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MNT: Comparative Effectiveness of MNT Services (2009)

Citation:

Berra K, Ma J, Klieman L, Hyde S, Monti V, Guardado A, Rivera S, Stafford RS. Implementing cardiac risk-factor case management: Lessons learned in a county health system. Critical Pathways in Cardiology. 2007; 6(4): 173-179.

PubMed ID: 18091408
 
Study Design:
Randomized clinical trial.
Class:
A - Click here for explanation of classification scheme.
Quality Rating:
Negative NEGATIVE: See Quality Criteria Checklist below.
Research Purpose:

To identify lessons learned from a cardiovascular risk reduction case management program that may aid future case management implementation.

Inclusion Criteria:
  • Persons at elevated risk of coronary heart disease events, including those with existing congestive heart disease (CHD) or diabetes and those with a Framingham risk score of 10% or higher suggesting at least a moderate risk of a CHD event in the next 10 years
  • Aged 35 to 85 years
  • Multiethnic, low-income population in a county health system.
Exclusion Criteria:

None specifically mentioned.

Description of Study Protocol:

Recruitment

Recruitment methods were not described.

Design

Randomized clinical trial. Patients were randomized to case management plus usual primary care or primary care alone. 

Intervention

  • Case management plus usual primary care or primary care alone
  • Case management patients received face-to-face nurse and dietitian visits (mean of 14 hours, provided mostly as 40 to 60 minute sessions) over 17 months
  • Visits emphasized intensive and individualized care, continuity of care and a linkage to primary care physicians and specialty services, patient education about disease self-management, guideline-specified drug therapy for cardiovascular risk factors including blood pressure, dyslipidemia and hyperglycemia and behavior change to improve physical activity, nutrition, weight management, stress reduction and medication adherence. 

 

 

Data Collection Summary:

Timing of Measurements

Measurements made over a mean 17 years of follow-up.

Dependent Variables

CHD risk reduction.

Independent Variables

Case management plus usual primary care or usual primary care alone.

 

 

Description of Actual Data Sample:
  • Initial N: Randomized to case management plus usual primary care (N=212) or primary care alone (N=207)
  • Attrition (final N): 341 patients available for follow-up (81%)
  • Age: 35 to 85 years
  • Other relevant demographics: The Heart to Heart population was predominately middle-aged, obese, female and diabetic
  • Location: San Mateo County, California.

 

Summary of Results:

Other Findings

Findings demonstrated statistically significant reductions in mean Framingham Risk for case management vs. usual primary care (1.56% absolute decrease in 10-year CHD risk, P=0.007).

Favorable changes were noted across most major CHD risk factors, including systolic and diastolic blood pressure, HDL-cholesterol, LDL-cholesterol, hemoglobin A1c, minutes of physical activity per week and BMI.

Lessons learned are the need for the following:

  • Strategies for implementing case management in low-income, ethnically diverse populations
  • Methods for developing clinically more effective case management
  • Approaches to increase the efficiency of cardiovascular case management.
Author Conclusion:

Case management for cardiac risk factors faces notable implementation barriers, particularly in county health systems. Specific implementation solutions recommended may help confront these barriers and improve diffusion of this evidence-based and patient-centered model of care.

Funding Source:
Government: NHLBI Grant R01 HL070781
Reviewer Comments:

Many study details, such as recruitment methods, interventions, measurements and statistical analysis, were not described.

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? ???
  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? No
  2.4. Were the subjects/patients a representative sample of the relevant population? ???
3. Were study groups comparable? ???
  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? ???
  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? 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? No
  4.1. Were follow-up methods described and the same for all groups? No
  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%.) No
  4.3. Were all enrolled subjects/patients (in the original sample) accounted for? ???
  4.4. Were reasons for withdrawals similar across groups? ???
  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? ???
  5.1. In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate? ???
  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.) ???
  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? ???
  6.1. In RCT or other intervention trial, were protocols described for all regimens studied? No
  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? Yes
  6.4. Was the amount of exposure and, if relevant, subject/patient compliance measured? ???
  6.5. Were co-interventions (e.g., ancillary treatments, other therapies) described? ???
  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? ???
  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? ???
  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? Yes
  7.4. Were the observations and measurements based on standard, valid, and reliable data collection instruments/tests/procedures? ???
  7.5. Was the measurement of effect at an appropriate level of precision? ???
  7.6. Were other factors accounted for (measured) that could affect outcomes? ???
  7.7. Were the measurements conducted consistently across groups? ???
8. Was the statistical analysis appropriate for the study design and type of outcome indicators? ???
  8.1. Were statistical analyses adequately described and the results reported appropriately? No
  8.2. Were correct statistical tests used and assumptions of test not violated? No
  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)? N/A
  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? 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