Cardiovascular DiseasesNCT02515578
Southwest Health Extension Partnership to Enhance Research Dissemination
A study testing Enhanced practice transformation support and Standard practice transformation support in people with Cardiovascular Diseases, run by University of Colorado, Denver at 1 site in United States.
Trial summary
Heart disease and strokes cause one in three deaths reported each year in the United States. Primary care practices need to implement new research findings that help decrease patients' risk for heart disease and stroke. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Enhanced practice transformation support and Standard practice transformation support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,508 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to 31 Jul 2018
- Phase
- Interventional
- 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 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be staff or clinicians (including physicians, nurse practitioners, and physician assistants) in an enrolled primary care practice
- Primary care practices must be family medicine or general internal medicine practices with a maximum of ten lead clinicians
- Primary care practices must be either independent or, if part of a larger organization, demonstrate on careful screening that they do not receive significant quality improvement support from the larger organization
Who cannot join
- Primary care practices with more than 10 lead clinicians
- Non-independent primary care practices that receive significant quality improvement support from their system or organization
- Clinicians and staff who do not speak or read English
Trial locations and contacts
1 site in 1 country.
About this study
Heart disease and strokes cause one in three deaths reported each year in the United States. Primary care practices need to implement new research findings that help decrease patients' risk for heart disease and stroke. This project will help to build primary care practice capacity for quality improvement and change management in small and medium size primary care practices in Colorado and New Mexico. This project will also help practices implement patient-centered outcomes research findings.
Read the detailed description
Cardiovascular disease (CVD) causes one in three deaths reported each year in the United States. Strategies derived from patient-centered outcomes research (PCOR) that address CVD risk factors can greatly reduce the burden of CVD. Primary care practices must transform to deliver a higher level of PCOR evidence-based prevention to decrease cardiovascular risk. PCOR interventions that emphasize patient-centered care including self-management support, team-based care, improved information systems, and active quality improvement have been shown to be effective. Practices often require assistance integrating new programs into clinical operations. Practice facilitation has been shown to enhance implementation of new programs for patients with chronic disease in primary care. Other methods of practice support, including academic detailing, collaborative learning sessions, and health information technology assistance, have also been shown to be effective, by themselves and in combination with practice facilitation. Patient involvement may also aid practice transformation. Increasingly, practices are actively including patients as part of the change process through the creation of patient advisory councils and including patients in practice quality improvement teams. Another method of patient involvement to inform implementation of evidence-based care is the Boot Camp Translation process, in which patients collaborate with primary care clinicians, staff members, and community members to translate best practices into culturally and community relevant implementation at the local level. However, while these efforts have had considerable success, no study has looked at the incremental value of adding patient engagement strategies to the more standard approaches to practice transformation listed above. This project would implement the Southwest Health Extension Program to Enhance Research Dissemination (SHEPERD) as a cooperative program to build primary care practice capacity for quality improvement, change management, and implementation of PCOR findings in small and medium size primary care practices in Colorado and New Mexico, with an initial focus on cardiovascular care. It also would conduct a cluster randomized trial with an external matched cohort control group to examine the Reach, Effectiveness, Adoption, Implementation, and Maintenance of two approaches to practice transformation to implement PCOR interventions for reducing cardiovascular risks in primary care practices, comparing the impact of 1) a standard practice transformation support intervention (including practice facilitation, practice assessment with feedback, HIT assistance, academic detailing, and collaborative learning sessions) to 2) an approach that adds patient engagement activities (including patient advisory councils and boot camp translation) as part of the practice transformation support. This project will provide critical information regarding the added value of patient engagement in practice transformation efforts and will also result in a network of practices across the region with increased capacity for practice transformation and implementation of PCOR findings.
- Conditions
- Cardiovascular Diseases
- Being tested
- Enhanced practice transformation support, Standard practice transformation support
- Keywords
- Primary Health Care, Cardiovascular Diseases, Quality Improvement
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced practice transformation supportOther
Standard practice transformation supportOther
| Study group | Role | What they receive |
|---|---|---|
| Standard practice transformation support | Active comparator | Primary care practices will receive a cardiovascular care toolkit, practice facilitation, practice assessment with feedback, health information technology assistance, academic detailing, and periodic collaborative learning sessions Receives: Other: Standard practice transformation support |
| Enhanced practice transformation support | Experimental | Primary care practices will receive practice facilitation, practice assessment with feedback, health information technology assistance, academic detailing, and periodic collaborative learning sessions PLUS patient advisory council support and a modified cardiovascular care toolkit based on combined practice and patient input regarding the local context. Receives: Other: Enhanced practice transformation support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of documentation of aspirin therapy in patients with ischemic vascular disease.
