Clinical trial NCT06310512: Efficacy of Pharmacist Interventions Through the "Medication Therapy Management Pathway in Hypertensive Patients"
Official title: Efficacy of Pharmacist Interventions Through the "Medication Therapy Management Pathway in Hypertensive Patients":A Prospective, Multicenter, Randomized, Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hypertension
Medication Therapy Management
Lead sponsor: Beijing Anzhen Hospital
Sponsor class: OTHER
First posted: 2024-03-15
Enrollment: 420
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of this Randomized Controlled Trial is to carry out in adult patients with primary hypertension whose blood pressure control is not up to standard. The main question it aims to answer are:

To explore the effect of pharmacists' implementation of "the medication therapy management pathway in hypertensive patients"on the patients with hypertension.

Participants will receive structured drug treatment management at the first diagnosis. During on-site follow-up in the first, third and sixth months, as well as telephone follow-up in the second week, second and fourth months, patients will be evaluated, corresponding information will be collected and possible interventions will be taken.

Researchers will compare the non intervention group to see if patients' blood pressure will also be reduced without intervention.

Detailed description: The purpose of this study is to explore the effectiveness, safety, and cost-effectiveness of pharmacists implementing the Drug Treatment Management Pathway in the treatment of hypertension patients. This trial is a prospective, multi-center, randomized, controlled study. We plan to enroll 420 patients with primary hypertension who are over 18 years old and whose blood pressure control is not up to standard. Qualified participants who meet the inclusion and exclusion criteria were randomly divided into an intervention group of 280 cases and a non intervention group of 140 cases in a 2:1 ratio.

Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years old, male or female;
2. Outpatients diagnosed with primary hypertension who have not received treatment or are receiving antihypertensive medication;
3. Mild to moderate hypertensive patients with substandard blood pressure: home blood pressure \>140/90 mmHg at least once in the last month or more, and the average sitting blood pressure in the clinic on the day of enrollment is \>140/90 mmHg;
4. Expected survival \> 12 months;
5. Voluntary participation in the trial and signing the informed consent form.

Exclusion Criteria:

1. Severe hypertension (mean SBP ≥180mmHg, or mean DBP ≥110mmHg), hypertensive emergency or hypertensive sub-emergency (systolic blood pressure \>180 mmHg or diastolic blood pressure \>120 mmHg);
2. Have a history or diagnosis of secondary hypertension, including but not limited to the following: renal hypertension, renal vascular hypertension, aortic stenosis, pheochromocytoma, Cushing's syndrome, cystic nephropathy, etc., but drug-induced hypertension is not an exclusion criterion;
3. Patients in the acute stage of the disease requiring emergency medical consultation;
4. patients with mental disorder, hearing impairment, intellectual disability, aphasia, etc., resulting in the inability to communicate or to comply with the study agreement
5. Patients with tumors;
6. Any other reasons that the investigator considers unsuitable for participation in the clinical trial that may affect the efficacy and safety evaluation of the study (including, but not limited to, the investigator's judgment that the subject lives far away and cannot be followed up as scheduled).

Primary outcomes:
measure: systolic blood pressure
timeFrame: 6 months
Secondary outcomes:
measure: diastolic blood pressure
timeFrame: 6 months
measure: Change from baseline in mean sitting systolic blood pressure at 3 months
timeFrame: 3 months
measure: Change from baseline in number of medication-related problems (MRP) at 6 months
timeFrame: 6 months
measure: Average number of medication-related problems (MRP) resolved after 6 months
timeFrame: 6 months
measure: The compliance rate of blood pressure after 6 months
timeFrame: 6 months
measure: Effective rate of blood pressure lowering after 6 months
timeFrame: 6 months
measure: Time to BP Attainment in Intervention and Non-Intervention Groups
timeFrame: From the date of enrollment to the date when the patient's first blood pressure meets the standard, the evaluation is conducted up to 6 months
measure: Changes from baseline in adherence scores at 6 months,the General Medication Compliance Scale (GMAS) was used.
timeFrame: 6 months
measure: Economic indicators，mainly including the cost of implementing intervention measures and the impact of intervention measures on patient diagnosis and treatment costs
timeFrame: 6 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital
state: Beijing
Study officials:
affiliation: Beijing Anzhen Hospital
name: Yang Lin
role: STUDY_DIRECTOR
References: