EAL

MNT: RDN in Medical Team (2015)

Citation:

Cueto-Manzano AM, Martinez-Ramirez HR, Cortes-Sanabria L. Comparison of primary health-care models in the management of chronic kidney disease. Kidney International Supplements. 2013; 3: 210-214. PubMed ID: 25018986

Study Design:

Non-Randomized Controlled Trial

Class:

C - Click here for explanation of classification scheme.

Quality Rating:

POSITIVE: See Quality Criteria Checklist below.

Research Purpose:

To test the hypothesis that, besides adequate training of family physicians, a multiple educative approach directed at patients and guided by a multi-disciplinary health care team would attain better results on lifestyle habits and renal function of type 2 diabetes mellitus (DM2) patients with early chronic kidney disease (CKD) than a conventional approach in which the primary physician plays the major role in treating patients and decides when to refer to other health professionals.

Inclusion Criteria:

Diagnosis of DM2
Patient at two family medicine units of the Mexican Institute of Social Security (IMSS)
No previous diagnosis of CKD or diagnosis of early CKD [presence of microalbuminuria with normal or slightly decreased GFR (at least 60ml per minute per 1.73m²)].

Exclusion Criteria:

No DM2 diagnosis
Not a patient at the two family medicine units of the Mexican Institute of Social Security (IMSS)
Diagnosis of CKD beyond early stage.

Description of Study Protocol:

Recruitment
DM2 patients from two family medicine units of the Mexican Institute of Social Security in the Greater Guadalajara.

Design

DM2 patients from two family medicine units of the Mexican Institute of Social Security were included in the study. One unit was assigned to evaluate a multiple intervention model it had implemented for several years; no subject had been previously exposed to this model. Another unit was randomly selected as a control cohort from among 20 units using a conventional healthcare model. After agreeing to participate, all subjects received an educational intervention (two hours a week over four weeks) comprising information sessions guided by a multi-disciplinary team:

Emotional management skills (conducted by social worker)
Nutritional advice (by a dietitian)
Exercise (by a physical trainer)
Health-related problems (by family physician).

Appointments were made every three months to evaluate the status of individuals and groups, perform group dynamics, establish goals for the next meeting and identify individuals requiring individual report. The conventional healthcare model subjects were managed only by the family physician, who provided assessments and treatments and decided if a subject needed to be referred to other health professionals. All patients completed a lifestyle questionnaire (IMEVID) at baseline and at the end of follow-up (six months) and had clinical and biochemical evaluations performed every three months. Concurrently, all patients made regular monthly visits to the family physician.

Additionally, all family physicians received an educational intervention regarding DM2 and CKD by means of an interactive theory-practice model based on the content of the Clinical Practice Guidelines for Prevention, Diagnosis and Treatment of Early CKD. To measure clinical competence, a previously validated questionnaire on diabetic nephropathy was completed by all physicians at baseline and after course conclusion.

Blinding Used
None.

Intervention
Primary healthcare model in management of chronic kidney disease.

Statistical Analysis

Data expressed as mean plus or minus standard deviation or median when dimensional variables had parametric or non-parametric distribution, respectively, or as percentage in the case of nominal values
Comparison between groups were performed using independent Student's T-test, Mann-Whitney U-test or X² tests, as appropriate
Intragroup analysis performed using paired-samples Student T-test, Wilcoxon or McNemar tests, as appropriate
P<0.05 accepted as significant.

Data Collection Summary:

Timing of Measurements

Lifestyle questionnaire at baseline and at the end of follow-up (six months)
Clinical (body mass index, waist circumference, systolic and diastolic blood pressure) and biochemical evaluations [hemoglobin A_1C, total cholesterol, high density lipoprotein cholesterol (HDL-C), low density lipoprotein cholesterol (LDL-C), triglycerides, uric acid] performed every three months
Socio-demographic characteristics collected at baseline
Medical treatment results (antihypertensive drug use, angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, aspirin, non-steroidal anti-inflammatory drugs, lipid-lowering drugs and anti-diabetics drugs).

Dependent Variables

Clinical evaluations (body mass index, waist circumference, systolic and diastolic blood pressure)
Biochemical evaluations (hemoglobin A_1C, total cholesterol, HDL-C, LDL-C, triglycerides, uric acid, glomerular filtration rate and albuminuria or creatinine)
Lifestyle patterns (knowledge of disease, adherence to treatment, emotion management, exercise, tobacco consumption, alcohol consumption and diet)
Clinical competence of family physicians
Medical treatment results.

Independent Variables

Primary healthcare model in management of chronic kidney disease.

Control Variables

Age
Gender
Family history of diabetes, hypertension and CKD
Literacy
Duration of diabetes
Presence and duration of hypertension.

Description of Actual Data Sample:

Initial N: 96 subjects (53 males, 43 females)
Attrition (final N): 78 subjects have completed six months of follow up (39 subjects in each cohort)
Age: MIM cohort, 62.1±11 years; CHCM cohort, 61±10 years
Ethnicity: Not described.
Other relevant demographics: Baseline socio-demographic characteristics including illiteracy, smoking, alcoholism, duration of diabetes and hypertension and family history were similar between cohorts
Anthropometrics: No significant differences in body mass index, weight and waist circumference between cohorts at baseline
Location: Greater Guadalajara area, Mexico.

