Patient Priorities Care-North Carolina (PPC-NC)
Primary Purpose
Multiple Chronic Conditions
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Patient Priorities Care
Sponsored by
About this trial
This is an interventional health services research trial for Multiple Chronic Conditions
Eligibility Criteria
Inclusion Criteria:
- Age 55 or older
- 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
- Medicare or Medicare-Medicaid eligibility
- English speaking
- Current patient with a participating clinician
Exclusion criteria:
- 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"?
- End stage renal disease on dialysis
- Nursing home residence
- Inability to independently provide informed consent due to dementia or severe psychiatric illness (based on ICD-10 codes or clinician input)
Sites / Locations
- UNC Primary Care of Cary
- UNC Family Medicine at Panther Creek
- UNC Internal Medicine at Panther Creek
- UNC Internal Medicine at Goldsboro
- UNC Primary Care at Kenly
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention Arm - Implementing Patient Priorities Care
Control Arm
Arm Description
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.
Control arm practices will receive no intervention and patients will receive usual care.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT04233554
First Posted
January 15, 2020
Last Updated
April 20, 2023
Sponsor
University of North Carolina, Chapel Hill
Collaborators
Yale University, North Carolina Translational and Clinical Sciences Institute, National Institute on Aging (NIA)
1. Study Identification
Unique Protocol Identification Number
NCT04233554
Brief Title
Patient Priorities Care-North Carolina
Acronym
PPC-NC
Official Title
Implementation and Evaluation of Patient Priorities Care-North Carolina for Older Adults With Multiple Chronic Conditions
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Unable to identify enough practices and clinicians to participate in the study.
Study Start Date
December 2022 (Anticipated)
Primary Completion Date
April 30, 2025 (Anticipated)
Study Completion Date
April 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
Yale University, North Carolina Translational and Clinical Sciences Institute, National Institute on Aging (NIA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Chronic Conditions
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention Arm - Implementing Patient Priorities Care
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Arm
Arm Type
No Intervention
Arm Description
Control arm practices will receive no intervention and patients will receive usual care.
Intervention Type
Behavioral
Intervention Name(s)
Patient Priorities Care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Mean Treatment Burden Score (Baseline to Month 6)
Description
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.
Time Frame
Baseline, Month 6
Title
Change in Mean Treatment Burden Score (Baseline to Month 12)
Description
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.
Time Frame
Baseline, Month 12
Secondary Outcome Measure Information:
Title
Change in Mean Shared Decision Making Score (Baseline to Month 6)
Description
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.
Time Frame
Baseline, Month 6
Title
Change in Mean Shared Decision Making Score (Baseline to Month 12)
Description
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.
Time Frame
Baseline, Month 12
Title
Change in Electronic Health Record Documentation of Decision-making Based on Patients' Health Priorities (Baseline to Month 12)
Description
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.
Time Frame
Baseline, Month 12
Title
Change in Number of Prescribed Medications (Baseline to Month 6)
Description
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.
Time Frame
Baseline, Month 6
Title
Change in Number of Prescribed Medications (Baseline to Month 12)
Description
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.
Time Frame
Baseline, Month 12
Title
Change in Number of Self-Management Tasks
Description
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.
Time Frame
Baseline, Month 12
Title
Percentage of Diagnostic Tests, Referrals, and Procedures Ordered or Avoided
Description
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.
Time Frame
Baseline, Month 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 55 or older
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
Medicare or Medicare-Medicaid eligibility
English speaking
Current patient with a participating clinician
Exclusion criteria:
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"?
End stage renal disease on dialysis
Nursing home residence
Inability to independently provide informed consent due to dementia or severe psychiatric illness (based on ICD-10 codes or clinician input)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Crystal Cené, MD, MPH
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
UNC Primary Care of Cary
City
Cary
State/Province
North Carolina
ZIP/Postal Code
27511
Country
United States
Facility Name
UNC Family Medicine at Panther Creek
City
Cary
State/Province
North Carolina
ZIP/Postal Code
27519
Country
United States
Facility Name
UNC Internal Medicine at Panther Creek
City
Cary
State/Province
North Carolina
ZIP/Postal Code
27519
Country
United States
Facility Name
UNC Internal Medicine at Goldsboro
City
Goldsboro
State/Province
North Carolina
ZIP/Postal Code
27534
Country
United States
Facility Name
UNC Primary Care at Kenly
City
Kenly
State/Province
North Carolina
ZIP/Postal Code
27542
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
31589281
Citation
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.
Results Reference
result
Links:
URL
http://patientprioritiescare.org
Description
Website for Patient Priorities Care
Learn more about this trial
Patient Priorities Care-North Carolina
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