Designing and Implementing a Comparative Effectiveness Study of Two Strategies for Delivering High Quality CHD Prevention: Methods and Participant Characteristics for the Heart to Health Study

Sheridan, Stacey L.; Draeger, Lindy B.; Pignone, Michael P.; Sloane, Philip D.; Samuel-Hodge, Carmen; Finkelstein, Eric A.; Gizlice, Ziya; Vu, Maihan B.; Gitterman, Daniel P.; Bangdiwala, Shrikant I.; Donahue, Katrina E.; Evenson, Kelly; Ammerman, Alice S.; Keyserling, Thomas C.

doi:10.1016/j.cct.2013.07.013

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Designing and Implementing a Comparative Effectiveness Study of Two Strategies for Delivering High Quality CHD Prevention: Methods and Participant Characteristics for the Heart to Health Study

11 2013
By Sheridan, Stacey L. ; Draeger, Lindy B. ; Pignone, Michael P. ; ...
http://dx.doi.org/10.1016/j.cct.2013.07.013
Source: Contemp Clin Trials. 2013; 36(2):394-405

[PDF-1.66 MB]

English

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Details:

Alternative Title:

Contemp Clin Trials
Personal Author:

Sheridan, Stacey L. ; Draeger, Lindy B. ; Pignone, Michael P. ; Sloane, Philip D. ; Samuel-Hodge, Carmen ; ... More +

Sheridan, Stacey L. ; Draeger, Lindy B. ; Pignone, Michael P. ; Sloane, Philip D. ; Samuel-Hodge, Carmen ; Finkelstein, Eric A. ; Gizlice, Ziya ; Vu, Maihan B. ; Gitterman, Daniel P. ; Bangdiwala, Shrikant I. ; Donahue, Katrina E. ; Evenson, Kelly ; Ammerman, Alice S. ; Keyserling, Thomas C. Less -
Description:

Background

Although lifestyle and medications are effective for coronary heart disease (CHD) risk reduction, few studies have examined the comparative effectiveness of various strategies for delivering high quality CHD risk reduction. In this paper, we report on the design and baseline characteristics of participants for just such a trial.

Methods

We conducted a randomized trial of the same lifestyle and medication intervention delivered in two alternate formats: counselor-delivered or web-based. The trial was conducted at 5 diverse practices in a family medicine research network and included men and women age 35–79 who were at high risk of CHD events based on 10-year predicted Framingham risk of ≥10% or a known history of cardiovascular disease. After individual-level randomization, participants in both arms received a decision aid plus four intensive intervention visits and 3 maintenance visits over 12 months. The primary outcome was change in 10-year predicted CHD risk among patients without prior cardiovascular disease. Secondary outcomes, measured among all participants, included changes in CHD risk factors, cost-effectiveness, and acceptability at 4 and 12-month follow-up.

Results

We randomized 489 eligible patients: 389 without and 100 with a known history of cardiovascular disease. Mean age was 62.3. 75% were white, 25% African American. 45% had a college education. 88% had health insurance. Mean 10-year predicted CHD risk was 16.9%.

Conclusion

We have successfully recruited a diverse sample of practices and patients that will provide a rich sample in which to test the comparative effectiveness of two strategies to implement high quality CHD prevention.
Subjects:

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Adult Aged Clinical Protocols Comparative Effectiveness Research Coronary Disease Cost-Benefit Analysis Counseling Decision Support Techniques Female Humans Male Middle Aged Risk Factors Risk Reduction Behavior Telemedicine Treatment Outcome
Keywords:

[+]

Coronary Heart Disease Evidence-Based Practice Prevention Therapy/Computer-Assisted
Source:

Contemp Clin Trials. 2013; 36(2):394-405
Pubmed ID:

23916919
Pubmed Central ID:

PMC4115064
Document Type:

Journal Article
Funding:

P30DK056350/DK/NIDDK NIH HHSUnited States/ ; P30 DK056350/DK/NIDDK NIH HHSUnited States/ ; 1U48DP002658/DP/NCCDPHP CDC HHSUnited States/ ; P30 DK093002/DK/NIDDK NIH HHSUnited States/ ; U48 DP002658/DP/NCCDPHP CDC HHSUnited States/

P30DK056350/DK/NIDDK NIH HHSUnited States/ ; P30 DK056350/DK/NIDDK NIH HHSUnited States/ ; 1U48DP002658/DP/NCCDPHP CDC HHSUnited States/ ; P30 DK093002/DK/NIDDK NIH HHSUnited States/ ; U48 DP002658/DP/NCCDPHP CDC HHSUnited States/ Less -
Volume:

36
Issue:

2
Collection(s):

CDC Public Access
Main Document Checksum:

[+]

urn:sha256:ef8f8aa6fa51d2e3706243ab877589acf41a363228fd7e63a6507dd041528160
Download URL:

https://stacks.cdc.gov/view/cdc/30052/cdc_30052_DS1.pdf
File Type:

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