Summary of Results:

Key Findings

Lifestyle results
- Results of the lifestyle questionnaire were not significantly different between cohorts at baseline and reflected an unhealthy lifestyle
- After six months, total score and dietary habits displayed improvement in both cohorts, however these and other variables evaluated by the instrument showed more improvement in MIM than in CHCM cohorts.
Clinical and biochemical results
- Concomitantly with changes in lifestyle, blood pressure decreased in patents of both cohorts
- Body mass index, waist circumference and hemoglobin A_1C significantly decreased in patients in MIM cohort and were unchanged in CHCM cohort.
Renal function results: At the six-month follow-up, GFR was maintained at similar levels in patients of both cohorts, however albuminuria significantly decreased only in MIM cohort and remained unchanged in CHCM cohort
Medical treatment results
- Patients of both cohorts significantly increased (P<0.05) the number of antihypertensive drugs used and had a non-significant trend to increase the use of angiotensin-converting enzyme inhibitors and angiotensin receptor blockers
- The final number of antihypertensives was significantly higher (P<0.05) in CHCM than in MIM
- Both cohorts significantly increased use of aspirin (P<0.05) and decreased use of other non-steroidal anti-inflammatory drugs (P<0.05)
- Increase in the number of lipid-lowering drugs used in both cohorts, but only statistically significant (P<0.05) in MIM patients.
Clinical competence of family physicians
- 37 family physicians participated; 16 in MMI and 21 in CHCM
- No differences were found in terms of age, gender and years of work experience at baseline
- Clinical competence of both cohorts significantly improved after intervention (P<0.05).

Variables	MMI (N=39)		CHMC (N=39)
Variables	Baseline	Final	Baseline	Final
Knowledge of Disease Highest possible score: 8	2.8±2.9	5.4±2.7 ^{a, b}	3.6±2.4	4.5±2.5
Adherence to Treatment Highest possible score: 16	11.3±4.5	13.8±3.0	12.2±3.7	12.5±3.4
Emotion Management Highest possible score: 12	7.3±3.5	9.8±3.2 ^{a, b}	5.7±3.3	6.3±3.7
Exercise Highest possible score: 12	6.0±4.0	7.3±3.4 ^{a, b}	5.9±4.0	5.8±3.5
Tobacco Consumption Highest possible score: 8	7.6±1.4	8.0±0^b	6.9±2.4	7.2±1.7
Alcohol Consumption Highest possible score: 8	6.6±2.3	7.6±1.2^{a, b}	6.2±2.7	6.7±2.1
Diet Highest possible score: 36	25.5±5.7	29.7±3.7^{a, b}	24.6±5.1	27.9±3.9^a
Total Score of Lifestyle Questionnaire Highest possible score: 100	66.5±12.5	79.5±10^{a, b}	65.5±11.5	71.7±10.8^a
Systolic Blood Pressure (mmHg)	150±25	140±30^a	157±22	144±21^a
Diastolic Blood Pressure (mmHg)	82±11	77±11^a	83±11	78±9^a
Body Mass Index (kg/m²)	27.9±4.4	27±4.3^{a, b}	29.6±4.9	29.3±5.5
Waist Circumference (cm)	99±11	96±11^a	100±11	100±12
Hemoglobin A_1C (%)	10.2±2.2	9.1±2.4^a	9.4±2.3	9.6±2.3
Total Cholesterol (mg/dl)	202 (177-235)	194 (169-226)	196 (175-219)	195 (167-220)
Triglycerides (mg/dl)	177 (119-266)	166 (127-214)	174 (130-238)	180 (135-266)
Uric Acid (mg/dl)	5.4±1.7	5.7±1.3	5.1±1.7	5.6±1.8^a

a: P<0.05 vs. baseline in same cohort
b: P<0.05 vs. same evaluation of the CHCM cohort.

Author Conclusion:

A MIM achieves better control of lifestyle related variables in DM2 patients with stages one and two of CKD, which are not modified by physicians acting in a CHCM
It is also important to adequately train primary health-care professionals in the management of early CKD
Broadly, implementation of a MIM in a primary healthcare setting may have better results than CHCM in avoiding or slowing progression of CKD.

Funding Source:

Government:

National Health and Medical Research Council of Australia, National Institutes of Health,

Not-for-profit

ISN COMGAN Research and Prevention Committee

Reviewer Comments:

Study limitations include:

Small sample size
Short follow-up period
External validity questionable without further multi-center studies.

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)	No
	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.)	Yes
	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?	Yes
	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?	N/A
	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?	Yes
	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?	N/A
	6.2.	In observational study, were interventions, study settings, and clinicians/provider described?	Yes
	6.3.	Was the intensity and duration of the intervention or exposure factor sufficient to produce a meaningful effect?	Yes
	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?	Yes
	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?	No
	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?	Yes
	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?		No
	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)?	No
	8.5.	Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)?	No
	8.6.	Was clinical significance as well as statistical significance reported?	Yes
	8.7.	If negative findings, was a power calculation reported to address type 2 error?	N/A
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