HypertensionPROVENCT01677533
Program for Research on the Outcomes of VA Education
A study testing Data, Panel Management Support and Education in people with Hypertension and Smoking Cessation, run by VA New York Harbor Healthcare System at 2 sites in United States.
Trial summary
The PROVE aims to test the efficacy of panel management support and educational intervention in VA Primary Care Clinical Microsystems. The study will test three increasingly intensive methods for implementing panel management strategies among health care providers in VA primary care clinics: providing only panel data… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Smoking Cessation
- What is being tested?
- Data, Panel Management Support and Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,000 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Sep 2009to 31 Aug 2015
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- non-specialized primary care clinical microsystems
Who cannot join
- specialized clinical microsystems
- pilot clinical patient-aligned care teams
Trial locations and contacts
2 sites in 1 country.
United States2 sites
VA NYHHS Brooklyn Campus
Brooklyn, New York, 11209
VA NYHHS Manhattan Campus
New York, New York, 10010
About this study
Official title: Program for Research on the Outcomes of VA Education: Controlled Study of Panel Management and Microsystem Education Interventions to Improve Outcomes in Hypertension and Smoking Cessation
The PROVE aims to test the efficacy of panel management support and educational intervention in VA Primary Care Clinical Microsystems. The study will test three increasingly intensive methods for implementing panel management strategies among health care providers in VA primary care clinics: providing only panel data, providing panel management support, and providing support plus clinical microsystem-enhancing education and training.It is hypothesized that the group receiving panel management and educational interventions will have better smoking cessation and hypertension outcomes than the group receiving only panel management assistance. It is further supposed that the later will have better smoking cessation and hypertension patient outcomes than the data-only group.
Read the detailed description
Objective:
The specific aims for this study are: (1) to identify health professional educational and clinical microsystem determinants of outcomes for hypertension and smoking cessation in veterans. (2) to test the efficacy of three increasingly intensive methods for implementing panel management strategies among health care providers in VA primary care clinics: providing only panel data, providing panel management support, and providing support plus clinical microsystem-enhancing education and training.
Research design:
This project will consist of two phases. Phase I (one year) is the development of the necessary measurement and data infrastructure to assess health professional education, microsystem function, and clinical outcomes. In Phase 2 (two years) the study team will conduct a clinical demonstration project, comparing three interventions in a randomized controlled trial. Primary care teams will be randomly allocated to one of three arms: 1) panel management data, 2) panel management data and support, and 3) panel management data, support and education. The investigators will assess the impact of the implementation of panel management on primary patient outcomes in hypertension and smoking cessation (blood pressure and quit rates). The investigative team will also assess the impact of the implementation of panel management on secondary, intermediary, patient (patient activation, adherence, behavior change), provider (knowledge and attitudes, self-efficacy, job satisfaction) and microsystem outcomes (collective efficacy, teamwork, use of data, redesign of patient processes and provider roles/responsibilities, use of panel management strategies).
Methodology:
The study will utilize a multi-method, quasi-experimental design at VA NYHHS. Primary care is delivered through two teams at the Manhattan and five teams at the Brooklyn campuses. Patients, staff, nurses, and physicians are assigned to specific teams, thereby limiting contamination in this study.
- Conditions
- Hypertension, Smoking Cessation
- Being tested
- Data, Panel Management Support, Education
- Keywords
- Panel management, Clinical microsystems, Hypertension management, Smoking cessation, Continuing medical education, Quality improvement,, Population health
- Medical subject headings
- Hypertension, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DataOther
The microsystem teams of providers, nurses, and clerks will receive monthly reports of their performance measures, which will include process and outcome data for smoking cessation and blood pressure control for veterans in their panel. The reports will provide lists of individual patients in the panel with unmet goals on VA performance measures. They will receive written informational material describing principles and practices of panel management and evidence-based guidelines for hypertension management and smoking cessation.
Panel Management SupportOther
Also called Panel management assistant
PMAs will meet regularly with the members of the microsystem team for one hour/week. The team will be asked to review progress on the health status of their patient panel and to plan strategies for improving their outcomes that the PMA will then implement. A PMA toolkit of panel management strategies will be established that will include guidelines for using VA databases to identify care gaps and reaching out to panel patients via phone and mail to intervene (e.g. reconnect patients to care with appointments, assess and enhance medication adherence, connect patients with VA services, motivational interviewing, and communication with the team about patient issues.
