Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

My Life, My Healthcare

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03017196
Recruitment Status : Recruiting
First Posted : January 11, 2017
Last Update Posted : February 27, 2019
Sponsor:
Collaborator:
Gordon and Betty Moore Foundation
Information provided by (Responsible Party):
Kasey R. Boehmer, Mayo Clinic

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.


Condition or disease Intervention/treatment Phase
Chronic Disease Other: My Life, My Healthcare Discussion Aid Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 7410 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: My Life, My Healthcare
Actual Study Start Date : January 2017
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. Patient Assessment of Chronic Illness Care (PACIC) [ Time Frame: 6 months ]
    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 :
  1. Illness Intrusiveness Scale [ Time Frame: 6 months ]
    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?"

  2. General Self-Rated Health [ Time Frame: 6 months ]
    "In general, would you say your health is: Excellent, Very Good, Good, Fair, Poor?"

  3. Communicate with Physician Self-Efficacy Subscale [ Time Frame: 6 months ]
    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?"

  4. Consultation Care Measure [ Time Frame: 6 months ]
    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

  5. Self-efficacy to Manage Disease in General Subscale [ Time Frame: 6 months ]
    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. Treatment Burden Questionnaire (TBQ) [ Time Frame: 6 months ]
    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)."

  7. Relational Coordination of Care Team [ Time Frame: 6 months ]
    assesses seven domains of coordinated teams: frequent, timely, accurate, and problem-solving communication, shared goals, shared knowledge, and mutual respect.

  8. Care Team Assessment of Chronic Illness Care (ACIC) [ Time Frame: 6 months ]
    Measures clinician, coach, and clinical team satisfaction with care delivery.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03017196


Contacts
Layout table for location contacts
Contact: Emma M. Behnken 507-293-0177 Behnken.Emma@mayo.edu

Locations
Layout table for location information
United States, Kentucky
Primary Care Centers of East Kentucky Recruiting
Hazard, Kentucky, United States, 41701
Contact: Jing Li       jingli.tj@uky.edu   
Lewis County Primary Care Center, Inc. Recruiting
Vanceburg, Kentucky, United States, 41179
Contact: Jing Li       jingli.tj@uky.edu   
United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Emma M. Behnken    507-293-0177    Behnken.Emma@mayo.edu   
Mayo Health System - Springfield Recruiting
Springfield, Minnesota, United States, 56087
Contact: Kelsey Nylander, D.O.    507-723-6207      
United States, North Carolina
Vidant Multispecialty Clinic Belhaven Recruiting
Belhaven, North Carolina, United States, 27810
Contact: Paul Bray       pbray@vidanthealth.com   
Elizabeth Family Medicine Recruiting
Charlotte, North Carolina, United States, 28207
Contact: Brisa Hernandez       Brisa.Hernandez@carolinashealthcare.org   
CMC- Union Family Medicine Recruiting
Charlotte, North Carolina, United States, 28208
Contact: Brisa Hernandez       Brisa.Hernandez@carolinashealthcare.org   
Vidant Family Medicine Chocowinity Recruiting
Chocowinity, North Carolina, United States, 28717
Contact: Paul Bray    252-717-4402    pbray@vidanthealth.com   
United States, Wisconsin
Mayo Clinic Health System La Crosse Recruiting
La Crosse, Wisconsin, United States, 54601
Contact: Kristen Dall-Winther, MD         
Sponsors and Collaborators
Mayo Clinic
Gordon and Betty Moore Foundation
Investigators
Layout table for investigator information
Principal Investigator: Kasey R. Boehmer, MPH Mayo Clinic

Additional Information:
Layout table for additonal information
Responsible Party: Kasey R. Boehmer, M.P.H., Mayo Clinic
ClinicalTrials.gov Identifier: NCT03017196     History of Changes
Other Study ID Numbers: 16-007340
First Posted: January 11, 2017    Key Record Dates
Last Update Posted: February 27, 2019
Last Verified: February 2019
Additional relevant MeSH terms:
Layout table for MeSH terms
Chronic Disease
Disease Attributes
Pathologic Processes