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Pre-Visit Prioritization for Complex Patients With Diabetes (PVP)

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pre-Visit Tool
Usual Care Control
Sponsored by
Kaiser Permanente
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Diabetes Mellitus, Type 2 focused on measuring Electronic Medical Records, Primary Health Care, Diabetes Mellitus, Type 2

Eligibility Criteria

21 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Pre-Visit Tool

    Usual Care Control

    Arm Description

    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 whose primary care physicians are allocated to the control arm will continue with usual care

    Outcomes

    Primary Outcome Measures

    Glycemic Control (HbA1c control (% patients < 7.0% and mean HbA1c levels)
    We will compare HbA1c control (% patients < 7.0% and mean HbA1c levels) between intervention and control arms

    Secondary Outcome Measures

    Patient assessment of visit communication (measures of communication quality using validated instruments)
    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

    Full Information

    First Posted
    February 24, 2015
    Last Updated
    March 26, 2019
    Sponsor
    Kaiser Permanente
    Collaborators
    National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02375932
    Brief Title
    Pre-Visit Prioritization for Complex Patients With Diabetes
    Acronym
    PVP
    Official Title
    Pre-Visit Prioritization for Complex Primary Care Patients With Diabetes
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2015 (undefined)
    Primary Completion Date
    October 21, 2016 (Actual)
    Study Completion Date
    October 31, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Kaiser Permanente
    Collaborators
    National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Patients with type 2 diabetes are increasingly complex. Lack of time to address all patient and provider priorities during primary care visits represents a barrier to effective primary care. The investigators propose to design, implement, and evaluate in a randomized clinical trial a web-based tool linked to the electronic health record (EHR) that will enable complex patients to easily define care priorities for their upcoming visit.
    Detailed Description
    Patients with type 2 diabetes are increasingly living with multiple concurrent conditions and complicated medical regimens. For these patients, diabetes management decisions and treatment goals must be addressed within the larger context of other competing health concerns. In parallel, clinical advances have led to a substantial increase in the number of tasks that primary care providers must perform during each visit. These twin trends present a formidable challenge to effective diabetes primary care. We hypothesize that among complex patients not meeting diabetes management goals, a web-based health IT tool to help patients explicitly prioritize all health issues (both related and unrelated to diabetes) and then submit these priorities directly into the electronic health record (EHR) for a scheduled visit with their primary care provider will result in more effective diabetes management over time. To test this hypothesis, we propose to design, implement, and evaluate in a randomized clinical trial a web-based tool linked to the EHR that will enable complex patients to easily define care priorities for their upcoming visit.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetes Mellitus, Type 2
    Keywords
    Electronic Medical Records, Primary Health Care, Diabetes Mellitus, Type 2

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    146 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Pre-Visit Tool
    Arm Type
    Experimental
    Arm Description
    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
    Arm Title
    Usual Care Control
    Arm Type
    Active Comparator
    Arm Description
    Patients whose primary care physicians are allocated to the control arm will continue with usual care
    Intervention Type
    Behavioral
    Intervention Name(s)
    Pre-Visit Tool
    Intervention Description
    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
    Intervention Type
    Behavioral
    Intervention Name(s)
    Usual Care Control
    Intervention Description
    Patients continue to receive usual care from their primary care provider
    Primary Outcome Measure Information:
    Title
    Glycemic Control (HbA1c control (% patients < 7.0% and mean HbA1c levels)
    Description
    We will compare HbA1c control (% patients < 7.0% and mean HbA1c levels) between intervention and control arms
    Time Frame
    1 year after enrollment
    Secondary Outcome Measure Information:
    Title
    Patient assessment of visit communication (measures of communication quality using validated instruments)
    Description
    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
    Time Frame
    Shortly after visit with PCP

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Richard W Grant, MD MPH
    Organizational Affiliation
    Division of Research, Kaiser Permanente Northern California
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    24944911
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    26820612
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    29225438
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    27916628
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    30746642
    Citation
    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.
    Results Reference
    derived

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    Pre-Visit Prioritization for Complex Patients With Diabetes

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