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Drug Related Problems Post Hospital DischargeNCT01806038

Drug-Related Problems and Healthcare Utilization Post-Hospital Discharge

A study testing RPh Counseling + Outpatient Med Dispensing at Discharge and Discharge Med Dispensing Plus Counseling - Current Practice in people with Drug Related Problems Post Hospital Discharge and Healthcare Utilization, run by Duke University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
RPh Counseling + Outpatient Med Dispensing at Discharge and Discharge Med Dispensing Plus Counseling - Current Practice
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 siteUnited States
Study dates
Mar 2013to May 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Duke University Hospital

    Durham, North Carolina, 27710

Other trials in United States

About this study

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.

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.

Being tested
RPh Counseling + Outpatient Med Dispensing at Discharge, Discharge Med Dispensing Plus Counseling - Current Practice
Keywords
Adverse events, Drug interactions, Healthcare utilization, Discharge medication counseling

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RPh Counseling + Outpatient Med Dispensing at DischargeOther

    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

  • Discharge Med Dispensing Plus Counseling - Current PracticeOther

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

Study groups in NCT01806038
Study groupRoleWhat they receive
RPh Counseling + Outpatient DispensingExperimentalOn 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.
Receives: Other: RPh Counseling + Outpatient Med Dispensing at Discharge
Routine Med Dispensing + CounselingActive comparatorAt hospital discharge, patients will receive standard discharge procedures and obtain discharge medications per their usual process
Receives: Other: Discharge Med Dispensing Plus Counseling - Current Practice

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 30 days post-hospital discharge

Secondary outcomes (3)
  1. Healthcare utilization

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

    Measured: 30 days post-hospital discharge

  2. Hospital readmissions

    Number of hospital readmissions

    Measured: 30 days post-hospital discharge

  3. Treatment delays

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

    Measured: Within 24 hours after hospital discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Mar 2013 (estimated)
  2. Study startMar 2013
  3. Primary completionApr 2014
  4. Study completionMay 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01806038
Sponsor's protocol ID
Pro00042998
Status last verified
Apr 2014
First submitted
5 Mar 2013
Last updated
13 Nov 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing RPh Counseling + Outpatient Med Dispensing at Discharge and Discharge Med Dispensing Plus Counseling - Current Practice in people with Drug Related Problems Post Hospital Discharge and Healthcare Utilization, run by Duke University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2014.

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