Pre-Visit Prioritization for Complex Patients With Diabetes

NCT02375932 | Completed

• 2 other identifiers: CN-13-1579R01DK099108
• Study Type: interventional
• Target: 146
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

Electronic Medical Records; Primary Health Care; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• 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

  1 year after enrollment

Secondary Outcomes (1)

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

  Shortly after visit with PCP

Study Arms (2)

Pre-Visit Tool

EXPERIMENTAL

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

Behavioral: Pre-Visit Tool

Usual Care Control

ACTIVE COMPARATOR

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

Behavioral: Usual Care Control

Interventions

Pre-Visit Tool 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

Pre-Visit Tool

Usual Care Control BEHAVIORAL

Patients continue to receive usual care from their primary care provider

Usual Care Control

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Kaiser Permanente: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Related Publications (5)

• 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.

  PMID: 24944911 BACKGROUND

• 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.

  PMID: 26820612 RESULT

• 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.

  PMID: 29225438 RESULT

• 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.

  PMID: 27916628 RESULT

• 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.

  PMID: 30746642 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Richard W Grant, MD MPH

  Division of Research, Kaiser Permanente Northern California

  PRINCIPAL INVESTIGATOR

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: February 24, 2015
• First Posted: March 3, 2015
• Study Start: March 1, 2015
• Primary Completion: October 21, 2016
• Study Completion: October 31, 2017
• Last Updated: March 28, 2019

Record last verified: 2019-03