NCT03600389

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
414

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2016

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

May 1, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 26, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2018

Completed
Last Updated

July 5, 2019

Status Verified

July 1, 2019

Enrollment Period

1.9 years

First QC Date

May 1, 2018

Last Update Submit

July 2, 2019

Conditions

Keywords

Patient Health PrioritiesHealth Outcome GoalsHealthcare Preferences

Outcome Measures

Primary Outcomes (4)

  • 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).

    6-12 Months

  • 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).

    6-12 Months

  • 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).

    6-12 Months

  • Health Care Utilization

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

    6-12 months

Secondary Outcomes (2)

  • Older Patient Assessment of Care for Chronic Conditions (O-PACIC) subscales

    6-12 Months

  • Combined items from the Treatment Burden Questionnaire (TBQ) that appear to measure similar constructs.

    6-12 Months

Study Arms (2)

Intervention Arm (Implementing Patient Priorities Care)

EXPERIMENTAL

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

Control Arm (Not Implementing Patient Priorities Care)

NO INTERVENTION

Routine Care

Interventions

Intervention Arm (Implementing Patient Priorities Care)

Eligibility Criteria

Age66 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Multiple Chronic Conditions

Condition Hierarchy (Ancestors)

Chronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Interviewer and chart abstractor is blinded to the nature of the intervention and to the group assignment.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 1, 2018

First Posted

July 26, 2018

Study Start

October 1, 2016

Primary Completion

August 31, 2018

Study Completion

August 31, 2018

Last Updated

July 5, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share