The percent of patients aged 18 years and older with Ischemic Vascular Disease (IVD) with documented use of aspirin or other antithrombotic. This is a practice-level indicator of documentation of care processes for cardiovascular disease.
Measured: Baseline, 3, 6, 9, 12, and 15 months from baseline
Change of documentation of blood pressure in patients with a diagnosis of hypertension.
The percent of patients aged 18 - 85 who had a diagnosis of hypertension (HTN) and whose blood pressure (BP) was adequately controlled (<140/90) during the measurement year. This is a practice-level indicator of documentation of care processes for cardiovascular disease.
Measured: Baseline, 3, 6, 9, 12, and 15 months from baseline
Change of documentation of blood pressure in patients with adequately controlled blood pressure.
The percent of patients aged 18 - 85 who had a diagnosis of hypertension (HTN) and whose blood pressure (BP) was adequately controlled (age 18-59 and/or people with diabetes or chronic kidney disease <140/90; age 60-85 <150/90) during the measurement year. This is a practice-level indicator of documentation of care processes for cardiovascular disease.
Measured: Baseline, 3, 6, 9, 12, and 15 months from baseline
Change of documentation of fasting LDL in patients with a fasting LDL at or below the LDL goal.
The percent of patients aged 20 - 79 who had a fasting LDL test performed and whose risk-stratified fasting LDL is at or below the recommended LDL goal. This is a practice-level indicator of documentation of care processes for cardiovascular disease.
Measured: Baseline, 3, 6, 9, 12, and 15 months from baseline
Change of documentation of patients who had a fasting LDL test performed and prescribed a statin based on risk.
The percent of patients aged 20 - 79 who had a fasting LDL test performed and who are prescribed a recommended dose of statin based on risk status if indicated. This is a practice-level indicator of documentation of care processes for cardiovascular disease.
Measured: Baseline, 3, 6, 9, 12, and 15 months from baseline
Change of documentation of patients screened about tobacco use.
The percent of patients aged 18 years or older screened about tobacco use one or more times within 24 months AND who received cessation counseling intervention if identified as a tobacco user. This is a practice-level indicator of documentation of care processes for cardiovascular disease.
Measured: Baseline, 3, 6, 9, 12, and 15 months from baseline
Secondary outcomes (1)
Change of the documentation in primary care practice's.
This primary care practice capacity to implement PCOR findings and improve quality and implementation of the planned comprehensive approach. The measure is based on practice-level scores of change process capacity, adaptive reserve, clinician experience and implementation of patient-centered medical home components.
Measured: Baseline, 9 and 15 months from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2015 (estimated)
- Study startOct 2015
- Primary completion31 Jul 2018
- Study completion31 Jul 2018
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 University of Colorado, DenverThe 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5,508 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- University of New Mexico
- Responsible party
- Sponsor
- Investigators
- W. Perry Dickinson, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02515578
- Sponsor's protocol ID
- 15-0403
- Status last verified
- Jan 2021
- First submitted
- 15 Jul 2015
- Last updated
- 25 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Zittleman L, Westfall JM, Callen D, Herrick AM, Nkouaga C, Simpson M, Dickinson LM, Fernald D, Kaufman A, English AF, Dickinson WP, Nease DE Jr. Does engagement matter? The impact of patient and community engagement on implementation of cardiovascular health materials in primary care settings. BMC Prim Care. 2024 Apr 25;25(1):135. doi: 10.1186/s12875-024-02365-w.
PubMed 38664665Fernald DH, Mullen R, Hall T, Bienstock A, Kirchner S, Knierim K, de la Cerda D, Callan D, Rhyne RL, Dickinson LM, Dickinson WP. Exemplary Practices in Cardiovascular Care: Results on Clinical Quality Measures from the EvidenceNOW Southwest Cooperative. J Gen Intern Med. 2020 Nov;35(11):3197-3204. doi: 10.1007/s11606-020-06094-5. Epub 2020 Aug 17.
