Patient Priorities Care-North Carolina (PPC-NC)

Implementation and Evaluation of Patient Priorities Care-North Carolina for Older Adults With Multiple Chronic Conditions

The long-term goal of this research is to re-engineer clinical decision-making for older adults with multiple chronic conditions (MCC) to focus on patients' self-identified health priorities. The overall objective of this study is to implement and evaluate an intervention called Patient Priorities Care (PPC) intervention with 20 primary care clinicians in North Carolina (NC), using a hybrid effectiveness-implementation design. Guided by the Minimally Disruptive Medicine model, the central hypothesis is that clinical decision-making guided by patients' priorities will result in less burdensome care for patients and their families, increase patient goal setting, facilitate patient-provider shared decision-making, and improve patient quality of life and satisfaction with care. As the prevalence, costs, and treatment burden of MCC continue to rise, new approaches to care are urgently needed in this growing population. Findings from this study will inform practical approaches for aligning clinical decision-making in older adults with MCC with their health priorities.

Study Overview

• Status: Withdrawn
• Conditions: Multiple Chronic Conditions
• Intervention / Treatment: Behavioral: Patient Priorities Care

Detailed Description

Multiple chronic conditions (MCC) among older adults are prevalent and costly. Almost 70% of Americans 65 years and older, most of whom are Medicare beneficiaries, have at least two chronic medical conditions and 14% have 6 or more chronic conditions, which lowers life expectancy and reduces quality of life (QOL). Over 90% of the Medicare spending is devoted to individuals with MCC. Despite these facts, health care and research are primarily focused on single diseases. Living with MCC is complex and burdensome. Individuals with MCC are burdened by the work required to manage their illnesses. This work includes processing complex and sometimes conflicting information about symptoms and treatments, integrating clinician recommendations into their daily lives, monitoring their disease and managing symptoms and medications, enlisting support from others, and coordinating and following-through with frequent clinician visits. Family members are intimately involved in supporting health-related behaviors of individuals with MCC. On average, patients with MCC and their family caregivers spend 2 hours a day on health-related activities plus an additional 2 hours for every visit to a health care facility (between travel time, wait time, and actual time receiving the health service). Medicare patients see, on average, 2 primary care clinicians and 5 specialists annually. Attending frequent clinician visits increases treatment burden for these patients, independent of the actual treatments received. This fragmented provision of health care for older adults with MCC and their family members requires a simplified, coordinated approach to care that reduces burden on patients and families.

Patient priorities care (PPC) is an innovative solution to address the discrepancy between the care older adults with MCC receive and the outcomes they want. When faced with tradeoffs between desired QOL outcomes and health care options that can increase treatment burden, individuals vary in their health priorities. Patients' health priorities include both their health outcome goals and their health care preferences. Health outcome goals are the personal health and life outcomes that patients hope to achieve through their health care (i.e., function, survival, social activities, or symptom relief). To inform clinical decision-making, health outcome goals should be specific, measurable, actionable, realistic, and time-bound (SMART) and aligned with what matters most to patients (patients' values). The overall goal is to evaluate effectiveness and implementation of PPC- an approach to clinical decision-making that is used by patients' existing clinical care team members, in North Carolina. The feasibility and efficacy of this approach has previously been demonstrated in a large primary care practice in Connecticut.

The investigators will randomize 20 primary care clinicians to PPC-NC or usual care (UC). Clinicians randomized to UC will not receive the PPC-NC intervention.

