EAL

MNT: RDN in Medical Team (2015)

Citation:

Green BB, Anderson ML, Cook AJ, Catz S, Fishman PA, McClure JB, Reid RJ. e-Care for heart wellness: a feasibility trial to decrease blood pressure and cardiovascular risk. American Journal of Preventative Medicine, 2014; 46 (4): 368-377.

PubMed ID: 24650839

Study Design:

Randomized Controlled Trial

Class:

A - Click here for explanation of classification scheme.

Quality Rating:

POSITIVE: See Quality Criteria Checklist below.

Research Purpose:

To evaluate feasibility of collaborative, dietitian-led team care that included home blood pressure (BP), weight, and fruit and vegetable intake monitoring with feedback, counseling and care coordination (between the patient and their physician for medication changes) delivered using electronic health record (EHR) linked secure messaging. Also, to evaluate whether the intervention would lead to weight loss, reduced BP and reduced cardiovascular disease (CVD) risk scores.

Inclusion Criteria:

Recruited between 2010 and 2011 from four Group Health Medical Centers in Western Washington
35 to 69 years of age
At least two years of enrollment with health system and one primary care visit in previous two years
BP over 40mmHg systolic or over 90mmHg diastolic at the most recent primary care visit
BMI over 26kg/m²
Framingham CVD risk score between 10% and 25%
Patients with BP over 140mmHg systolic or over 90mmHg diastolic at the screening visit were eligible to participate
Informed consent provided.

Exclusion Criteria:

History of CVD, diabetes, severe illnesses (e.g., renal failure or dementia) or illnesses that would make participation difficult (e.g., pregnancy, schizophrenia or alcohol dependence).

Description of Study Protocol:

Recruitment
Recruited between 2010 and 2011 from four Group Health Medical Centers in Western Washington.

Design

Participants were randomized to usual care (UC) or web-dietitian (WD) care using a stratified block randomization design
UC participants were told during the baseline visit that BP was high and were encouraged to follow up with their physician for appropriate care. They also received a copy of laboratory results including Framingham 10-year CVD risk via patient website and by mail.
No other interventions were provided to the UC Group
WD participants received the same information as WD patients and were also provided with a scale, pedometer and home BP monitor and trained to use the devices. They were also scheduled to see a Group Health dietitian at their regular clinic for one visit and asked to complete a questionnaire routinely used by dietitian about physical activity, dietary habits, prior attempts to lose weight and tobacco and alcohol use. WD patients also completed a standard three-day food diary.
During the in-person visit with WD patients, the dietitian obtained baseline information and created a plan to reduce CVD risk
Planned follow-up occurred via secure messaging to report BP, weight, and fruit and vegetable intake as well as receiving ongoing feedback
If needed, dietitians encouraged patients and their physicians to intensify antihypertensive and lipid-lowering medications
Primary outcomes were change in systolic BP and weight loss of at least four kg at six months
Feasibility outcomes included intervention utilization and satisfaction.

Blinding Used
None.

Intervention
Intervention to decrease BP, CVD risk and weight (described above).

Statistical Analysis

Planned sample size of 100 randomized subjects provided 80% power to detect effect size of 0.6 standard deviation (SD) for the continuous outcomes assuming 90% follow-up at the six-month visit
Linear regression models were used to estimate differences between groups in mean change from baseline for the continuous primary outcomes of BP, weight and CVD risk score, adjusted for sex and baseline value
Generalized linear regression models with a log link were used to estimate intervention effects on binary outcomes, BP control (adjusting for sex, baseline systolic BP and BMI) and losing four kg (adjusted for sex and baseline weight)
Analysis used complete case approach, excluding participants who did not return for a follow-up visit.

Data Collection Summary:

Timing of Measurements

Systolic and diastolic BP, CVD risk and weight, as well as the proportion of patients with BP control (systolic BP of less than 140mmHg, diastolic less than 90mmHg) and weight loss of at least four kg, measured at baseline research visit prior to randomization and at six months after randomization
Lab values drawn at baseline and six months.

Dependent Variables

BP and weight measured in person
CVD risk calculated using Framingham 10-year global CVD risk score questions
Serum lipids
Hemoglobin A1c
Fasting blood glucose
Total cholesterol
High density lipoprotein (HDL-C) levels
Hypertensive medication use and intensification
Low density lipoprotein (LDL-C) levels
Fruit and vegetable intake
Weight
Body mass index (BMI)
Waist circumference.

Independent Variables

Intervention to decrease CVD, BP and weight.

Control Variables

Smoking status
Baseline age
Race
Gender
Education level
Employment
Martial status.

Description of Actual Data Sample:

Initial N: 101 subjects (42 females, 59 males)
Attrition (final N): 90 subjects
Age: 56.9±7.0 years
Ethnicity: White, 85%; black, 5%; Asian, 3%; Other, 7%.

Other Relevant Demographics

Education: 12 years or less or GED, 6%; some post high school, 32%; four-year college degree, 35%; graduate school, 26%. No significant difference between UC and WD Groups.
Employed full-time: 74% overall. No significant difference between UC and WD Groups.
Married, living with partner: 75% overall. No significant difference between UC and WD Groups.

Anthropometrics

Weight was not significantly different between UC and WD Groups at baseline
Waist circumference was not significantly different between UC and WD Groups at baseline.

Location
Western Washington.

Summary of Results:

Key Findings

At the six-month follow-up, WD participants had lost significantly more weight than UC participants and were three times more likely to have lost at least four kg
Both the UC and WD Groups had reductions in systolic BP from baseline, with 54% of the WD Group having controlled BP, compared to 40% in the UC Group (P=0.16)
CVD risk decreased from baseline with an adjusted mean change in risk score of -4.1 in the WD Group, compared to -2.8 in the UC Group (P=0.1)
Increases in daily fruit and vegetable intake were statistically significant in the WD Group (+2.3 servings), compared to the UC Group (zero servings; P<0.01)
Physical activity levels were not statistically significant between groups
Groups were similar in changes in LDL-C, HDL-C, hemoglobin A1c and fasting blood glucose
Initiation and intensification of hypertensive medication occurred more often in the WD Group and BP medication adherence did not differ by group
Quality of life measures for obesity and weight loss showed greater (not statistically significant) differences in the WD Group than the UC Group
At six months, WD participants were statistically more likely to be satisfied with BP care, compared to UC participants (+1.3 points vs. -0.5 points) and patient assessment of chronic illness care (+2 points vs -0.1 points; P<0.05)
WD participants statistically significantly more likely to report that they received patient-centered care consistent with CCM, compared to UC participants for all five domains and total score.

Variables	UC Group Mean±SD	WD Group Mean±SD	Adjusted Difference Between Groups	P-Value
Systolic BP (mmHg) Unadjusted	139.1±14.1	136.4±13.9	N/A	N/A
Systolic BP (mmHg) Adjusted Mean Change	-11.4 (-15.4, -7.3)	-13.9 (-18.1, -9.8)	-2.6 (-8.6, 3.4)	0.4
Diastolic BP (mmHg) Unadjusted	84.6±9.5	84 ±10.2	N/A	N/A
Diastolic BP (mmHg) Adjusted Mean Change	-6.6 (-9.2, -3.9)	-8.5 (-11.3, -5.8)	-2.0(-6.0, 2.0)	0.32
Weight (kg) Unadjusted	99.7 ± 17.4	97 ± 17.8	N/A	N/A
Weight (kg) Adjusted Mean Change	-0.5 (-1.6, 0.7)	-3.7 (-4.9, -2.5)	-3.2 (-5.0, -1.5)	<0.01
CVD Risk Score Unadjusted	13.8±4.8	11.4± 4.4	N/A	N/A
CVD Adjusted Mean Change	-2.8 (-3.9, -1.7)	-4.1 (-5.2, -3.0)	-1.3 (-2.9, 0.3)	0.1
BP Control Unadjusted	18± 39.1	24± 54.5	N/A	N/A
BP Adjusted Relative Risk	1.0 (ref)	1.39 (0.88, 2.21)	-	0.16
Number Lost ≥4 kg Weight (%)	5± 10.9	14± 31.8	N/A	N/A
Number Lost ≥4 kg Adjusted Relative Risk	1.0 (ref)	2.96 (1.16, 7.53)	-	0.02

Author Conclusion:

The e-Care for Heart Wellness trial demonstrated a promising BP/CVD risk reduction intervention
The WD intervention resulted in decreased weight, BP and CVD risk
The study was feasible to conduct using Group Health-employed dietitians and existing EHR systems for secure e-mail communications and high rates of patient participation and satisfaction.

Funding Source:

Government:

National Heart, Lung and Blood Institute of NIH

Reviewer Comments:

Study limitations include:

Small sample size
Lack of sufficient power to demonstrate whether reductions in BP and CVD risk were significant
Short follow-up period
Racially homogenous sample
Self-reported measures.

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?	No
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?	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.)	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?	Yes
	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?	No
	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?	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