Cardiovascular DiseasesPhase 2GLAD HeartNCT00224848
Guideline Adherence for Heart Health
A Phase 2 study testing Palm-Pilot Intervention in people with Cardiovascular Diseases and Hypercholesterolemia, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
This study addresses the challenges associated with implementation of clinical practice guidelines (CPG's) and is motivated by our interest in gaining insight regarding the following general research questions about CPG implementation: A. Read more about this study
- Who is it for?
- Ages 21 to 84 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Hypercholesterolemia, Hypertension
- What is being tested?
- Palm-Pilot Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- No sites listed yet
- Study dates
- Jul 2002to Aug 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 84 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Inclusion/exclusion criteria are based on practice characteristics. Practices are considered the study participants. However, because of the individual nature of the intervention tool, individual healthcare providers in the participating practices will be asked to participate voluntarily in the intervention and data collection. We anticipate approximately 320 healthcare providers to be included in these 64 practices. The research study will not directly intervene on patients of participating healthcare providers. However, patient charts will be assessed to evaluate changes in the practice's screening and management behaviors. Patient records will be included in this project in proportion to patient representation in participating primary care practices in NC and in proportion to their rates of cholesterol screening.
Potentially eligible patients for the chart abstraction sample will be adults, ages 21 through 84 years, seen in the participating primary care practices during the baseline (July 1, 2001 - June 30, 2003) or follow-up (March 1, 2004 - February 28, 2006) periods. We are examining two-year periods to increase the proportion of patients that has been screened. We can include "year 0" (July 1, 2001 - June 30, 2002), because ATPIII was published in May 2001. Although the guidelines do not exclude persons older than 84 years, at present we propose to restrict the evaluation sample to the aforementioned age group, due to acknowledged controversies regarding the appropriate preventive strategies in the very old.
Practice Inclusion Criteria:
Primary Care Practices (Internal Medicine or Family Medicine) Within 3-hour driving radius of WFUSM At least 50% of practice's providers willing to participate in study Willingness to accept randomization assignment Willingness to participate in chart audit Have a computer suitable for connectivity with the PDAs for installation of software upgrades and for printing of patient-specific reports for medical record documentation purposes
Practice Exclusion Criteria:
Academic practices
Provider Inclusion Criteria:
Practicing healthcare provider affiliated with a primary care practice participating in GLAD Heart.
Willingness to participate
Provider Exclusion Criteria:
None
Potentially eligible patients for the chart abstraction sample will be adults, ages 21 through 84 years, seen in the participating primary care practices during the baseline (July 1, 2001 - June 30, 2003) or follow-up (March 1, 2004 - February 28, 2006) periods. We are examining two-year periods to increase the proportion of patients that has been screened. We can include "year 0" (July 1, 2001 - June 30, 2002), because ATPIII was published in May 2001. Although the guidelines do not exclude persons older than 84 years, at present we propose to restrict the evaluation sample to the aforementioned age group, due to acknowledged controversies regarding the appropriate preventive strategies in the very old.
About this study
This study addresses the challenges associated with implementation of clinical practice guidelines (CPG's) and is motivated by our interest in gaining insight regarding the following general research questions about CPG implementation:
- Can physician adherence to complex CPGs be promoted by use of a hand-held computerized decision support tool providing patient-specific recommendations, documentation, and drug dosing assistance? B. Will increased adherence to CPGs reduce variation in management by age, gender and race/ethnicity such that disparities in healthcare are reduced or eliminated? C. What are the cost implications of using PDA-based technology to promote CPG adherence?
Read more
This randomized, controlled, unblinded, practice-based trial will address these research questions by testing the following hypotheses in a 2 year behavioral intervention period:
- The absolute proportion of patients that is treated appropriately with respect to lipid-lowering drug therapy within 4 months after testing will be increased by a net of at least 9% by the intervention as measured in baseline and follow-up independent cross-sectional samples of eligible patients (primary endpoint).
- The absolute proportion of patients that is treated to the appropriate low density lipoprotein cholesterol (LDL-C) goal during follow-up of the baseline cohort of eligible patients is increased by a net of at least 12% by the intervention (secondary endpoint).
- The proportions of eligible patients that are appropriately screened, risk-stratified, and counseled regarding therapeutic lifestyle changes are increased by the intervention (tertiary endpoints).
- The intervention effect in subgroups defined by disease status (CVD, diabetes or neither), age, gender, and race/ethnicity reduces any disparities observed at baseline (exploratory analyses).
- In addition, we will estimate the marginal cost effectiveness of the intervention for the primary endpoint.
The aims were modified in Year 1 to include an attention control group to enable evaluating and testing the impact of strategies to improve adherence to the recently released JNC 7 guideline by testing the following hypotheses:
- The absolute proportion of patients that is treated appropriately with respect to blood pressure lowering drug therapy will be 10% greater in intervention practices than in comparison practices as measured in follow-up independent cross-sectional samples of eligible patients (primary endpoint).
- The absolute proportion of patients that is treated to the appropriate blood pressure goal during follow-up will be 10% greater in the intervention practices (secondary endpoint).
- The intervention effect in subgroups defined by disease status (CVD, diabetes or neither), age, gender, and race/ethnicity reduces any disparities observed at baseline (exploratory analyses).
- In addition, we will estimate the marginal cost effectiveness of the intervention for the primary endpoint.
Read the detailed description
BACKGROUND:
Many investigators have identified "gaps" in the quality of care delivered in routine practice in the U.S. According to the Institute of Medicine (IOM) report "Crossing the Quality Chasm: A New Health System for the 21st Century," the "gap" between evidence and practice might be better termed a "chasm". High blood cholesterol was identified as one of 15 high priority conditions for Department of Health and Human Services (DHHS) initial focus. In addition, the report stresses the importance of increased use of information technology to support clinical and administrative processes. Six major aims are spelled out in the IOM report "health care should be safe, effective, patient-centered, timely, efficient and equitable." We have developed an intervention that is grounded in this philosophy. Specifically, we are focusing on a guideline that promotes the timely use of safe and effective interventions in a patient-tailored manner. A hand-held computerized decision support tool will be a core component of the intervention to support consistent and efficient medical decision-making. Although our goal is to improve overall adherence with the chosen guideline, we expect that the quality improvement process will result in increased equity, reflected in reduced disparities with respect to appropriate treatment between patient subgroups defined by gender, race/ethnicity, and age.
DESIGN NARRATIVE:
GLAD Heart is a randomized trial. The study intervention (academic detailing on ATPIII and a hand-held computerized decision support tool that provides patient-specific, ATPIII-based risk stratification and treatment recommendations for cholesterol management) and an attention control intervention (academic detailing on JNC7 and automated blood pressure devices) will be delivered at the level of randomization which is the practice. All practices (N=64) will receive usual care, consisting of guideline dissemination, baseline performance feedback, continuing education, and patient education materials. Outcomes will be assessed based on patient level data from chart reviews (N 20,000) of adult patients eligible for cholesterol measurement. To assess ATPIII-related outcomes, we will compare changes in baseline and follow-up chart abstraction between the two arms. To assess JNC7-related outcomes, we will compare differences in follow-up chart abstraction only between the two arms. Appropriate analytic methods will be used to analyze these correlated data. Impact evaluation for both arms will be conducted via baseline and follow-up surveys of participating providers. Process evaluation will be conducted by tracking use of the PDA-based tool and monitoring appropriate use of the automated blood pressure devices. Other tracking information will be collected to ensure intervention and data collection success.
- Conditions
- Cardiovascular Diseases, Hypercholesterolemia, Hypertension
- Being tested
- Palm-Pilot Intervention
- Medical subject headings
- Cardiovascular Diseases, Hypercholesterolemia, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palm-Pilot InterventionBehavioural
Both groups received guideline dissemination, patient activation materials, continuing education (CE) and feedback based on baseline chart audit. The intervention included academic detailing (AD) and a hand-held computerized decision support tool that provided patient-specific, ATPIII-based risk stratification and treatment recommendations. CE sessions offered information relevant to ATPIII and JNC7 and focused on the evidence base. AD offerings focused on strategies to apply concepts to practice and were specific to the randomized arm. Investigators visited each practice at baseline to educate physicians about the guideline and evidence supporting prevention of CVD, and to provide training on use of the Palm tool. Visits were conducted as "lunch and learn" sessions. The tool was a modified version of NHLBI's PDA decision support program and indicates specific drug therapies and dosages needed to achieve cholesterol reduction and prints documentation. A user's manual was developed.
| Study group | Role | What they receive |
|---|---|---|
| ATP III | Experimental | A novel practice-based intervention, based on the ATP III Clinical Practice Guideline, which includes the use of a personal digital assistant (PDA) based decision support tool. Receives: Behavioral: Palm-Pilot Intervention |
| JNC 7 | Active comparator | A novel practice-based intervention, based on the JNC-7 blood pressure Clinical Practice Guideline, which includes the use of am automated blood pressure measurement device. Receives: Behavioral: Palm-Pilot Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients treated appropriately with respect to lipid-lowering therapy within four months after lipid testing
Measured: Measured at 2 years
Rate of appropriate treatment among patients with high blood pressure
Measured: Measured at 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2005 (estimated)
- Study startJul 2002
- Primary completionSep 2007
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- David C Goff, Jr, MD, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00224848
- Sponsor's protocol ID
- 314
- Other IDs
- R01HL070742
- Acronym
- GLAD Heart
- Status last verified
- Aug 2008
- First submitted
- 21 Sep 2005
- Last updated
- 7 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Ellis SD, Bertoni AG, Bonds DE, Clinch CR, Balasubramanyam A, Blackwell C, Chen H, Lischke M, Goff DC Jr. Value of recruitment strategies used in a primary care practice-based trial. Contemp Clin Trials. 2007 May;28(3):258-67. doi: 10.1016/j.cct.2006.08.009. Epub 2006 Sep 1.
PubMed 17030154Bertoni AG, Bonds DE, Steffes S, Jackson E, Crago L, Balasubramanyam A, Chen H, Goff DC Jr. Quality of cholesterol screening and management with respect to the National Cholesterol Education's Third Adult Treatment Panel (ATPIII) guideline in primary care practices in North Carolina. Am Heart J. 2006 Oct;152(4):785-92. doi: 10.1016/j.ahj.2006.04.017.
PubMed 16996859Bertoni AG, Bonds DE, Chen H, Hogan P, Crago L, Rosenberger E, Barham AH, Clinch CR, Goff DC Jr. Impact of a multifaceted intervention on cholesterol management in primary care practices: guideline adherence for heart health randomized trial. Arch Intern Med. 2009 Apr 13;169(7):678-86. doi: 10.1001/archinternmed.2009.44.
PubMed 19364997
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Guideline Adherence for Heart Health
- ClinicalTrials.gov ID
- NCT00224848
- Acronym / sponsor ID
- GLAD Heart / 314
- Conditions
- Cardiovascular Diseases, Hypercholesterolemia, Hypertension
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Jul 2002
- Primary completion
- Sep 2007 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 23 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study addresses the challenges associated with implementation of clinical practice guidelines (CPG's) and is motivated by our interest in gaining insight regarding the following general research questions about CPG implementation:
- Can physician adherence to complex CPGs be promoted by use of a hand-held computerized decision support tool providing patient-specific recommendations, documentation, and drug dosing assistance? B. Will increased adherence to CPGs reduce variation in management by age, gender and race/ethnicity such that disparities in healthcare are reduced or eliminated? C. What are the cost implications of using PDA-based technology to promote CPG adherence?
This randomized, controlled, unblinded, practice-based trial will address these research questions by testing the following hypotheses in a 2 year behavioral intervention period:
- The absolute proportion of patients that is treated appropriately with respect to lipid-lowering drug therapy within 4 months after testing will be increased by a net of at least 9% by the intervention as measured in baseline and follow-up independent cross-sectional samples of eligible patients (primary endpoint).
- The absolute proportion of patients that is treated to the appropriate low density lipoprotein cholesterol (LDL-C) goal during follow-up of the baseline cohort of eligible patients is increased by a net of at least 12% by the intervention (secondary endpoint).
- The proportions of eligible patients that are appropriately screened, risk-stratified, and counseled regarding therapeutic lifestyle changes are increased by the intervention (tertiary endpoints).
- The intervention effect in subgroups defined by disease status (CVD, diabetes or neither), age, gender, and race/ethnicity reduces any disparities observed at baseline (exploratory analyses).
- In addition, we will estimate the marginal cost effectiveness of the intervention for the primary endpoint.
The aims were modified in Year 1 to include an attention control group to enable evaluating and testing the impact of strategies to improve adherence to the recently released JNC 7 guideline by testing the following hypotheses:
- The absolute proportion of patients that is treated appropriately with respect to blood pressure lowering drug therapy will be 10% greater in intervention practices than in comparison practices as measured in follow-up independent cross-sectional samples of eligible patients (primary endpoint).
- The absolute proportion of patients that is treated to the appropriate blood pressure goal during follow-up will be 10% greater in the intervention practices (secondary endpoint).
- The intervention effect in subgroups defined by disease status (CVD, diabetes or neither), age, gender, and race/ethnicity reduces any disparities observed at baseline (exploratory analyses).
- In addition, we will estimate the marginal cost effectiveness of the intervention for the primary endpoint.
Detailed description
BACKGROUND:
Many investigators have identified "gaps" in the quality of care delivered in routine practice in the U.S. According to the Institute of Medicine (IOM) report "Crossing the Quality Chasm: A New Health System for the 21st Century," the "gap" between evidence and practice might be better termed a "chasm". High blood cholesterol was identified as one of 15 high priority conditions for Department of Health and Human Services (DHHS) initial focus. In addition, the report stresses the importance of increased use of information technology to support clinical and administrative processes. Six major aims are spelled out in the IOM report "health care should be safe, effective, patient-centered, timely, efficient and equitable." We have developed an intervention that is grounded in this philosophy. Specifically, we are focusing on a guideline that promotes the timely use of safe and effective interventions in a patient-tailored manner. A hand-held computerized decision support tool will be a core component of the intervention to support consistent and efficient medical decision-making. Although our goal is to improve overall adherence with the chosen guideline, we expect that the quality improvement process will result in increased equity, reflected in reduced disparities with respect to appropriate treatment between patient subgroups defined by gender, race/ethnicity, and age.
