Patient Priorities Care (PPC) (PPC)
Primary Purpose
Multiple Chronic Conditions
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Patient Priorities Care
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Chronic Conditions focused on measuring Patient Health Priorities, Health Outcome Goals, Healthcare Preferences
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention Arm (Implementing Patient Priorities Care)
Control Arm (Not Implementing Patient Priorities Care)
Arm Description
Aligning healthcare recommendations to achieve patients' specific health outcome goals within the context of what patients are willing and able to do.
Routine Care
Outcomes
Primary Outcome Measures
Treatment Burden Questionnaire (TBQ)
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).
Older Patient Assessment of Care for Chronic Conditions (O-PACIC)
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).
CollaboRATE
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).
Health Care Utilization
Measures of changes in health care utilization drawn from review of patient medical records
Secondary Outcome Measures
Older Patient Assessment of Care for Chronic Conditions (O-PACIC) subscales
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).
Combined items from the Treatment Burden Questionnaire (TBQ) that appear to measure similar constructs.
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).
Full Information
NCT ID
NCT03600389
First Posted
May 1, 2018
Last Updated
July 2, 2019
Sponsor
Yale University
Collaborators
The John A. Hartford Foundation, Gordon and Betty Moore Foundation, Robert Wood Johnson Foundation, Patient-Centered Outcomes Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT03600389
Brief Title
Patient Priorities Care (PPC)
Acronym
PPC
Official Title
Patient Priorities Care for Older Adults With Multiple Chronic Conditions Achieved Through Primary and Specialty Care Alignment: Patient Priorities Care (PPC)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
October 1, 2016 (Actual)
Primary Completion Date
August 31, 2018 (Actual)
Study Completion Date
August 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
The John A. Hartford Foundation, Gordon and Betty Moore Foundation, Robert Wood Johnson Foundation, Patient-Centered Outcomes Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Patient Priorities Care aligns healthcare decision-making and care by all clinicians with patients' own health priorities. Patient Priorities Care involves not only the health outcome goals that patients want to achieve, but also their preferences for healthcare. This approach is about aligning what outcomes patients want from their healthcare with what they are willing and able to do to achieve these outcomes. The approach begins with a member of the healthcare team helping patients identify their health outcome goals and their care preferences and preparing them to interact with their clinicians around these goals and preferences. The goals and preferences are transmitted to the patient's clinicians who use them in decision-making and communication with the patient and other clinicians.
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Chronic Conditions
Keywords
Patient Health Priorities, Health Outcome Goals, Healthcare Preferences
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Interviewer and chart abstractor is blinded to the nature of the intervention and to the group assignment.
Allocation
Non-Randomized
Enrollment
414 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention Arm (Implementing Patient Priorities Care)
Arm Type
Experimental
Arm Description
Aligning healthcare recommendations to achieve patients' specific health outcome goals within the context of what patients are willing and able to do.
Arm Title
Control Arm (Not Implementing Patient Priorities Care)
Arm Type
No Intervention
Arm Description
Routine Care
Intervention Type
Behavioral
Intervention Name(s)
Patient Priorities Care
Primary Outcome Measure Information:
Title
Treatment Burden Questionnaire (TBQ)
Description
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).
Time Frame
6-12 Months
Title
Older Patient Assessment of Care for Chronic Conditions (O-PACIC)
Description
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).
Time Frame
6-12 Months
Title
CollaboRATE
Description
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).
Time Frame
6-12 Months
Title
Health Care Utilization
Description
Measures of changes in health care utilization drawn from review of patient medical records
Time Frame
6-12 months
Secondary Outcome Measure Information:
Title
Older Patient Assessment of Care for Chronic Conditions (O-PACIC) subscales
Description
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).
Time Frame
6-12 Months
Title
Combined items from the Treatment Burden Questionnaire (TBQ) that appear to measure similar constructs.
Description
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).
Time Frame
6-12 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
66 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31589281
Citation
Tinetti ME, Naik AD, Dindo L, Costello DM, Esterson J, Geda M, Rosen J, Hernandez-Bigos K, Smith CD, Ouellet GM, Kang G, Lee Y, Blaum C. Association of Patient Priorities-Aligned Decision-Making With Patient Outcomes and Ambulatory Health Care Burden Among Older Adults With Multiple Chronic Conditions: A Nonrandomized Clinical Trial. JAMA Intern Med. 2019 Oct 7;179(12):1688-97. doi: 10.1001/jamainternmed.2019.4235. Online ahead of print.
Results Reference
derived
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Patient Priorities Care (PPC)
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