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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
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

66 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

    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
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    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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