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NCT Number: NCT06674512

The Effectiveness of Pharmaceutical Service for INPATDRP

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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang Provincial, 310014, China

Location contact

Jieping Yan, Phd

CONTACT

[email protected]

13588461492

About this study

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:

  • Collecting information, assessing the patient's condition, and checking the medication plan.
  • Identifying and solving problems with medications.
  • Providing guidance on medications and creating personal medication lists.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Clinical Pharmacist-led Pharmaceutical Services

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.

Primary outcomes

  1. Number of DRPs

    Time frame: One year from inclusion

    Number of drug related problems identified in inpatient

  2. Change in DRPs

    Time frame: One year from inclusion

    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.

Secondary outcomes

  1. Medication Adherence

    Time frame: One year from inclusion

    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.

  2. Patients' knowledge

    Time frame: One year from inclusion

    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.

  3. Patient satisfaction in the experimental group

    Time frame: One year from inclusion

    Patient satisfaction in the intervention group was assessed using a patient satisfaction questionnaire.

Study contacts

Contact information is provided by the study sponsor or research team.

Jieping Yan, Phd

CONTACT

[email protected]

86 571 85893117

Sponsors and collaborators

Lead sponsor

Zhejiang Provincial People's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Nov 5, 2024
Registry last updated
Nov 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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