Quality of Health CareNCT00793065
Evaluating the Effects of EHRs, P4P and Medical Home Redesign in the Hudson Valley
An observational study of Quality of Health Care and Electronic Health Records, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
The investigators will conduct a longitudinal cohort study with concurrent controls. The investigators will include all primary care physicians in the Hudson Valley including family practitioners, internists, and pediatricians. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Quality of Health Care, Electronic Health Records
- What is being tested?
- Electronic health record (EHR) and Medical Home redesign
- How many people
- 438 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Dec 2012
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: All primary care physicians (i.e. general internists, pediatricians and family practice physicians) in the Hudson Valley who are members of the Taconic Independent Practice Association (IPA).
Who may be able to join
- Primary care physicians working in the offices practices in the Hudson Valley, and who are members of the Taconic IPA.
Who cannot join
- Physicians who opt out from the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Weill Cornell Medical College
New York, New York, 10021
About this study
The investigators will conduct a longitudinal cohort study with concurrent controls. The investigators will include all primary care physicians in the Hudson Valley including family practitioners, internists, and pediatricians. The purpose of this study is to determine the effects of implementing electronic health records (EHRs), pay-for-performance incentives for physicians (P4P), and Medical Home redesign on health care quality, cost and patient experience in the Hudson Valley.
Read the detailed description
The Hudson Valley is implementing several innovative programs to potentially improve quality and reduce the cost of health care delivered. First the Taconic Health Information Network and Communities Regional Health Information Organization (THINC RHIO) is facilitating diffusion of EHRs in office practices in the Hudson Valley. Second, THINC RHIO is also offering a strategic approach to pay-for-performance. Third, an additional component of the THINC P4P project will be an added financial incentive for private practice physicians who implement and reach Level II of Physician Practice Connections® - Patient Centered Medical Home (PCMH)™, NCQA's new national recognition system for physician practices. Our study will seek to determine the effect of each of these initiatives on health care quality and cost of care in the Hudson Valley. We will also measure the patient experience before and after implementation of the Medical Home.
- Conditions
- Quality of Health Care, Electronic Health Records
- Being tested
- Electronic health record (EHR), Medical Home redesign
- Keywords
- electronic health records, health information technology, physician incentives, quality of health care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic health record (EHR)Other
Computer-based system that allows physicians to access and manage patient records electronically.
Medical Home redesignOther
Implementation of NCQA Level III Medical Home
| Study group | Role | What they receive |
|---|---|---|
| 1 | Physicians that are using paper-based medical charts and who are not receiving Medical Home redesign incentives. | |
| 2 | Physicians that are using Electronic Health Records (EHRs) and who are not undergoing Medical Home redesign. Receives: Other: Electronic health record (EHR) | |
| 3 | Physicians that are using Electronic Health Records (EHRs) and undergoing Medical Home redesign. Receives: Other: Electronic health record (EHR); Other: Medical Home redesign |
What is being measured
The primary outcome is the main question the study is designed to answer.
health care quality (as determined by previously selected and approved quality indicators)
Measured: 5 years
health care utilization
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2008 (estimated)
- Study startJan 2008
- Primary completionDec 2012
- Study completionDec 2012
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 Quality of Health CareStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 438 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- New York State Department of Health, The Commonwealth Fund, Taconic Health Information Network and Community (THINC), Taconic Independent Practice Association (TIPA)
- Responsible party
- Sponsor
- Investigators
- Lisa M Kern, MD, MPH, Principal investigator, Weill Medical College of Cornell UniversityRainu Kaushal, MD, MPH, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00793065
- Sponsor's protocol ID
- 0508190240
- Status last verified
- Feb 2017
- First submitted
- 14 Nov 2008
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Kern LM, Edwards A, Kaushal R. The Patient-Centered Medical Home and Associations With Health Care Quality and Utilization: A 5-Year Cohort Study. Ann Intern Med. 2016 Mar 15;164(6):395-405. doi: 10.7326/M14-2633. Epub 2016 Feb 16.
PubMed 26882534Kaushal R, Edwards A, Kern LM; HITEC Investigators. Association between electronic health records and health care utilization. Appl Clin Inform. 2015 Jan 28;6(1):42-55. doi: 10.4338/ACI-2014-10-RA-0089. eCollection 2015.
