DM: Medical Nutrition Therapy (2001)

Citation:
 
Study Design:
Class:
- Click here for explanation of classification scheme.
Quality Rating:
Research Purpose:
  1. Assess the acceptance and ease of use of Nutrition Practice Guidelines for Type 1 Diabetes Mellitus by dietitians in a variety of settings.
  2. Determine if MNT provided by dietitians who used the guidelines was different from practices of dietitians who provided usual care.
  3. Measure the effect of use of practice guidelines on patient control of blood glucose.
  4. Compare patient satisfaction between those given practice guidelines care and those given usual care.
Inclusion Criteria:

Dietitians:

Provided MNT to >3 patients with type 1 diabetes mellitus per month

Patients:

  • Diagnosis of diabetes >2 mos and <15 yr.
  • Diagnosis made <40 yr of age.
  • Body weight: <120% IBW
Exclusion Criteria:
None specifically mentioned.
Description of Study Protocol:

Recruitment:

  of dietitians:  announcement with mail-in form published in the newsletter of the ADA Diabetes Care and Education  dietetic practice group; also nominations by presidents of state dietetic associations.  Volunteers were assigned randomly to a usual care group or a practice guidelines group.

  of patients: Participating dietitians were expected to recruit and enroll 3 to 15 patients who met the inclusion criteria.

Design

Volunteer dietitians were assigned randomly to a practice guidelines group or a usual care group; all patients seen by a dietitian at the health care setting received either practice guidelines care or usual care as defined by the dietitian's group assignment. 

The sample size was calculated at 40 patients in each group to detect a meaningful HbA1c change within groups of 0.75 and a HbA1c difference between groups of 1 point at alpha=0.05 and power = 0.80.

Intervention

Dietitians in the usual care group were instructed to "continue to see patients and provide usual care but not to make any changes for the next 3-4 months".

Dietitians in the practice guidelines group were instructed to read the practice guidelines and to "think about modifications needed for your nutrition care to meet the new guidelines.  In some cases the changes may be minor; in other cases dramatic changes may be indicated  Plan ahead for any necessary adjustment in assessment, goal setting, intervention, referrals, scheduled follow-up, and/or documentaion."

Telephone hot line made available for answering questions for all participating in the study (both groups of dietitians and all subjects).

Blinding Used: none

Statistical Analysis

  •  t test and chi-square test were used to compare characteristics and perceptions of dietitians and patients between groups
  • differences in the frequency of documentation of nutrition care were compared between groups using chi-square test
  • differences in number of visits and total contact time between groups assessed using the t test for independent groups
  • paired tests indicated significance of HbA1c from baseline to 3 months
  • effect of each nutrition care alternative on 3-month HbA1c determined using analysis of covariance with the baseline value as a covariate. 
  • significance level for all tests was P< 0.05

 

Data Collection Summary:

Timing of Measurements

  1. Dietitian questionnaire for demographic information
  2. Field test dietitian feedback form; used to monitor changes in dietitian practices at 2 months. 
  3. Medical record audit by investigators at 3 months
  4. Patient survey at 3 months

Dependent Variables

  • HbA1c at baseline and 3 months; measured by laboratory at each dietitians work site 
  • patient satisfaction with nutrition care
  • patient perceived quality of life
  • dietitian's perceptions about care with and without guidelines
  • dietitians' reactions to guidelines (practice guidelines group only)
  • dietitians' desires related to content and formato of practice guidelines(usual care group). 

Independent Variables

  •  medical records audited for diabetes history, medical managment, baseline and 3-month HbA1c levels, and details of nutrition care provided

Control Variables

  • Region
  • Gender
  • Age
  • number of other diagnoses
  • years of duration of diabetes
  • diaetes management class
  • total contact time
  • number of visits

 

Description of Actual Data Sample:

Initial N:

51 dietitians agreed to be in the study, 24 in the usual care group (14 were able to recruit subjects;11 submitted usable date) and 27 in the practice guidelines group (13 were able to recruit subjects; 8 submitted usable data).

Attrition (final N):  Reasons for dietitians' withdrawal from study included time limitations, few patients who met inclusion criteria, burdensom internal approval process, disapproval by administration, or perceived complexity of the study.

Outcome analysis included records from 54 patients (30 usual care and 24 practice guidelines patients).  23 additional records were submitted by were excluded because of incomplete data or not meeting the inclusion criteria for the study.

Age: Practice guidelines dietitians were older than usual care dietitians, but there was no difference in level of education or years working with diabetic patients.

Usual care patients were significantly younger than practice guidelines patients.  The groups were dissimilar in other ways and that was considered in the analysis.

Ethnicity: All dietitians but one were white

Other Relevant Demographics: practice guidelines dietitians had a higher caseload of patients with diabetes each month compared to usual care dietitians

Anthropometrics: not applicable

Location:  all regions of the US represented

 

 

 

Summary of Results:

Effects of Practice Guidelines on dietitian practices:

Dietitians in the Practice Guidelines group:

  1. spent 63% more time with their patients (108 vs. 60 minutes).
  2. spent 60 minutes vs. 30 minutes during the first RD visit.
  3. were more likely to see the patient for a 3rd or 4th visit during the 3 mos study period
  4. more likely to do an assessment and discuss results with patient at 1st visit
  5. more likely to refer patients to another provider and less likely to consult with other team members

Blood glucose outcomes:

Improvement in HbA1c level at 3 mos was observed in 53% of usual care and 88% in the Practice Guidelines group and significantly greater in the Practice Guidelines group (-0.33 vs. –1.00) (P=0.018).

 

HbA1c (%)

Baseline N=30

3 months N=24

Usual care

9.53±1.67

9.2±1.81

Practice Guidelines

9.15±2.11

8.15±1.59

Patient satisfaction and quality of life:

No significant differences were found between the intervention groups in patient satisfaction.

Author Conclusion:

Dietitians responded positively to practice guidelines for type 1 diabetes. Use of guidelines resulted in changes in dietitian practices and produced greater improvements in patient blood glucose outcomes at 3 mos compared to usual care.

Practice guidelines did not significantly influence patient satisfaction with care or perceived quality of life.

The attrition rate of dietitians participating in the study was high (48%) but attrition was primarily because of the low number of patients with type 1 diabetes mellitus—this may reflect inadequate follow-up of patients with type 1 diabetes.

Funding Source:
Not-for-profit
0
Foundation associated with industry:
Reviewer Comments:

The study period was quite short (only 3 mos). Often behavior change takes longer than this (for both the dietitian and the patient).

One of the limitations of this type of study is inadequate funding for longer 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) Yes
  3.2. Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline? No
  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? No
  5.1. In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate? No
  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? 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? 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? 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? No
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)? 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? 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