The Effectiveness of Pharmaceutical Service for INPATDRP

Evaluating the Effectiveness of Pharmaceutical Service for Inpatient with Drug-related Problems（INPATDRP）: a Randomized Controlled Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Drug Related Problem
• Intervention / Treatment: Behavioral: Clinical Pharmacist-led Pharmaceutical Services

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.

• Study Type: Interventional
• Enrollment (Estimated): 220
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jieping Yan, Phd; Phone Number: 86 571 85893117; Email: yanjieping@hmc.edu.cn

Study Locations

• China
  • Zhejiang Provincial
    • Hangzhou, Zhejiang Provincial, China, 310014
      • Zhejiang Provincial People's Hospital
      • Contact: Jieping Yan, Phd; Phone Number: 13588461492; Email: yanjieping@hmc.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual care
Experimental: Clinical Pharmacist-led Pharmaceutical Services; In addition to usual care services, the intervention group was provided with pharmaceutical care by a clinical pharmacist.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of DRPs	Number of drug related problems identified in inpatient	One year from inclusion
Change in DRPs	Determination of drug-related problems (DRP) using Pharmaceutical Care Network Europe (PCNE) Version 9.1. The basic classification has 3 primary domains for problems, 9 primary domains for causes and 5 primary domains for Planned Interventions, 3 primary domains for level of acceptance (of interventions) and 4 primary domains for the Status of the problem.	One year from inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medication Adherence	The Morisky Adherence Scale was used, with scores less than 6 being low adherence, 6-7.75 being moderate adherence, and 8 being high adherence.	One year from inclusion
Patients' knowledge	Using the medication knowledge evaluation tool, medication knowledge evaluation questionnaire with 7 questions,The patient scores 1 point if he/she knows the correct answer, 0 points if he/she does not know and -1 if the information given is incorrect. Score goes from -7 (patient who answers all questions incorrectly) to 7 (patient who answer all questions correctly) for each medication that the patient is taking. A score of 0 has no particular significance, apart from being in the middle of the two extremes.	One year from inclusion
Patient satisfaction in the experimental group	Patient satisfaction in the intervention group was assessed using a patient satisfaction questionnaire.	One year from inclusion

Collaborators and Investigators

• Sponsor: Zhejiang Provincial People's Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: October 27, 2024
• First Submitted That Met QC Criteria: November 3, 2024
• First Posted (Estimated): November 5, 2024

Study Record Updates

• Last Update Posted (Estimated): November 5, 2024
• Last Update Submitted That Met QC Criteria: November 3, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Inpatient; Clinical Pharmacist; Drug Related Problem
• Other Study ID Numbers: KY2024148

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No