My Life, My Healthcare

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.

Study Overview

• Status: Completed
• Conditions: Chronic Disease
• Intervention / Treatment: Other: My Life, My Healthcare Discussion Aid

• Study Type: Interventional
• Enrollment (Actual): 1929
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Hazard, Kentucky, United States, 41701
      • Primary Care Centers of East Kentucky
    • Vanceburg, Kentucky, United States, 41179
      • Lewis County Primary Care Center, Inc.
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester
    • Springfield, Minnesota, United States, 56087
      • Mayo Health System - Springfield
  • North Carolina
    • Belhaven, North Carolina, United States, 27810
      • Vidant Multispecialty Clinic Belhaven
    • Charlotte, North Carolina, United States, 28207
      • Elizabeth Family Medicine
    • Charlotte, North Carolina, United States, 28208
      • CMC- Union Family Medicine
    • Chocowinity, North Carolina, United States, 28717
      • Vidant Family Medicine Chocowinity
  • Wisconsin
    • La Crosse, Wisconsin, United States, 54601
      • Mayo Clinic Health System La Crosse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

InclusionCriteria: Particpant population will include patients 18 years of age or older who have one or more chronic conditions and do not have any barriers to consent (such as major cognitive disabilities) will be eligible for enrollment. Clinicians who treat patients with chronic conditions at participating sites are eligible for enrollment.

Exclusion Criteria: Patients who do not have a chronic condition, or have barriers to consent such as cognitive impairment will be excluded from the study. Health professionals who do not treat patients with chronic conditions will not be included.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; 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; The My Life, My Healthcare instrument is a conversational tool designed to help patients and clinicians discuss capacity in clinical conversations of primary care.
No Intervention: Control; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Illness Intrusiveness Scale	This identifies the extent to which the treatment regimen interferes with life by asking "How much does your illness and/or its treatment interfere with..." things like "your work, including job, house work, chores, or errands?"	6 months
General Self-Rated Health	"In general, would you say your health is: Excellent, Very Good, Good, Fair, Poor?"	6 months
Communicate with Physician Self-Efficacy Subscale	This 3-item scale has been used in work by Lorig et al. for chronic disease, and asks questions such as "How confident are you that you can discuss openly with your doctor any personal problems that may be related to your illness?"	6 months
Consultation Care Measure	This 20-item scale is a valid and discriminating tool to measure communication and partnership, personal relationship, health promotion, positive and clear approach to the problem, and interest in effect of healthcare on patient's life within a single pat	6 months
Self-efficacy to Manage Disease in General Subscale	asks questions such as "How confident are you that you can do all the things necessary to manage your condition on a regular basis?"	6 months
Treatment Burden Questionnaire (TBQ)	The questionnaire measures the perceived burden of taking medications, self-monitoring and other self-management activities by asking participants to rate the impact of these tasks on a scale from 1-10 with items such as: "The taste, shape or size of your tablets and/or the annoyances caused by your injections (e.g., pain, bleeding, bruising or scars)."	6 months
Relational Coordination of Care Team	assesses seven domains of coordinated teams: frequent, timely, accurate, and problem-solving communication, shared goals, shared knowledge, and mutual respect.	6 months
Care Team Assessment of Chronic Illness Care (ACIC)	Measures clinician, coach, and clinical team satisfaction with care delivery.	6 months

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: Gordon and Betty Moore Foundation
• Investigators: Principal Investigator: Kasey R. Boehmer, MPH, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): July 1, 2019
• Study Completion (Actual): July 1, 2019

Study Registration Dates

• First Submitted: January 6, 2017
• First Submitted That Met QC Criteria: January 10, 2017
• First Posted (Estimate): January 11, 2017

Study Record Updates

• Last Update Posted (Actual): June 5, 2020
• Last Update Submitted That Met QC Criteria: June 3, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Chronic Disease
• Other Study ID Numbers: 16-007340