Effect of a Pharmacist-led Multifaceted Intervention on Treatment Outcomes in Hypertensive Patients

Official title

Effect of a Pharmacist-led Multifaceted Intervention on Treatment Outcomes in Hypertensive Patients: a Cluster Randomised Clinical Trial

Overview

The objective of this cluster randomized controlled trial is to evaluate the effectiveness of a pharmacist-led multifaceted intensive blood pressure intervention on poorly controlled hypertensive patients in phase 1 (1 month, 3 months, 6 months, 12 months) and phase 2 (24 months) post randomization.

Detailed description

This cluster randomized trial is conducted in eight tertiary hospitals of China, and we planned to enroll 100 participants at each hospital. The eight hospitals will be randomly divided into an intervention group or a control group in a 1:1 ratio. A total of 800 patients with poorly controlled blood pressure aged 18-80 years will be recruited into the study. The pharmacist-led multifaceted intervention is comprised of all the following five components: 1) Health education: lectures on hypertension related knowledge, the potential risks of hypertension, and guidance on healthy lifestyle, etc; 2) home blood pressure telemonitoring; 3) Medication consultation: including the usage, dosage, precautions and adverse reactions of hypertension drugs; 4) Medication reminders: remind subjects to take medication on time by Wechat or Messages; 5) Formulation of individualized medication regimen: efficacy evaluation and drug realignment. However, the control group received routine hypertension health education, standardized blood pressure measurement and regular follow-up.

The primary outcome is to assess the change in blood pressure control rate, time in target range (TTR), adherence to antihypertensive medication rate, and cardiovascular disease (CVDs) between the intervention group and the control group from baseline to follow-up at 1 month, 3 months, 6 months, 12 and 24 months post randomization. The secondary outcome is to assess the change in the mean systolic and diastolic pressures, and the medication appropriateness measured by the medication appropriateness index (MAI) between the two groups in phase 1 and 2. Meanwhile, the BMI, alcohol use and smoking will be also assessed in phase 1, and the incidence of hypertension-related adverse events will be assessed in phase 2.

Interventions

• Behavioral pharmacist-led multifaceted intervention
  Based on the blood pressure management model of pharmacist-led multifaceted intervention, clinical pharmacists who have received unified training provide pharmaceutical intervention and lifestyle guidance to subjects in the intervention group according to standard protocol. Pharmaceutical interventions include health education, medication adherence (medication consultation, medication reminder), medication reorganization, and rational use of medication. At the same time, clinical pharmacists su
• Behavioral conventional health education
  The subjects receive conventional hypertension health education, standard blood pressure measurement training and regular follow-up in the control group.

Primary outcome measures

• Blood pressure control rate [Time frame: baseline, 1 month, 3 months, 6 months, 12 months and 24 months after baseline]
• Time in target range (TTR) [Time frame: baseline, 1 month, 3 months, 6 months, 12 months and 24 months after baseline]
• Medication Adherence [Time frame: baseline, 1 month, 3 months, 6 months and 12 months after baseline]
• Cardiovascular events and all-cause death [Time frame: baseline and 24 months after baseline]

Secondary outcome measures (8)

• Mean systolic and diastolic pressure changes [Time frame: baseline, 1 month, 3 months, 6 months, 12 months and 24 months after baseline]
• Medication Appropriateness Index [Time frame: baseline, 1 month, 3 months, 6 months, 12 months and 24 months after baseline]
• Body Mass Index (BMI) [Time frame: baseline, 1 month, 3 months, 6 months and 12 months after baseline]
• Alcohol consumption [Time frame: baseline, 1 month, 3 months, 6 months and 12 months after baseline]
• Nicotine consumption [Time frame: baseline, 1 month, 3 months, 6 months and 12 months after baseline]
• Medication Adherence [Time frame: baseline and 24 months after baseline]
• Patients' medical costs [Time frame: baseline, 1 month, 3 months, 6 months and 12 months after baseline]
• Hypertension-related adverse events rate [Time frame: baseline and 24 months after baseline]

Eligibility criteria

Inclusion Criteria (subjects must meet all of the following criteria to be included):

• 1\) age 18-80 years;
• 2\) patients with hypertension (diagnostic criteria: defined as systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg according to the "Guidelines for the prevention and treatment of hypertension in China in 2023", based on the blood pressure measurement of three times on different days), who are currently taking anti-hypertensive medication and are judged by the research physician to have poor blood pressure control;
• 3\) able to use smartphones and WeChat proficiently, and can communicate and upload pictures proficiently;
• 4\) able to take care of yourself and communicate normally, and willing to cooperate with the research physician to complete the study and follow-up;
• 5\) permanent residents of the city where the center is located;
• 6\) voluntarily participate and sign the informed consent form

Exclusion Criteria(subjects will be excluded if they meet any of the following criteria):

• 1\) patients with advanced disease (such as patients undergoing dialysis or liver failure), or with a life expectancy of less than 2 years as determined by the research physician;
• 2\) combined with psychiatric disease, cognitive impairment, communication disorder, or inability to cooperate with the researchers;
• 3\) combined with cerebrovascular disease, stroke, severe liver and kidney dysfunction, severe heart failure, cancer and history of organ transplantation, etc.;
• 4\) patients who are pregnant, breastfeeding, or planning to conceive in the next 2 years.

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

Single blind

Primary purpose

Health services research

Study locations

China · 1 center

• Xijing hospital — Xi'an

Identifiers

NCT: NCT06558877 · KY20242276

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