The Effectiveness of Pharmaceutical Service for INPATDRP

NCT ID: NCT06674512

Last Updated: 2024-11-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-31
• Study Completion Date: 2026-06-30

Brief Summary

Medication risk is defined as the potential for loss or harm that may result from the use of medications during the course of treatment. Drug-related problems (DRPs) are defined as events or situations involving drug therapy that actually or potentially interfere with desired health outcomes. DRPs represent a significant aspect of medication risk in hospitalized patients, and the study and management of DRPs can effectively reduce the incidence of medication risk. DRPs are associated with both therapeutic efficacy and adverse drug events, and the timely identification and reduction of DRPs can enhance clinical efficacy and prevent the occurrence of adverse events.

DRPs pose a challenge to the clinician, and that may affect patient's clinical outcomes and may result in morbidity or mortality and increased health care costs. Health care costs may become a burden to the patient or may be to the government or to the third parties. Clinical Pharmacy is a discipline that promotes the quality use of medicines through evidence-based medicine and helps in identification and resolving DRPs. A clinical pharmacist through his/her clinical accuracy checking may identify DRPs and come out with suitable solutions to resolve the same.

Consequently, the aims of our study were to investigate the efficacy and safety effects of pharmacist-implemented drug-related problems (DRPs)-based interventions on patients' medication therapy.

Detailed Description

The study was conducted as a parallel randomized controlled study in a large general hospital in China.The study planned to enroll 220 inpatients aged 18 to 100. Subjects were randomly assigned to the intervention and control groups. Pharmacists managed patients' medications using a process for solving problems. This included:

1. Collecting information, assessing the patient's condition, and checking the medication plan.

2. Identifying and solving problems with medications.

3. Providing guidance on medications and creating personal medication lists.

4. Following up and reassessing. For patients in the intervention group, medication therapy management was done at the first visit. This included assessment, information collection, and possible interventions at the first visit and at the 1, 3, and 6 month follow-up visits. In the control group, patients were assessed at the first visit and at the 1, 3, and 6month follow-up visits. Information was collected, dosage and contraindications were explained, and necessary interventions were performed in the third month.

Conditions

Drug Related Problem

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Clinical Pharmacist-led Pharmaceutical Services

In addition to usual care services, the intervention group was provided with pharmaceutical care by a clinical pharmacist.

Group Type: EXPERIMENTAL

Clinical Pharmacist-led Pharmaceutical Services

Intervention Type: BEHAVIORAL

Pharmacists developed an intervention plan to reduce DRPs and improve patients' quality of life by assessing patients' medication knowledge, drug-related problems, and adherence problems in the intervention group in the order of urgency, importance, and priority to be addressed. The plan included a list of patients' medication or lifestyle-related problems, a list of programs based on the assessed problems, and other information.

Usual care

Usual care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Clinical Pharmacist-led Pharmaceutical Services

Pharmacists developed an intervention plan to reduce DRPs and improve patients' quality of life by assessing patients' medication knowledge, drug-related problems, and adherence problems in the intervention group in the order of urgency, importance, and priority to be addressed. The plan included a list of patients' medication or lifestyle-related problems, a list of programs based on the assessed problems, and other information.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Hospitalized patients;

2. Hospitalization duration >3 d;

3. Adult patients aged ≥18 years and ≤100 years (only adult patients aged 18 years or older were included in the medication management study because of the difference in study methodology between minor and adult patients);

4. Patients or close relatives gave informed consent and were willing to communicate with the clinical pharmacist and receive medication life education.

2. Patients who are in the acute phase of the disease requiring emergency medical consultation;

3. Those with any serious or life-threatening diseases (heart, lung, liver, kidney failure, hematologic diseases, malignant tumors, etc.);

4. Patients with psychiatric disorders, hearing impairments, intellectual disabilities, aphasia, etc. that make them unable to communicate or comply with the study protocol;

5. Any other reasons that the investigator believes may affect the efficacy and safety evaluation of this study other reasons not suitable for participation in this clinical trial (including, but not limited to, the investigator's judgment that the subject lives far away and is unable to follow up as scheduled).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang Provincial People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang Provincial, China

Countries

China

Central Contacts

Jieping Yan, Phd

Role: CONTACT

yanjieping@hmc.edu.cn

86 571 85893117

Facility Contacts

Jieping Yan, Phd

Role: primary

yanjieping@hmc.edu.cn

13588461492

Other Identifiers

KY2024148

Identifier Type: -

Identifier Source: org_study_id