Clinical trial NCT03786978: Pharmaceutical Care in the Reduction of Readmission Rates in Diabetes Melitus
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: Diabetes mellitus
Pharmaceutical care
Educational intervention
Pharmacoeconomic evaluation
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2018-12-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized clinical trial study
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Patients with DM and other comorbidities hospitalized for any reason at HCPA
* Patients who are literate or have a literate caregiver;
* Signature in the Term of Consent.

Exclusion Criteria:

* Limited ability to communicate and read in Portuguese and absence of responsible caregiver at the patient room;
* Neuropsychiatric diseases (psychosis, delirium or severe dementia);
* Terminal illness;
* Transplanted patients or users of warfarin, as these patients receive formal guidance from the HCPA pharmaceutical team;
* Auditory or visual impairment that, at the discretion of the investigator, prevents the patient from participating in the study;
* Do not have own mobile number or a close family member living in the same household.

Primary outcomes:
measure: Short term readmission rate
timeFrame: 30 days after basal hospital discharge
Secondary outcomes:
measure: Readmission rate - 60 days
timeFrame: 60 days after basal hospital discharge
measure: Readmission rate - 90 days
timeFrame: 90 days after basal hospital discharge
measure: Long term readmission rate- 180 days
timeFrame: 180 days after basal hospital discharge
measure: Long term readmission rate- 365 days
timeFrame: 365 days after basal hospital discharge
measure: Economic evaluation
timeFrame: 365 days
Other outcomes:
Locations:
Study officials:
affiliation: Federal University of Health Science of Porto Alegre
name: Ticiana C Rodrigues, PhD
role: PRINCIPAL_INVESTIGATOR
References: