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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in United States

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 groups in NCT00657696
Study groupRoleWhat they receive
Group 1Physicians and staff in VA non-contract primary care outpatient clinics and patients seen in last 12 months in the same clinics
Group 2Patients 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.

  1. 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.

  1. First posted14 Apr 2008 (estimated)
  2. Study start28 Jan 2009
  3. Primary completion30 Mar 2012
  4. Study completion30 Mar 2012

Resources

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)
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

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.

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