NCT01806038

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

March 5, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 7, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

November 13, 2014

Status Verified

April 1, 2014

Enrollment Period

1.1 years

First QC Date

March 5, 2013

Last Update Submit

November 11, 2014

Conditions

Keywords

Adverse eventsDrug interactionsHealthcare utilizationDischarge medication counseling

Outcome Measures

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

    30 days post-hospital discharge

Secondary Outcomes (3)

  • Healthcare utilization

    30 days post-hospital discharge

  • Hospital readmissions

    30 days post-hospital discharge

  • Treatment delays

    Within 24 hours after hospital discharge

Study Arms (2)

RPh Counseling + Outpatient Dispensing

EXPERIMENTAL

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

Routine Med Dispensing + Counseling

ACTIVE COMPARATOR

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

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

RPh Counseling + Outpatient Dispensing

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

Routine Med Dispensing + Counseling

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Hospital

Durham, North Carolina, 27710, United States

Location

Study Officials

  • Paul W. Bush, PharmD, MBA

    Department of Pharmacy, Duke University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2013

First Posted

March 7, 2013

Study Start

March 1, 2013

Primary Completion

April 1, 2014

Study Completion

May 1, 2014

Last Updated

November 13, 2014

Record last verified: 2014-04

Locations