Clinical trial NCT06674512: The Effectiveness of Pharmaceutical Service for INPATDRP
Official title: Evaluating the Effectiveness of Pharmaceutical Service for Inpatient with Drug-related Problems（INPATDRP）: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Drug Related Problem
Keywords: Drug Related Problem
Inpatient
Clinical Pharmacist
Lead sponsor: Zhejiang Provincial People's Hospital
Sponsor class: OTHER
First posted: 2024-11-05
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Exclusion Criteria:

1. Those who did not meet the inclusion criteria;
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).

Primary outcomes:
measure: Number of DRPs
timeFrame: One year from inclusion
measure: Change in DRPs
timeFrame: One year from inclusion
Secondary outcomes:
measure: Medication Adherence
timeFrame: One year from inclusion
measure: Patients' knowledge
timeFrame: One year from inclusion
measure: Patient satisfaction in the experimental group
timeFrame: One year from inclusion
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang Provincial People's Hospital
state: Zhejiang Provincial
Study officials:
References: