HypertensionCVRSLiveNCT03660631
Dissemination of the Cardiovascular Risk Service
A study testing CVRS Intervention in people with Hypertension and Diabetes Mellitus, run by Korey Kennelty at 14 sites in United States.
Trial summary
The objective of this study is to evaluate the implementation of of a remote, pharmacist-led cardiovascular risk service (CVRS) in 12 large, organizationally and culturally diverse hospitals and health-systems, many with high proportions of minority and underserved patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Diabetes Mellitus
- What is being tested?
- CVRS Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 542 participants
- Where
- 14 sitesUnited States
- Study dates
- 27 Sep 2018to 30 Dec 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient Subjects:
- English or Spanish speaking
- Seen in the clinic at least once in the previous 12 months
- Currently has one of the following diseases:
- Diabetes with HA1c 9.0% or greater and/or
- Hypertension (uncomplicated) with systolic blood pressure 150 mm Hg or greater
Who cannot join
- Inability to give consent
- Nursing home residence
- No telephone
- Additional patient subject exclusions:
- Cancer with a life expectancy less than 24 months
- Pregnancy
- Diagnosis of dementia
- Plans to terminate care from the clinic within 24 months
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Texas Tech University Health Science Center
Amarillo, Texas, 79106
University of North Carolina
Chapel Hill, North Carolina, 27514
University of Illinois at Chicago: Mile Square Health Center
Chicago, Illinois, 60608
Genesis Family Medical Center
Davenport, Iowa, 52804
Henry Ford Health System: Harbortown
Detroit, Michigan, 48207
Community Health Center of Snohomish County
Everett, Washington, 98203
University of Iowa
Iowa City, Iowa, 52242
Carle Foundation Hospital
Mahomet, Illinois, 61853
Temple University
Philadelphia, Pennsylvania, 19140
Idaho State University
Pocatello, Idaho, 83201
Carle Foundation Hospital
Rantoul, Illinois, 61866
UIHC River Crossing
Riverside, Iowa, 52327
Siouxland Family Medicine Center
Sioux City, Iowa, 51104
Northeast Iowa Family Practice Center
Waterloo, Iowa, 50702
About this study
The objective of this study is to evaluate the implementation of of a remote, pharmacist-led cardiovascular risk service (CVRS) in 12 large, organizationally and culturally diverse hospitals and health-systems, many with high proportions of minority and underserved patients.
Read the detailed description
Cardiovascular disease (CVD) causes 2,200 deaths in Americans every day with one death every 39 seconds. Yet effective implementation of research-based interventions that reduce CVD-related illness and death remains a substantial challenge. The objective of this study is to test the scalability of a pharmacist-led, remote CVD risk and prevention services model in large, organizationally and culturally diverse hospitals and health-systems, many with high proportions of minority and underserved patients, using a pragmatic cluster-randomized design. This service is called the Cardiovascular Risk Service (CVRS). There are limited data on the barriers and facilitators of implementation to enhance the CVRS in these types of diverse, complex health-systems. Therefore, scaling up our effective, innovative team-based intervention will require an assessment of barriers and facilitators to CVRS adoption, implementation, and maintenance. Our central hypothesis is that barriers and facilitators to CVRS implementation will vary across diverse primary care offices. We will use mixed methods including interviews, observations, and an innovative physician-pharmacist collaboration survey we developed to predict implementation of pharmacy-based services. The rationale for this proposed study is that overcoming barriers to implementation of a novel strategy to improve secondary prevention of CVD will lead to innovative strategies for broader adoption by health systems throughout the US.
