Pharmaceutical Care in the Reduction of Readmission Rates in Diabetes Melitus

NCT03786978 | Completed

• 1 other identifier: 150118
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetes Mellitus

Keywords

Diabetes mellitus; Pharmaceutical care; Educational intervention; Pharmacoeconomic evaluation

Outcome Measures

Primary Outcomes (1)

• Short term readmission rate

  Hospital readmissions after basal hospital discharge

  30 days after basal hospital discharge

Secondary Outcomes (5)

• Readmission rate - 60 days

  60 days after basal hospital discharge

• Readmission rate - 90 days

  90 days after basal hospital discharge

• Long term readmission rate- 180 days

  180 days after basal hospital discharge

• Long term readmission rate- 365 days

  365 days after basal hospital discharge

• Economic evaluation

  365 days

Study Arms (2)

Structured pharmaceutical care

EXPERIMENTAL

Patients receive a structured pharmaceutical care until one year after hospital discharge

Behavioral: Structured pharmaceutical care

Comparator group

ACTIVE COMPARATOR

Patient received a single phone call 30 days after basal hospital discharge.

Behavioral: Comparator

Interventions

Structured pharmaceutical care BEHAVIORAL

Patients receive a structured pharmaceutical care from one year after basal hospital discharge

Structured pharmaceutical care

Comparator BEHAVIORAL

Patient received a single phone call 30 days after basal hospital discharge.

Comparator group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Ticiana C Rodrigues, PhD

  Federal University of Health Science of Porto Alegre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessor made a blind evaluation from the study outcomes.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized clinical trial study

Study Record Dates

• First Submitted: December 21, 2018
• First Posted: December 26, 2018
• Study Start: September 9, 2015
• Primary Completion: December 31, 2017
• Study Completion: January 30, 2018
• Last Updated: January 7, 2019

Record last verified: 2015-09

Data Sharing

• IPD Sharing: Will not share