Effect of a pharmacotherapeutic management protocol in patients hospitalized with cardiovascular diseases

• Register: REBEC
• Last refreshed on: 29 April 2013
• Main ID: RBR-26ydc3
• Date of registration: 27/10/2011
• Primary sponsor: Alfredo Dias de Oliveira Filho - Brazil
• Public title: Effect of a pharmacotherapeutic management protocol in patients hospitalized with cardiovascular diseases
• Scientific title: Improving Medication Adherence and Clinical Outcomes Following Hospitalization in Chronic Cardiovascular Disease
• Date of first enrolment: 07/01/2010
• Target sample size: 380
• Recruitment status: recruiting
• URL: http://www.ensaiosclinicos.gov.br/rg/RBR-26ydc3/
• Study design: Single-blind randomized controlled trial with two arms.

Countries of recruitment

Brazil

Contacts

• Name: Alfredo de Oliveira Filho
• Affiliation: Fundação de Apoio à Pesquisa do Estado de Alagoas

• Name: Alfredo de Oliveira Filho
• Affiliation: Universidade Federal de Alagoas

Key inclusion & exclusion criteria

Inclusion criteria: Aiming maximum inclusiveness we recruited all patients who had a discharge diagnosis
of CVD and who were on antihypertensive medication.
Exclusion criteria: Patients were excluded if they reported already using any tool to improve their adherence.

Age minimum: 18Y
Age maximum: 90
Gender: -

Health Condition(s) or Problem(s) studied

Cardiovascular diseases
N04.452.706.477
E02.760.400
F01.145.488.500.500
E02

Intervention(s)

We have developed our intervention based on four-item Morisky Medication Adherence Scale (MMAS-4), which has been shown to be predictive of adherence to cardiovascular medications and blood pressure control, aiming to prevent both intentional and unintentional non-adherence behaviour (INAB and UNAB respectively). This protocol consists
of 2 distinct parts: patient-centered verbal instructions (to prevent INAB) and written material about prescribed medications (to prevent UNAB).

The main elements of the discharge counseling were as follows: a) information about disease process/prognosis; b) information about discharge medications (eg, therapeutic goals; how to monitor drug treatment, especially drug-food interactions and adverse drug reactions; and how to handle inaccurate dosing systems or unusual dosage forms). Subjects considered critical to success of treatment were discussed with the patient. Additional information (e.g., dosage schedule) was written on a drug treatment card adapted as a refrigerator magnet.

The intervention occurred in the patient's room after the confirmation of discharge.

Participants in the control group received hospital's usual care.

We estimated that a sample size of at least 32 patients in each group would provide 80% power to detect a 30% difference in medication adherence by using a t-test with a 2-sided ? level of 0.05.

Primary Outcome(s)

Medication adherence was assessed by phone call with the eight-item Morisky Medication Adherence Scale (MMAS-8).
Medication adherence was assessed at 1 month post hospital discharge and re-assessed 1 year after hospital discharge.
The study was closed 12 months after
the last patient had been discharged. Patients who had been readmitted to the study site hospital during the 12-month follow-up period did not receive the intervention again.

Secondary Outcome(s)

Readmission and mortality rates

1 year after their inclusion in study, consenting participants were asked to report the number of hospitalizations related to cardiovascular diseases in the study year via phone call. Deaths were confirmed via death certificate.

Secondary ID(s)

010186/2009-01

Source(s) of Monetary Support

Fundação de Apoio à Pesquisa do Estado de Alagoas - Brazil

Secondary Sponsor(s)

Universidade Federal de Alagoas - Brazil