Surgical PatientsNCT04941820
The Impact of Clinical Pharmacist in the Identification and Management of Treatment Related Problems in the Surgery Ward
A study testing clinical pharmacist intervention in people with Surgical Patients, run by University of Jordan at 1 site in Jordan.
Trial summary
Patients in the surgery ward are at risk of morbidity and mortality from various types of treatment-related problems (TRPs). The primary aim of this study is to assess the impact of the clinical pharmacist in the identification and management of TRPs in the surgery ward. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Surgical Patients
- What is being tested?
- clinical pharmacist intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteJordan
- Study dates
- 29 Sep 2019to 6 Feb 2020
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Admission for elective, urgent, or emergency surgery
- age 18 years or older
- Expected length of stay of 3 days or more in the general surgical ward or the SICU
Who cannot join
- Pregnancy, breastfeeding, drug or alcohol abuse, active malignancy, or admission for plastic surgery
Trial locations and contacts
1 site in 1 country.
About this study
Patients in the surgery ward are at risk of morbidity and mortality from various types of treatment-related problems (TRPs). The primary aim of this study is to assess the impact of the clinical pharmacist in the identification and management of TRPs in the surgery ward.
Read the detailed description
Patients were randomly assigned to intervention (n=50) and usual care (n=50) arms. The clinical pharmacist assessed the types, frequencies, and clinical significance of TRPs for all recruited patients at baseline. Patients and treating surgeons in the intervention arm received recommendations concerning the identified TRPs, while the usual care arm did not. The number of TRPs was reevaluated at follow-up.
- Conditions
- Surgical Patients
- Being tested
- clinical pharmacist intervention
- Keywords
- clinical pharmacist, general surgical ward, RCT, SICU
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clinical pharmacist interventionOther
clinical pharmacist intervention
| Study group | Role | What they receive |
|---|---|---|
| Clinical pharmacist intervention + usual care arm | Experimental | Patients in the clinical pharmacist intervention + usual care arm received the clinical pharmacist intervention as well as usual care provided by the surgical team Receives: Other: clinical pharmacist intervention |
| Usual care arm (Control arm) | No intervention | Patients in the control arm received usual care by the surgical team without a coordinated contribution from the clinical pharmacist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptance rate of clinical pharmacist's recommended interventions
(Number of recommendations accepted by surgeons) / (total number of recommendations submitted to surgeons by the clinical pharmacist) *100
Measured: 19-week
Implementation rate of clinical pharmacist's recommended interventions
(Number of recommendations implemented by surgeons and patients) / (total number of recommendations submitted to surgeons and patients by the clinical pharmacist) *100
Measured: 19-week
The impact of the clinical pharmacist on the identification and management of TRPs in the surgery ward
Measured by comparing the means of differences in the number of TRPs identified at baseline and at the time of short-term follow-up in the intervention and usual care groups
Measured: 19-week
Secondary outcomes (1)
Surgeons' attitudes and satisfaction towards the provided clinical pharmacy services
Measured by a self-administered questionnaire
Measured: 19-week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2021
- Study start29 Sep 2019
- Primary completion6 Feb 2020
- Study completion6 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Surgical PatientsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All patients were followed up prospectively for their length of hospital stay, and recommendations concerning each identified TRP were provided to the surgeons responsible for patients in the intervention group. Likewise, patient counseling and encouraging adherence to therapy were provided solely to patients in the intervention group. Patients in the control group received usual care by the surgical team without a coordinated contribution from the clinical pharmacist.
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jordan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hiba Al Fahmawi, University of Jordan
- Investigators
- Hiba I. Al Fahmawi, PharmD, MSc, Study director, School of Pharmacy, The University of Jordan, Amman, Jordan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04941820
- Sponsor's protocol ID
- 80/2019/1943
- Status last verified
- Jun 2021
- First submitted
- 8 Jun 2021
- Last updated
- 28 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data that support the findings of this study are available on request from the corresponding author. The data are not publicly available due to privacy or ethical restrictions.
Publications
AbuRuz SM, Bulatova NR, Yousef AM. Validation of a comprehensive classification tool for treatment-related problems. Pharm World Sci. 2006 Aug;28(4):222-32. doi: 10.1007/s11096-006-9048-0. Epub 2006 Oct 26.
PubMed 17066238Basheti IA, Ayasrah SM, Ahmad M. Identifying treatment related problems and associated factors among hospitalized post-stroke patients through medication management review: A multi-center study. Saudi Pharm J. 2019 Feb;27(2):208-219. doi: 10.1016/j.jsps.2018.10.005. Epub 2018 Oct 19.
PubMed 30766431Bilal AI, Tilahun Z, Beedemariam G, Ayalneh B, Hailemeskel B, Engidawork E. Attitude and satisfaction of health care providers towards clinical pharmacy services in Ethiopia: A post-deployment survey. J Pharm Policy Pract. 2016 Mar 8;9:7. doi: 10.1186/s40545-016-0058-6. eCollection 2016.
PubMed 26962456Hepler CD. Clinical pharmacy, pharmaceutical care, and the quality of drug therapy. Pharmacotherapy. 2004 Nov;24(11):1491-8. doi: 10.1592/phco.24.16.1491.50950.
