NCT03017196

Brief Summary

This study is designed to answer the following questions: "Is the My Life, My Healthcare Discussion Aid feasible for use in primary care? Does it positively impact patient and healthcare teams' care experience and communication, while reducing patient treatment burden?" Through implementation of the My Life, My Healthcare Discussion Aid for patients with chronic conditions, the study team hypothesizes that it will be feasible to implement in routine primary care practice and positively impact patient and healthcare teams experience of chronic care, while reducing patient treatment burden.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,929

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Geographic Reach
1 country

9 active sites

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

January 1, 2017

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

January 6, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 11, 2017

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

June 5, 2020

Status Verified

June 1, 2020

Enrollment Period

2.5 years

First QC Date

January 6, 2017

Last Update Submit

June 3, 2020

Conditions

Chronic Disease

Outcome Measures

Primary Outcomes (1)

  • Patient Assessment of Chronic Illness Care (PACIC)

    The 20-item scale measures goal setting, coordination of care, decision support, problem solving, and patient activation, and prompts the patient to reflect with items such as: "Over the past 6 months, when I received care for my chronic conditions, I was: helped to make a treatment plan that I could carry out in my daily life."

    6 months

Secondary Outcomes (8)

  • Illness Intrusiveness Scale

    6 months

  • General Self-Rated Health

    6 months

  • Communicate with Physician Self-Efficacy Subscale

    6 months

  • Consultation Care Measure

    6 months

  • Self-efficacy to Manage Disease in General Subscale

    6 months

  • +3 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

Sites randomized to intervention will be expected to implement the My Life, My Healthcare Discussion Aid in their practice for at least a 6-month period.

Other: My Life, My Healthcare Discussion Aid

Control

NO INTERVENTION

Sites randomized to control will not be expected to implement the My Life, My Healthcare Discussion Aid in practice. They will be expected to practice chronic care as usual.

Interventions

My Life, My Healthcare Discussion AidOTHER

The My Life, My Healthcare instrument is a conversational tool designed to help patients and clinicians discuss capacity in clinical conversations of primary care.

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Primary Care Centers of East Kentucky

Hazard, Kentucky, 41701, United States

Location

Lewis County Primary Care Center, Inc.

Vanceburg, Kentucky, 41179, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Mayo Health System - Springfield

Springfield, Minnesota, 56087, United States

Location

Vidant Multispecialty Clinic Belhaven

Belhaven, North Carolina, 27810, United States

Location

Elizabeth Family Medicine

Charlotte, North Carolina, 28207, United States

Location

CMC- Union Family Medicine

Charlotte, North Carolina, 28208, United States

Location

Vidant Family Medicine Chocowinity

Chocowinity, North Carolina, 28717, United States

Location

Mayo Clinic Health System La Crosse

La Crosse, Wisconsin, 54601, United States

Location

Related Publications (1)

  • Boehmer KR, Thota A, Organick-Lee P, Branda M, Lee A, Giblon R, Behnken E, Tapp H, May C, Montori V. Care for patients living with chronic conditions using the ICAN Discussion Aid: A mixed methods cluster-randomized trial. PLoS One. 2024 Dec 4;19(12):e0314605. doi: 10.1371/journal.pone.0314605. eCollection 2024.

    PMID: 39630656DERIVED

Related Links

MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Kasey R. Boehmer, MPH

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.P.H.

Study Record Dates

First Submitted

January 6, 2017

First Posted

January 11, 2017

Study Start

January 1, 2017

Primary Completion

July 1, 2019

Study Completion

July 1, 2019

Last Updated

June 5, 2020

Record last verified: 2020-06

Locations

US(9)