Chronic DiseaseLearn & RelateNCT00657696
Learning and Relationships in Primary Care
An observational study of Chronic Disease, run by VA Office of Research and Development at 2 sites in United States.
Trial summary
Within every primary care clinic is a small team of people who provide care to a group of patients who consider this clinic to be their medical home. Rapid advances in medical knowledge and technology require that these teams constantly adapt so that they can provide the best care to their patients. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Disease
- How many people
- 7,905 participants
- Where
- 2 sitesUnited States
- Study dates
- 28 Jan 2009to 30 Mar 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: clinicians and staff in VA primary care outpatient clinics in VISN 17
Who may be able to join
- Clinician or clinical staff in a non-contract VA primary care outpatient clinic.
- Patient seen in a non-contract VA primary care outpatient clinic in the prior 12 months.
Who cannot join
- None
Trial locations and contacts
2 sites in 1 country.
United States2 sites
South Texas Health Care System, San Antonio, TX
San Antonio, Texas, 78229
Central Texas Veterans Health Care System, Temple, TX
Temple, Texas, 76504
About this study
Official title: Learning and Relationships in Primary Care Clinical Microsystems
Within every primary care clinic is a small team of people who provide care to a group of patients who consider this clinic to be their medical home. Rapid advances in medical knowledge and technology require that these teams constantly adapt so that they can provide the best care to their patients. The goal of this study is to examine how people in these primary care teams learn and relate to each other as they change an adapt. This will be done by observing and interviewing people who work in these teams and by giving them and their patients a survey to fill out. We will then look at the performance of these clinics to see if it is related to how they learn and the quality of their relationships. Our ultimate goal is to design effective interventions that will improve the quality and outcomes of care received by Veterans in primary care outpatient clinics within the VHA.
Read the detailed description
Anticipated Impacts on Veterans Healthcare: Our ultimate goal is to improve the health of veterans by designing interventions at the clinical microsystem level that will facilitate the integration of KM-SD roles in primary care through improving relationships and learning. We anticipate that such a cross-cutting intervention has the potential to improve clinical performance as well as staff and patient satisfaction. If we are successful, this could be a breakthrough in the efficiency of VA organizational change. Project Background: The way in which we conceptualize the basic nature of the primary care clinic (PCC) greatly influences our beliefs and ideas about what should work to improve its operations. If we view it as a production line, then we design our improvement efforts using systems engineering techniques aimed at standardizing, reducing variation, and improving efficiency. If instead we view the PCC as an organic and complex social system, then we might design our improvement efforts using methods designed to embrace rather than eliminate surprise (which is inevitable in health care settings), to enhance the connections and communication between the individuals in the PCC rather than focusing on improving the skill sets of the individuals, and to use feedback and time for reflection as part of a strategy for the PCC to make sense of their own operations and behaviors in relation to their mission and goals. For the purpose of this proposal, this latter approach will be denoted by the term knowledge management techniques. We propose to study whether PCC performance correlates with the presence of higher levels of use of knowledge management techniques within PCCs. The VA has been in the forefront of implementing some knowledge management practices, such as sue of performance data systems and integrated health records, but has not yet paid sufficient attention to other such as relationship management, increasing diversity in decision making, active learning, and sense-making. Project Objectives: Describe the range of knowledge management techniques, including relationship management and active learning) currently employed by 15 VA and 5 VA contract PCCs. 2. Analyze the relationship between the nature and roles of relationships and learning in PCCs and their performance across multiple outcomes including clinical performance measures, worker satisfaction and turnover, and patient satisfaction. Our research propositions are: (1) High performing PCCs exhibit higher quality relationships and more active learning than low performing clinics; (2) The quality of relationship within PCCs will have the largest effects on worker and patient satisfaction. Research Propositions: 1. High performing VA and VA contract primary care clinics will exhibit higher quality relationships and more active learning than low performing clinics. 2.a. Variation in temporal change in both relationships and learning among the 20 clinics over the 30 months will be observed. 2.b. The temporal change in relationships (such as stable, improving or deteriorating between adjacent years) will be associated with a similar temporal change in patient and employee satisfaction.2 c. The temporal change in learning (such as stable, improving or deteriorating between adjacent years) will be associated with a similar temporal change in process of care quality indicators and with intermediate clinical outcomes. Project Methods: Descriptive, iterative study of 15 VA and 5 VA contract primary care clinics within VISN 17. Using ethnographic, qualitative and quantitative data collection methods, each clinic will be profiled on the nature of relationships between staff and between staff and patients and the nature of learning. Clinical outcomes (patient functional status, BP, cholesterol, HgA1c, preventable admissions), patient satisfaction, employee satisfaction and turnover will serve as outcomes. The association of these outcomes with the nature of relationships and learning will be explored qualitatively and quantitatively. Stability of these profiles will be evaluated in two subsequent waves of data collection.