DESIGN NARRATIVE:
GLAD Heart is a randomized trial. The study intervention (academic detailing on ATPIII and a hand-held computerized decision support tool that provides patient-specific, ATPIII-based risk stratification and treatment recommendations for cholesterol management) and an attention control intervention (academic detailing on JNC7 and automated blood pressure devices) will be delivered at the level of randomization which is the practice. All practices (N=64) will receive usual care, consisting of guideline dissemination, baseline performance feedback, continuing education, and patient education materials. Outcomes will be assessed based on patient level data from chart reviews (N 20,000) of adult patients eligible for cholesterol measurement. To assess ATPIII-related outcomes, we will compare changes in baseline and follow-up chart abstraction between the two arms. To assess JNC7-related outcomes, we will compare differences in follow-up chart abstraction only between the two arms. Appropriate analytic methods will be used to analyze these correlated data. Impact evaluation for both arms will be conducted via baseline and follow-up surveys of participating providers. Process evaluation will be conducted by tracking use of the PDA-based tool and monitoring appropriate use of the automated blood pressure devices. Other tracking information will be collected to ensure intervention and data collection success.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ATP III | Experimental | Behavioral: Palm-Pilot InterventionA novel practice-based intervention, based on the ATP III Clinical Practice Guideline, which includes the use of a personal digital assistant (PDA) based decision support tool. |
| JNC 7 | Active comparator | Behavioral: Palm-Pilot InterventionA novel practice-based intervention, based on the JNC-7 blood pressure Clinical Practice Guideline, which includes the use of am automated blood pressure measurement device. |
Who may qualify
- Ages
- 21 to 84 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Palm-Pilot InterventionBoth groups received guideline dissemination, patient activation materials, continuing education (CE) and feedback based on baseline chart audit. The intervention included academic detailing (AD) and a hand-held computerized decision support tool that provided patient-specific, ATPIII-based risk stratification and treatment recommendations. CE sessions offered information relevant to ATPIII and JNC7 and focused on the evidence base. AD offerings focused on strategies to apply concepts to practice and were specific to the randomized arm. Investigators visited each practice at baseline to educate physicians about the guideline and evidence supporting prevention of CVD, and to provide training on use of the Palm tool. Visits were conducted as "lunch and learn" sessions. The tool was a modified version of NHLBI's PDA decision support program and indicates specific drug therapies and dosages needed to achieve cholesterol reduction and prints documentation. A user's manual was developed. | Behavioural | ATP III, JNC 7 |
Primary outcome
Proportion of patients treated appropriately with respect to lipid-lowering therapy within four months after lipid testing
Time frame: Measured at 2 years
Rate of appropriate treatment among patients with high blood pressure
Time frame: Measured at 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2016.
- Results publication: PubMed 17030154Ellis SD, Bertoni AG, Bonds DE, Clinch CR, Balasubramanyam A, Blackwell C, Chen H, Lischke M, Goff DC Jr. Value of recruitment strategies used in a primary care practice-based trial. Contemp Clin Trials. 2007 May;28(3):258-67. doi: 10.1016/j.cct.2006.08.009. Epub 2006 Sep 1.
- Results publication: PubMed 16996859Bertoni AG, Bonds DE, Steffes S, Jackson E, Crago L, Balasubramanyam A, Chen H, Goff DC Jr. Quality of cholesterol screening and management with respect to the National Cholesterol Education's Third Adult Treatment Panel (ATPIII) guideline in primary care practices in North Carolina. Am Heart J. 2006 Oct;152(4):785-92. doi: 10.1016/j.ahj.2006.04.017.
- Derived from this study: PubMed 19364997Bertoni AG, Bonds DE, Chen H, Hogan P, Crago L, Rosenberger E, Barham AH, Clinch CR, Goff DC Jr. Impact of a multifaceted intervention on cholesterol management in primary care practices: guideline adherence for heart health randomized trial. Arch Intern Med. 2009 Apr 13;169(7):678-86. doi: 10.1001/archinternmed.2009.44.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David C Goff, Jr, MD, PhD principal investigator
Wake Forest University Health Sciences
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Palm-Pilot Intervention in people with Cardiovascular Diseases and Hypercholesterolemia, run by National Heart, Lung, and Blood Institute (NHLBI).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients treated appropriately with respect to lipid-lowering therapy within four months after lipid testing (time frame: Measured at 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00224848, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2016.