EAL

MNT: RDN in Medical Team (2015)

Citation:

Study Design:

Class:

- Click here for explanation of classification scheme.

Quality Rating:

Research Purpose:

To present the results of an online diabetes management program called Engaging and Motivating Patients Online With Enhanced Resources for Diabetes (EMPOWER-D).

Inclusion Criteria:

Aged 18 years or older
Type 2 diabetes
A1C 7.5% or higher
Seen within the past 12 months.

Exclusion Criteria:

Initial diagnosis of type 2 diabetes within the last 12 months
Inability to speak or read English
Lack of regular Internet access with e-mail capabilities
Unwillingness to perform any self-monitoring at home
Diagnosis of a terminal illness or entry into hospice care
Pregnancy, planning a pregnancy or currently lactating
Current enrollment in a care management program
Family household member enrolled in EMPOWER-D study
Resident of a long-term care facility
Plans to discontinue primary care at the included sites during the study period
Uninsured.

Description of Study Protocol:

Recruitment

Participants were recruited from March 2008 through December 2009 through electronic health records at the Palo Alto Medical Foundation (PAMF) .

Design

Participants were randomly assigned to one of two study arms [intervention (INT) or usual care (UC)] and followed for 12 months.

Blinding Used

Data collectors were blinded to randomization status.

Intervention

Participants randomized to the INT group had three in-person visits:
- A 90-minute group visit introducing the online tools
- A 90-minute one-to-one consultation visit with a nurse care manager to develop a shared care plan
- A 60-minute visit with a RD.
A pharmacist reviewed all INT participants’ charts, made recommendations about medication management and was consulted by the care team as needed.
The INT utilized an online system that included:
- Wireless glucometer upload system that transmits home glucometer readings to PAMF’s electronic health record
- Personalized diabetes summary status report
- Nutrition log
- Insulin record
- Exercise log
- Online messaging with the patient’s healthcare team, including nurse care managers (NCM) and RD
- Advice and medication changes from the NCM
- Patient-specific text and video educational content from NCMs.
UC patients continued to receive standard-of-care treatment, including reminders about annual and preventive guideline-based laboratory tests and screening. UC participants received no EMPOWER-D treatment interventions.

Statistical Analysis

The study design was powered to detect net A1C improvements of 0.5% or larger
A sample size of 200 participants per arm was calculated to provide 91% power to detect an effect size of 0.36, assuming a 15% loss in follow-up
Two-sample T-tests, X² tests, ANOVA and Kruskal-Wallist test were used as appropriate
Intent-to-treat analysis was conducted.

Data Collection Summary:

Timing of Measurements

Clinical measurements were collected at six and 12 months.

Dependent Variables

Primary: Glucose control (A1C)
Secondary:
- Blood pressure
- LDL
- Ten-year Framingham cardiovascular risk
- Satisfaction
- Psychosocial well-being.

Independent Variables

Intervention (INT) vs. Usual Care (UC).

Control Variables

Baseline A1C
Age
Gender
Race
Ethnicity.

Description of Actual Data Sample:

Initial N: N=415 (249 male, 166 female)
Attrition (final N): N=379 (91%) were included in final analysis (INT: N=186; UC: N=193)
Age: Aged 26 to 85 years (INT: Mean=54.0±10.7 years; UC: Mean=53.5±10.2 years).

Ethnicity

59% white
21% Asian
9% Hispanic.

Other relevant demographics

Demographic characteristics, including education level, were comparable between groups.

Anthropometrics

Baseline clinical measures were comparable between groups.

Location

Mountain View, CA.

Summary of Results:

Key Findings

At six months, participants in the INT group had significantly better diabetes control than those in the UC group (-1.32% INT vs. -0.66% UC; P<0.001)
At 12 months, the difference in A1C was not significant between groups (-1.14% INT vs. -0.95% UC; P=0.133).

Other Findings

The INT group had significantly better control of their LDL at 12 months compared with the UC group (-6.1mg per dL INT vs. 0.0mg per dL UC; P=0.001)
There were no statistically significant differences between INT and UC groups at 12 months for blood pressure, weight or Framingham risk.

Author Conclusion:

A nurse-led, multi-disciplinary health team could manage a population of diabetic patients primarily using online management and communication tools.

Funding Source:

Government:

Agency for Healthcare Research and Quality

University/Hospital:

Stanford University, Indiana University

Not-for-profit

Palo Alto Medical Foundation

Other non-profit:

In-Kind support reported by Industry:

Yes

Reviewer Comments:

Limitation: Study was conducted in a large, integrated group practice. Results may not apply to smaller, independent practices.

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?	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?	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?	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)?	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?	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