Impact of a Pharmaceutical Care Model in the Reduction of Readmission Rate in Diabetes Melitus Patients in a Public University Hospital, South Brazil
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 主要终点
- Short term readmission rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
The outcomes assessor made a blind evaluation from the study outcomes.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Structured pharmaceutical care
Patients receive a structured pharmaceutical care until one year after hospital discharge
干预措施: Structured pharmaceutical care (Behavioral)
Comparator group
Patient received a single phone call 30 days after basal hospital discharge.
干预措施: Comparator (Behavioral)
结局指标
主要结局
Short term readmission rate
时间窗: 30 days after basal hospital discharge
Hospital readmissions after basal hospital discharge
次要结局
- Long term readmission rate- 365 days(365 days after basal hospital discharge)
- 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)
- Economic evaluation(365 days)