PubMed 32808208English AF, Dickinson LM, Zittleman L, Nease DE Jr, Herrick A, Westfall JM, Simpson MJ, Fernald DH, Rhyne RL, Dickinson WP. A Community Engagement Method to Design Patient Engagement Materials for Cardiovascular Health. Ann Fam Med. 2018 Apr;16(Suppl 1):S58-S64. doi: 10.1370/afm.2173.
PubMed 29632227
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Southwest Health Extension Partnership to Enhance Research Dissemination
- ClinicalTrials.gov ID
- NCT02515578
- Acronym / sponsor ID
- 15-0403
- Conditions
- Cardiovascular Diseases
- Keywords
- Primary Health Care, Cardiovascular Diseases, Quality Improvement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,508 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- University of New Mexico
- Study start
- Oct 2015 (actual)
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 31 Jul 2018 (actual)
- First posted
- 5 Aug 2015 (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.
Heart disease and strokes cause one in three deaths reported each year in the United States. Primary care practices need to implement new research findings that help decrease patients' risk for heart disease and stroke. This project will help to build primary care practice capacity for quality improvement and change management in small and medium size primary care practices in Colorado and New Mexico. This project will also help practices implement patient-centered outcomes research findings.
Detailed description
Cardiovascular disease (CVD) causes one in three deaths reported each year in the United States. Strategies derived from patient-centered outcomes research (PCOR) that address CVD risk factors can greatly reduce the burden of CVD. Primary care practices must transform to deliver a higher level of PCOR evidence-based prevention to decrease cardiovascular risk. PCOR interventions that emphasize patient-centered care including self-management support, team-based care, improved information systems, and active quality improvement have been shown to be effective. Practices often require assistance integrating new programs into clinical operations. Practice facilitation has been shown to enhance implementation of new programs for patients with chronic disease in primary care. Other methods of practice support, including academic detailing, collaborative learning sessions, and health information technology assistance, have also been shown to be effective, by themselves and in combination with practice facilitation. Patient involvement may also aid practice transformation. Increasingly, practices are actively including patients as part of the change process through the creation of patient advisory councils and including patients in practice quality improvement teams. Another method of patient involvement to inform implementation of evidence-based care is the Boot Camp Translation process, in which patients collaborate with primary care clinicians, staff members, and community members to translate best practices into culturally and community relevant implementation at the local level. However, while these efforts have had considerable success, no study has looked at the incremental value of adding patient engagement strategies to the more standard approaches to practice transformation listed above. This project would implement the Southwest Health Extension Program to Enhance Research Dissemination (SHEPERD) as a cooperative program to build primary care practice capacity for quality improvement, change management, and implementation of PCOR findings in small and medium size primary care practices in Colorado and New Mexico, with an initial focus on cardiovascular care. It also would conduct a cluster randomized trial with an external matched cohort control group to examine the Reach, Effectiveness, Adoption, Implementation, and Maintenance of two approaches to practice transformation to implement PCOR interventions for reducing cardiovascular risks in primary care practices, comparing the impact of 1) a standard practice transformation support intervention (including practice facilitation, practice assessment with feedback, HIT assistance, academic detailing, and collaborative learning sessions) to 2) an approach that adds patient engagement activities (including patient advisory councils and boot camp translation) as part of the practice transformation support. This project will provide critical information regarding the added value of patient engagement in practice transformation efforts and will also result in a network of practices across the region with increased capacity for practice transformation and implementation of PCOR findings.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard practice transformation support | Active comparator | Other: Standard practice transformation supportPrimary care practices will receive a cardiovascular care toolkit, practice facilitation, practice assessment with feedback, health information technology assistance, academic detailing, and periodic collaborative learning sessions |
| Enhanced practice transformation support | Experimental | Other: Enhanced practice transformation supportPrimary care practices will receive practice facilitation, practice assessment with feedback, health information technology assistance, academic detailing, and periodic collaborative learning sessions PLUS patient advisory council support and a modified cardiovascular care toolkit based on combined practice and patient input regarding the local context. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Must be staff or clinicians (including physicians, nurse practitioners, and physician assistants) in an enrolled primary care practice
- Primary care practices must be family medicine or general internal medicine practices with a maximum of ten lead clinicians
- Primary care practices must be either independent or, if part of a larger organization, demonstrate on careful screening that they do not receive significant quality improvement support from the larger organization
Key exclusion criteria (3 listed)
- Primary care practices with more than 10 lead clinicians
- Non-independent primary care practices that receive significant quality improvement support from their system or organization
- Clinicians and staff who do not speak or read English
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 |
|---|---|---|
| Enhanced practice transformation support | Other | Enhanced practice transformation support |
| Standard practice transformation support | Other | Standard practice transformation support |
Primary outcome
Change of documentation of aspirin therapy in patients with ischemic vascular disease.