PubMed 15537552
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Clinical Pharmacist in the Identification and Management of Treatment Related Problems in the Surgery Ward
- ClinicalTrials.gov ID
- NCT04941820
- Acronym / sponsor ID
- 80/2019/1943
- Conditions
- Surgical Patients
- Keywords
- clinical pharmacist, general surgical ward, RCT, SICU
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of JordanUniversity, hospital or other
- Study start
- 29 Sep 2019 (actual)
- Primary completion
- 6 Feb 2020 (actual)
- Study completion
- 6 Feb 2020 (actual)
- First posted
- 28 Jun 2021 (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.
Patients in the surgery ward are at risk of morbidity and mortality from various types of treatment-related problems (TRPs). The primary aim of this study is to assess the impact of the clinical pharmacist in the identification and management of TRPs in the surgery ward.
Detailed description
Patients were randomly assigned to intervention (n=50) and usual care (n=50) arms. The clinical pharmacist assessed the types, frequencies, and clinical significance of TRPs for all recruited patients at baseline. Patients and treating surgeons in the intervention arm received recommendations concerning the identified TRPs, while the usual care arm did not. The number of TRPs was reevaluated at follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- All patients were followed up prospectively for their length of hospital stay, and recommendations concerning each identified TRP were provided to the surgeons responsible for patients in the intervention group. Likewise, patient counseling and encouraging adherence to therapy were provided solely to patients in the intervention group. Patients in the control group received usual care by the surgical team without a coordinated contribution from the clinical pharmacist.
| Arm | Type | Receives |
|---|---|---|
| Clinical pharmacist intervention + usual care arm | Experimental | Other: clinical pharmacist interventionPatients in the clinical pharmacist intervention + usual care arm received the clinical pharmacist intervention as well as usual care provided by the surgical team |
| Usual care arm (Control arm) | No intervention | –Patients in the control arm received usual care by the surgical team without a coordinated contribution from the clinical pharmacist |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Admission for elective, urgent, or emergency surgery
- age 18 years or older
- Expected length of stay of 3 days or more in the general surgical ward or the SICU
Key exclusion criteria (1 listed)
- Pregnancy, breastfeeding, drug or alcohol abuse, active malignancy, or admission for plastic surgery
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 |
|---|---|---|
| clinical pharmacist interventionclinical pharmacist intervention | Other | Clinical pharmacist intervention + usual care arm |
Primary outcome
Acceptance rate of clinical pharmacist's recommended interventions
Time frame: 19-week
(Number of recommendations accepted by surgeons) / (total number of recommendations submitted to surgeons by the clinical pharmacist) *100
Implementation rate of clinical pharmacist's recommended interventions
Time frame: 19-week
(Number of recommendations implemented by surgeons and patients) / (total number of recommendations submitted to surgeons and patients by the clinical pharmacist) *100
The impact of the clinical pharmacist on the identification and management of TRPs in the surgery ward
Time frame: 19-week
Measured by comparing the means of differences in the number of TRPs identified at baseline and at the time of short-term follow-up in the intervention and usual care groups
1 secondary outcome
Surgeons' attitudes and satisfaction towards the provided clinical pharmacy services
Time frame: 19-week
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 28 Jun 2021.
- Background: PubMed 17066238AbuRuz SM, Bulatova NR, Yousef AM. Validation of a comprehensive classification tool for treatment-related problems. Pharm World Sci. 2006 Aug;28(4):222-32. doi: 10.1007/s11096-006-9048-0. Epub 2006 Oct 26.
- Background: PubMed 30766431Basheti IA, Ayasrah SM, Ahmad M. Identifying treatment related problems and associated factors among hospitalized post-stroke patients through medication management review: A multi-center study. Saudi Pharm J. 2019 Feb;27(2):208-219. doi: 10.1016/j.jsps.2018.10.005. Epub 2018 Oct 19.
- Background: PubMed 26962456Bilal AI, Tilahun Z, Beedemariam G, Ayalneh B, Hailemeskel B, Engidawork E. Attitude and satisfaction of health care providers towards clinical pharmacy services in Ethiopia: A post-deployment survey. J Pharm Policy Pract. 2016 Mar 8;9:7. doi: 10.1186/s40545-016-0058-6. eCollection 2016.
- Background: PubMed 15537552Hepler CD. Clinical pharmacy, pharmaceutical care, and the quality of drug therapy. Pharmacotherapy. 2004 Nov;24(11):1491-8. doi: 10.1592/phco.24.16.1491.50950.
- Individual participant dataSharing planned: No. The data that support the findings of this study are available on request from the corresponding author. The data are not publicly available due to privacy or ethical restrictions.
Related trials for Surgical Patients
Not yet recruiting
Safety Study of Microlyte DualGuard
Wound Closure, Wound Care
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
Active, not recruitingPhase 2
Trial Exploring Combined Neoadjuvant Therapy With Pembrolizumab/Lenvatinib + Adjuvant Pembrolizumab in Pat. With NSCLC
Non Small Cell Lung Cancer
Not yet recruiting
Feasibility Study of a Conversational Chatbot for Outpatient Postoperative Follow-up in Otorhinolaryngology (ENT): Acceptability, Patterns of Use, and Patient Experience.
Surgery Ambulatory, ENT Surgery
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
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.
Hiba I. Al Fahmawi, PharmD, MSc study director
School of Pharmacy, The University of Jordan, Amman, Jordan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing clinical pharmacist intervention in people with Surgical Patients, run by University of Jordan at 1 site in Jordan.
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 3 inclusion and 1 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 28 Jun 2021. 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 Jordan. 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?
Acceptance rate of clinical pharmacist's recommended interventions (time frame: 19-week). The study lists 3 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 NCT04941820, which also lists 4 linked publications.
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 28 Jun 2021.