PubMed 25848412Kern LM, Edwards A, Kaushal R. The patient-centered medical home, electronic health records, and quality of care. Ann Intern Med. 2014 Jun 3;160(11):741-9. doi: 10.7326/M13-1798.
PubMed 24887615
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effects of EHRs, P4P and Medical Home Redesign in the Hudson Valley
- ClinicalTrials.gov ID
- NCT00793065
- Acronym / sponsor ID
- 0508190240
- Conditions
- Quality of Health Care, Electronic Health Records
- Keywords
- electronic health records, health information technology, physician incentives, quality of health care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 438 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- New York State Department of Health, The Commonwealth Fund, Taconic Health Information Network and Community (THINC), Taconic Independent Practice Association (TIPA)
- Study start
- Jan 2008 (actual)
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 19 Nov 2008 (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 investigators will conduct a longitudinal cohort study with concurrent controls. The investigators will include all primary care physicians in the Hudson Valley including family practitioners, internists, and pediatricians. The purpose of this study is to determine the effects of implementing electronic health records (EHRs), pay-for-performance incentives for physicians (P4P), and Medical Home redesign on health care quality, cost and patient experience in the Hudson Valley.
Detailed description
The Hudson Valley is implementing several innovative programs to potentially improve quality and reduce the cost of health care delivered. First the Taconic Health Information Network and Communities Regional Health Information Organization (THINC RHIO) is facilitating diffusion of EHRs in office practices in the Hudson Valley. Second, THINC RHIO is also offering a strategic approach to pay-for-performance. Third, an additional component of the THINC P4P project will be an added financial incentive for private practice physicians who implement and reach Level II of Physician Practice Connections® - Patient Centered Medical Home (PCMH)™, NCQA's new national recognition system for physician practices. Our study will seek to determine the effect of each of these initiatives on health care quality and cost of care in the Hudson Valley. We will also measure the patient experience before and after implementation of the Medical Home.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Physicians that are using paper-based medical charts and who are not receiving Medical Home redesign incentives. |
| 2 | – | Other: Electronic health record (EHR)Physicians that are using Electronic Health Records (EHRs) and who are not undergoing Medical Home redesign. |
| 3 | – | Other: Electronic health record (EHR), Other: Medical Home redesignPhysicians that are using Electronic Health Records (EHRs) and undergoing Medical Home redesign. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All primary care physicians (i.e. general internists, pediatricians and family practice physicians) in the Hudson Valley who are members of the Taconic Independent Practice Association (IPA).
Key inclusion criteria (1 listed)
- Primary care physicians working in the offices practices in the Hudson Valley, and who are members of the Taconic IPA.
Key exclusion criteria (1 listed)
- Physicians who opt out from the study.
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 |
|---|---|---|
| Electronic health record (EHR)Computer-based system that allows physicians to access and manage patient records electronically. | Other | 2, 3 |
| Medical Home redesignImplementation of NCQA Level III Medical Home | Other | 3 |
Primary outcome
health care quality (as determined by previously selected and approved quality indicators)
Time frame: 5 years
health care utilization
Time frame: 5 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 23 Feb 2017.
- Derived from this study: PubMed 26882534Kern LM, Edwards A, Kaushal R. The Patient-Centered Medical Home and Associations With Health Care Quality and Utilization: A 5-Year Cohort Study. Ann Intern Med. 2016 Mar 15;164(6):395-405. doi: 10.7326/M14-2633. Epub 2016 Feb 16.
- Derived from this study: PubMed 25848412Kaushal R, Edwards A, Kern LM; HITEC Investigators. Association between electronic health records and health care utilization. Appl Clin Inform. 2015 Jan 28;6(1):42-55. doi: 10.4338/ACI-2014-10-RA-0089. eCollection 2015.
- Derived from this study: PubMed 24887615Kern LM, Edwards A, Kaushal R. The patient-centered medical home, electronic health records, and quality of care. Ann Intern Med. 2014 Jun 3;160(11):741-9. doi: 10.7326/M13-1798.
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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.
Lisa M Kern, MD, MPH principal investigator
Weill Medical College of Cornell University
Rainu Kaushal, MD, MPH principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Quality of Health Care and Electronic Health Records, run by Weill Medical College of Cornell University 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 1 inclusion and 1 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 23 Feb 2017. 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?
health care quality (as determined by previously selected and approved quality indicators) (time frame: 5 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 NCT00793065, 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 23 Feb 2017.