Diabetes Mellitus Clinical Trial
Official title:
Impact of a Pharmaceutical Care Model in the Reduction of Readmission Rate in Diabetes Melitus Patients in a Public University Hospital, South Brazil
Diabetes mellitus (DM) is associated with the frequent use of polypharmacy at different times
of administration and requires special attention from the patient or caregivers in order to
properly treatment performed. The degree of Functional Literacy in Health is defined as the
ability to apply literacy skills to health-related materials, including prescriptions,
package inserts, and home care instructions. Several questionnaires are used in research and
clinical practice to assess the pronunciation and understanding of commonly used medical
terms, as the SAHLPA-18 (Short Assessment of Health Literacy for Portuguese Speaking Adults).
The Brief Medication Questionnaire (BMQ) evaluates adherence to medication use from a
patient's perspective.
During the basal visit, after the characterization of the sample (n= 100), inpatients from
Hospital de Clínicas de Porto Alegre (HCPA) were randomized to interventional or comparator
group. The interventional group was follow up during a year after basal discharge. Comparator
group received only a phone call, 30 days after the basal discharge, to question how was
their healthy status. Readmission rates were evaluated for both groups. Also, a economic
evaluation was made to measure the readmission rates in terms of costs.
The first outcome of the clinical study was to measure the readmission rate through a
structured pharmaceutical care model after basal hospital discharge and measure the effect of
this intervention in terms of readmission reduction in a short term period of 30 days,
regardless of the hospitalization reason.
As secondary outcomes the investigators measured the readmission rates after basal hospital
discharge and the effect of the intervention in terms of readmission reduction in 60, 90,180
and 365 days after basal hospital discharge. Also, the readmission costs in terms of
cost-effectiveness were evaluate.
The sample consisted of 100 patients with DM associated with other comorbidities,
hospitalized for any reason in the HCPA, of both sexes, older than 18 years.
Informed consent, demographic and validated questionnaires data were collected in the basal
visit. After that, patients were randomized to:
Group 1: comparator; Group 2: structured pharmaceutical intervention.
Seven days after basal hospital discharge, drugs adherence was verified.
The interventional group received pharmaceutical care at basal hospitalization stay, after
randomization, have their prescription reviewed until 7 days after discharge of basal
hospitalization and also received structured phone calls and mobile SMS (Short Message
Service) during one year follow up (30, 60, 180 and 365 days).
Electronic medical records of the included patients (intervention and comparator groups) were
reviewed monthly for 12 months, aiming to identify access to emergency services or hospital
readmissions at the HCPA and, consequently, the reasons for readmissions and outcomes.
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