NCT04171596

Brief 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. 1.To determine whether the PCC intervention increases patient satisfaction and/or patient activation.
  2. 2.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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 14, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 11, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 11, 2019

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 19, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 21, 2019

Completed
Last Updated

November 21, 2019

Status Verified

November 1, 2019

Enrollment Period

8 months

First QC Date

November 19, 2019

Last Update Submit

November 19, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • Number of patients enrolled

    Number of patients enrolled as measured by enrollment logs

    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

    Up to 1 year

Secondary Outcomes (2)

  • Patient satisfaction

    Up to 1 year

  • Number of additional clinic visits

    Up to 1 year

Study Arms (1)

Primary care coordination

EXPERIMENTAL
Behavioral: Primary care coordination

Interventions

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.

Primary care coordination

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Member of the Duke Integrative Primary Care clinic in Durham, NC who have been members for at least 1 year.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke Integrative Medicine

Durham, North Carolina, 27705, United States

Location

Study Officials

  • Oliver Glass, PhD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2019

First Posted

November 21, 2019

Study Start

February 14, 2018

Primary Completion

October 11, 2018

Study Completion

April 11, 2019

Last Updated

November 21, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations