Efficacy of Pharmacist Interventions Through the "Medication Therapy Management Pathway in Hypertensive Patients":A Prospective, Multicenter, Randomized, Controlled Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hypertension
- Sponsor
- Beijing Anzhen Hospital
- Enrollment
- 420
- Locations
- 1
- Primary Endpoint
- systolic blood pressure
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Lin Yang
Professor
Beijing Anzhen Hospital
Eligibility Criteria
Inclusion Criteria
- •Age ≥18 years old, male or female;
- •Outpatients diagnosed with primary hypertension who have not received treatment or are receiving antihypertensive medication;
- •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;
- •Expected survival \> 12 months;
- •Voluntary participation in the trial and signing the informed consent form.
Exclusion Criteria
- •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);
- •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;
- •Patients in the acute stage of the disease requiring emergency medical consultation;
- •patients with mental disorder, hearing impairment, intellectual disability, aphasia, etc., resulting in the inability to communicate or to comply with the study agreement
- •Patients with tumors;
- •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).
Outcomes
Primary Outcomes
systolic blood pressure
Time Frame: 6 months
Change from baseline in mean seated systolic blood pressure at 6 months
Secondary Outcomes
- Average number of medication-related problems (MRP) resolved after 6 months(6 months)
- diastolic blood pressure(6 months)
- Change from baseline in mean sitting systolic blood pressure at 3 months(3 months)
- Change from baseline in number of medication-related problems (MRP) at 6 months(6 months)
- The compliance rate of blood pressure after 6 months(6 months)
- Effective rate of blood pressure lowering after 6 months(6 months)
- Time to BP Attainment in Intervention and Non-Intervention Groups(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)
- Changes from baseline in adherence scores at 6 months,the General Medication Compliance Scale (GMAS) was used.(6 months)
- Economic indicators，mainly including the cost of implementing intervention measures and the impact of intervention measures on patient diagnosis and treatment costs(6 months)