time of hospital discharge
  • Patients without a telephone for follow up
  • Patients with hearing and/or visual impairment
  • Patients discharged to police custody
  • Patients who are likely to be discharged the same day as admission
  • Patients who, in the judgment of the Attending Physician, are not candidates for this study
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
44 participants (actual)

Study arms

  • Experimental
    RPh Counseling + Outpatient Dispensing

    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.

    Other: RPh Counseling + Outpatient Med Dispensing at Discharge

  • Active comparator
    Routine Med Dispensing + Counseling

    At hospital discharge, patients will receive standard discharge procedures and obtain discharge medications per their usual process

    Other: Discharge Med Dispensing Plus Counseling - Current Practice

Interventions

  • OtherRPh Counseling + Outpatient Med Dispensing at Discharge

    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

  • OtherDischarge Med Dispensing Plus Counseling - Current Practice

    At hospital discharge, patients will receive standard discharge procedures and obtain discharge medications per their usual process

06

What researchers measure

Primary outcomes

  1. Drug-related problems (composite of adverse drug reactions, drug interactions, and failure to receive drugs) during the first 30 days post-hospital discharge

    Time frame: 30 days post-hospital discharge

Secondary outcomes

  1. Healthcare utilization

    Number of emergency department visits, urgent care visits, and unanticipated visits to outpatient providers

    Time frame: 30 days post-hospital discharge

  2. Hospital readmissions

    Number of hospital readmissions

    Time frame: 30 days post-hospital discharge

  3. Treatment delays

    Number of patients who experience treatment delays, defined as inability to obtain medications prescribed at discharge

    Time frame: Within 24 hours after hospital discharge

07

Study locations

1 site
  • Duke University Hospital
    Durham, North Carolina 27710, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 13, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01806038
Lead sponsor
Duke University
Responsible party
Sponsor
First posted
Mar 7, 2013
Start date
Mar 2013
Primary completion
Apr 2014
Completion
May 2014
Last update
Nov 13, 2014

Study contacts

Paul W. Bush, PharmD, MBA
principal investigator · Department of Pharmacy, Duke University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2014. You cannot join it, but the record below documents what was studied.

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