Care Coordination in Primary CareNCT04171596
Feasibility of Care Coordination
A study testing Primary care coordination in people with Care Coordination in Primary Care, run by Duke University at 1 site in United States.
Trial summary
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: 1. To determine whether the PCC intervention increases patient satisfaction and/or patient activation. 2. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Care Coordination in Primary Care
- What is being tested?
- Primary care coordination
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Feb 2018to 11 Apr 2019
- Phase
- Interventional
- 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
Who may be able to join
- Member of the Duke Integrative Primary Care clinic in Durham, NC who have been members for at least 1 year.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke Integrative Medicine
Durham, North Carolina, 27705
About this study
Official title: 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.
Read the 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.
- Conditions
- Care Coordination in Primary Care
- Being tested
- Primary care coordination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary care coordinationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Primary care coordination | Experimental | Not described Receives: Behavioral: Primary care coordination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients enrolled
Number of patients enrolled as measured by enrollment logs
Measured: 6 months
Number of patients that completed minimum intervention
Number of patients that completed a minimum of 3 intervention calls as measured by call logs
Measured: Up to 1 year
Secondary outcomes (2)
Patient satisfaction
Number of patients that stated they were satisfied as measured by an internally-designed questionnaire
Measured: Up to 1 year
Number of additional clinic visits
Number of additional clinic visits as determined by visits scheduled due to referrals that happened within the intervention
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2019
- Study start14 Feb 2018
- Primary completion11 Oct 2018
- Study completion11 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Care Coordination in Primary CareStudies of the same condition, open and under way.
- More trials run by Duke 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Oliver Glass, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04171596
- Sponsor's protocol ID
- Pro00087885
- Status last verified
- Nov 2019
- First submitted
- 19 Nov 2019
- Last updated
- 21 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Care Coordination in an Integrative Primary Care Concierge Practice
- ClinicalTrials.gov ID
- NCT04171596
- Acronym / sponsor ID
- Pro00087885
- Conditions
- Care Coordination in Primary Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 14 Feb 2018 (actual)
- Primary completion
- 11 Oct 2018 (actual)
- Study completion
- 11 Apr 2019 (actual)
- First posted
- 21 Nov 2019 (actual)
- 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 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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Primary care coordination | Experimental | Behavioral: Primary care coordination |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Member of the Duke Integrative Primary Care clinic in Durham, NC who have been members for at least 1 year.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Primary care coordinationA 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. | Behavioural | Primary care coordination |
Primary outcome
Number of patients enrolled
Time frame: 6 months
Number of patients enrolled as measured by enrollment logs
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
2 secondary outcomes
Patient satisfaction
Time frame: Up to 1 year
Number of additional clinic visits
Time frame: Up to 1 year
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 21 Nov 2019.
- 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.
Oliver Glass, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Primary care coordination in people with Care Coordination in Primary Care, run by Duke 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 21 Nov 2019. 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?
Number of patients enrolled (time frame: 6 months). 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?
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 21 Nov 2019.