Clinical trial NCT04510948: Patient Priority Care for Older Adults With Multiple Chronic Conditions
Official title: Patient Priority Care for Older Adults With Multiple Chronic Conditions Achieved Through Primary and Specialty Care Alignment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Chronic Conditions
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: Yale University
name: Donaghue Medical Research Foundation
First posted: 2020-08-12
Enrollment: 264
Sex: ALL
Minimum age (years): 66
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The aim of this project is to test, using a parallel group design involving 2 matched primary care sites, whether PPC decreases patient treatment burden and unwanted and unnecessary health care as well as assess what the value of this program is for patients.
Primary purpose: TREATMENT

Brief summary: Healthcare for older adults with multiple chronic conditions (MCCs) is burdensome and of uncertain benefit, resulting in unwanted and unhelpful care. Patient Priorities Care (PPC) aligns care with patients' health priorities (i.e. the health outcomes most desired given the healthcare each is willing and able to receive). The aim of this project is to test, using a parallel group design involving 2 matched primary care sites, whether PPC decreases patient treatment burden and unwanted and unnecessary health care as well as assess what the value of this program is for patients.

Detailed description: Healthcare for older adults with multiple chronic conditions (MCCs) is burdensome and of uncertain benefit, resulting in unwanted and unhelpful care. Patient Priorities Care (PPC) is an approach that aligns care with patients' health priorities (i.e. the health outcomes most desired given the healthcare each is willing and able to receive). PPC offers the opportunity to increase value by improving both outputs (desired health outcomes) and inputs (healthcare preferences) for these major users of healthcare.

We will employ a quasi-experimental, usual care (UC) group design, involving 2 primary care sites (1 PPC and 1 UC. Patients are assigned to intervention or usual care arms based on their primary care practice location. We will use analytic techniques (e.g., inverse propensity score weighting) designed to reduce selection bias and balance PPC and UC sites in terms of baseline characteristics. Data collection will occur through quantitative and qualitative interviews and health encounter information in the Electric Health Record(EHR).

Patient Priorities Care requires the elicitation and documentation of patient health outcome goals and care preferences and the alignment of clinical care with goals and priorities to achieve patients' health outcome goals and reduce the burden of multi-morbidity. Participants will be enrolled in the Patient Priorities Care Program and speak with a trained health priorities facilitator to elicit their healthcare preferences and health outcome goals, which together constitute their health priorities. This information will be documented, entered into the EHR, and shared with the clinicians who will then use the Patient Priorities Care approach with patients to inform and guide treatment decisions. Patients will participate in the program and be followed for up to one year from the health priorities identification visit.

To determine the value of PPC, comparable primary care sites within the Cleveland Clinic will be assigned to PPC or Usual care (UC). Clinicians and staff at the PPC site will be trained to identify and align decision-making with the health priorities of older adults with MCCs. Value will be compared using patient and provider-reported outcomes, healthcare utilization, and possibly costs at PPC and UC sites.

The ultimate goal of our work is to implement and evaluate this approach to care for older adults with multiple chronic conditions that focuses on what matters most to them and is less fragmented and burdensome, resulting in better quality and outcomes at lower cost. This study will focus on evaluating practice change at test sites at the Cleveland Clinic.

Eligibility criteria: Inclusion Criteria:

1. Age 66 and older
2. In the Cleveland Clinic patient population
3. In the clinician practices selected as intervention or usual care practice sites
4. Clinically identified by: Those who meet any of several criteria i. 3 chronic conditions (See appendix 0 for the complete list) ii. 10 medications iii. \>2 ED visits over the past year iv. \>1 hospitalization (or \>10 days in hospital) v. receive any care coordination services vi. 2 specialists over past year

Exclusion Criteria:

1. In hospice or meeting hospice criteria for any condition
2. Advanced dementia or moderate to profound intellectual disabilities
3. Not English speaking
4. Nursing home resident

Primary outcomes:
measure: Treatment Burden
timeFrame: from baseline to follow-up at 8-9 months
measure: Achievement of Desired Activities
timeFrame: at follow-up (8-9 months) The scale instructions do not reference timeframe.
measure: Health Care Utilization Defined by Healthcare Contact Days
timeFrame: from 3 months prior to 12 months following baseline interview
Secondary outcomes:
measure: Shared Decision Making and Goal Ascertainment
timeFrame: at 8-9 months follow-up
Other outcomes:
Locations:
city: Lakewood
country: United States
facility: Cleveland Clinic Lakewood Family Health Center
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Ardeshir Hashmi, MD
role: PRINCIPAL_INVESTIGATOR
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