Patient EngagementLINCCNCT02286193
Creating a Clinic-Community Liaison Role in Primary Care: Engaging Patients and Community in Health Care Innovation
An observational study of Patient Engagement and Community Integration, run by Kaiser Permanente.
Trial summary
This project will engage patients and health care teams to develop, implement, and rigorously evaluate a new lay health worker role (Community Resource Specialist, CRS) for primary care teams. The CRS will link patients and healthcare clinics with community resources. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Patient Engagement, Community Integration
- What is being tested?
- Patient clinical encounters with Community Resource Specialist (CRS)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 418 participants
- Where
- No sites listed yet
- Study dates
- Mar 2013to Mar 2016
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Child, Adult, Older adult
Study population: Group Health primary care patients at one of three pilot clinics who are referred or self-refer to work with a Community Resource Specialist (CRS)
Who may be able to join
- Enrolled at Group Health Cooperative, Seattle, Washington, in one of three pilot primary care clinics
- Referred or self-referred to the CRS for connection to community resources to support health goals
Who cannot join
- Not enrolled at Group Health
- Not enrolled in one of the pilot clinics
About this study
This project will engage patients and health care teams to develop, implement, and rigorously evaluate a new lay health worker role (Community Resource Specialist, CRS) for primary care teams. The CRS will link patients and healthcare clinics with community resources.
Read the detailed description
Patients are served best when multiple organizations work together to meet healthcare needs. In the Chronic Care Model, community resources supplement productive interactions between patients and care teams. However, healthcare delivery systems and health research have given relatively little attention to the model's community features. This project engages patients in designing a primary care community liaison role (Community Resource Specialist, CRS) connecting patients to clinic and community resources that support chronic disease prevention and management. The CRS role will enhance primary care by better integrating community resources into patient care.
The proposed design effort will:
- develop tools and work processes that promote meaningful patient engagement in creating a CRS concept and role
- integrate the CRS role into primary care teams
- assess effects of this role on patient-centered outcomes.
The patient engagement process will use principles from Lean, a quality improvement method, to engage all primary care stakeholders, particularly patients and clinical staff. The project will integrate community resources into the patient-centered medical home model of Group Health, a nonprofit healthcare system that provides coverage and care.
The project will enhance patient resources and options for managing and preventing chronic illness and improve patient-centered outcomes.
The project's specific aims are:
- Aim 1: Develop, implement, and evaluate new methods to involve patients intensively in care design. The investigators will create processes and tools to select and train participants and facilitate their productive contributions to care design. The investigators will document the approach's benefits and challenges using qualitative and quantitative data.
- Aim 2: Design and pilot a new CRS role for primary care teams. Robust engagement of patients in designing this new primary care team role will result in innovative, patient-centered solutions. The investigators will pilot this service at three clinics. The aim of the new service is to help patients more readily access the healthcare and community resources they need for preventing and treating chronic disease. The CRS also may help educate clinic staff about available community resources and increase the primary care team's use of holistic approaches to health.
- Aim 3: Evaluate the design and efficacy of the CRS. The investigators will conduct both formative and outcome evaluations of the CRS role.
- Conditions
- Patient Engagement, Community Integration
- Being tested
- Patient clinical encounters with Community Resource Specialist (CRS)
- Medical subject headings
- Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient clinical encounters with Community Resource Specialist (CRS)Behavioural
CRS will work with patients to create goals, develop action plans and link to community resources to support goals
| Study group | Role | What they receive |
|---|---|---|
| Patients presenting to Community Resource Specialist (CRS) | Primary care patients who are referred or self-refer to the CRS for education and linkage to community resources that can help support health goals Receives: Behavioral: Patient clinical encounters with Community Resource Specialist (CRS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Receiving a Resource for Community Services
Number of patients who completed at least one visit with the CRS and were given a referral for at least one resource, service, or organization. This was assessed by abstraction and coding of CRS documentation in the medical record.
