- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04171596
Feasibility of Care Coordination
Feasibility of Care Coordination in an Integrative Primary Care Concierge Practice
The primary aim of this study is to determine feasibility of incorporating a primary care coordinator (PCC) into an integrative concierge primary care practice. Secondary aims include:
- To determine whether the PCC intervention increases patient satisfaction and/or patient activation.
- To determine whether regular telephone contacts from a PCC over a period of 6 months increases the number of visits and services by DIPC members.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The Duke Integrative Primary Care (DIPC) clinic in Durham, North Carolina currently serves over 600 patients, and offers a full range of primary care services. The practice is a fee-based model where patients pay a monthly fee to access primary care services, and includes several membership benefits. These benefits include longer appointment times, visits with physicians trained in integrative medicine, access to the Duke Health and Fitness Center, on-site discounts, and use of facilities at Duke Integrative Medicine.
Preliminary information gathered show that DIPC members state reasons of value, cost and underutilization for cancelling their memberships. Underutilized primary care memberships may represent missed opportunities to increase patient satisfaction, improve patient outcomes, and maximize clinic revenue.
DIPC employs an administrative coordinator responsible for assisting patients with enrolling and renewing their primary care memberships, but to date, there has not been a clinical care coordinator role in the DIPC clinic.
This study will provide the basis for understanding the feasibility of incorporating care coordination into the Duke Integrative Primary Care practice. In addition, cost and effort of the care coordinator will be compared to additional volume, revenue and patient satisfaction data to increase understanding of the value proposition. Further, information gathered during this study could suggest possible impact on membership retention rates, as well as inform next steps for continuous improvement initiatives for the integrative primary care practice.
Primary aim: To determine feasibility of incorporating a PCC into an integrative concierge primary care practice.
Secondary aims:
- To determine whether the PCC intervention increases patient satisfaction and/or patient activation.
- To determine whether regular telephone contacts from a PCC over a period of 6 months increases the number of visits and services by DIPC members.
After each subject completes an online consent and a pre-intervention questionnaire housed in a REDCap database, the PCC intervention will begin for that subject. A registered nurse currently employed at Duke Integrative Medicine, who is also trained as an integrative health coach, will serve in the PCC role. The intervention will flow as follows:
The PCC will call study participants every 2 months during the 6 months (more frequently as needed) for a semi-structured phone check-in, and will track the intervention through the REDCap database. The PCC will use guiding questions to frame the call, but will also:
Respond Ask follow-up questions Provide suggestions that are guided by the patient response and appropriateness to the individual situation and needs and scope of practice.
Prior to the call, the PCC will review the patient chart to see if any outstanding orders, medical visits due, and review the patient health goals (known as the "pre-work").
The PCC will call the patient to provide intervention. If patient is not available, the PCC will leave a message, or contact via MyChart to see about scheduling a time to talk.
After the 6-month intervention is complete, the study coordinator will send each individual subject a link to the post-intervention questionnaire in REDCap, and will follow up with each subject to ensure completion of this questionnaire.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
North Carolina
-
Durham, North Carolina, United States, 27705
- Duke Integrative Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Member of the Duke Integrative Primary Care clinic in Durham, NC who have been members for at least 1 year.
Exclusion Criteria:
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Primary care coordination
|
A registered nurse currently employed at Duke Integrative Medicine, who is also trained as an integrative health coach, will serve in the PCC role. The intervention will flow as follows: The PCC will call study participants every 2 months during the 6 months (more frequently as needed) for a semi-structured phone check-in, and will track the intervention through the REDCap database. The PCC will use guiding questions to frame the call, but will also: Respond Ask follow-up questions Provide suggestions that are guided by the patient response and appropriateness to the individual situation and needs and scope of practice. Prior to the call, the PCC will review the patient chart to see if any outstanding orders, medical visits due, and review the patient health goals (known as the "pre-work"). The PCC will call the patient to provide intervention. If patient is not available, the PCC will leave a message, or contact via MyChart to see about scheduling a time to talk. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of patients enrolled
Time Frame: 6 months
|
Number of patients enrolled as measured by enrollment logs
|
6 months
|
|
Number of patients that completed minimum intervention
Time Frame: Up to 1 year
|
Number of patients that completed a minimum of 3 intervention calls as measured by call logs
|
Up to 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient satisfaction
Time Frame: Up to 1 year
|
Number of patients that stated they were satisfied as measured by an internally-designed questionnaire
|
Up to 1 year
|
|
Number of additional clinic visits
Time Frame: Up to 1 year
|
Number of additional clinic visits as determined by visits scheduled due to referrals that happened within the intervention
|
Up to 1 year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Pro00087885
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Care Coordination in Primary Care
-
University of Nevada, Las VegasEunice Kennedy Shriver National Institute of Child Health and Human Development...Active, not recruitingPreventive Care / Anticipatory Guidance | Retention in Care | Food Insecurity Among Children | Care Coordination in Primary Care | Food Insecurity in Post Partum WomenUnited States
-
John James ParkerClínica de Familia La Romana, Dominican RepublicEnrolling by invitationMental Health | Care Coordination | Family Planning | Primary Care | Postpartum CareDominican Republic
-
Lisa TuchmanHealth Resources and Services Administration (HRSA)CompletedCare Coordination | Health Care Transition
-
Miami VA Healthcare SystemCompletedGeriatric Assessment | Veterans | Care-Coordination | Outpatient CareUnited States
-
University Hospital, BordeauxCompletedCare Coordination in OncologyFrance
-
Ohio State UniversityAmerican Society of Health-System Pharmacy FoundationWithdrawnHome Visits | Transitional Care CoordinationUnited States
-
University of North Carolina, Chapel HillPatient-Centered Outcomes Research InstituteCompletedExperiences With Health Care Coordination
-
Centre Hospitalier Universitaire de Saint EtienneNot yet recruitingGeriatric | Care Coordination | Readmission, HospitalFrance
-
Universitätsklinikum Hamburg-EppendorfCompletedAny Condition Treated in Primary CareGermany
-
Universidad Autonoma de MadridIlustre Colegio Profesional de Fisioterapeutas de la Comunidad de MadridNot yet recruitingMusculoskeletal Pain | Chronic Pain | Primary Health Care | Care Coordination | Chronic Non-cancer PainSpain
Clinical Trials on Primary care coordination
-
Carlos III Health InstituteHealth Department of the Basque GovernmentCompleted
-
Kun SunBill and Melinda Gates FoundationCompletedCongenital Heart Disease (CHD) | Cluster Randomized Trial | Auscultation for Clinical Evaluation | Screening Tool | Artificial Intelligence (AI)China
-
University of California, San FranciscoUrban Institute; Laura and John Arnold Foundation; Feeding AmericaCompletedDiabetes MellitusUnited States
-
University of Maryland, BaltimoreCompleted
-
Norwegian University of Science and TechnologyCompleted
-
East Carolina UniversityThe Kate B. Reynolds Charitable TrustCompleted
-
Syracuse VA Medical CenterSyracuse UniversityCompleted
-
Wake Forest University Health SciencesPatient-Centered Outcomes Research InstituteRecruitingChildren With Medical ComplexityUnited States
-
VA Office of Research and DevelopmentCompletedSmokingUnited States