- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03695081
Patient Pathway Pharmacist - Optimal Drug-related Care
June 28, 2023 updated by: Ben Tore Henriksen, Sykehuset i Vestfold HF
Patient Pathway Pharmacist: Drug Optimisation for Hip Fracture Patients - Facilitating a Safe Patient Handover: a Descriptive Study
Medication errors represent the most common cause of patient injury and one of the most frequently reported health related deviation in Norway.
The addition of a dedicated clinical pharmacist throughout the hip fracture patient pathway (patient pathway pharmacist) is believed to improve patient safety and ensure optimal drug-related patient care.
The pharmacist will perform medication reconciliation at admission to hospital, medication review after surgery and assist physicians with discharge summary.
Six weeks after discharge the patient pathway pharmacist will perform a second drug reconciliation and medication review.
This study will assess the pharmacists' place and specific tasks in the patient pathway, describe areas where the pharmacist contribute to increased quality of care and assess the benefits and/or disadvantages experienced with introducing a patient pathway pharmacist.
The estimated number of patients included is 60.
Current practice will be determined by investigating the last 50 patients' medical record and a questionnaire to health care professionals involved in treatment of hip fracture patients.
Data from medication reconciliation and drug review will be collected and compared to current practice.
After the inclusion period, focus group surveys and/or semi-structured interviews will be executed to describe the perceived improvement in the quality of care.
Primary endpoints are: 1) Medication reconciliation score at admission 2) Number of inappropriate drugs for elderly 3) Discharge summary score 4) Discharge summaries following procedure.
Secondary endpoints are readmissions and mortality after 30 and 90 days.
Qualitative endpoints: 1) Health care professionals experience of current drug-related practice 2) Experienced advantages and disadvantages of a patient pathway pharmacist.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Tønsberg, Norway
- Vestfold Hospital Trust
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Hip fracture patients in Vestfold county, Norway
Exclusion Criteria:
- Patients under 18 years
- Terminally ill
- Hip fracture patients who do not follow the standardized patient pathway at Vestfold Regional Hospital
- Patients who do not consent to be included in the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Patient Pathway Pharmacist intervention
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|
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No Intervention: No intervention
Business as usual.
The Patient Pathway Pharmacist is not involved and the nurses and physicians are responsible for medicine reconciliation, -review and section in the discharge summary.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Discharge summary score
Time Frame: At discharge (estimated five days after fracture/inclusion)
|
In the discharge summary, the section describing drugs is scored in accordance with the national patient safety program
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At discharge (estimated five days after fracture/inclusion)
|
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Admission summary score
Time Frame: At hospital admission (estimated to be within 24 hours after fracture)
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In the admission summary, the section describing drugs is scored.
The score is adjusted from the discharge summary score to fit the admission note.
|
At hospital admission (estimated to be within 24 hours after fracture)
|
|
Discharge summaries written in accordance with procedure
Time Frame: At discharge (estimated five days after fracture/inclusion)
|
In the discharge summary, the section describing drugs should be in accordance with procedure.
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At discharge (estimated five days after fracture/inclusion)
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Number of inappropriate drugs at discharge
Time Frame: During hospitalisation, after surgery (estimated to be within five days after fracture/inclusion)
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After surgery the medication review may reduce the number of inappropriate drugs (on the STOPP-list).
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During hospitalisation, after surgery (estimated to be within five days after fracture/inclusion)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Readmission
Time Frame: 30 days after discharge
|
Patients who are readmitted to hospital is quantified
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30 days after discharge
|
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Readmission
Time Frame: 90 days after discharge
|
Patients who are readmitted to hospital is quantified
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90 days after discharge
|
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Death
Time Frame: 30 days after discharge
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The number patients who dies is quantified
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30 days after discharge
|
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Death
Time Frame: 90 days after discharge
|
The number of patients who dies is quantified
|
90 days after discharge
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Experience of current practice
Time Frame: Prior to or during the early start of the intervention
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A questionnaire will be distributed to all health care professionals involved in the treatment of hip fracture patients
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Prior to or during the early start of the intervention
|
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Experience of patient pathway pharmacist
Time Frame: Within three months after last included patient
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Focus groups or semi-structured interviews will be performed to assess the advantages and/or disadvantages of introducing a patient pathway pharmacist.
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Within three months after last included patient
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 3, 2018
Primary Completion (Actual)
June 15, 2019
Study Completion (Actual)
June 28, 2023
Study Registration Dates
First Submitted
September 11, 2018
First Submitted That Met QC Criteria
October 2, 2018
First Posted (Actual)
October 3, 2018
Study Record Updates
Last Update Posted (Actual)
June 29, 2023
Last Update Submitted That Met QC Criteria
June 28, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Keywords
- Hospital readmissions
- Hospitalisation
- Hip
- Fracture
- Medication errors
- Hospitalization
- Femoral neck fractures
- Medication review
- Intertrochanteric fractures
- Medication reconciliation
- Hospital readmission
- Medicine review
- Patient handoff
- Patient hand over
- Trochanteric fractures
- Subtrochanteric fractures
- Injuries, Hip
- Femoral fractures
Additional Relevant MeSH Terms
Other Study ID Numbers
- 59475
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.