Impact of Pharmacist-Led Counselling on Medication Adherence and Blood Pressure in Hypertensive Outpatients

Hypertension is the commonest chronic condition seen in Indian outpatient departments, and poor adherence to antihypertensive medicines is one of the main reasons blood pressure stays uncontrolled. Patients skip doses when they feel well, stop drugs because of side effects, run out of tablets between visits or simply do not understand why lifelong therapy is needed.

This project measures whether structured, pharmacist-led counselling improves medication adherence and blood-pressure control in adult hypertensive outpatients. It is a prospective, open-label, controlled pre–post study in the Medicine OPD of a tertiary-care teaching hospital. Patients are allocated to an intervention group, which receives a counselling session at baseline, a patient information leaflet in the local language, a pictogram medication calendar and telephone reminders, and a usual-care group, which receives routine care only.

Adherence is measured with the Hill-Bone Compliance to High Blood Pressure Therapy Scale and pill counts, and blood pressure is measured with a validated digital device at baseline, 6 weeks and 12 weeks. Changes within and between groups are analysed with paired and independent tests in SPSS.

The project fits the PCI Pharm.D Year V Project Work slot (six months, 20 hours per week), results in a 40–50-page report, and demonstrates the pharmacist's role in chronic-disease care that the Pharm.D programme was created to build.

Abstract

A prospective, open-label, controlled study will be conducted over six months in the Medicine outpatient department of a tertiary-care hospital to assess the impact of pharmacist-led counselling on adherence and blood pressure among adults with essential hypertension. Participants will be allocated to intervention and usual-care groups. Adherence (Hill-Bone scale, pill count) and blood pressure will be measured at baseline, 6 and 12 weeks and compared within and between groups.

Introduction

Hypertension is a major risk factor for stroke, coronary disease and kidney failure. Although effective, inexpensive drugs are available — many on the National List of Essential Medicines — control rates in India remain low. Non-adherence is a key modifiable cause. Pharmacists meet patients at every refill and are well placed to explain the disease, the purpose of each drug, how to take it and what side effects to expect.

Review and gap

Indian studies of pharmacist counselling in hypertension generally show improved knowledge and adherence, but many are uncontrolled before–after studies, use licensed adherence scales without permission, or report adherence without a clinical outcome such as blood pressure. There is a need for a controlled design with a freely usable validated scale and an objective clinical end-point.

Proposed work

• Develop and validate a counselling module and a bilingual patient information leaflet with the guide and a physician.
• Allocate eligible patients to intervention or usual care.
• Deliver counselling at baseline with reinforcement at 6 weeks and fortnightly telephone reminders.
• Measure adherence and blood pressure at three time-points.

Feasibility

• Setting: the Medicine OPD sees a large number of hypertensive follow-up patients every week.
• Resources: the Hill-Bone scale is freely available for research; leaflets are printed in-house; a validated BP monitor is available in the Department of Pharmacy Practice.
• Time: recruitment in months 1–2, follow-up to month 5, analysis and report in month 6.
• Ethics: IEC approval and written informed consent are mandatory before recruitment.

Many hypertensive patients attending government and teaching-hospital outpatient departments in India do not take their medicines as prescribed. Short consultation times leave little room for explaining the disease, and patients often receive their drugs without being told how long to continue them, what to do if a dose is missed, or which side effects are harmless. The consequence is uncontrolled blood pressure, avoidable complications and repeated changes of therapy that are really failures of adherence rather than of the drugs.

The hospital has no structured pharmacist counselling service and no data on how much counselling could improve adherence. This study addresses that gap by measuring the effect of a structured, pharmacist-led counselling programme on adherence and blood pressure, compared with usual care, using a validated scale, an objective pill count and standardised BP measurement.

In scope

• Adults with essential hypertension on at least one antihypertensive drug for ≥ 3 months attending the Medicine OPD.
• Counselling covering disease, drugs, dosing, missed doses, side effects, lifestyle and home BP monitoring.
• Adherence and BP measured at three time-points over 12 weeks; patient satisfaction at the end.

Out of scope

• Changing prescriptions — all therapy decisions remain with the treating physician.
• Secondary hypertension, pregnancy-induced hypertension and in-patients.
• Long-term cardiovascular outcomes and cost-effectiveness (future scope).

Study design: prospective, open-label, controlled pre–post interventional study.

Setting and duration: Medicine OPD of a tertiary-care teaching hospital; six months (recruitment months 1–2, follow-up to month 5, analysis month 6).

Sample size: to detect a mean difference of 2 points in Hill-Bone score between groups with SD 3.5, α = 0.05 (two-sided) and 80% power, n per group = 2(Z₁₋α/₂ + Z₁₋β)²σ²/Δ² = 2(1.96 + 0.84)² × 3.5²/2² ≈ 48. Allowing 20% loss to follow-up, 60 patients per group (120 total) are recruited.

Allocation: consecutive eligible patients are allocated alternately by OPD day (intervention days and usual-care days) to prevent contamination between patients waiting together; this is stated as a quasi-randomised design and its limitation is discussed.

Inclusion criteria: age 30–75 years; diagnosis of essential hypertension; on antihypertensive drugs for ≥ 3 months; able to attend follow-up; reachable by telephone; written informed consent.

Exclusion criteria: secondary hypertension, pregnancy, severe cognitive impairment, terminal illness, participation in another study.

Instruments: data-collection form (demographics, comorbidities, drugs, BP); Hill-Bone Compliance to High Blood Pressure Therapy Scale — 14 items, medication-taking, appointment-keeping and salt-intake subscales, scored 14–56 where higher means worse adherence, translated and back-translated into the local language and piloted; pill count adherence (%) = (tablets dispensed − tablets returned)/tablets prescribed for the period × 100; validated automated BP monitor with the mean of two seated readings after five minutes' rest; patient-satisfaction questionnaire.

Intervention: 20–25-minute one-to-one counselling at baseline, a leaflet, a pictogram calendar, fortnightly telephone reminders and reinforcement at 6 weeks.

Ethics: IEC approval; ICMR National Ethical Guidelines (2017); written informed consent; usual-care patients receive the counselling and leaflet after the 12-week visit so no one is denied the service.

Statistical analysis: SPSS. Normality by Shapiro–Wilk; baseline comparability by independent t-test/chi-square; within-group change by paired t-test or Wilcoxon signed-rank; between-group change by independent t-test or Mann–Whitney U; repeated-measures ANOVA across three time-points; proportion at target BP by chi-square; p < 0.05.