Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03600389
Other study ID # 1601017608
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 1, 2016
Est. completion date August 31, 2018

Study information

Verified date July 2019
Source Yale University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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)


Recruitment information / eligibility

Status Completed
Enrollment 414
Est. completion date August 31, 2018
Est. primary completion date August 31, 2018
Accepts healthy volunteers No
Gender All
Age group 66 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Patient Priorities Care


Locations

Country Name City State
n/a

Sponsors (5)

Lead Sponsor Collaborator
Yale University Gordon and Betty Moore Foundation, Patient-Centered Outcomes Research Institute, Robert Wood Johnson Foundation, The John A. Hartford Foundation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary Health Care Utilization Measures of changes in health care utilization drawn from review of patient medical records 6-12 months
Secondary 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). 6-12 Months
Secondary 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). 6-12 Months
See also
  Status Clinical Trial Phase
Recruiting NCT05345041 - Church-based Intervention to Improve Physical Function in African Americans N/A
Completed NCT03537053 - An Approach to "Move a Little & Often" With Health Conditions N/A
Recruiting NCT03885401 - Enhanced Care Planning for Patients With Multiple Chronic Conditions N/A
Recruiting NCT04922320 - Effect of Patient Priorities Care Implementation in Older Veterans With Multiple Chronic Conditions N/A
Completed NCT04056663 - Health-circuit Evaluation as a Digital Support for the Management of Patients at Risk of Hospitalization N/A
Active, not recruiting NCT03474692 - Virta Health Registry
Completed NCT04566107 - Self-Management Interventions Using Mobile Health for the Multimorbid N/A
Completed NCT04568382 - Diabetes Communication and Treatment Burden N/A
Recruiting NCT05708768 - Digital, Innovative, Sustainable, and Knowledge-based Acute Municipal Healthcare Services Illness and Trauma
Recruiting NCT05778630 - Emotions and Cognitions in Pediatric Chronic Physical Conditions N/A
Recruiting NCT05877846 - Precision Medicine and Physical Function N/A
Recruiting NCT05600465 - Behavioral Activation + Occupational Therapy: An Innovative Intervention for Empowered Self-Management of Multiple Chronic Conditions N/A
Active, not recruiting NCT05303194 - Patient Priorities Care for Hispanics With Dementia N/A
Completed NCT05156073 - Shared Decision Making About Medication Use for People With Multiple Health Problems N/A
Recruiting NCT04188470 - Optimising Drug Therapy in Polymedicated Patients According to the Person-centered Care Model N/A
Terminated NCT04595851 - Pharmacists Coordinated Care Oncology Model (PCOM) for Patients Taking Oral Anti-cancer Medications N/A
Recruiting NCT06044571 - Optimizing Telehealth-delivery of a Weight Loss Intervention in Older Adults N/A
Completed NCT03745703 - MOCHA Moving Forward: a CBPR Investigation of Chronic Disease Prevention in Older, Low-income African-American Men N/A
Recruiting NCT05913206 - Understanding Factors in Decision Making for Children With Medical Complexity N/A
Completed NCT04492527 - Student-delivered Telehealth Program for COVID-19 Education and Health Promotion N/A