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

Overview

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.

Interventions

• Behavioral 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.

Primary outcome measures

• Number of DRPs [Time frame: One year from inclusion]
• Change in DRPs [Time frame: One year from inclusion]

Secondary outcome measures (3)

• Medication Adherence [Time frame: One year from inclusion]
• Patients' knowledge [Time frame: One year from inclusion]
• Patient satisfaction in the experimental group [Time frame: One year from inclusion]

Eligibility criteria

Inclusion criteria

• Hospitalized patients;
• Hospitalization duration >3 d;
• 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);
• Patients or close relatives gave informed consent and were willing to communicate with the clinical pharmacist and receive medication life education.

Exclusion criteria

• Those who did not meet the inclusion criteria;
• Patients who are in the acute phase of the disease requiring emergency medical consultation;
• Those with any serious or life-threatening diseases (heart, lung, liver, kidney failure, hematologic diseases, malignant tumors, etc.);
• Patients with psychiatric disorders, hearing impairments, intellectual disabilities, aphasia, etc. that make them unable to communicate or comply with the study protocol;
• 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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Health services research

Study locations

China · 1 center

• Zhejiang Provincial People's Hospital — Hangzhou

Identifiers

NCT: NCT06674512 · KY2024148

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