Patient Priorities Care (PPC) (PPC)

• ClinicalTrials.gov Identifier: NCT03600389
• Recruitment Status: Completed
• First Posted: July 26, 2018
• Last Update Posted: July 5, 2019
• Sponsor: Yale University
• Collaborators: The John A. Hartford Foundation; Gordon and Betty Moore Foundation; Robert Wood Johnson Foundation; Patient-Centered Outcomes Research Institute
• Information provided by (Responsible Party): Yale University

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.

Condition or disease	Intervention/treatment	Phase
Multiple Chronic Conditions	Behavioral: Patient Priorities Care	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 414 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Masking Description: Interviewer and chart abstractor is blinded to the nature of the intervention and to the group assignment.
• Primary Purpose: Treatment
• Official Title: Patient Priorities Care for Older Adults With Multiple Chronic Conditions Achieved Through Primary and Specialty Care Alignment: Patient Priorities Care (PPC)
• Actual Study Start Date: October 1, 2016
• Actual Primary Completion Date: August 31, 2018
• Actual Study Completion Date: August 31, 2018

Arms and Interventions

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.	Behavioral: Patient Priorities Care
No Intervention: Control Arm (Not Implementing Patient Priorities Care); Routine Care

Outcome Measures

Primary Outcome Measures :

1. 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).
2. 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).
3. 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).
4. Health Care Utilization [ Time Frame: 6-12 months ]
   Measures of changes in health care utilization drawn from review of patient medical records

Secondary Outcome Measures :

1. 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).
2. 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).

Eligibility Criteria

• Ages Eligible for Study: 66 Years and older (Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

No Contacts or Locations Provided

  Study Documents (Full-Text)

Documents provided by Yale University:

Study Protocol  [PDF] March 21, 2018

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Yale University
• ClinicalTrials.gov Identifier: NCT03600389
• Other Study ID Numbers: 1601017608
• First Posted: July 26, 2018
• Last Update Posted: July 5, 2019
• Last Verified: July 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Yale University:

Patient Health Priorities; Health Outcome Goals; Healthcare Preferences

Additional relevant MeSH terms:

Disease; Multiple Chronic Conditions; Pathologic Processes; Chronic Disease; Disease Attributes