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Multiple Chronic ConditionsPPCNCT03600389

Patient Priorities Care (PPC)

A study testing Patient Priorities Care in people with Multiple Chronic Conditions, run by Yale University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 66 years and older
Conditions the study is for
Multiple Chronic Conditions
What is being tested?
Patient Priorities Care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
414 participants
Where
No sites listed yet
Study dates
1 Oct 2016to 31 Aug 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 66 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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

Who cannot join

  • End stage renal disease
  • Unable to consent (e.g. dementia)
  • In hospice or meeting hospice criteria
  • Nursing home resident
  • Not English speaking

About this study

Official title: Patient Priorities Care for Older Adults With Multiple Chronic Conditions Achieved Through Primary and Specialty Care Alignment: Patient Priorities Care (PPC)

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.

Read the 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)

Being tested
Patient Priorities Care
Keywords
Patient Health Priorities, Health Outcome Goals, Healthcare Preferences
Medical subject headings
Multiple Chronic Conditions

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Patient Priorities CareBehavioural

Study groups in NCT03600389
Study groupRoleWhat they receive
Intervention Arm (Implementing Patient Priorities Care)ExperimentalAligning healthcare recommendations to achieve patients' specific health outcome goals within the context of what patients are willing and able to do.
Receives: Behavioral: Patient Priorities Care
Control Arm (Not Implementing Patient Priorities Care)No interventionRoutine Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 6-12 Months

  2. 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).

    Measured: 6-12 Months

  3. 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).

    Measured: 6-12 Months

  4. Health Care Utilization

    Measures of changes in health care utilization drawn from review of patient medical records

    Measured: 6-12 months

Secondary outcomes (2)

  1. 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).

    Measured: 6-12 Months

  2. 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).

    Measured: 6-12 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jul 2018
  2. Study start1 Oct 2016
  3. Primary completion31 Aug 2018
  4. Study completion31 Aug 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
414 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03600389
Sponsor's protocol ID
1601017608
Acronym
PPC
Status last verified
Jul 2019
First submitted
1 May 2018
Last updated
5 Jul 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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 Dec 1;179(12):1688-1697. doi: 10.1001/jamainternmed.2019.4235.

    PubMed 31589281

Questions about this trial

What is this clinical trial studying?

A study testing Patient Priorities Care in people with Multiple Chronic Conditions, run by Yale University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment Burden Questionnaire (TBQ) (time frame: 6-12 Months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03600389, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2019.

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