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Patient Pathway Pharmacist - Optimal Drug-related Care

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ClinicalTrials.gov Identifier: NCT03695081
Recruitment Status : Recruiting
First Posted : October 3, 2018
Last Update Posted : April 4, 2019
Sponsor:
Collaborator:
Hospital Pharmacies Enterprise, South Eastern Norway
Information provided by (Responsible Party):
Ben Tore Henriksen, Sykehuset i Vestfold HF

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hip Fractures Aging Patient Fall Procedure: Patient Pathway Pharmacist intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description:

An intervention group is compared to a cross-sectional retrospective group.

A group of 60 patients with hip fracture will get an intervention by a clinical pharmacist who performs medication reconciliation and medication review during hospitalisation, they will receive a discharge summary where the medication part is optimised. After six weeks the patients will be get a follow-up with a second medication reconciliation and - review. This group will be compared with the last 50 patients with hip fracture who did not get the intervention.

Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Patient Pathway Pharmacist: Drug Optimisation for Hip Fracture Patients - Facilitating a Safe Patient Handover: a Descriptive Study
Actual Study Start Date : September 3, 2018
Estimated Primary Completion Date : April 10, 2019
Estimated Study Completion Date : August 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Patient Pathway Pharmacist intervention
  1. Medication reconciliation at admission to hospital
  2. Medication review post surgery
  3. Optimised list of drugs in the discharge summary, in accordance with hospital procedures
  4. Medication reconciliation, six weeks after discharge
  5. Medication review, six weeks after discharge
Procedure: Patient Pathway Pharmacist intervention
  1. Medication reconciliation at admission to hospital
  2. Medication review post surgery
  3. Optimised list of drugs in the discharge summary, in accordance with hospital procedures
  4. Medication reconciliation, six weeks after discharge
  5. Medication review, six weeks after discharge

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.



Primary Outcome Measures :
  1. 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

  2. Admission summary score [ Time Frame: At hospital admission (estimated to be within 24 hours after fracture) ]
    In the admission summary, the section describing drugs is scored. The score is adjusted from the discharge summary score to fit the admission note.

  3. 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.

  4. Number of inappropriate drugs at discharge [ Time Frame: During hospitalisation, after surgery (estimated to be within five days after fracture/inclusion) ]
    After surgery the medication review may reduce the number of inappropriate drugs (on the STOPP-list).


Secondary Outcome Measures :
  1. Readmission [ Time Frame: 30 days after discharge ]
    Patients who are readmitted to hospital is quantified

  2. Readmission [ Time Frame: 90 days after discharge ]
    Patients who are readmitted to hospital is quantified

  3. Death [ Time Frame: 30 days after discharge ]
    The number patients who dies is quantified

  4. Death [ Time Frame: 90 days after discharge ]
    The number of patients who dies is quantified


Other Outcome Measures:
  1. Experience of current practice [ Time Frame: Prior to or during the early start of the intervention ]
    A questionnaire will be distributed to all health care professionals involved in the treatment of hip fracture patients

  2. Experience of patient pathway pharmacist [ Time Frame: Within three months after last included patient ]
    Focus groups or semi-structured interviews will be performed to assess the advantages and/or disadvantages of introducing a patient pathway pharmacist.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03695081


Contacts
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Contact: Ben Tore Henriksen, MSc 004792499756 ben.tore.henriksen@sykehusapotekene.no
Contact: Maria Krogseth, PhD, MD 004797154442 mariakrogseth@gmail.com

Locations
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Norway
Vestfold Hospital Trust Recruiting
Tønsberg, Norway
Contact: Ben Tore Henriksen, MSc    004792499756    ben.tore.henriksen@sykehusapotekene.no   
Contact: Maria Krogseth, MD, PhD    004797154442    mariakrogseth@gmail.com   
Sponsors and Collaborators
Sykehuset i Vestfold HF
Hospital Pharmacies Enterprise, South Eastern Norway

Additional Information:
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Responsible Party: Ben Tore Henriksen, Clinical Pharmacist, Sykehuset i Vestfold HF
ClinicalTrials.gov Identifier: NCT03695081     History of Changes
Other Study ID Numbers: 59475
First Posted: October 3, 2018    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ben Tore Henriksen, Sykehuset i Vestfold HF:
Medicine review
Patient handoff
Patient hand over
Intertrochanteric fractures
Trochanteric fractures
Subtrochanteric fractures
Hospital readmission
Hospital readmissions
Injuries, Hip
Hospitalization
Hospitalisation
Hip
Fracture
Femoral fractures
Femoral neck fractures
Medication errors
Medication review
Medication reconciliation

Additional relevant MeSH terms:
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Fractures, Bone
Hip Fractures
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries