Pre-Visit Prioritization for Complex Patients With Diabetes

NCT ID: NCT02375932

Last Updated: 2019-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

146 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2017-10-31

Brief Summary

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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

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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.

Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

Pre-Visit Tool

Intervention Type BEHAVIORAL

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

Usual Care Control

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

Group Type ACTIVE_COMPARATOR

Usual Care Control

Intervention Type BEHAVIORAL

Patients continue to receive usual care from their primary care provider

Interventions

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Pre-Visit Tool

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

Usual Care Control

Patients continue to receive usual care from their primary care provider

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

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
Minimum Eligible Age

21 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

Kaiser Permanente

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Richard W Grant, MD MPH

Role: PRINCIPAL_INVESTIGATOR

Division of Research, Kaiser Permanente Northern California

References

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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.

Reference Type BACKGROUND
PMID: 24944911 (View on PubMed)

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.

Reference Type RESULT
PMID: 26820612 (View on PubMed)

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.

Reference Type RESULT
PMID: 29225438 (View on PubMed)

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.

Reference Type RESULT
PMID: 27916628 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30746642 (View on PubMed)

Other Identifiers

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R01DK099108

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CN-13-1579

Identifier Type: -

Identifier Source: org_study_id

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