Pharmacists Intervention to Improve Hypertension Management in Primary Care (APOTHECARE)

Pharmacists Intervention to Improve Hypertension Management in Primary Care (APOTHECARE): A Cluster-randomized Trial

Arterial hypertension is the single largest contributor to mortality world-wide, and only 30-50% of diagnosed and treated patients achieve their blood pressure goal. The APOTHECARE trial is designed to identify treated patients with uncontrolled hypertension in community pharmacies in order to improve blood pressure control through intensification of antihypertensive therapy.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Behavioral: Referral of hypertensive patients to the attending physician

Detailed Description

Patients with medically treated arterial hypertension, who attend a pharmacy in order to obtain their antihypertensive medication are invited to participate in the trial.

The main inclusion criteria is uncontrolled hypertension, as determined by an automated office blood pressure measurement at a threshold of 135/85 mmHg.

Main exclusion criteria include a first-ever prescription of an antihypertensive agent, resistant hypertension, systolic blood pressure ≥ 180 mmHg and dialysis.

Randomization occurs on the level of pharmacies (cluster randomization).

Patients in the interventional arm are immediately referred to their treating physician for up-titration of antihypertensive therapy. Re-examination of automated automated office blood-pressure occurs in the respective pharmacy, and patients are referred to their treating physician again if required. These measures are accompanied by a structured and educational blood pressure record card.

Patients in the observational arm undergo periodic automated office blood pressure measurements and are referred to their treating physician at the end of the trial in case of persistently uncontrolled blood pressure.

• Study Type: Interventional
• Enrollment (Actual): 497
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Alland, Austria, 2534
    • Buchen-Apotheke
  • Bad Erlach, Austria, 2822
    • Apotheke Bad Erlach
  • Bad Vöslau, Austria, 2540
    • Kur-Apotheke
  • Baden, Austria, 2500
    • Landschafts-Apotheke
  • Furth, Austria, 3511
    • Apotheke Am Goettweiger
  • Gaming, Austria, 3292
    • Oetscherland-Apotheke
  • Gaweinstal, Austria, 2191
    • Apotheke Zum heiligen Georg
  • Gmünd, Austria, 3950
    • Apotheke Gmuend Neustadt
  • Gmünd, Austria, 3950
    • Apotheke Zum Auge Gottes
  • Gramatneusiedl, Austria, 2440
    • Marien-Apotheke
  • Himberg, Austria, 2325
    • St. Georgs-Apotheke
  • Kirchberg am Wagram, Austria, 3470
    • Apotheke Zu Maria Trost
  • Klosterneuburg, Austria, 3400
    • Stadt-Apotheke
  • Klosterneuburg, Austria, 3412
    • Die Blaue Apotheke
  • Korneuburg, Austria, 2100
    • Kreis-Apotheke Zum schwarzen Adler
  • Langenlois, Austria, 3550
    • Adler-Apotheke
  • Langenlois, Austria, 3550
    • Kamptal-Apotheke
  • Lilienfeld, Austria, 3180
    • Kronen-Apotheke
  • Neunkirchen, Austria, 2620
    • Apotheke Zur Madonna
  • Neunkirchen, Austria, 2620
    • Merkur-Apotheke
  • Oberwaltersdorf, Austria, 2522
    • Triesting-Apotheke,
  • Pitten, Austria, 2823
    • Apotheke Zum heiligen Georg
  • Pottendorf, Austria, 2486
    • Apotheke Zum St. Nikolaus
  • Purgstall, Austria, 3251
    • Apotheke Purgstall
  • Pöggstall, Austria, 3650
    • Apotheke Zur Mariahilf
  • Rannersdorf, Austria, 2324
    • Wallhof-Apotheke
  • Sankt Poelten, Austria, 3100
    • Apotheke Sued
  • Sankt Poelten, Austria, 3100
    • Center Apotheke
  • Sankt Poelten, Austria, 3100
    • Hippolyt-Apotheke
  • Sankt Pölten, Austria, 3100
    • Rosen-Apotheke
  • Schrems, Austria, 3943
    • Stadt-Apotheke
  • Seitenstetten Markt, Austria, 3353
    • Linden-Apotheke
  • Traisen, Austria, 3160
    • Johannes-Apotheke
  • Traismauer, Austria, 3133
    • Apotheke Zur Mutter Gottes
  • Tribuswinkel, Austria, 2512
    • Activ Apotheke Tribuswinkel
  • Vienna, Austria, 1010
    • Urania Apotheke
  • Vienna, Austria, 1050
    • Siebenbrunnen Apotheke
  • Vienna, Austria, 1100
    • Heilfried Apotheke
  • Vienna, Austria, 1110
    • Ludwigs Apotheke
  • Vienna, Austria, 1170
    • Friedrichs Apotheke
  • Vienna, Austria, 1170
    • Linden Apotheke
  • Vienna, Austria, 1180
    • Adler Apotheke
  • Vienna, Austria, 1200
    • Arkaden Apotheke
  • Vienna, Austria, 1210
    • Rosen Apotheke
  • Vienna, Austria, 1220
    • Apotheke Neu Kagran
  • Vienna, Austria, 1220
    • St. Hubertus Apotheke
  • Vienna, Austria, 1230
    • Birken Apotheke
  • Wiener Neustadt, Austria, 2700
    • Apotheke Zur Mariahilf
  • Wiener Neustadt, Austria, 2700
    • Bahnhof-Apotheke
  • Wiener Neustadt, Austria, 2700
    • Zehnerguertel-Apotheke
  • Wimpassing, Austria, 2632
    • Apotheke Wimpassing
  • Wolkersdorf, Austria, 2120
    • Apotheke Zur heiligen Dreifaltigkeit
  • Zwettl Stadt, Austria, 3910
    • Apotheke Zum schwarzen Adler
  • Zwettl Stadt, Austria, 3910
    • Kuenringer Apotheke

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Written informed consent
• Age > 18 years
• Medically pre-treated arterial hypertension
• Automated office blood pressure ≥ 135 mmHg systolic or ≥ 85 mmHg diastolic

Exclusion Criteria:

• First ever prescription of antihypertensive medication
• First prescription of a new antihypertensive substance or dose adjustment
• Prior therapy with 4 or more different antihypertensive substances
• Systolic blood pressure ≥ 180 mmHg
• Dialysis
• Adherence to the study protocol not to be anticipated
• Inclusion into the study at another study site

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Interventional Arm; Immediate referral of hypertensive patients to the attending physician based on automated office blood pressure measurements	Behavioral: Referral of hypertensive patients to the attending physician; Immediate referral to the treating physician in case of elevated automated office blood pressure measurements
NO_INTERVENTION: Observational Arm; Repeated automated office blood pressure measurements and referral of hypertensive patients to the attending physician after completion of the trial

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients with systolic blood pressure <135 mmHg and diastolic blood pressure < 85 mmHg at 10 weeks of follow-up (automated office blood pressure measurement)	Primary endpoint	10 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in average systolic blood pressure (automated office blood pressure measurement)	Secondary endpoint	10 weeks
Change in average systolic blood pressure (automated office blood pressure measurement)	Secondary endpoint	20 weeks
Proportion of patients with systolic blood pressure <135 mmHg and diastolic blood pressure < 85 mmHg (automated office blood pressure measurement)	Secondary endpoint	20 weeks
Proportion of patients with systolic blood pressure <135 mmHg and diastolic blood pressure < 85 mmHg (home blood pressure, mean of available readings)	Secondary endpoint, patients with available home blood pressure measurements	20 weeks

Collaborators and Investigators

• Sponsor: Wilhelminenspital Vienna
• Collaborators: Association for the Promotion of Research in Atherosclerosis, Thrombosis and Vascular Biology; Österreichische Apothekerkammer, Landesgeschäftsstelle Niederösterreich; Institute for Cardiometabolic Diseases, Karl Landsteiner Society
• Investigators: Principal Investigator: Miklos Rohla, MD, 3rd Medical Department, Cardiology and Intensive Care Medicine, Wilhelminenhospital, Vienna, Austria; Study Chair: Thomas W Weiss, MD, PhD, 3rd Medical Department, Cardiology and Intensive Care Medicine, Wilhelminenhospital, Vienna, Austria

Publications and helpful links

General Publications

• Rohla M, Haberfeld H, Tscharre M, Huber K, Weiss TW. Pharmacist interventions to improve blood pressure control in primary care: a cluster randomised trial. Int J Clin Pharm. 2022 Nov 8. doi: 10.1007/s11096-022-01452-1. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 16, 2017
• Primary Completion (ACTUAL): December 31, 2019
• Study Completion (ACTUAL): December 31, 2019

Study Registration Dates

• First Submitted: September 5, 2017
• First Submitted That Met QC Criteria: September 5, 2017
• First Posted (ACTUAL): September 7, 2017

Study Record Updates

• Last Update Posted (ACTUAL): April 7, 2020
• Last Update Submitted That Met QC Criteria: April 5, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: APOTHECARE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No