Patient Priorities Care-North Carolina

NCT04233554 | Withdrawn

• 2 other identifiers: 19-2380R01AG062686
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 5

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.

Conditions

Multiple Chronic Conditions

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Change in Mean Shared Decision Making Score (Baseline to Month 6)

  Baseline, Month 6

• Change in Mean Shared Decision Making Score (Baseline to Month 12)

  Baseline, Month 12

• Change in Electronic Health Record Documentation of Decision-making Based on Patients' Health Priorities (Baseline to Month 12)

  Baseline, Month 12

• Change in Number of Prescribed Medications (Baseline to Month 6)

  Baseline, Month 6

• Change in Number of Prescribed Medications (Baseline to Month 12)

  Baseline, Month 12

Study Arms (2)

Intervention Arm - Implementing Patient Priorities Care

EXPERIMENTAL

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

Control Arm

NO INTERVENTION

Control arm practices will receive no intervention and patients will receive usual care.

Interventions

Patient Priorities Care BEHAVIORAL

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.

Intervention Arm - Implementing Patient Priorities Care

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Yale University: collaborator
• North Carolina Translational and Clinical Sciences Institute: collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (5)

UNC Primary Care of Cary

Cary, North Carolina, 27511, United States

Location

UNC Family Medicine at Panther Creek

Cary, North Carolina, 27519, United States

Location

UNC Internal Medicine at Panther Creek

Cary, North Carolina, 27519, United States

Location

UNC Internal Medicine at Goldsboro

Goldsboro, North Carolina, 27534, United States

Location

UNC Primary Care at Kenly

Kenly, North Carolina, 27542, United States

Location

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.

  PMID: 31589281 RESULT

Related Links

• Website for Patient Priorities Care

MeSH Terms

Conditions

Multiple Chronic Conditions

Condition Hierarchy (Ancestors)

Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Crystal Cené, MD, MPH

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2020
• First Posted: January 18, 2020
• Study Start: December 1, 2022
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: April 24, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: 9 to 36 months following publication
• Access Criteria: Either IRB, REB or IEC approval and an executed DUA with UNC.

Locations

US (5)