Hip FracturesNCT03695081
Patient Pathway Pharmacist - Optimal Drug-related Care
A study testing Patient Pathway Pharmacist intervention in people with Hip Fractures and Aging, run by Sykehuset i Vestfold HF at 1 site in Norway.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Fractures, Aging, Patient Fall
- What is being tested?
- Patient Pathway Pharmacist intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteNorway
- Study dates
- 3 Sep 2018to 28 Jun 2023
- 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
- Hip fracture patients in Vestfold county, Norway
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Hip Fractures, Aging, Patient Fall
- Being tested
- Patient Pathway Pharmacist intervention
- 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
- Medical subject headings
- Hip Fractures, Hip Injuries, Fractures, Bone, Femoral Fractures, Femoral Neck Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient Pathway Pharmacist interventionProcedure or surgery
- 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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Discharge summary score
In the discharge summary, the section describing drugs is scored in accordance with the national patient safety program
Measured: 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.
Measured: 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.
Measured: 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).
Measured: During hospitalisation, after surgery (estimated to be within five days after fracture/inclusion)
Secondary outcomes (4)
Readmission
Patients who are readmitted to hospital is quantified
Measured: 30 days after discharge
Readmission
Patients who are readmitted to hospital is quantified
Measured: 90 days after discharge
Death
The number patients who dies is quantified
Measured: 30 days after discharge
Death
The number of patients who dies is quantified
Measured: 90 days after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2018
- Study start3 Sep 2018
- Primary completion15 Jun 2019
- Study completion28 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- 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)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sykehuset i Vestfold HF
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Pharmacy Enterprise, South Eastern Norway
- Responsible party
- Principal investigator, Ben Tore Henriksen, Sykehuset i Vestfold HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03695081
- Sponsor's protocol ID
- 59475
- Status last verified
- Jun 2023
- First submitted
- 11 Sep 2018
- Last updated
- 29 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37312222
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Pathway Pharmacist: Drug Optimisation for Hip Fracture Patients - Facilitating a Safe Patient Handover: a Descriptive Study
- ClinicalTrials.gov ID
- NCT03695081
- Acronym / sponsor ID
- 59475
- Conditions
- Hip Fractures, Aging, Patient Fall
- Keywords
- Medicine review, Patient handoff, Patient hand over, Intertrochanteric fractures, Trochanteric fractures, Subtrochanteric fractures, Hospital readmission, Hospital readmissions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Sykehuset i Vestfold HFUniversity, hospital or other
- Collaborators
- Hospital Pharmacy Enterprise, South Eastern Norway
- Study start
- 3 Sep 2018 (actual)
- Primary completion
- 15 Jun 2019 (actual)
- Study completion
- 28 Jun 2023 (actual)
- First posted
- 3 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Patient Pathway Pharmacist intervention | Experimental | Procedure: Patient Pathway Pharmacist intervention1. 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Hip fracture patients in Vestfold county, Norway
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient Pathway Pharmacist intervention1. 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 or surgery | Patient Pathway Pharmacist intervention |
Primary outcome
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
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.
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.
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).
4 secondary outcomes
Readmission
Time frame: 30 days after discharge
Readmission
Time frame: 90 days after discharge
Death
Time frame: 30 days after discharge
Death
Time frame: 90 days after discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2023.
- Derived from this study: PubMed 37312222Henriksen 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.
- Score of the drug section in discharge summaries - The Norwegian Patient Safety Programme: In Safe HandsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient Pathway Pharmacist intervention in people with Hip Fractures and Aging, run by Sykehuset i Vestfold HF at 1 site in Norway.
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 1 inclusion and 4 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 29 Jun 2023. 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 Norway. 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?
Discharge summary score (time frame: At discharge (estimated five days after fracture/inclusion)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03695081, which also lists 1 linked publication.
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 29 Jun 2023.