MNT: RDN in Medical Team (2015)
- Attendance at selected fee-for-services primary care practices in rural counties as defined by the U.S. Census Bureau
- Type II diabetes diagnosis
- Signed informed consent.
- No type 2 diabetes diagnosis
- Not a patient at selected primary care practices.
Recruitment
Recruited from rural primary care practices.
Design
In three purposively selected, rural, fee-for-service, primary care practices, African American patients with type 2 diabetes received point-of-care education, coaching and medication intensification from a diabetes care management team consisting of a nurse, pharmacist and dietitian. The six key elements of the intervention design included education with behavioral coaching, treatment intensification, point-of-care management, expanded roles of clinic staff to facilitate management, a team-care approach and physician leadership. As a control, African American patients from five randomly selected practices, matched for practice and patient characteristics, received usual care. The effects of the intervention on intermediate (median 18 months) and long-term (median 36 months) changes in glycated hemoglobin (hemoglobin A1C) levels, blood pressure and lipid levels as well as the proportion of patients meeting target values were evaluated.
Intervention
Point-of-care diabetes care management involving education, self-management coaching and medication adjustment from a team, including a nurse case manager, pharmacist and dietitian.
Statistical Analysis
- Descriptive statistics (means and T-tests for continuous variables; proportions and X2 statistics for categorical variables) were used to characterize the study patients' demographic characteristics and diabetes-specific outcome measures at baseline
- Intention to treat analysis used
- Univariate analysis completed by independent samples T-tests were used to compare intervention and control outcome means
- X2 analysis was used to evaluate the number and percentage of patients who met target goals at baseline and at the intermediate and final evaluations
- Linear mixed-modeling strategy to examine change in hemoglobin A1C
- Multivariate logistic regression
- Economic analysis.
Timing of Measurements
Collected by unblinded staff at baseline, 18 months (intermediate) and 36 months (long-term):- Demographic characteristics including age, sex, insurance, duration of diabetes
- Height
- Weight
- Blood pressure using standard procedures
- Blood specimen measuring total cholesterol, low density lipoprotein cholesterol (LDL), high density lipoprotein cholesterol (HDL) and glycemic control (hemoglobin A1C).
Dependent Variables
- Blood pressure using standard procedures
- Blood specimen measuring total cholesterol, low density lipoprotein cholesterol (LDL), high density lipoprotein cholesterol (HDL) and glycemic control (hemoglobin A1C).
Independent Variables
Method of diabetes care management.Control Variables
- Demographic characteristics including age, sex, insurance, duration of diabetes
- Height
- Weight.
- Initial N: N=727 subjects
- Attrition (final N): N=676 subjects (intervention group, 66% female and 34% male; control group, 63% female and 37% male)
- Age: Ages 59.5±12 years for intervention group, 60.6±12.4 years for control group
- Ethnicity: African American
- Other relevant demographics: No statistically significant differences in demographics between subjects in the intervention and control groups
- Anthropometrics: No statistically significant differences in baseline clinical parameters between subjects in the intervention and control groups
- Location: North Carolina, United States.
Key Findings
- Mean hemoglobin A1C levels decreased significantly more from baseline to the 18 month (P<0.05) and the 36 month (P<0.05) follow-up among intervention practice subjects than among control subjects
- Mean change in LDL-cholesterol and HDL-cholesterol values in intervention practice patients was significantly greater than in control practice patients in univariate comparisons
- Significantly greater percentage of patients in the intervention subjects achieved a hemoglobin A1C value near 7.0% at the final assessment (P<0.01)
- Proportion of subjects achieving a systolic blood pressure of less than 140mm Hg was substantially greater in the intervention practices at 18 months and 36 months
- In multivariate linear modeling, the mean decrease in hemoglobin A1C levels from baseline to final follow-up for intervention practice subjects was significantly greater when compared with control practice subjects (F(v1, v6)=17.97; P=0.005) even when controlling for other variables.
Control Practice (N=359 Patients) Mean (SD) |
Intervention Practice (N=368) Mean (SD) |
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Baseline | 18 Months | 36 Months | Baseline | 18 Months | 36 Months | |
Hemoglobin A1C (%) | 7.9 (2.2) | 7.7 (1.9) | 7.8 (2.0) | 7.9 (2.1) | 7.4 (1.6)a | 7.4 (1.9)b |
Systolic/diastolic blood pressure (mm Hg) | 138 (18) | 139 (16) | 140 (17) | 135 (16) | 135 (14) | 135 (16) |
Diastolic blood pressure (mm Hg) | 81 (10) | 80 (9) | 79 (10) | 79 (8) | 78 (9) | 78 (9) |
LDL-cholesterol (mg per dL) | 101 (36) | 99 (38) | 97 (32) | 105 (33) | 95 (32) | 99 (36)a |
HDL-cholesterol (mg per dL) | 50 (13.3) | 51 (13,4) | 50 (13.3) | 50 (12.7) | 50 (13.6) | 52 (13.9)a |
Total cholesterol (mg per dL) | 176 (39.7) | 177 (42.5) | 170 (38.1) | 182 (38.1) | 171 (37.7) | 176 (39.1) |
a P<0.05 in univariate comparison of change, b P<0.005 in multivariate model comparison, c P<0.01 in univariate comparison.
Multivariate Model of Change in Hemoglobin A1C Level from Baseline to Final Follow-up
Multivariate Linear Model | Multivariate Logistic Regression Model Change in Percentage with HbA1C 7.5% or More | |||
Variable | Model Parameter (Standard Error) | Effect P-value | Odds Ratio | 95% Confidence Ratio |
Age | 0.022 (0.006) | <0.001 | 1.041 | 1.007 to 1.075 |
Sex | 0.184 (0.138) | Not Significant | 0.804 | 0.356 to 1.818 |
Duration of diabetes | -0.026 (0.01) | 0.009 | 0.998 | 0.955 to 1.043 |
Number of visits per year | 0.008 (0.029) | Not significant | 1.08 | 0.898 to 1.3 |
Baseline HbA1C level | 0.606 (0.3) | <0.001 | 0.417 | (0.308 to 0.564) |
Intervention vs. control clinic effect | 0.005 | 0.393 | 0.156 to 0.988 |
Other Findings
- Mean duration of diabetes:
- Intervention group: 13±6.4 years
- Control group: 11±7.2 years
- A total of 1.6 full-time equivalent coach educators covered an annual diabetes panel of 1,280 patients at the cost of approximately $115 per patient per year.
Not-for-profit |
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Quality Criteria Checklist: Primary Research
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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? | 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? | 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? | No | |
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? | Yes | |
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? | 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)? | No | |
8.5. | Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)? | Yes | |
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 | |