- Conditions
- Hypertension, Diabetes Mellitus
- Being tested
- CVRS Intervention
- Medical subject headings
- Hypertension, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CVRS InterventionBehavioural
- Evaluate gaps in therapy
- Contact patients regularly by email, phone and/or text message
- Assess and counsel for medication adherence, side effects, life-style behaviors
- Develop an action plan and send recommendations to provider
| Study group | Role | What they receive |
|---|---|---|
| CVRS Early Intervention | Experimental | Patients participating in intervention offices will receive the pharmacist-led CVRS intervention for 12 months. Receives: Behavioral: CVRS Intervention |
| CVRS Delayed Intervention | Other | Patients participating in control site offices will not have any contact with the CVRS pharmacist for the first 12 months of their participation in the study. They will receive the study intervention during months 13-24. Receives: Behavioral: CVRS Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Factors influencing intervention implementation fidelity
Themes will be identified through interviews with key individuals involved in implementation of study intervention. Data from interviews will be analyzed using ATLAS ti to determine frequency and density of themes identified in interviews.
Measured: 12 months following the start of the intervention at each site
Effect of physician/pharmacist collaboration on implementation fidelity
Development of implementation fidelity measures and adherence to fidelity measures
Measured: 12 months following the start of the intervention at each site
Secondary outcomes (4)
Adherence to guidelines for primary and secondary prevention of cardiovascular disease
The percent of select Guideline Advantage criteria met by subjects in the Early Intervention arm versus the Delayed Intervention arm
Measured: 12 months after the start of the intervention for each subject
Reach and adoption of intervention
Proportion of patients and providers participating who were approached
Measured: 12 months following the start of the intervention at each site
Development of payment contracts
Create a template for payment contracts between clinical sites and the CVRS
Measured: 36 months following the start of recruitment
Development of payment contracts
The number of clinical sites that successfully negotiate payment contracts with the CVRS
Measured: 36 months following the start of recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2018
- Study start27 Sep 2018
- Primary completion30 Jun 2023
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patient subjects will participate in their office's randomization group (intervention or control) for the 1st 12 months of their participation. After 12 months, each patient subject in the control group will receive the study intervention for months 13-24. Patient subjects in the intervention will be followed by study pharmacists during months 13-24.
- Masking
- None (open label)
- Enrolment
- 542 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korey Kennelty
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Korey Kennelty, University of Iowa
- Investigators
- Korey Kennelty, PharmD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03660631
- Sponsor's protocol ID
- 201710812
- Acronym
- CVRSLive
- Status last verified
- Aug 2024
- First submitted
- 20 Aug 2018
- Last updated
- 13 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 1. Provide de-identified SAS datasets in transport format with the protocol, data dictionaries user manual . A data sharing agreement will be required. 2. Share data with all participating sites and place study links and information on PBRN website136 3. Present results to other PBRNs through AHRQ meetings. 4. Post the development and results on the .213 PRagmatic-Explanatory Continuum Indicator Summary
Publications
Kennelty KA, Engblom NJ, Carter BL, Hollingworth L, Levy BT, Finkelstein RJ, Parker CP, Xu Y, Jackson KL, Dawson JD, Dorsey KK. Dissemination of a telehealth cardiovascular risk service: The CVRS live protocol. Contemp Clin Trials. 2021 Mar;102:106282. doi: 10.1016/j.cct.2021.106282. Epub 2021 Jan 12.
PubMed 33444781
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dissemination of the Cardiovascular Risk Service
- ClinicalTrials.gov ID
- NCT03660631
- Acronym / sponsor ID
- CVRSLive / 201710812
- Conditions
- Hypertension, Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 542 participants (actual)
- Lead sponsor
- Korey KenneltyUniversity, hospital or other
- Study start
- 27 Sep 2018 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 6 Sep 2018 (actual)
- 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.
The objective of this study is to evaluate the implementation of of a remote, pharmacist-led cardiovascular risk service (CVRS) in 12 large, organizationally and culturally diverse hospitals and health-systems, many with high proportions of minority and underserved patients.
