EAL

MNT: RDN in Medical Team (2015)

Citation:

Costa e Silva R, Pellanda L, Portal V, maciel P, Furquim A, Schaan B. Transdiciplinary approach to the follow-up of patients after myocardial infarction. Clinics, 2008; 63: 489-496.

PubMed ID: 18719760

Study Design:

Randomized Controlled Trial

Class:

A - Click here for explanation of classification scheme.

Quality Rating:

POSITIVE: See Quality Criteria Checklist below.

Research Purpose:

To test the effectiveness of transdisciplinary care as compared to conventional care provided to patients after their first acute myocardial infarction (AMI).

Inclusion Criteria:

Hospitalized for first AMI (inclusion criteria not otherwise described).

Exclusion Criteria:

Not described.

Description of Study Protocol:

Recruitment

Subjects were patients that had been hospitalized for their first AMI.

Design

This randomized clinical trial contained two groups: The Transdisciplinary Care Group (TC, intervention) and the Conventional Care Group (CC, control), which were distributed randomly in blocks of 20 by randomization software
During their hospital stay, all patients received treatment according to the American Heart Association guidelines. Before discharge, they were visited by a dietitian who conducted a nutritional evaluation and prescribed a post-discharge diet plan.
CC patients were discharged and referred to the conventional outpatient clinic, where they were seen only by the appointed cardiologist
TC patients were referred for continued care to the outpatient clinic, which employed a trans-disciplinary approach
The follow-up period was six months.

Blinding Used

The patients and health professionals involved in outpatient treatment were not blinded as to the treatment allocation.

Intervention

Trans-disciplinary care was provided at the outpatient clinic by a cardiologist, endocrinologist, nurse and dietitian
Patients were seen at 60 to 90 days after AMI and 120 to 180 days after AMI. The visits followed National Cholesterol Education Program (NCEP) guidelines.
Patients were initially seen by a nurse. Drugs in use and smoking status were reviewed. Patients who were still smoking were advised to stop by the nurse and cardiologist. In diabetic patients, capillary glycemia was measured, lower limbs were examined and adherence to oral anti-diabetic agents and insulin were reviewed.
The dietitian then evaluated body weight and performed a nutritional review, followed by reinforcement of healthy nutritional habits. An individualized management plan was formulated with the patient, family, physician and other members of the health care team.
The visit ended with an evaluation by the cardiologist, which included medical history, physical examination and complementary tests
Diabetic patients were evaluated by an endocrinologist. Drug prescription followed the American Diabetes Association guidelines.
Patients who did not have any signs of ischemia eight weeks after AMI were encouraged to perform aerobic exercises, especially walking
All health professionals worked as a team and discussed the patients’ needs and management before they were released.

Statistical Analysis

A power calculation estimated that 80 individuals were needed in each group for 80% power
Intent-to-treat analysis was conducted
Chi-square test: Differences in initial characteristics and outcomes among the comparison groups for nominal variables
Student’s T-test: Differences in initial characteristics and outcomes among the comparison groups for continuous variables
ANOVA for repeated measures: Follow-up comparisons.

Data Collection Summary:

Timing of Measurements

Baseline and 60 to 180 days post-AMI.

Dependent Variables

Primary outcome was clinical improvement evaluated by means of a constructed index comprising:

Body weight
Blood pressure
Smoking
Physical activity
Medication compliance.

Secondary outcomes:

Death
Re-hospitalization
A combination of death and re-hospitalization.

Independent Variables

Transdisciplinary care conventional care.

Description of Actual Data Sample:

Initial N
153 (97 male, 53 female).

Attrition (Final N)

146 (71 in CC, 75 in TC)
Seven patients died while still in the hospital after being randomized
5% attrition.

Age
58.0±11.2 years.

Ethnicity
Not described.

Other Relevant Demographics
26.0% were more than 65 years old.

Anthropometrics:

64.6% were sedentary
86.3% had AMI with ST-segment elevation
32.7% reported a personal history of diabetes mellitus before AMI
72.2% reported a personal history of arterial hypertension
The groups were similar to each other at baseline.

Location
Brazil.

Summary of Results:

Key Findings

The clinical improvement index was very good in 33.3% TC patients and 30.4% of CC patients (P=1.000)
Compliance with diet was higher with TC (50.0%) vs. CC (26.1%; P=0.007)
Compliance with visits was higher with TC (73.3%) vs. CC (40.3%; P<0.001)
Other clinical outcomes, including re-hospitalization and death, were similar between groups
The percentages of patients who achieved targets for body weight reduction, blood pressure and lipid levels were not different between groups.

Author Conclusion:

Compliance with diet and visits was higher with trans-disciplinary care than with conventional care. However, the trans-disciplinary approach did not provide more clinical benefits than the conventional approach for patients after their first acute myocardial infarction.

Funding Source:

University/Hospital:

Institute of Cardiology of Rio Grande do Sul/Fundacao Universitaria de Cardiologia; Endocrine Division, Hospital de Clinicas de Porto Alegre

Reviewer Comments:

Relatively small sample size
Short duration of follow-up (six months). A longer follow-up period might disclose differences in end-points since they are directly related to compliance with diet and visits.
Contamination of the control group with patients from the intervention group: Many patients in the TC Group were sent back to CC by their physicians.

