- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02375932
Pre-Visit Prioritization for Complex Patients With Diabetes (PVP)
Pre-Visit Prioritization for Complex Primary Care Patients With Diabetes
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Primary care physicians (PCPs) at Kaiser Permanente Northern California with potentially eligible patients (type 2 diabetes and HbA1c > 8.0%) wil be recruited and consented to participate in this study. PCPs will review lists of potentially eligible patients of theirs (defined below). Patients approved by PCP's allocated to the intervention arm will be sent a secure message on the PCPs behalf asking them to review the Pre-Visit Prioritization Questionnaire to identify top priorities for discussion at the next scheduled visit.
Patient Inclusion Criteria:
- Current adult member (> 21 years old)
- Diagnosis of type 2 diabetes with most recent HbA1c > 8.0%
- English as primary language
- Registered on kp.org.
Patient Exclusion Criteria:
- Excluded by PCP, and/or: terminal illness, in hospice care or reside in a long-term care facility, severe mental illness (e.g. schizophrenia or personality disorder), currently or recently pregnant, and/or significant dementia
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Pre-Visit Tool
Patients whose primary care physicians are allocated to the intervention arm will receive a secure electronic message shortly after scheduling an appointment with their provider asking them to complete a pre-visit prioritization survey using the kp.org patient portal
|
Patients receive a secure electronic message from their primary providers asking them to prepare for their visit by reviewing important areas of care and identifying their top priorities for discussion at a scheduled visit
|
Active Comparator: Usual Care Control
Patients whose primary care physicians are allocated to the control arm will continue with usual care
|
Patients continue to receive usual care from their primary care provider
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Glycemic Control (HbA1c control (% patients < 7.0% and mean HbA1c levels)
Time Frame: 1 year after enrollment
|
We will compare HbA1c control (% patients < 7.0% and mean HbA1c levels) between intervention and control arms
|
1 year after enrollment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient assessment of visit communication (measures of communication quality using validated instruments)
Time Frame: Shortly after visit with PCP
|
We will call a subset of patients in the intervention and control arms after attending a visit with their PCP to assess measures of communication quality using validated instruments
|
Shortly after visit with PCP
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Richard W Grant, MD MPH, Division of Research, Kaiser Permanente Northern California
Publications and helpful links
General Publications
- Grant RW, Adams AS, Bayliss EA, Heisler M. Establishing visit priorities for complex patients: A summary of the literature and conceptual model to guide innovative interventions. Healthc (Amst). 2013 Dec;1(3-4):117-122. doi: 10.1016/j.hjdsi.2013.07.008.
- Grant RW, Uratsu CS, Estacio KR, Altschuler A, Kim E, Fireman B, Adams AS, Schmittdiel JA, Heisler M. Pre-Visit Prioritization for complex patients with diabetes: Randomized trial design and implementation within an integrated health care system. Contemp Clin Trials. 2016 Mar;47:196-201. doi: 10.1016/j.cct.2016.01.012. Epub 2016 Jan 26.
- Zamudio CD, Sanchez G, Altschuler A, Grant RW. Influence of Language and Culture in the Primary Care of Spanish-Speaking Latino Adults with Poorly Controlled Diabetes: A Qualitative Study. Ethn Dis. 2017 Dec 7;27(4):379-386. doi: 10.18865/ed.27.4.379. eCollection 2017 Fall.
- Grant RW, Altschuler A, Uratsu CS, Sanchez G, Schmittdiel JA, Adams AS, Heisler M. Primary care visit preparation and communication for patients with poorly controlled diabetes: A qualitative study of patients and physicians. Prim Care Diabetes. 2017 Apr;11(2):148-153. doi: 10.1016/j.pcd.2016.11.003. Epub 2016 Dec 1.
- Vo MT, Uratsu CS, Estacio KR, Altschuler A, Kim E, Alexeeff SE, Adams AS, Schmittdiel JA, Heisler M, Grant RW. Prompting Patients with Poorly Controlled Diabetes to Identify Visit Priorities Before Primary Care Visits: a Pragmatic Cluster Randomized Trial. J Gen Intern Med. 2019 Jun;34(6):831-838. doi: 10.1007/s11606-018-4756-4. Epub 2019 Feb 11.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CN-13-1579
- R01DK099108 (U.S. NIH Grant/Contract)
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.
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