Time frame: Baseline, 3, 6, 9, 12, and 15 months from baseline
The percent of patients aged 18 years and older with Ischemic Vascular Disease (IVD) with documented use of aspirin or other antithrombotic. This is a practice-level indicator of documentation of care processes for cardiovascular disease.
Change of documentation of blood pressure in patients with a diagnosis of hypertension.
Time frame: Baseline, 3, 6, 9, 12, and 15 months from baseline
The percent of patients aged 18 - 85 who had a diagnosis of hypertension (HTN) and whose blood pressure (BP) was adequately controlled (<140/90) during the measurement year. This is a practice-level indicator of documentation of care processes for cardiovascular disease.
Change of documentation of blood pressure in patients with adequately controlled blood pressure.
Time frame: Baseline, 3, 6, 9, 12, and 15 months from baseline
The percent of patients aged 18 - 85 who had a diagnosis of hypertension (HTN) and whose blood pressure (BP) was adequately controlled (age 18-59 and/or people with diabetes or chronic kidney disease <140/90; age 60-85 <150/90) during the measurement year. This is a practice-level indicator of documentation of care processes for cardiovascular disease.
Change of documentation of fasting LDL in patients with a fasting LDL at or below the LDL goal.
Time frame: Baseline, 3, 6, 9, 12, and 15 months from baseline
The percent of patients aged 20 - 79 who had a fasting LDL test performed and whose risk-stratified fasting LDL is at or below the recommended LDL goal. This is a practice-level indicator of documentation of care processes for cardiovascular disease.
Change of documentation of patients who had a fasting LDL test performed and prescribed a statin based on risk.
Time frame: Baseline, 3, 6, 9, 12, and 15 months from baseline
The percent of patients aged 20 - 79 who had a fasting LDL test performed and who are prescribed a recommended dose of statin based on risk status if indicated. This is a practice-level indicator of documentation of care processes for cardiovascular disease.
Change of documentation of patients screened about tobacco use.
Time frame: Baseline, 3, 6, 9, 12, and 15 months from baseline
The percent of patients aged 18 years or older screened about tobacco use one or more times within 24 months AND who received cessation counseling intervention if identified as a tobacco user. This is a practice-level indicator of documentation of care processes for cardiovascular disease.
1 secondary outcome
Change of the documentation in primary care practice's.
Time frame: Baseline, 9 and 15 months from baseline
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 25 Jan 2021.
- Derived from this study: PubMed 38664665Zittleman L, Westfall JM, Callen D, Herrick AM, Nkouaga C, Simpson M, Dickinson LM, Fernald D, Kaufman A, English AF, Dickinson WP, Nease DE Jr. Does engagement matter? The impact of patient and community engagement on implementation of cardiovascular health materials in primary care settings. BMC Prim Care. 2024 Apr 25;25(1):135. doi: 10.1186/s12875-024-02365-w.
- Derived from this study: PubMed 32808208Fernald DH, Mullen R, Hall T, Bienstock A, Kirchner S, Knierim K, de la Cerda D, Callan D, Rhyne RL, Dickinson LM, Dickinson WP. Exemplary Practices in Cardiovascular Care: Results on Clinical Quality Measures from the EvidenceNOW Southwest Cooperative. J Gen Intern Med. 2020 Nov;35(11):3197-3204. doi: 10.1007/s11606-020-06094-5. Epub 2020 Aug 17.
- Derived from this study: PubMed 29632227English AF, Dickinson LM, Zittleman L, Nease DE Jr, Herrick A, Westfall JM, Simpson MJ, Fernald DH, Rhyne RL, Dickinson WP. A Community Engagement Method to Design Patient Engagement Materials for Cardiovascular Health. Ann Fam Med. 2018 Apr;16(Suppl 1):S58-S64. doi: 10.1370/afm.2173.
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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.
W. Perry Dickinson, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced practice transformation support and Standard practice transformation support in people with Cardiovascular Diseases, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. 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 25 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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?
Change of documentation of aspirin therapy in patients with ischemic vascular disease. (time frame: Baseline, 3, 6, 9, 12, and 15 months from baseline). The study lists 6 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 NCT02515578, 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 25 Jan 2021.