HypertensionPPLNCT00903071
Personalized Physician Learning to Improve Hypertension Care
A study testing Real PPL and Sim PPL in people with Hypertension, run by HealthPartners Institute at 1 site in United States.
Trial summary
In this project the investigators implement and test the ability of a Personalized Physician Learning (PPL) intervention to improve hypertension (HT) care with the following specific aims: Specific Aim 1: Implement two versions of a Personalized Physician Learning (PPL) intervention and assess the ability of these… Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Real PPL and Sim PPL
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to May 2013
- 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Practicing physician at 1 of 2 medical groups.
- Be a general internist of family physician.
- Provide ongoing clinical care to at least 25 adult patients with uncontrolled hypertension. Additional patient criteria include;
- 22 years or more on date of physician randomization.
- Charlson score less than 4.
- Be linked to a primary care physician who has consented to the study.
- Have 2 consecutive office blood pressure readings above the 7th Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC7) goal, within a 12 month time period.
Who cannot join
- Physicians practicing at a second clinic for more than 1 day per week. Additional patient criteria;
- Less than 22 years of age.
- Charlson score of >= 4
Trial locations and contacts
1 site in 1 country.
United States1 site
HealthPartners Research Foundation
Minneapolis, Minnesota, 55440
About this study
Official title: Personalized Physician Learning Intervention to Improve Hypertension Care
In this project the investigators implement and test the ability of a Personalized Physician Learning (PPL) intervention to improve hypertension (HT) care with the following specific aims:
Specific Aim 1: Implement two versions of a Personalized Physician Learning (PPL) intervention and assess the ability of these interventions to improve hypertension control in primary care practice.
Read more
- Hypothesis 1: Patients of physicians who receive the REAL+PPL Intervention (Group 1) will subsequently have better HT control compared to patients of control group physicians (Group 3).
- Hypothesis 2: Patients of physicians who receive the SIM+PPL Intervention (Group 2) will subsequently have better HT control compared to patients of control group physicians (Group 3).
- Hypothesis 3: Patients of physicians who receive the REAL+PPL (Group 1) will subsequently have better HT control compared to patients of physicians who receive the SIM+PPL (Group 2).
Specific Aim 2: Assess the cost-effectiveness of the SIM+PPL and REAL+PPL interventions, relative to no intervention.
Read the detailed description
The objective of this project is to improve hypertension (HT) control by implementing two Personalized Physician Learning interventions designed for primary care physicians (PCPs). Improved HT control has long been identified as a major national health care priority because uncontrolled HT is a leading cause of stroke(CVA), congestive heart failure (CHF), chronic kidney disease (CKD), end-stage renal disease (ESRD),myocardial infarction (MI), and other adverse health events. The cost of uncontrolled HT and its sequelae is estimated to be at least $100 billion dollars a year in the U.S., and there has been only minimal improvement in HT care in recent decades. Currently, of an estimated 68 million Americans with HT, about 42 million remain uncontrolled.
Personalized Physician Learning (PPL) interventions are powerful enough to change physician behavior and improve HT care. The PPL interventions in this project are directed to individual primary care physicians(PCPs) using a simple 3-step approach: (a) Analyze each physician's pre-intervention patterns of HT care to identify specific failures of physician decision making in HT care, (b) Provide each physician with a series of personalized HT learning cases designed to correct the failures of decision making that result in that physician's observed patterns of HT care. Learning cases provide iterative on-screen feedback of blood pressure (BP) changes in response to a sequence of changes in therapy, expert-generated suggestions for better HT care, and adaptive selection of subsequent cases until identified errors in decision making are mastered. (c) Assess intervention impact on the care of actual patients with HT in the post-intervention period, to assess transfer of learning from the simulated to the office practice environment. The PPL intervention strategy is based on recent work in cognitive science and learning theory and has been successfully applied in other research and educational settings, although it has yet to be applied to HT care.
- Conditions
- Hypertension
- Being tested
- Real PPL, Sim PPL
- Keywords
- Hypertension, Primary Care, Physician Learning
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real PPLBehavioural
See above arm description
Sim PPLBehavioural
See above arm description
| Study group | Role | What they receive |
|---|---|---|
| REAL PPL | Active comparator | REAL+PPL profiles PCP performance using real electronic medical record derived data to identify each PCP's specific failures of decision making in HT care antecedent to the personalized learning intervention. Receives: Behavioral: Real PPL |
| SIM PPL | Active comparator | SIM+PPL, profiles PCP performance using simulated cases to identify each PCP's specific failures of decision making in HT care antecedent to the personalized learning intervention. Receives: Behavioral: Sim PPL |
| Control | No intervention | No intervention -control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypertension control
Measured: 12 month pre and 12 month post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2009 (estimated)
- Study startMar 2010
- Primary completionDec 2011
- Study completionMay 2013
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
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- HealthPartners Institute
- Sponsor type
- University, hospital or other
- Collaborators
- University of Minnesota, Kaiser Permanente, National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Patrick J O'Connor, MD, MPH, Principal investigator, HealthPartners Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00903071
- Sponsor's protocol ID
- 07-090
- Other IDs
- R01HL089451-01A1
- Acronym
- PPL
- Status last verified
- Jun 2014
- First submitted
- 13 May 2009
- Last updated
- 16 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
O'Connor PJ, Magid DJ, Sperl-Hillen JM, Price DW, Asche SE, Rush WA, Ekstrom HL, Brand DW, Tavel HM, Godlevsky OV, Johnson PE, Margolis KL. Personalised physician learning intervention to improve hypertension and lipid control: randomised trial comparing two methods of physician profiling. BMJ Qual Saf. 2014 Dec;23(12):1014-22. doi: 10.1136/bmjqs-2014-002807. Epub 2014 Sep 16.
PubMed 25228778
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Physician Learning Intervention to Improve Hypertension Care
- ClinicalTrials.gov ID
- NCT00903071
- Acronym / sponsor ID
- PPL / 07-090
- Conditions
- Hypertension
- Keywords
- Hypertension, Primary Care, Physician Learning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- HealthPartners InstituteUniversity, hospital or other
- Collaborators
- University of Minnesota, Kaiser Permanente, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Mar 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 15 May 2009 (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.
In this project the investigators implement and test the ability of a Personalized Physician Learning (PPL) intervention to improve hypertension (HT) care with the following specific aims:
Specific Aim 1: Implement two versions of a Personalized Physician Learning (PPL) intervention and assess the ability of these interventions to improve hypertension control in primary care practice.
- Hypothesis 1: Patients of physicians who receive the REAL+PPL Intervention (Group 1) will subsequently have better HT control compared to patients of control group physicians (Group 3).
- Hypothesis 2: Patients of physicians who receive the SIM+PPL Intervention (Group 2) will subsequently have better HT control compared to patients of control group physicians (Group 3).
- Hypothesis 3: Patients of physicians who receive the REAL+PPL (Group 1) will subsequently have better HT control compared to patients of physicians who receive the SIM+PPL (Group 2).
Specific Aim 2: Assess the cost-effectiveness of the SIM+PPL and REAL+PPL interventions, relative to no intervention.
Detailed description
The objective of this project is to improve hypertension (HT) control by implementing two Personalized Physician Learning interventions designed for primary care physicians (PCPs). Improved HT control has long been identified as a major national health care priority because uncontrolled HT is a leading cause of stroke(CVA), congestive heart failure (CHF), chronic kidney disease (CKD), end-stage renal disease (ESRD),myocardial infarction (MI), and other adverse health events. The cost of uncontrolled HT and its sequelae is estimated to be at least $100 billion dollars a year in the U.S., and there has been only minimal improvement in HT care in recent decades. Currently, of an estimated 68 million Americans with HT, about 42 million remain uncontrolled.
Personalized Physician Learning (PPL) interventions are powerful enough to change physician behavior and improve HT care. The PPL interventions in this project are directed to individual primary care physicians(PCPs) using a simple 3-step approach: (a) Analyze each physician's pre-intervention patterns of HT care to identify specific failures of physician decision making in HT care, (b) Provide each physician with a series of personalized HT learning cases designed to correct the failures of decision making that result in that physician's observed patterns of HT care. Learning cases provide iterative on-screen feedback of blood pressure (BP) changes in response to a sequence of changes in therapy, expert-generated suggestions for better HT care, and adaptive selection of subsequent cases until identified errors in decision making are mastered. (c) Assess intervention impact on the care of actual patients with HT in the post-intervention period, to assess transfer of learning from the simulated to the office practice environment. The PPL intervention strategy is based on recent work in cognitive science and learning theory and has been successfully applied in other research and educational settings, although it has yet to be applied to HT care.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| REAL PPL | Active comparator | Behavioral: Real PPLREAL+PPL profiles PCP performance using real electronic medical record derived data to identify each PCP's specific failures of decision making in HT care antecedent to the personalized learning intervention. |
| SIM PPL | Active comparator | Behavioral: Sim PPLSIM+PPL, profiles PCP performance using simulated cases to identify each PCP's specific failures of decision making in HT care antecedent to the personalized learning intervention. |
| Control | No intervention | –No intervention -control group |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Practicing physician at 1 of 2 medical groups.
- Be a general internist of family physician.
- Provide ongoing clinical care to at least 25 adult patients with uncontrolled hypertension. Additional patient criteria include;
- 22 years or more on date of physician randomization.
- Charlson score less than 4.
Key exclusion criteria (3 listed)
- Physicians practicing at a second clinic for more than 1 day per week. Additional patient criteria;
- Less than 22 years of age.
- Charlson score of >= 4
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 |
|---|---|---|
| Real PPLSee above arm description | Behavioural | REAL PPL |
| Sim PPLSee above arm description | Behavioural | SIM PPL |
Primary outcome
Hypertension control
Time frame: 12 month pre and 12 month post intervention
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 16 Jun 2014.
- Derived from this study: PubMed 25228778O'Connor PJ, Magid DJ, Sperl-Hillen JM, Price DW, Asche SE, Rush WA, Ekstrom HL, Brand DW, Tavel HM, Godlevsky OV, Johnson PE, Margolis KL. Personalised physician learning intervention to improve hypertension and lipid control: randomised trial comparing two methods of physician profiling. BMJ Qual Saf. 2014 Dec;23(12):1014-22. doi: 10.1136/bmjqs-2014-002807. Epub 2014 Sep 16.
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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.
Patrick J O'Connor, MD, MPH principal investigator
HealthPartners Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Real PPL and Sim PPL in people with Hypertension, run by HealthPartners Institute 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 7 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 16 Jun 2014. 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?
Hypertension control (time frame: 12 month pre and 12 month post intervention). 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 NCT00903071, 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 16 Jun 2014.