- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03600389
Patient Priorities Care (PPC) (PPC)
Patient Priorities Care for Older Adults With Multiple Chronic Conditions Achieved Through Primary and Specialty Care Alignment: Patient Priorities Care (PPC)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Many older adults with Multiple Chronic Conditions receive conflicting recommendations and care that may be fragmented across clinicians. Older adults vary in what's most important when faced with tradeoffs and vary in the health-related activities they are willing and able to complete to achieve their desired outcomes. A potential solution to these problems is to move from decision-making predicated solely on disease-guidelines to decision-making based on achieving each patient's own specific health outcome goals (e.g., relief of symptoms sufficient to allow specific functional activity) within the context of what they are willing and able to do (i.e. care preferences) to achieve these outcomes.
The primary aims of the Patient Priorities Care (PPC) pilot is to assess the feasibility of aligning primary and specialty care to focus on the health priorities (i.e. specific and actionable outcome goals and care preferences) of older adults with multiple chronic conditions (MCC)
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age >65 years
- Member of Pro-Health Practice for >=3 years
Determined to be an appropriate candidate evidenced by ANY of the following:
- Multiple Chronic Conditions (presence of >3 active health problems)
- >10 medications
- ≥ 1 hospitalization over the past year
- ≥ 2 emergency department visits over the past year
- Seen by >2 specialists (excluding GYN and eye) over the past year
Exclusion Criteria:
- End stage renal disease
- Unable to consent (e.g. dementia)
- In hospice or meeting hospice criteria
- Nursing home resident
- Not English speaking
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention Arm (Implementing Patient Priorities Care)
Aligning healthcare recommendations to achieve patients' specific health outcome goals within the context of what patients are willing and able to do.
|
|
No Intervention: Control Arm (Not Implementing Patient Priorities Care)
Routine Care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Treatment Burden Questionnaire (TBQ)
Time Frame: 6-12 Months
|
Measure to assess treatment burden among patients with one or more chronic conditions.
Summary score is 0-150 with lower numbers indicating less burden.
This is an exploratory study and the investigators will compare the intervention to control group to determine if the intervention group scores are lower on the TBQ (i.e. less burden).
|
6-12 Months
|
Older Patient Assessment of Care for Chronic Conditions (O-PACIC)
Time Frame: 6-12 Months
|
Measure to assess chronically-ill patients' perceptions of the degree to which health care delivery is integrated and coordinated.
Summary score is 1-5 with higher score indicated greater integration.
This is an exploratory study and the investigators will compare the intervention to control group to determine if the intervention group scores higher on O-PACIC (i.e.
greater integration).
|
6-12 Months
|
CollaboRATE
Time Frame: 6-12 Months
|
Measure of shared decision making in clinical encounters.
Summary score is 0-100 with higher score indicated greater shared decision making.
This is an exploratory study and the investigator will compare the intervention to control group to determine if the intervention group scores higher on CollaboRATE (i.e.
greater shared decision-making).
|
6-12 Months
|
Health Care Utilization
Time Frame: 6-12 months
|
Measures of changes in health care utilization drawn from review of patient medical records
|
6-12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Older Patient Assessment of Care for Chronic Conditions (O-PACIC) subscales
Time Frame: 6-12 Months
|
Sub-scales within the O-PACIC including patient activation (sub-scores range from 1-5 with higher score indicating greater activation), delivery system design/support (sub-scale score ranges from 1-5 with higher scores indicating greater system design/support), goal setting (sub-scale scores range from 1-5 with higher scores indicating improved goal setting), problem-solving/contextual counseling (sub-scale scores range from 1-5 with higher scores indicating improved problem-solving/contextual counseling), and follow-up/coordination (sub-scale scores range from 1-5 with higher scores indicating greater follow-up/coordination).
|
6-12 Months
|
Combined items from the Treatment Burden Questionnaire (TBQ) that appear to measure similar constructs.
Time Frame: 6-12 Months
|
Items that assess self-management tasks (3 items that range from 0-30 with lower scores indicating less self-management burden), medical visits (2 items that range from 0-20 with lower scores indicating less burden from doctor visits), laboratory tests and other examinations (1 item that ranges from 0-10 with lower scores indicating less burden from lab exams), relationships with providers (1 item with scores ranging from 0-10 with lower scores indicating less burden from relationships with providers), medications (4 items with scores ranging from 0-40 with lower scores indicating less burden from medications).
|
6-12 Months
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1601017608
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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