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Pharmaceutical Care in the Reduction of Readmission Rates in Diabetes Melitus

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ClinicalTrials.gov Identifier: NCT03786978
Recruitment Status : Completed
First Posted : December 25, 2018
Last Update Posted : January 7, 2019
Sponsor:
Information provided by (Responsible Party):
Hospital de Clinicas de Porto Alegre

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.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus Behavioral: Structured pharmaceutical care Behavioral: Comparator Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized clinical trial study
Masking: Single (Outcomes Assessor)
Masking Description: The outcomes assessor made a blind evaluation from the study outcomes.
Primary Purpose: Supportive Care
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
Actual Study Start Date : September 9, 2015
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : January 30, 2018

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Short term readmission rate [ Time Frame: 30 days after basal hospital discharge ]
    Hospital readmissions after basal hospital discharge


Secondary Outcome Measures :
  1. Readmission rate - 60 days [ Time Frame: 60 days after basal hospital discharge ]
    Hospital readmissions after basal hospital discharge

  2. Readmission rate - 90 days [ Time Frame: 90 days after basal hospital discharge ]
    Hospital readmissions after basal hospital discharge

  3. Long term readmission rate- 180 days [ Time Frame: 180 days after basal hospital discharge ]
    Hospital readmissions after basal hospital discharge

  4. Long term readmission rate- 365 days [ Time Frame: 365 days after basal hospital discharge ]
    Hospital readmissions after basal hospital discharge

  5. Economic evaluation [ Time Frame: 365 days ]
    Comparison between costs from readmission in both randomized groups



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03786978


Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Investigators
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Principal Investigator: Ticiana C Rodrigues, PhD Federal University of Health Science of Porto Alegre

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Responsible Party: Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT03786978     History of Changes
Other Study ID Numbers: 150118
First Posted: December 25, 2018    Key Record Dates
Last Update Posted: January 7, 2019
Last Verified: September 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hospital de Clinicas de Porto Alegre:
Diabetes mellitus
Pharmaceutical care
Educational intervention
Pharmacoeconomic evaluation

Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases