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Patient Priority Care for Older Adults With Multiple Chronic Conditions (PPC-CCF)

Primary Purpose

Multiple Chronic Conditions

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Patient Priorities Care
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Chronic Conditions

Eligibility Criteria

66 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cleveland Clinic Lakewood Family Health Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention (Implementing Patient Priorities Care)

Usual Care (Not implementing PPC)

Arm Description

Patient Priorities Care requires the elicitation and documentation of patient health outcome goals and care preferences and the alignment of clinical care with health goals and healthcare preferences (collectively referred to as health priorities). Participants will be contacted by a trained priorities facilitator in-person or over the phone to elicit their health priorities. This information will be documented in the PPC- GOALS AND PREFERENCES form in 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 receive routine clinical care.

Outcomes

Primary Outcome Measures

Treatment burden
Change in patient score on 'Treatment Burden Questionnaire' (TBQ, score range 0-150, Cronbach's alpha=0.90)
Achievement of desired activities
Change in patient score on PROMIS Ability to Participate in Social Roles and Activities Shot Form 6a (score range 6-30; Cronbach's alpha = 0.98)
Health care utilization defined by healthcare contact days
Number of health care contact days defined as number of ED visits, days in hospital +.5*number of outpatient encounters for procedures, tests, healthcare visits

Secondary Outcome Measures

Shared decision making and goal ascertainment
Change in patient score on CollaboRATE tool (score 0-100, Cronbach's alpha=0.89) from baseline to follow-up up at 8-9 months and response to Cleveland Clinic ACO survey item "When starting a new medication, did your provider ask what you thought was best for you?"
Alignment of healthcare with patient preferences (coded based on review of EHR)
Dichotomous variable indicating whether medications or self-management tasks were added or stopped per patient preference. Data will be abstracted using a data dictionary which guided abstraction in pilot studies.

Full Information

First Posted
August 11, 2020
Last Updated
January 24, 2023
Sponsor
The Cleveland Clinic
Collaborators
Yale University, Donaghue Medical Research Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT04510948
Brief Title
Patient Priority Care for Older Adults With Multiple Chronic Conditions
Acronym
PPC-CCF
Official Title
Patient Priority Care for Older Adults With Multiple Chronic Conditions Achieved Through Primary and Specialty Care Alignment
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 14, 2020 (Actual)
Primary Completion Date
January 15, 2022 (Actual)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Cleveland Clinic
Collaborators
Yale University, Donaghue Medical Research Foundation

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
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.

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
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Outcomes Assessor
Masking Description
Baseline and follow up interviews will be conducted by a rater blinded to the group assignment.
Allocation
Non-Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention (Implementing Patient Priorities Care)
Arm Type
Experimental
Arm Description
Patient Priorities Care requires the elicitation and documentation of patient health outcome goals and care preferences and the alignment of clinical care with health goals and healthcare preferences (collectively referred to as health priorities). Participants will be contacted by a trained priorities facilitator in-person or over the phone to elicit their health priorities. This information will be documented in the PPC- GOALS AND PREFERENCES form in the EHR and shared with the clinicians who will then use the Patient Priorities Care approach with patients to inform and guide treatment decisions.
Arm Title
Usual Care (Not implementing PPC)
Arm Type
No Intervention
Arm Description
Patients will receive routine clinical care.
Intervention Type
Behavioral
Intervention Name(s)
Patient Priorities Care
Other Intervention Name(s)
PPC
Intervention Description
Patient Priorities Care (PPC) is an innovative approach to shared decision-making that draws from existing professional training. PPC requires the elicitation and documentation of patient health outcome goals and care preferences and the alignment of clinical care with health goals and healthcare preferences. This information will be collected and documented in the EHR by facilitators and shared with the clinicians who will then use the PPC approach with patients to inform and guide treatment decisions. The PCPs will be trained in decisional strategies that have been shown to help align care with patients' health priorities. While encouraged to use these decisional strategies, PCPs will be free to make the recommendations they feel most appropriate for each patient. This intervention has been developed to be integrated seamlessly into usual care.
Primary Outcome Measure Information:
Title
Treatment burden
Description
Change in patient score on 'Treatment Burden Questionnaire' (TBQ, score range 0-150, Cronbach's alpha=0.90)
Time Frame
from baseline to follow-up at 8-9 months
Title
Achievement of desired activities
Description
Change in patient score on PROMIS Ability to Participate in Social Roles and Activities Shot Form 6a (score range 6-30; Cronbach's alpha = 0.98)
Time Frame
from baseline to follow-up at 8-9 months
Title
Health care utilization defined by healthcare contact days
Description
Number of health care contact days defined as number of ED visits, days in hospital +.5*number of outpatient encounters for procedures, tests, healthcare visits
Time Frame
from 3 months prior to 12 months following baseline interview
Secondary Outcome Measure Information:
Title
Shared decision making and goal ascertainment
Description
Change in patient score on CollaboRATE tool (score 0-100, Cronbach's alpha=0.89) from baseline to follow-up up at 8-9 months and response to Cleveland Clinic ACO survey item "When starting a new medication, did your provider ask what you thought was best for you?"
Time Frame
at 8-9 months follow-up
Title
Alignment of healthcare with patient preferences (coded based on review of EHR)
Description
Dichotomous variable indicating whether medications or self-management tasks were added or stopped per patient preference. Data will be abstracted using a data dictionary which guided abstraction in pilot studies.
Time Frame
Variable will be coded based on review of EHR covering the 12 months post baseline follow-up.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
66 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 66 and older In the Cleveland Clinic patient population In the clinician practices selected as intervention or usual care practice sites 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: In hospice or meeting hospice criteria for any condition Advanced dementia or moderate to profound intellectual disabilities Not English speaking Nursing home resident
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ardeshir Hashmi, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic Lakewood Family Health Center
City
Lakewood
State/Province
Ohio
ZIP/Postal Code
44107
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Dedientified data may be shared on a case-by-case basis after compliance and regulatory approval have been obtained.
IPD Sharing Time Frame
After publication. Data will be retained for a period of six year after study closure.
IPD Sharing Access Criteria
Access will be provided on a case-by-case basis pending approval by the Cleveland Clinic IRB and law department.
Citations:
PubMed Identifier
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Citation
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Links:
URL
https://patientprioritiescare.org/
Description
Patient Priorities Care helps patients and clinicians focus all decision-making and healthcare on what matters most: patients' own health priorities. It was developed by clinicians, patients, caregivers, health system leaders, and payers.

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Patient Priority Care for Older Adults With Multiple Chronic Conditions

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