The PPC process begins when a 'facilitator' (i.e. an individual with motivational interviewing skills) meets with the patient and helps patients identify their value-based priorities during a structured conversation. Values, which represent what matters most to individuals, tend to remain stable over time and form the basis of patients' health outcome goals. Patients' values are clarified using questions such as "What would make your life not worth living if you were unable to do it?" and "What would you like to be able to do that you cannot do now?" Based on these values, the facilitator helps patients identify their health outcome goals, which are the specific, measurable, actionable, and realistic, and time-bound health and life outcomes (e.g. walk ½ mile daily to visit grandchildren) that patients hope to achieve through their health care, given their care preferences. Care preferences refer to the health care activities (e.g., medications, self-management tasks, health care visits, testing, and procedures) that patients are or are not willing and able to do to achieve their health outcome goals. After the facilitator identifies' the patients' health care priorities, the clinician will work to align clinical decision-making around those priorities during routine clinic visits. This can be manifested by stopping, starting, or continuing therapies in response to knowing the patients' priorities. Patients' priorities will be communicated between care team members via the electronic health record (EHR).

The facilitator and clinicians will be trained in the PPC approach with an initial training, followed by ongoing support from the research team, using quality improvement principles. The investigators will collect the following practice-level data for both PPC-NC and UC clinicians: number of patients, number of encounters, number and type of clinicians, payer mix, and patient demographics of the practices (age, sex, race/ethnicity). The investigators will also collect: socio-demographic factors (age, sex, race/ethnicity, educational level, living arrangement, and marital status), subjective social status, health literacy, and cognitive impairment. A research assistant will collect all patient-reported survey data using the web-based application REDCap (Research Electronic Data Capture) three times over a one year period (baseline, 6 months later, and 12 months post baseline. The investigators will use mixed effects models to compare the primary and secondary patient-reported outcomes between PPC-NC and UC clinicians.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Cary, North Carolina, United States, 27511
      • UNC Primary Care of Cary
    • Cary, North Carolina, United States, 27519
      • UNC Family Medicine at Panther Creek
    • Cary, North Carolina, United States, 27519
      • UNC Internal Medicine at Panther Creek
    • Goldsboro, North Carolina, United States, 27534
      • UNC Internal Medicine at Goldsboro
    • Kenly, North Carolina, United States, 27542
      • UNC Primary Care at Kenly

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age 55 or older
2. Multiple chronic conditions (presence of greater than 2 active health problems) AND either prescribed more than 10 medications or visits to more than two specialists (excluding gynecologists and ophthalmologists) over the past year or have had at least one hospitalization over the past two years
3. Medicare or Medicare-Medicaid eligibility
4. English speaking
5. Current patient with a participating clinician

Exclusion criteria:

