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Patient Pathway Pharmacist - Optimal Drug-related Care

Primary Purpose

Hip Fractures, Aging, Patient Fall

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Patient Pathway Pharmacist intervention
Sponsored by
Sykehuset i Vestfold HF
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hip Fractures focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Vestfold Hospital Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Patient Pathway Pharmacist intervention

No intervention

Arm Description

Medication reconciliation at admission to hospital Medication review post surgery Optimised list of drugs in the discharge summary, in accordance with hospital procedures Medication reconciliation, six weeks after discharge Medication review, six weeks after discharge

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.

Outcomes

Primary Outcome Measures

Discharge summary score
In the discharge summary, the section describing drugs is scored in accordance with the national patient safety program
Admission summary score
In the admission summary, the section describing drugs is scored. The score is adjusted from the discharge summary score to fit the admission note.
Discharge summaries written in accordance with procedure
In the discharge summary, the section describing drugs should be in accordance with procedure.
Number of inappropriate drugs at discharge
After surgery the medication review may reduce the number of inappropriate drugs (on the STOPP-list).

Secondary Outcome Measures

Readmission
Patients who are readmitted to hospital is quantified
Readmission
Patients who are readmitted to hospital is quantified
Death
The number patients who dies is quantified
Death
The number of patients who dies is quantified

Full Information

First Posted
September 11, 2018
Last Updated
June 28, 2023
Sponsor
Sykehuset i Vestfold HF
Collaborators
Hospital Pharmacy Enterprise, South Eastern Norway
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1. Study Identification

Unique Protocol Identification Number
NCT03695081
Brief Title
Patient Pathway Pharmacist - Optimal Drug-related Care
Official Title
Patient Pathway Pharmacist: Drug Optimisation for Hip Fracture Patients - Facilitating a Safe Patient Handover: a Descriptive Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
September 3, 2018 (Actual)
Primary Completion Date
June 15, 2019 (Actual)
Study Completion Date
June 28, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sykehuset i Vestfold HF
Collaborators
Hospital Pharmacy Enterprise, South Eastern Norway

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fractures, Aging, Patient Fall
Keywords
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
Non-Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patient Pathway Pharmacist intervention
Arm Type
Experimental
Arm Description
Medication reconciliation at admission to hospital Medication review post surgery Optimised list of drugs in the discharge summary, in accordance with hospital procedures Medication reconciliation, six weeks after discharge Medication review, six weeks after discharge
Arm Title
No intervention
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Patient Pathway Pharmacist intervention
Intervention Description
Medication reconciliation at admission to hospital Medication review post surgery Optimised list of drugs in the discharge summary, in accordance with hospital procedures Medication reconciliation, six weeks after discharge Medication review, six weeks after discharge
Primary Outcome Measure Information:
Title
Discharge summary score
Description
In the discharge summary, the section describing drugs is scored in accordance with the national patient safety program
Time Frame
At discharge (estimated five days after fracture/inclusion)
Title
Admission summary score
Description
In the admission summary, the section describing drugs is scored. The score is adjusted from the discharge summary score to fit the admission note.
Time Frame
At hospital admission (estimated to be within 24 hours after fracture)
Title
Discharge summaries written in accordance with procedure
Description
In the discharge summary, the section describing drugs should be in accordance with procedure.
Time Frame
At discharge (estimated five days after fracture/inclusion)
Title
Number of inappropriate drugs at discharge
Description
After surgery the medication review may reduce the number of inappropriate drugs (on the STOPP-list).
Time Frame
During hospitalisation, after surgery (estimated to be within five days after fracture/inclusion)
Secondary Outcome Measure Information:
Title
Readmission
Description
Patients who are readmitted to hospital is quantified
Time Frame
30 days after discharge
Title
Readmission
Description
Patients who are readmitted to hospital is quantified
Time Frame
90 days after discharge
Title
Death
Description
The number patients who dies is quantified
Time Frame
30 days after discharge
Title
Death
Description
The number of patients who dies is quantified
Time Frame
90 days after discharge
Other Pre-specified Outcome Measures:
Title
Experience of current practice
Description
A questionnaire will be distributed to all health care professionals involved in the treatment of hip fracture patients
Time Frame
Prior to or during the early start of the intervention
Title
Experience of patient pathway pharmacist
Description
Focus groups or semi-structured interviews will be performed to assess the advantages and/or disadvantages of introducing a patient pathway pharmacist.
Time Frame
Within three months after last included patient

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Vestfold Hospital Trust
City
Tønsberg
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.itryggehender24-7.no/reduser-pasientskader/legemiddelrelaterte-skader/legemiddelsamstemming-og-legemiddelgjennomgang/_/attachment/download/33b5eb0c-4f62-4d42-862f-b9f95f09423c:12bcc5de3b8e1ff2e4bdb9937951300d8d6f35cc/tiltakspakke-for-samstemming-av-legemiddellister.pdf
Description
Score of the drug section in discharge summaries - The Norwegian Patient Safety Programme: In Safe Hands

Learn more about this trial

Patient Pathway Pharmacist - Optimal Drug-related Care

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