Aligning Patients and Their Primary Care Providers

NCT ID: NCT02707146

Last Updated: 2019-04-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

750 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2018-12-31

Brief Summary

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This project focuses on improving the patient-provider primary care visit interaction by addressing the need to align patient and provider priorities in a way that incorporates patients' goals and preferences while supporting the clinical work of their providers.

Detailed Description

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The aim of this clinical trial is to enroll new and/or complex patients and their physicians in a 12-month randomized study. At each scheduled primary care visit during the trial period, Intervention Patients will be provided with a waiting room Tablet loaded with the "Visit Planner" intervention tool designed to support prioritization and discussion of top health care concerns. Control Patients will be given a written educational handout to review. Patient-centered outcomes will be obtained at baseline and after visits using validated survey instruments. Clinical outcomes focus on differences in quality of care. If successful, this approach to aligning patient and provider visit priorities can potentially be disseminated and adapted to a wide variety of different care settings.

Conditions

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Primary Health Care Quality of Health Care Comorbidity Communication Medical Informatics Applications

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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Tablet in the waiting room

Patients in the intervention arm will be met in the waiting room prior to their primary care visit and will use the "Visit Planner" tool application on the tablet

Group Type EXPERIMENTAL

Visit Planner

Intervention Type BEHAVIORAL

The Visit Planner is an application hosted on an iPad that guides the patient in preparing for the primary care visit

iPad

Intervention Type DEVICE

Health Education Handout

Patients in the control arm will be met in the waiting room prior to their primary care visit and will be given an educational pamphlet on health lifestyle to review

Group Type ACTIVE_COMPARATOR

Attention Control Pamphlet

Intervention Type OTHER

Patients in the attention control arm will receive an approved educational handout on health lifestyle

Interventions

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Visit Planner

The Visit Planner is an application hosted on an iPad that guides the patient in preparing for the primary care visit

Intervention Type BEHAVIORAL

Attention Control Pamphlet

Patients in the attention control arm will receive an approved educational handout on health lifestyle

Intervention Type OTHER

iPad

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Kaiser Permanente member with an assigned primary care provider, with at least one quality care gap at baseline (overdue screening tests, elevated risk factor levels, sub-optimal adherence to chronically prescribed medicines, current smoker)
* Patients must be either:

* 1\) relatively new to their provider (0-3 visits in past 18 months) or if associated with their provider for \> 18 months,
* 2\) have evidence for medical complexity (4 or more prescribed medicines, in a chronic disease management program, or recently admitted to hospital or emergency department)

Exclusion Criteria

* Excluded by their primary care provider
Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Patient-Centered Outcomes Research Institute

OTHER

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, KPNC

Locations

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Oakland Medical Center

Oakland, California, United States

Site Status

Countries

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United States

References

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Grant RW, Lyles C, Uratsu CS, Vo MT, Bayliss EA, Heisler M. Visit Planning Using a Waiting Room Health IT Tool: The Aligning Patients and Providers Randomized Controlled Trial. Ann Fam Med. 2019 Mar;17(2):141-149. doi: 10.1370/afm.2352.

Reference Type RESULT
PMID: 30858257 (View on PubMed)

Kowalski CP, McQuillan DB, Chawla N, Lyles C, Altschuler A, Uratsu CS, Bayliss EA, Heisler M, Grant RW. 'The Hand on the Doorknob': Visit Agenda Setting by Complex Patients and Their Primary Care Physicians. J Am Board Fam Med. 2018 Jan-Feb;31(1):29-37. doi: 10.3122/jabfm.2018.01.170167.

Reference Type RESULT
PMID: 29330237 (View on PubMed)

Lyles CR, Altschuler A, Chawla N, Kowalski C, McQuillan D, Bayliss E, Heisler M, Grant RW. User-Centered Design of a Tablet Waiting Room Tool for Complex Patients to Prioritize Discussion Topics for Primary Care Visits. JMIR Mhealth Uhealth. 2016 Sep 14;4(3):e108. doi: 10.2196/mhealth.6187.

Reference Type RESULT
PMID: 27627965 (View on PubMed)

Ruvalcaba D, Nagao Peck H, Lyles C, Uratsu CS, Escobar PR, Grant RW. Translating/Creating a Culturally Responsive Spanish-Language Mobile App for Visit Preparation: Case Study of "Trans-Creation". JMIR Mhealth Uhealth. 2019 Apr 5;7(4):e12457. doi: 10.2196/12457.

Reference Type RESULT
PMID: 30950803 (View on PubMed)

Santo EC, Vo MT, Uratsu CS, Grant RW. Patient-Defined Visit Priorities in Primary Care: Psychosocial Versus Medically-Related Concerns. J Am Board Fam Med. 2019 Jul-Aug;32(4):513-520. doi: 10.3122/jabfm.2019.04.180380.

Reference Type DERIVED
PMID: 31300571 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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CN-14-2070-H

Identifier Type: -

Identifier Source: org_study_id

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