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My Life, My Healthcare

Primary Purpose

Chronic Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
My Life, My Healthcare Discussion Aid
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Chronic Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Primary Care Centers of East Kentucky
  • Lewis County Primary Care Center, Inc.
  • Mayo Clinic in Rochester
  • Mayo Health System - Springfield
  • Vidant Multispecialty Clinic Belhaven
  • Elizabeth Family Medicine
  • CMC- Union Family Medicine
  • Vidant Family Medicine Chocowinity
  • Mayo Clinic Health System La Crosse

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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."

Secondary Outcome Measures

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?"
General Self-Rated Health
"In general, would you say your health is: Excellent, Very Good, Good, Fair, Poor?"
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?"
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
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?"
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)."
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.
Care Team Assessment of Chronic Illness Care (ACIC)
Measures clinician, coach, and clinical team satisfaction with care delivery.

Full Information

First Posted
January 6, 2017
Last Updated
June 3, 2020
Sponsor
Mayo Clinic
Collaborators
Gordon and Betty Moore Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT03017196
Brief Title
My Life, My Healthcare
Official Title
My Life, My Healthcare
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
January 2017 (Actual)
Primary Completion Date
July 2019 (Actual)
Study Completion Date
July 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
Gordon and Betty Moore Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Disease

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1929 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
My Life, My Healthcare Discussion Aid
Intervention Description
The My Life, My Healthcare instrument is a conversational tool designed to help patients and clinicians discuss capacity in clinical conversations of primary care.
Primary Outcome Measure Information:
Title
Patient Assessment of Chronic Illness Care (PACIC)
Description
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."
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Illness Intrusiveness Scale
Description
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?"
Time Frame
6 months
Title
General Self-Rated Health
Description
"In general, would you say your health is: Excellent, Very Good, Good, Fair, Poor?"
Time Frame
6 months
Title
Communicate with Physician Self-Efficacy Subscale
Description
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?"
Time Frame
6 months
Title
Consultation Care Measure
Description
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
Time Frame
6 months
Title
Self-efficacy to Manage Disease in General Subscale
Description
asks questions such as "How confident are you that you can do all the things necessary to manage your condition on a regular basis?"
Time Frame
6 months
Title
Treatment Burden Questionnaire (TBQ)
Description
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)."
Time Frame
6 months
Title
Relational Coordination of Care Team
Description
assesses seven domains of coordinated teams: frequent, timely, accurate, and problem-solving communication, shared goals, shared knowledge, and mutual respect.
Time Frame
6 months
Title
Care Team Assessment of Chronic Illness Care (ACIC)
Description
Measures clinician, coach, and clinical team satisfaction with care delivery.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kasey R. Boehmer, MPH
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Primary Care Centers of East Kentucky
City
Hazard
State/Province
Kentucky
ZIP/Postal Code
41701
Country
United States
Facility Name
Lewis County Primary Care Center, Inc.
City
Vanceburg
State/Province
Kentucky
ZIP/Postal Code
41179
Country
United States
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Mayo Health System - Springfield
City
Springfield
State/Province
Minnesota
ZIP/Postal Code
56087
Country
United States
Facility Name
Vidant Multispecialty Clinic Belhaven
City
Belhaven
State/Province
North Carolina
ZIP/Postal Code
27810
Country
United States
Facility Name
Elizabeth Family Medicine
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
CMC- Union Family Medicine
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28208
Country
United States
Facility Name
Vidant Family Medicine Chocowinity
City
Chocowinity
State/Province
North Carolina
ZIP/Postal Code
28717
Country
United States
Facility Name
Mayo Clinic Health System La Crosse
City
La Crosse
State/Province
Wisconsin
ZIP/Postal Code
54601
Country
United States

12. IPD Sharing Statement

Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

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