EducationOther
Also called Educational Intervention
The educational intervention will be administered throughout the duration of the study. Our initial educational focus will be on content (concepts of population health and panel management) and process (practice change methodology). Subsequent education will be process oriented, reviewing the changing system of care and discussing its functioning. Education will cover panel management strategies, microsystem theory and skills, and specific strategies regarding the management of hypertension and smoking cessation. It will include monthly seminars, reading materials, web-based modules, and skill building workshops, and PMA-conducted monthly academic detailing using panel data and feedback. After the first three months, academic detailing will only be implemented on an as-needed basis.
| Study group | Role | What they receive |
|---|---|---|
| PM-Data | Active comparator | Team will receive data only. Receives: Other: Data |
| PM-Support | Experimental | Team will receive data and panel management support Receives: Other: Data; Other: Panel Management Support |
| PM-Education | Experimental | Team will receive data, panel management support, and educational interventions. Receives: Other: Data; Other: Panel Management Support; Other: Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Smoking Status
clinical outcome
Measured: Baseline and 12 months
Change in Blood Pressure Reading
clinical outcome
Measured: Baseline and 12 months
Secondary outcomes (10)
Change in weight
Measured: Baseline and most recent at 12 months
Change in Patient Activation
The Patient Activation Measure (PAM) is used to assess patients' self-reported knowledge, skill, and confidence in self-managing of health and chronic conditions
Measured: 6 months and 12 months
Change in Patient Perceptions of Quality of Care
Measured: 6 months and 12 months
Change in Provider Behavior change expertise
Measured: 6 months and 12 months
Change in Provider Self-efficacy with Panel Management Tasks
Measured: Baseline and 12 months
Change in Provider Job Satisfaction
Measured: Baseline and 12 months
Change in Microsystem function and collective efficacy
Measured: Baseline and 12 months
Change in Provider's assessments of training that they received in panel management and working within a PACT team
Measured: Baseline and 12 months
Change in Proportion of panel smokers offered smoking cessation resources by study arm
Measured: Baseline and 12 months
Change in Proportion of smokers on the panel received any cessation medications
This information will be culled from the Vista Smoking Database
Measured: Baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2012 (estimated)
- Study start1 Sep 2009
- Primary completion31 Aug 2014
- Study completion31 Aug 2015
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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA New York Harbor Healthcare System
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Mark Schwartz, VA New York Harbor Healthcare System
- Investigators
- Mark D Schwartz, Principal investigator, VA New York Harbor Healthcare SystemScott Sherman, M.D., M.P.H., Principal investigator, VA New York Harbor Healthcare SystemColleen Gillespie, PhD, Study director, NYU Langone HealthAnne Dembitzer, M.D., Study director, VA New York Harbor Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01677533
- Sponsor's protocol ID
- EDU 08-428-2
- Acronym
- PROVE
- Status last verified
- May 2018
- First submitted
- 28 Aug 2012
- Last updated
- 7 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Savarimuthu SM, Jensen AE, Schoenthaler A, Dembitzer A, Tenner C, Gillespie C, Schwartz MD, Sherman SE. Developing a toolkit for panel management: improving hypertension and smoking cessation outcomes in primary care at the VA. BMC Fam Pract. 2013 Nov 21;14:176. doi: 10.1186/1471-2296-14-176.
PubMed 24261337
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Program for Research on the Outcomes of VA Education: Controlled Study of Panel Management and Microsystem Education Interventions to Improve Outcomes in Hypertension and Smoking Cessation
- ClinicalTrials.gov ID
- NCT01677533
- Acronym / sponsor ID
- PROVE / EDU 08-428-2
- Conditions
- Hypertension, Smoking Cessation
- Keywords
- Panel management, Clinical microsystems, Hypertension management, Smoking cessation, Continuing medical education, Quality improvement,, Population health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,000 participants (actual)
- Lead sponsor
- VA New York Harbor Healthcare SystemUS federal agency
- Study start
- 1 Sep 2009 (actual)
- Primary completion
- 31 Aug 2014 (actual)
- Study completion
- 31 Aug 2015 (actual)
- First posted
- 3 Sep 2012 (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.
The PROVE aims to test the efficacy of panel management support and educational intervention in VA Primary Care Clinical Microsystems. The study will test three increasingly intensive methods for implementing panel management strategies among health care providers in VA primary care clinics: providing only panel data, providing panel management support, and providing support plus clinical microsystem-enhancing education and training.It is hypothesized that the group receiving panel management and educational interventions will have better smoking cessation and hypertension outcomes than the group receiving only panel management assistance. It is further supposed that the later will have better smoking cessation and hypertension patient outcomes than the data-only group.
Detailed description
Objective:
The specific aims for this study are: (1) to identify health professional educational and clinical microsystem determinants of outcomes for hypertension and smoking cessation in veterans. (2) to test the efficacy of three increasingly intensive methods for implementing panel management strategies among health care providers in VA primary care clinics: providing only panel data, providing panel management support, and providing support plus clinical microsystem-enhancing education and training.
