My Life, My Healthcare

Study Overview
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Brief Summary
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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.

Official Title
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My Life, My Healthcare

Conditions
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Chronic Disease

Intervention / Treatment
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* Other: My Life, My Healthcare Discussion Aid


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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