1. In hospice or clinician endorsement of a validated palliative care screening question* or clinician responding no to the question that s/he "would not be surprised if the patient passed away within the next 12 months"?
2. End stage renal disease on dialysis
3. Nursing home residence
4. Inability to independently provide informed consent due to dementia or severe psychiatric illness (based on ICD-10 codes or clinician input)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Arm - Implementing Patient Priorities Care; Practice staff and providers will be trained on how to identify patient health priorities. Staff and clinicians will implement Patient Priorities Care, document priorities in EHRs, and align patient priorities with health care decisions.	Behavioral: Patient Priorities Care; Patients will participate in a structured conversation in which the facilitator (i.e. social worker) helps patients identify their health goals, measurable, actionable, realistic outcomes (e.g. walk ½ mile daily). Both practice and patient level data will be collected.
No Intervention: Control Arm; Control arm practices will receive no intervention and patients will receive usual care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Mean Treatment Burden Score (Baseline to Month 6)	Treatment burden will be assessed using the Treatment burden questionnaire- a 15-item measure that assesses the workload imposed by healthcare on patients. Workload includes medication taking, self-monitoring, visits to the provider, laboratory tests, lifestyle changes, and administrative tasks to access and coordinate care. Scoring range is from 0 to 150. Investigators will assess between group change in means of difference in treatment burden score from baseline to month 6. Lower score indicates a worse outcome.	Baseline, Month 6
Change in Mean Treatment Burden Score (Baseline to Month 12)	Treatment burden will be assessed using the Treatment burden questionnaire- a 15-item measure that assesses the workload imposed by healthcare on patients. Workload includes medication taking, self-monitoring, visits to the provider, laboratory tests, lifestyle changes, and administrative tasks to access and coordinate care. Scoring range is from 0 to 150. Investigators will assess between group change in means of difference in treatment burden score from month 0 to month 12. Lower score indicates a worse outcome.	Baseline, Month 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Mean Shared Decision Making Score (Baseline to Month 6)	Investigators will assess shared decision making using the CollaboRATE measure. This 3-item measure assesses the process in which providers and patients work together to make decisions and select treatment. Participants rate, on a scale from 0-9, how much effort was placed into listening, understanding, and including the patient in health care decisions. Lower score indicates a worse outcome.	Baseline, Month 6
Change in Mean Shared Decision Making Score (Baseline to Month 12)	Investigators will assess shared decision making using the CollaboRATE measure. This 3-item measure assesses the process in which providers and patients work together to make decisions and select treatment. Participants rate, on a scale from 0-9, how much effort was placed into listening, understanding, and including the patient in health care decisions. Investigators will assess between group difference in means of differences in shared decision-making score between baseline and month 6. Lower score indicates a worse outcome.	Baseline, Month 12
Change in Electronic Health Record Documentation of Decision-making Based on Patients' Health Priorities (Baseline to Month 12)	Investigators will review clinician's notes in the electronic medical record over 12 months of follow-up for documentation of decision-making based on patients' health priorities.	Baseline, Month 12
Change in Number of Prescribed Medications (Baseline to Month 6)	Investigators will review clinician's notes in the electronic medical record over 12 months of follow-up for documentation of number (percentage) of patients with medications added or stopped over a 12 month period. Investigators will use a data dictionary to guide uniform abstraction.	Baseline, Month 6
Change in Number of Prescribed Medications (Baseline to Month 12)	Investigators will review clinician's notes in the electronic medical record over 12 months of follow-up for documentation of number (percentage) of patients with medications added or stopped over a 12 month period. Investigators will use a data dictionary to guide uniform abstraction.	Baseline, Month 12
Change in Number of Self-Management Tasks	Investigators will review clinician's notes in the electronic medical record over 12 months of follow-up for documentation of number (percentage) of patients with self-management tasks added or stopped over a 12 month period. Investigators will use a data dictionary to guide uniform abstraction.	Baseline, Month 12
Percentage of Diagnostic Tests, Referrals, and Procedures Ordered or Avoided	Investigators will review clinicians' notes in the electronic medical record over 12 months of follow-up for documentation of number (percentage) of patients with diagnostic tests, referrals, or procedures ordered or avoided (defined as mentioned in the electronic health record that they were decided against because they were deemed by the clinician not to be beneficial or unwanted by the patient) over a 12-month period. These measures will be reported in aggregate.	Baseline, Month 12

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: Yale University; National Institute on Aging (NIA); North Carolina Translational and Clinical Sciences Institute
• Investigators: Principal Investigator: Crystal Cené, MD, MPH, University of North Carolina, Chapel Hill

Publications and helpful links

General 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 Oct 7;179(12):1688-97. doi: 10.1001/jamainternmed.2019.4235. Online ahead of print.

Helpful Links

• Website for Patient Priorities Care

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2022
• Primary Completion (Anticipated): April 30, 2025
• Study Completion (Anticipated): April 30, 2025

Study Registration Dates

• First Submitted: January 15, 2020
• First Submitted That Met QC Criteria: January 15, 2020
• First Posted (Actual): January 18, 2020

Study Record Updates

• Last Update Posted (Actual): April 24, 2023
• Last Update Submitted That Met QC Criteria: April 20, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Chronic Disease; Disease; Multiple Chronic Conditions
• Other Study ID Numbers: 19-2380; R01AG062686 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
• IPD Sharing Time Frame: 9 to 36 months following publication
• IPD Sharing Access Criteria: Either IRB, REB or IEC approval and an executed DUA with UNC.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No