Measured: 3 months
Secondary outcomes (1)
Number of Participants Setting a Goal With Their CRS
Number of patients who completed at least one visit with the CRS and set a specific action-based goal with their CRS. Patients could meet with the CRS and receive referrals to resources without setting specific action-based goals. This was assessed by abstraction and coding of CRS documentation in the medical record.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2014 (estimated)
- Study startMar 2013
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Patient EngagementStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe 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
- Prospective
- Enrolment
- 418 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
- Investigators
- Clarissa Hsu, PhD, Principal investigator, Group Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02286193
- Sponsor's protocol ID
- 1011 Hsu PCORI Cycle 1
- Acronym
- LINCC
- Status last verified
- Oct 2017
- First submitted
- 5 Nov 2014
- Last updated
- 13 Nov 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Creating a Clinic-Community Liaison Role in Primary Care: Engaging Patients and Community in Health Care Innovation
- ClinicalTrials.gov ID
- NCT02286193
- Acronym / sponsor ID
- LINCC / 1011 Hsu PCORI Cycle 1
- Conditions
- Patient Engagement, Community Integration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 418 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- Mar 2013
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 7 Nov 2014 (estimated)
- Results
- Posted 7 Sep 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project will engage patients and health care teams to develop, implement, and rigorously evaluate a new lay health worker role (Community Resource Specialist, CRS) for primary care teams. The CRS will link patients and healthcare clinics with community resources.
Detailed description
Patients are served best when multiple organizations work together to meet healthcare needs. In the Chronic Care Model, community resources supplement productive interactions between patients and care teams. However, healthcare delivery systems and health research have given relatively little attention to the model's community features. This project engages patients in designing a primary care community liaison role (Community Resource Specialist, CRS) connecting patients to clinic and community resources that support chronic disease prevention and management. The CRS role will enhance primary care by better integrating community resources into patient care.
The proposed design effort will:
- develop tools and work processes that promote meaningful patient engagement in creating a CRS concept and role
- integrate the CRS role into primary care teams
- assess effects of this role on patient-centered outcomes.
The patient engagement process will use principles from Lean, a quality improvement method, to engage all primary care stakeholders, particularly patients and clinical staff. The project will integrate community resources into the patient-centered medical home model of Group Health, a nonprofit healthcare system that provides coverage and care.
The project will enhance patient resources and options for managing and preventing chronic illness and improve patient-centered outcomes.
The project's specific aims are:
- Aim 1: Develop, implement, and evaluate new methods to involve patients intensively in care design. The investigators will create processes and tools to select and train participants and facilitate their productive contributions to care design. The investigators will document the approach's benefits and challenges using qualitative and quantitative data.
- Aim 2: Design and pilot a new CRS role for primary care teams. Robust engagement of patients in designing this new primary care team role will result in innovative, patient-centered solutions. The investigators will pilot this service at three clinics. The aim of the new service is to help patients more readily access the healthcare and community resources they need for preventing and treating chronic disease. The CRS also may help educate clinic staff about available community resources and increase the primary care team's use of holistic approaches to health.
- Aim 3: Evaluate the design and efficacy of the CRS. The investigators will conduct both formative and outcome evaluations of the CRS role.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients presenting to Community Resource Specialist (CRS) | – | Behavioral: Patient clinical encounters with Community Resource Specialist (CRS)Primary care patients who are referred or self-refer to the CRS for education and linkage to community resources that can help support health goals |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Group Health primary care patients at one of three pilot clinics who are referred or self-refer to work with a Community Resource Specialist (CRS)
Key inclusion criteria (2 listed)
- Enrolled at Group Health Cooperative, Seattle, Washington, in one of three pilot primary care clinics
- Referred or self-referred to the CRS for connection to community resources to support health goals
Key exclusion criteria (2 listed)
- Not enrolled at Group Health
- Not enrolled in one of the pilot clinics
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 |
|---|---|---|
| Patient clinical encounters with Community Resource Specialist (CRS)CRS will work with patients to create goals, develop action plans and link to community resources to support goals | Behavioural | Patients presenting to Community Resource Specialist (CRS) |
Primary outcome
Number of Participants Receiving a Resource for Community Services
Time frame: 3 months
Number of patients who completed at least one visit with the CRS and were given a referral for at least one resource, service, or organization. This was assessed by abstraction and coding of CRS documentation in the medical record.
1 secondary outcome
Number of Participants Setting a Goal With Their CRS
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Clarissa Hsu, PhD principal investigator
Group Health Research Institute
Questions about this trial
What is this clinical trial studying?
An observational study of Patient Engagement and Community Integration, run by Kaiser Permanente.
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 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 13 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 7 Sep 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Receiving a Resource for Community Services (time frame: 3 months). 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 13 Nov 2017.