Detailed description
Cardiovascular disease (CVD) causes 2,200 deaths in Americans every day with one death every 39 seconds. Yet effective implementation of research-based interventions that reduce CVD-related illness and death remains a substantial challenge. The objective of this study is to test the scalability of a pharmacist-led, remote CVD risk and prevention services model in large, organizationally and culturally diverse hospitals and health-systems, many with high proportions of minority and underserved patients, using a pragmatic cluster-randomized design. This service is called the Cardiovascular Risk Service (CVRS). There are limited data on the barriers and facilitators of implementation to enhance the CVRS in these types of diverse, complex health-systems. Therefore, scaling up our effective, innovative team-based intervention will require an assessment of barriers and facilitators to CVRS adoption, implementation, and maintenance. Our central hypothesis is that barriers and facilitators to CVRS implementation will vary across diverse primary care offices. We will use mixed methods including interviews, observations, and an innovative physician-pharmacist collaboration survey we developed to predict implementation of pharmacy-based services. The rationale for this proposed study is that overcoming barriers to implementation of a novel strategy to improve secondary prevention of CVD will lead to innovative strategies for broader adoption by health systems throughout the US.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patient subjects will participate in their office's randomization group (intervention or control) for the 1st 12 months of their participation. After 12 months, each patient subject in the control group will receive the study intervention for months 13-24. Patient subjects in the intervention will be followed by study pharmacists during months 13-24.
| Arm | Type | Receives |
|---|---|---|
| CVRS Early Intervention | Experimental | Behavioral: CVRS InterventionPatients participating in intervention offices will receive the pharmacist-led CVRS intervention for 12 months. |
| CVRS Delayed Intervention | Other | Behavioral: CVRS InterventionPatients participating in control site offices will not have any contact with the CVRS pharmacist for the first 12 months of their participation in the study. They will receive the study intervention during months 13-24. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient Subjects:
Key exclusion criteria (8 listed)
- Inability to give consent
- Nursing home residence
- No telephone
- Cancer with a life expectancy less than 24 months
- Pregnancy
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 |
|---|---|---|
| CVRS Intervention1. Evaluate gaps in therapy 2. Contact patients regularly by email, phone and/or text message 3. Assess and counsel for medication adherence, side effects, life-style behaviors 4. Develop an action plan and send recommendations to provider | Behavioural | CVRS Delayed Intervention, CVRS Early Intervention |
Primary outcome
Factors influencing intervention implementation fidelity
Time frame: 12 months following the start of the intervention at each site
Themes will be identified through interviews with key individuals involved in implementation of study intervention. Data from interviews will be analyzed using ATLAS ti to determine frequency and density of themes identified in interviews.
Effect of physician/pharmacist collaboration on implementation fidelity
Time frame: 12 months following the start of the intervention at each site
Development of implementation fidelity measures and adherence to fidelity measures
4 secondary outcomes
Adherence to guidelines for primary and secondary prevention of cardiovascular disease
Time frame: 12 months after the start of the intervention for each subject
Reach and adoption of intervention
Time frame: 12 months following the start of the intervention at each site
Development of payment contracts
Time frame: 36 months following the start of recruitment
Development of payment contracts
Time frame: 36 months following the start of recruitment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
- Derived from this study: PubMed 33444781Kennelty KA, Engblom NJ, Carter BL, Hollingworth L, Levy BT, Finkelstein RJ, Parker CP, Xu Y, Jackson KL, Dawson JD, Dorsey KK. Dissemination of a telehealth cardiovascular risk service: The CVRS live protocol. Contemp Clin Trials. 2021 Mar;102:106282. doi: 10.1016/j.cct.2021.106282. Epub 2021 Jan 12.
- Individual participant dataSharing planned: Yes. 1. Provide de-identified SAS datasets in transport format with the protocol, data dictionaries user manual . A data sharing agreement will be required. 2. Share data with all participating sites and place study links and information on PBRN website136 3. Present results to other PBRNs through AHRQ meetings. 4. Post the development and results on the .213 PRagmatic-Explanatory Continuum Indicator Summary
Related trials for Hypertension
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
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.
Korey Kennelty, PharmD principal investigator
University of Iowa
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CVRS Intervention in people with Hypertension and Diabetes Mellitus, run by Korey Kennelty at 14 sites 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 6 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 13 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites 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?
Results are not available in the source record.
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?
Factors influencing intervention implementation fidelity (time frame: 12 months following the start of the intervention at each site). 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 NCT03660631, which also lists 1 linked publication.
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 13 Aug 2024.