Research design:
This project will consist of two phases. Phase I (one year) is the development of the necessary measurement and data infrastructure to assess health professional education, microsystem function, and clinical outcomes. In Phase 2 (two years) the study team will conduct a clinical demonstration project, comparing three interventions in a randomized controlled trial. Primary care teams will be randomly allocated to one of three arms: 1) panel management data, 2) panel management data and support, and 3) panel management data, support and education. The investigators will assess the impact of the implementation of panel management on primary patient outcomes in hypertension and smoking cessation (blood pressure and quit rates). The investigative team will also assess the impact of the implementation of panel management on secondary, intermediary, patient (patient activation, adherence, behavior change), provider (knowledge and attitudes, self-efficacy, job satisfaction) and microsystem outcomes (collective efficacy, teamwork, use of data, redesign of patient processes and provider roles/responsibilities, use of panel management strategies).
Methodology:
The study will utilize a multi-method, quasi-experimental design at VA NYHHS. Primary care is delivered through two teams at the Manhattan and five teams at the Brooklyn campuses. Patients, staff, nurses, and physicians are assigned to specific teams, thereby limiting contamination in this study.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PM-Data | Active comparator | Other: DataTeam will receive data only. |
| PM-Support | Experimental | Other: Data, Other: Panel Management SupportTeam will receive data and panel management support |
| PM-Education | Experimental | Other: Data, Other: Panel Management Support, Other: EducationTeam will receive data, panel management support, and educational interventions. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- non-specialized primary care clinical microsystems
Key exclusion criteria (2 listed)
- specialized clinical microsystems
- pilot clinical patient-aligned care teams
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 |
|---|---|---|
| DataThe microsystem teams of providers, nurses, and clerks will receive monthly reports of their performance measures, which will include process and outcome data for smoking cessation and blood pressure control for veterans in their panel. The reports will provide lists of individual patients in the panel with unmet goals on VA performance measures. They will receive written informational material describing principles and practices of panel management and evidence-based guidelines for hypertension management and smoking cessation. | Other | PM-Data, PM-Education, PM-Support |
| Panel Management SupportAlso: Panel management assistantPMAs will meet regularly with the members of the microsystem team for one hour/week. The team will be asked to review progress on the health status of their patient panel and to plan strategies for improving their outcomes that the PMA will then implement. A PMA toolkit of panel management strategies will be established that will include guidelines for using VA databases to identify care gaps and reaching out to panel patients via phone and mail to intervene (e.g. reconnect patients to care with appointments, assess and enhance medication adherence, connect patients with VA services, motivational interviewing, and communication with the team about patient issues. | Other | PM-Education, PM-Support |
| EducationAlso: Educational InterventionThe educational intervention will be administered throughout the duration of the study. Our initial educational focus will be on content (concepts of population health and panel management) and process (practice change methodology). Subsequent education will be process oriented, reviewing the changing system of care and discussing its functioning. Education will cover panel management strategies, microsystem theory and skills, and specific strategies regarding the management of hypertension and smoking cessation. It will include monthly seminars, reading materials, web-based modules, and skill building workshops, and PMA-conducted monthly academic detailing using panel data and feedback. After the first three months, academic detailing will only be implemented on an as-needed basis. | Other | PM-Education |
Primary outcome
Change in Smoking Status
Time frame: Baseline and 12 months
clinical outcome
Change in Blood Pressure Reading
Time frame: Baseline and 12 months
clinical outcome
10 secondary outcomes
Change in weight
Time frame: Baseline and most recent at 12 months
Change in Patient Activation
Time frame: 6 months and 12 months
Change in Patient Perceptions of Quality of Care
Time frame: 6 months and 12 months
Change in Provider Behavior change expertise
Time frame: 6 months and 12 months
Change in Provider Self-efficacy with Panel Management Tasks
Time frame: Baseline and 12 months
Change in Provider Job Satisfaction
Time frame: Baseline and 12 months
Change in Microsystem function and collective efficacy
Time frame: Baseline and 12 months
Change in Provider's assessments of training that they received in panel management and working within a PACT team
Time frame: Baseline and 12 months
Change in Proportion of panel smokers offered smoking cessation resources by study arm
Time frame: Baseline and 12 months
Change in Proportion of smokers on the panel received any cessation medications
Time frame: Baseline and 12 months
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 May 2018.
- Derived from this study: PubMed 24261337Savarimuthu SM, Jensen AE, Schoenthaler A, Dembitzer A, Tenner C, Gillespie C, Schwartz MD, Sherman SE. Developing a toolkit for panel management: improving hypertension and smoking cessation outcomes in primary care at the VA. BMC Fam Pract. 2013 Nov 21;14:176. doi: 10.1186/1471-2296-14-176.
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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.
Mark D Schwartz principal investigator
VA New York Harbor Healthcare System
Scott Sherman, M.D., M.P.H. principal investigator
VA New York Harbor Healthcare System
Colleen Gillespie, PhD study director
NYU Langone Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Data, Panel Management Support and Education in people with Hypertension and Smoking Cessation, run by VA New York Harbor Healthcare System at 2 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 1 inclusion and 2 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 7 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
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 in Smoking Status (time frame: Baseline and 12 months). 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 NCT01677533, 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 7 May 2018.