Diabetes MellitusNCT03786978
Pharmaceutical Care in the Reduction of Readmission Rates in Diabetes Melitus
A study testing Structured pharmaceutical care and Comparator in people with Diabetes Mellitus, run by Hospital de Clinicas de Porto Alegre.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Structured pharmaceutical care and Comparator
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 9 Sep 2015to 30 Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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
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.
Read the 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.
- Conditions
- Diabetes Mellitus
- Being tested
- Structured pharmaceutical care, Comparator
- Keywords
- Diabetes mellitus, Pharmaceutical care, Educational intervention, Pharmacoeconomic evaluation
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured pharmaceutical careBehavioural
Patients receive a structured pharmaceutical care from one year after basal hospital discharge
ComparatorBehavioural
Patient received a single phone call 30 days after basal hospital discharge.
| Study group | Role | What they receive |
|---|---|---|
| Structured pharmaceutical care | Experimental | Patients receive a structured pharmaceutical care until one year after hospital discharge Receives: Behavioral: Structured pharmaceutical care |
| Comparator group | Active comparator | Patient received a single phone call 30 days after basal hospital discharge. Receives: Behavioral: Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short term readmission rate
Hospital readmissions after basal hospital discharge
Measured: 30 days after basal hospital discharge
Secondary outcomes (5)
Readmission rate - 60 days
Hospital readmissions after basal hospital discharge
Measured: 60 days after basal hospital discharge
Readmission rate - 90 days
Hospital readmissions after basal hospital discharge
Measured: 90 days after basal hospital discharge
Long term readmission rate- 180 days
Hospital readmissions after basal hospital discharge
Measured: 180 days after basal hospital discharge
Long term readmission rate- 365 days
Hospital readmissions after basal hospital discharge
Measured: 365 days after basal hospital discharge
Economic evaluation
Comparison between costs from readmission in both randomized groups
Measured: 365 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2018
- Study start9 Sep 2015
- Primary completion31 Dec 2017
- Study completion30 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized clinical trial study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ticiana C Rodrigues, PhD, Principal investigator, Federal University of Health Science of Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03786978
- Sponsor's protocol ID
- 150118
- Status last verified
- Sep 2015
- First submitted
- 21 Dec 2018
- Last updated
- 7 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03786978
- Acronym / sponsor ID
- 150118
- Conditions
- Diabetes Mellitus
- Keywords
- Diabetes mellitus, Pharmaceutical care, Educational intervention, Pharmacoeconomic evaluation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- 9 Sep 2015 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 30 Jan 2018 (actual)
- First posted
- 26 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized clinical trial study
| Arm | Type | Receives |
|---|---|---|
| Structured pharmaceutical care | Experimental | Behavioral: Structured pharmaceutical carePatients receive a structured pharmaceutical care until one year after hospital discharge |
| Comparator group | Active comparator | Behavioral: ComparatorPatient received a single phone call 30 days after basal hospital discharge. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured pharmaceutical carePatients receive a structured pharmaceutical care from one year after basal hospital discharge | Behavioural | Structured pharmaceutical care |
| ComparatorPatient received a single phone call 30 days after basal hospital discharge. | Behavioural | Comparator group |
Primary outcome
Short term readmission rate
Time frame: 30 days after basal hospital discharge
Hospital readmissions after basal hospital discharge
5 secondary outcomes
Readmission rate - 60 days
Time frame: 60 days after basal hospital discharge
Readmission rate - 90 days
Time frame: 90 days after basal hospital discharge
Long term readmission rate- 180 days
Time frame: 180 days after basal hospital discharge
Long term readmission rate- 365 days
Time frame: 365 days after basal hospital discharge
Economic evaluation
Time frame: 365 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ticiana C Rodrigues, PhD principal investigator
Federal University of Health Science of Porto Alegre
Questions about this trial
What is this clinical trial studying?
A study testing Structured pharmaceutical care and Comparator in people with Diabetes Mellitus, run by Hospital de Clinicas de Porto Alegre.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short term readmission rate (time frame: 30 days after basal hospital discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2019.