Quality Criteria Checklist: Primary Research
Relevance Questions
	1.	Would implementing the studied intervention or procedure (if found successful) result in improved outcomes for the patients/clients/population group? (Not Applicable for some epidemiological studies)	Yes
	2.	Did the authors study an outcome (dependent variable) or topic that the patients/clients/population group would care about?	Yes
	3.	Is the focus of the intervention or procedure (independent variable) or topic of study a common issue of concern to dieteticspractice?	Yes
	4.	Is the intervention or procedure feasible? (NA for some epidemiological studies)	Yes

Validity Questions
1.	Was the research question clearly stated?		Yes
	1.1.	Was (were) the specific intervention(s) or procedure(s) [independent variable(s)] identified?	Yes
	1.2.	Was (were) the outcome(s) [dependent variable(s)] clearly indicated?	Yes
	1.3.	Were the target population and setting specified?	Yes
2.	Was the selection of study subjects/patients free from bias?		Yes
	2.1.	Were inclusion/exclusion criteria specified (e.g., risk, point in disease progression, diagnostic or prognosis criteria), and with sufficient detail and without omitting criteria critical to the study?	Yes
	2.2.	Were criteria applied equally to all study groups?	Yes
	2.3.	Were health, demographics, and other characteristics of subjects described?	Yes
	2.4.	Were the subjects/patients a representative sample of the relevant population?	Yes
3.	Were study groups comparable?		Yes
	3.1.	Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT)	Yes
	3.2.	Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline?	Yes
	3.3.	Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.)	???
	3.4.	If cohort study or cross-sectional study, were groups comparable on important confounding factors and/or were preexisting differences accounted for by using appropriate adjustments in statistical analysis?	N/A
	3.5.	If case control study, were potential confounding factors comparable for cases and controls? (If case series or trial with subjects serving as own control, this criterion is not applicable.)	N/A
	3.6.	If diagnostic test, was there an independent blind comparison with an appropriate reference standard (e.g., "gold standard")?	N/A
4.	Was method of handling withdrawals described?		Yes
	4.1.	Were follow-up methods described and the same for all groups?	Yes
	4.2.	Was the number, characteristics of withdrawals (i.e., dropouts, lost to follow up, attrition rate) and/or response rate (cross-sectional studies) described for each group? (Follow up goal for a strong study is 80%.)	Yes
	4.3.	Were all enrolled subjects/patients (in the original sample) accounted for?	Yes
	4.4.	Were reasons for withdrawals similar across groups?	Yes
	4.5.	If diagnostic test, was decision to perform reference test not dependent on results of test under study?	N/A
5.	Was blinding used to prevent introduction of bias?		Yes
	5.1.	In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate?	Yes
	5.2.	Were data collectors blinded for outcomes assessment? (If outcome is measured using an objective test, such as a lab value, this criterion is assumed to be met.)	Yes
	5.3.	In cohort study or cross-sectional study, were measurements of outcomes and risk factors blinded?	N/A
	5.4.	In case control study, was case definition explicit and case ascertainment not influenced by exposure status?	N/A
	5.5.	In diagnostic study, were test results blinded to patient history and other test results?	N/A
6.	Were intervention/therapeutic regimens/exposure factor or procedure and any comparison(s) described in detail? Were interveningfactors described?		Yes
	6.1.	In RCT or other intervention trial, were protocols described for all regimens studied?	Yes
	6.2.	In observational study, were interventions, study settings, and clinicians/provider described?	N/A
	6.3.	Was the intensity and duration of the intervention or exposure factor sufficient to produce a meaningful effect?	???
	6.4.	Was the amount of exposure and, if relevant, subject/patient compliance measured?	Yes
	6.5.	Were co-interventions (e.g., ancillary treatments, other therapies) described?	Yes
	6.6.	Were extra or unplanned treatments described?	N/A
	6.7.	Was the information for 6.4, 6.5, and 6.6 assessed the same way for all groups?	Yes
	6.8.	In diagnostic study, were details of test administration and replication sufficient?	N/A
7.	Were outcomes clearly defined and the measurements valid and reliable?		Yes
	7.1.	Were primary and secondary endpoints described and relevant to the question?	Yes
	7.2.	Were nutrition measures appropriate to question and outcomes of concern?	Yes
	7.3.	Was the period of follow-up long enough for important outcome(s) to occur?	???
	7.4.	Were the observations and measurements based on standard, valid, and reliable data collection instruments/tests/procedures?	Yes
	7.5.	Was the measurement of effect at an appropriate level of precision?	Yes
	7.6.	Were other factors accounted for (measured) that could affect outcomes?	N/A
	7.7.	Were the measurements conducted consistently across groups?	Yes
8.	Was the statistical analysis appropriate for the study design and type of outcome indicators?		Yes
	8.1.	Were statistical analyses adequately described and the results reported appropriately?	Yes
	8.2.	Were correct statistical tests used and assumptions of test not violated?	Yes
	8.3.	Were statistics reported with levels of significance and/or confidence intervals?	Yes
	8.4.	Was "intent to treat" analysis of outcomes done (and as appropriate, was there an analysis of outcomes for those maximally exposed or a dose-response analysis)?	Yes
	8.5.	Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)?	???
	8.6.	Was clinical significance as well as statistical significance reported?	N/A
	8.7.	If negative findings, was a power calculation reported to address type 2 error?	Yes
9.	Are conclusions supported by results with biases and limitations taken into consideration?		Yes
	9.1.	Is there a discussion of findings?	Yes
	9.2.	Are biases and study limitations identified and discussed?	Yes
10.	Is bias due to study's funding or sponsorship unlikely?		Yes
	10.1.	Were sources of funding and investigators' affiliations described?	Yes
	10.2.	Was the study free from apparent conflict of interest?	Yes