EAL

MNT: RDN in Medical Team (2015)

Citation:

Majumdar SR, Guirguis LM, Toth EL, Lewanczuk RZ, Lee TK, Johnson JA. Controlled trial of a multifaceted intervention for improving quality of care for rural patients with type 2 diabetes. Diabetes Care, 2003; 26 (11): 3,061-3,066.

PubMed ID: 14578240

Study Design:

Non-Randomized Controlled Trial

Class:

C - Click here for explanation of classification scheme.

Quality Rating:

NEUTRAL: See Quality Criteria Checklist below.

Research Purpose:

To assess effectiveness of multi-faceted rural diabetes outreach services in improving blood pressure, total cholesterol and blood glucose, as outlined in the Canadian Diabetes Association (CDA) guidelines.

Inclusion Criteria:

Type 2 diabetes
Gave informed consent
Had sufficient English literacy to answer questions.

Exclusion Criteria:

Unwilling or unable to provide consent or with fore-shortened life expectancy
Subjects already at the clinical targets (blood pressure less than 130/80mmHg, total cholesterol levels less than 4.0mmol per L and HbA1c below 115% of upper limit) at baseline.

Description of Study Protocol:

Recruitment

Two comparable and geographically adjacent rural health regions in Northern Alberta were selected and randomly allocated to Intervention and Control Groups
Subjects were recruited via referrals from diabetes health care professionals, local pharmacists, primary care professionals and self-referral within two Alberta regions.

Design

Prospective before-and-after study with concurrent controls
Study design for the Diabetes Outreach Van Enhancement (DOVE) intervention is described in previous publication and briefly summarized below
The Usual Care Group received bi-monthly visits by the CDA Traveling Diabetes Resource Program (CDA-TDRP; also referred to as "Van") to raise diabetes awareness and emphasize patient self-management.

Intervention

In addition to usual care (three monthly visits iwth CDA-TDRP), the DOVE intervention involved six monthly visits with a treatment team (specialist physician, nurse educator, dietitian and pharmacist) delivering educational messages about the interaction of blood pressure, cholesterol and glucose on macrovascular complications of diabetes.

Statistical Analysis

Primary outcome was defined as the porportion of subjects achieving a 10% improvement in blood pressure, total cholesterol or HbA1c
Chi-square analysis was completed with odds ratio and 95% confidence intervenal
Sample size estimation of 300 subjects with 80% power to detect any difference of more than 10% in the primary outcome; additional recruitment of 400 subject plannned to account for power to evaluate secondary outcomes and attrition
Multi-variate logistic regression was used to address potential imbalances in baseline indices (demographic or clinical parameters)
ANCOVA was used to assess changes in patient satisfaction between regions (adjusted for baseline differences and potential confounding factors)
All analysis were intent-to-treat.

Data Collection Summary:

Timing of Measurements

Baseline and six months.

Dependent Variables

Proportion achieving 10% improvement.

Independent Variables

Intervention Group (Usual Care vs. DOVE intervention)
Baseline blood pressure
Baseline total cholesterol
Baseline HbA1c
Demographic factors: Age, gender, indigeonous status, marital status, duration of diabetes and target medication)
Patient satisfaction.

Control Variables

Baseline differences between groups and potential confounding factors (did not describe).

Description of Actual Data Sample:

Initial N: 393; 210 for intervention (49% male) and 183 for control (38% male)
Attrition (final N): 353 (10% attrition) dropped out, died or were lost to follow-up (14 for intervention region and 26 for control)
Age: 63.9±12.7 years for intervention; 62.0±12.4 years for control
Ethnicity: Not described.

Other Relevant Demographics

Variable	Intervention N=210	Control N=183
Male**	48.7%	37.6%
Married**	66.7%	55.6%
Indigenous**	9.6%	46.6%
Completed HS	35.7%	29.0%
Duration of Diabetes**	7.4±7.8 years	9.4±9.2 years
Visited diabetes education clinic*	67%	50%
Years since last visit	3.4±4.4 years	4.0±4.6 years

*P<0.05
**P<0.01.

Anthropometrics

Variable	Intervention N=210	Control N=183
BMI (kg/m²)	33.5±7.4	33.1±9.1
Systolic Blood Pressure (mmHg)	130.4±19.0	132.2±18.2
Diastolic Blood Pressure (mmHg)**	72.5±11.4	79.7±10.4
Total Cholesterol (mmol/L)*	4.87±0.94	5.08±0.98
HbA1c (%)*	7.17±1.48	7.59±1.67

*P<0.05
**P<0.01.

Location
Alberta, Canada.

Summary of Results:

Key Findings

Percentage of participants achieving improvement in quality of diabetes care, stratefied by intervention and control status.

	Intervention	Control
Primary Composite Sample	37%	44%
HbA1c	14%	18%
Blood Pressure **	42%	25%
Total Cholesterol	13%	17%

**P<0.01

Controlling for baseline differences in demographic and clinical characteristics with multi-variate regression did not change the results
The adjusted OR for the primary outcome was 1.04 (95% CI, 0.64 to 1.70)
The likelihood of patients in the Intervention Group achieving a 10% improvement in blood pressure was significant (2.22 OR; 95% CI, 1.25 to 3.96), however total cholesterol and HbA1c was not significant between groups.

Other Findings

Insignificant changes in new medication usage was found (3% for blood pressure, 3% for cholesterol and 5% for glucose)
Significant improvements were observed in patient satisfaction with medical care in general and specifically with diabetes care among patients in the intervention region
Adjusted mean change score was 4.1 for the intervention and -11.9 for the control (P<0.001) for general care and 4.1 for the intervention vs. -3.7 for the control (P=0.008) for diabetes care.

Author Conclusion:

Compared to usual care, the diabetes outreach services improved the quality of diabetes care and patient satisfaction for rural patients, however with little improvements in cholesterol and glucose
Although there was a multi-discipinary approach, the primary method of delivery of evidence-based messages were by specialist phyisicans using group academic detailing (small groups).

Funding Source:

University/Hospital:

Caritas Health Group

Not-for-profit

Canada Diabetes Association; New Emerging Team (NET) grant to the Alliance for Canadian Health Outcomes Research in Diabetes

Other non-profit:

Other:

Institute of Health Economics; Alberta Heritage Foundation for Medical Research

Reviewer Comments:

Authors noted: Unable to adjust analysis for possible provider-level statistical clustering since multiple providers and specialists saw patients at distant referral centers. Not a randomized control trial. Only collected at 2 time points (before / after). No bliniding during data collection may lead to measurement bias. Potential volunteer bias due to regions and motivation for medical guidance. Short duration (6 months). Studied only 2 regions.
Authors commented on having a large enough sample for power to detect 10% change in health outcomes.
Lacked details about the intervention and only vague information on data collection. Unclear on what the dietitians role was beside provide consultation to the team. Was unable to find the original study proposal from the citation list. The limited details about the intervention was one main reason the study received neutral rating.

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?	N/A
	1.3.	Were the target population and setting specified?	???
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?		No
	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?	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?	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%.)	???
	4.3.	Were all enrolled subjects/patients (in the original sample) accounted for?	Yes
	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?		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.)	No
	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?		No
	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?	No
	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?	N/A
	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?		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?	???
	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?	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)?	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