- Conditions
- Chronic Disease
- Keywords
- primary health care, organizations, learning, quality of health care
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Physicians and staff in VA non-contract primary care outpatient clinics and patients seen in last 12 months in the same clinics | |
| Group 2 | Patients seen in last 12 months in Group 1 clinics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of care as measured by the External Performance Review Process(EPRP)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2008 (estimated)
- Study start28 Jan 2009
- Primary completion30 Mar 2012
- Study completion30 Mar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic DiseaseStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 7,905 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Jacqueline A Pugh, MD BA, Principal investigator, South Texas Health Care System, San Antonio, TX
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00657696
- Sponsor's protocol ID
- IIR 06-063
- Acronym
- Learn & Relate
- Status last verified
- Jun 2017
- First submitted
- 2 Apr 2008
- Last updated
- 6 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Learning and Relationships in Primary Care Clinical Microsystems
- ClinicalTrials.gov ID
- NCT00657696
- Acronym / sponsor ID
- Learn & Relate / IIR 06-063
- Conditions
- Chronic Disease
- Keywords
- primary health care, organizations, learning, quality of health care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7,905 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 28 Jan 2009 (actual)
- Primary completion
- 30 Mar 2012 (actual)
- Study completion
- 30 Mar 2012 (actual)
- First posted
- 14 Apr 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.
Within every primary care clinic is a small team of people who provide care to a group of patients who consider this clinic to be their medical home. Rapid advances in medical knowledge and technology require that these teams constantly adapt so that they can provide the best care to their patients. The goal of this study is to examine how people in these primary care teams learn and relate to each other as they change an adapt. This will be done by observing and interviewing people who work in these teams and by giving them and their patients a survey to fill out. We will then look at the performance of these clinics to see if it is related to how they learn and the quality of their relationships. Our ultimate goal is to design effective interventions that will improve the quality and outcomes of care received by Veterans in primary care outpatient clinics within the VHA.
Detailed description
Anticipated Impacts on Veterans Healthcare: Our ultimate goal is to improve the health of veterans by designing interventions at the clinical microsystem level that will facilitate the integration of KM-SD roles in primary care through improving relationships and learning. We anticipate that such a cross-cutting intervention has the potential to improve clinical performance as well as staff and patient satisfaction. If we are successful, this could be a breakthrough in the efficiency of VA organizational change. Project Background: The way in which we conceptualize the basic nature of the primary care clinic (PCC) greatly influences our beliefs and ideas about what should work to improve its operations. If we view it as a production line, then we design our improvement efforts using systems engineering techniques aimed at standardizing, reducing variation, and improving efficiency. If instead we view the PCC as an organic and complex social system, then we might design our improvement efforts using methods designed to embrace rather than eliminate surprise (which is inevitable in health care settings), to enhance the connections and communication between the individuals in the PCC rather than focusing on improving the skill sets of the individuals, and to use feedback and time for reflection as part of a strategy for the PCC to make sense of their own operations and behaviors in relation to their mission and goals. For the purpose of this proposal, this latter approach will be denoted by the term knowledge management techniques. We propose to study whether PCC performance correlates with the presence of higher levels of use of knowledge management techniques within PCCs. The VA has been in the forefront of implementing some knowledge management practices, such as sue of performance data systems and integrated health records, but has not yet paid sufficient attention to other such as relationship management, increasing diversity in decision making, active learning, and sense-making. Project Objectives: Describe the range of knowledge management techniques, including relationship management and active learning) currently employed by 15 VA and 5 VA contract PCCs. 2. Analyze the relationship between the nature and roles of relationships and learning in PCCs and their performance across multiple outcomes including clinical performance measures, worker satisfaction and turnover, and patient satisfaction. Our research propositions are: (1) High performing PCCs exhibit higher quality relationships and more active learning than low performing clinics; (2) The quality of relationship within PCCs will have the largest effects on worker and patient satisfaction. Research Propositions: 1. High performing VA and VA contract primary care clinics will exhibit higher quality relationships and more active learning than low performing clinics. 2.a. Variation in temporal change in both relationships and learning among the 20 clinics over the 30 months will be observed. 2.b. The temporal change in relationships (such as stable, improving or deteriorating between adjacent years) will be associated with a similar temporal change in patient and employee satisfaction.2 c. The temporal change in learning (such as stable, improving or deteriorating between adjacent years) will be associated with a similar temporal change in process of care quality indicators and with intermediate clinical outcomes. Project Methods: Descriptive, iterative study of 15 VA and 5 VA contract primary care clinics within VISN 17. Using ethnographic, qualitative and quantitative data collection methods, each clinic will be profiled on the nature of relationships between staff and between staff and patients and the nature of learning. Clinical outcomes (patient functional status, BP, cholesterol, HgA1c, preventable admissions), patient satisfaction, employee satisfaction and turnover will serve as outcomes. The association of these outcomes with the nature of relationships and learning will be explored qualitatively and quantitatively. Stability of these profiles will be evaluated in two subsequent waves of data collection.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –Physicians and staff in VA non-contract primary care outpatient clinics and patients seen in last 12 months in the same clinics |
| Group 2 | – | –Patients seen in last 12 months in Group 1 clinics |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- clinicians and staff in VA primary care outpatient clinics in VISN 17
Key inclusion criteria (2 listed)
- Clinician or clinical staff in a non-contract VA primary care outpatient clinic.
- Patient seen in a non-contract VA primary care outpatient clinic in the prior 12 months.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Quality of care as measured by the External Performance Review Process(EPRP)
Time frame: 3 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 6 Jun 2017.
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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.
Jacqueline A Pugh, MD BA principal investigator
South Texas Health Care System, San Antonio, TX
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Disease, run by VA Office of Research and Development 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 2 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 6 Jun 2017. 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?
Quality of care as measured by the External Performance Review Process(EPRP) (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jun 2017.