Pharmaceutical Care in the Reduction of Readmission Rates in Diabetes Melitus

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Behavioral: Structured pharmaceutical care; Behavioral: Comparator

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

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:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Structured pharmaceutical care; Patients receive a structured pharmaceutical care until one year after hospital discharge	Behavioral: Structured pharmaceutical care; Patients receive a structured pharmaceutical care from one year after basal hospital discharge
ACTIVE_COMPARATOR: Comparator group; Patient received a single phone call 30 days after basal hospital discharge.	Behavioral: Comparator; Patient received a single phone call 30 days after basal hospital discharge.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Short term readmission rate	Hospital readmissions after basal hospital discharge	30 days after basal hospital discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Readmission rate - 60 days	Hospital readmissions after basal hospital discharge	60 days after basal hospital discharge
Readmission rate - 90 days	Hospital readmissions after basal hospital discharge	90 days after basal hospital discharge
Long term readmission rate- 180 days	Hospital readmissions after basal hospital discharge	180 days after basal hospital discharge
Long term readmission rate- 365 days	Hospital readmissions after basal hospital discharge	365 days after basal hospital discharge
Economic evaluation	Comparison between costs from readmission in both randomized groups	365 days

Collaborators and Investigators

• Sponsor: Hospital de Clinicas de Porto Alegre
• Investigators: Principal Investigator: Ticiana C Rodrigues, PhD, Federal University of Health Science of Porto Alegre

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 9, 2015
• Primary Completion (ACTUAL): December 31, 2017
• Study Completion (ACTUAL): January 30, 2018

Study Registration Dates

• First Submitted: December 21, 2018
• First Submitted That Met QC Criteria: December 24, 2018
• First Posted (ACTUAL): December 26, 2018

Study Record Updates

• Last Update Posted (ACTUAL): January 7, 2019
• Last Update Submitted That Met QC Criteria: January 3, 2019
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: Diabetes mellitus; Pharmaceutical care; Educational intervention; Pharmacoeconomic evaluation
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: 150118

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