NCT03695081

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2018

Longer than P75 for not_applicable

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

September 3, 2018

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

September 11, 2018

Completed
22 days until next milestone

First Posted

Study publicly available on registry

October 3, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2019

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2023

Completed
Last Updated

June 29, 2023

Status Verified

June 1, 2023

Enrollment Period

10 months

First QC Date

September 11, 2018

Last Update Submit

June 28, 2023

Conditions

Keywords

Medicine reviewPatient handoffPatient hand overIntertrochanteric fracturesTrochanteric fracturesSubtrochanteric fracturesHospital readmissionHospital readmissionsInjuries, HipHospitalizationHospitalisationHipFractureFemoral fracturesFemoral neck fracturesMedication errorsMedication reviewMedication reconciliation

Outcome Measures

Primary Outcomes (4)

  • Discharge summary score

    In the discharge summary, the section describing drugs is scored in accordance with the national patient safety program

    At discharge (estimated five days after fracture/inclusion)

  • 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.

    At hospital admission (estimated to be within 24 hours after fracture)

  • Discharge summaries written in accordance with procedure

    In the discharge summary, the section describing drugs should be in accordance with procedure.

    At discharge (estimated five days after fracture/inclusion)

  • Number of inappropriate drugs at discharge

    After surgery the medication review may reduce the number of inappropriate drugs (on the STOPP-list).

    During hospitalisation, after surgery (estimated to be within five days after fracture/inclusion)

Secondary Outcomes (4)

  • Readmission

    30 days after discharge

  • Readmission

    90 days after discharge

  • Death

    30 days after discharge

  • Death

    90 days after discharge

Other Outcomes (2)

  • Experience of current practice

    Prior to or during the early start of the intervention

  • Experience of patient pathway pharmacist

    Within three months after last included patient

Study Arms (2)

Patient Pathway Pharmacist intervention

EXPERIMENTAL

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

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.

Interventions

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

Patient Pathway Pharmacist intervention

Eligibility Criteria

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

You may qualify if:

  • Hip fracture patients in Vestfold county, Norway

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vestfold Hospital Trust

Tønsberg, Norway

Location

Related Publications (1)

  • Henriksen BT, Krogseth M, Andersen RD, Davies MN, Nguyen CT, Mathiesen L, Andersson Y. Clinical pharmacist intervention to improve medication safety for hip fracture patients through secondary and primary care settings: a nonrandomised controlled trial. J Orthop Surg Res. 2023 Jun 13;18(1):434. doi: 10.1186/s13018-023-03906-2.

Related Links

MeSH Terms

Conditions

Hip FracturesHip InjuriesFractures, BoneFemoral FracturesFemoral Neck Fractures

Condition Hierarchy (Ancestors)

Wounds and InjuriesLeg Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Pharmacist

Study Record Dates

First Submitted

September 11, 2018

First Posted

October 3, 2018

Study Start

September 3, 2018

Primary Completion

June 15, 2019

Study Completion

June 28, 2023

Last Updated

June 29, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations