NCT02707146

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
750

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2016

Typical duration for not_applicable

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

March 1, 2016

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

March 4, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 14, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
5 months until next milestone

Results Posted

Study results publicly available

April 30, 2019

Completed
Last Updated

April 30, 2019

Status Verified

April 1, 2019

Enrollment Period

1.3 years

First QC Date

March 4, 2016

Results QC Date

February 28, 2019

Last Update Submit

April 8, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Aggregate Measure of Guideline-Based Clinical Care Gaps

    All patients enrolled in the study will have one or more guideline-based care gaps at baseline. Care gaps are defined as: overdue for cancer screening (mammography, colorectal cancer), overdue for chronic disease monitoring (blood pressure, HbA1c), above goal for chronic disease (SBP \> 140, HbA1c \> 8%), or medication related (not prescribed a statin if clinically indicated, not prescribed medicine for osteoporosis if indicated, \< 80% adherence to medication for diabetes, hypertension, or hyperlipidemia), or current smoker. The investigators will assess % of patients resolving baseline clinical care gaps after 12 months. The aggregate outcome will be defined as yes/no resolution of baseline care gap. The study arms will be compared using an aggregate measure of these guideline-based clinical care gaps.

    12 months

Secondary Outcomes (1)

  • Patient-reported Outcomes

    Within 1 week of primary care study visit

Study Arms (2)

Tablet in the waiting room

EXPERIMENTAL

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

Behavioral: Visit PlannerDevice: iPad

Health Education Handout

ACTIVE COMPARATOR

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

Other: Attention Control Pamphlet

Interventions

Visit PlannerBEHAVIORAL

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

Tablet in the waiting room

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

Health Education Handout
iPadDEVICE
Tablet in the waiting room

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Excluded by their primary care provider

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oakland Medical Center

Oakland, California, 94610, United States

Location

Related Publications (5)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Communication

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

Title
Dr. Richard Grant
Organization
Division of Research, Kaiser Permanente Northern California

Study Officials

  • Richard W Grant, MD MPH

    Division of Research, KPNC

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2016

First Posted

March 14, 2016

Study Start

March 1, 2016

Primary Completion

July 1, 2017

Study Completion

December 1, 2018

Last Updated

April 30, 2019

Results First Posted

April 30, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations