Trial Outcomes & Findings for Patient Priority Care for Older Adults With Multiple Chronic Conditions (NCT NCT04510948)

Last Updated: 2025-05-04

Results Overview

Change in patient score on 'Treatment Burden Questionnaire' (TBQ, score range 0-150, Cronbach's alpha=0.90) Lower score reflects less perceived treatment burden.

Recruitment status

COMPLETED

Study phase

Target enrollment

264 participants

Primary outcome timeframe

from baseline to follow-up at 8-9 months

Results posted on

2025-05-04

Participant Flow

Enrollment occurred between August 14, 2020 - May 14, 2021. The study followed a nonrandomized controlled trial design. One primary care site within Cleveland Clinic's multisite Primary Care Practice was selected as the PPC site. The UC site was identified as the optimal match to the PPC site using a multivariate matching procedure which calculated the multivariate distance between the PPC site and 11 potential UC sites.

Unit of analysis: Clinic

Participant milestones

Participant milestones
Measure	Intervention (Implementing Patient Priorities Care) 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.	Usual Care (Not Implementing PPC) Patients will receive routine clinical care.
Overall Study STARTED	129 1	135 1
Overall Study COMPLETED	116 1	113 1
Overall Study NOT COMPLETED	13 0	22 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Total is not 264 because of missing data.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: from baseline to follow-up at 8-9 months

Population: The baseline outcome is included to illustrate weighted balance of covariate before PPC is introduced, and the P values for the baseline outcome comparison are based on weighted and imputed data (same as the adjusted P values in Table 1).Of note, the baseline value of the outcome was included in outcome models at follow-up. Therefore, the difference between estimates for baseline and follow-up is not necessarily equal to the effect size reported.

Change in patient score on 'Treatment Burden Questionnaire' (TBQ, score range 0-150, Cronbach's alpha=0.90) Lower score reflects less perceived treatment burden.

Outcome measures

Outcome measures
Measure	Intervention (Implementing Patient Priorities Care) n=109 Participants 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. Patient Priorities Care: 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.	Usual Care (Not Implementing PPC) n=111 Participants Patients will receive routine clinical care.
Treatment Burden Baseline	11.9 score on a scale Interval 10.3 to 13.6	11.6 score on a scale Interval 9.3 to 14.0
Treatment Burden Follow up	12.7 score on a scale Interval 10.0 to 15.5	17.9 score on a scale Interval 13.1 to 22.7

PRIMARY outcome

Timeframe: at follow-up (8-9 months) The scale instructions do not reference timeframe.

Population: PROM IS Social Roles and Activities was inadvertently left out of the baseline interview.

Patient score on PROMIS Ability to Participate in Social Roles and Activities Shot Form 6a (score range 6-30; Cronbach's alpha = 0.98) Higher score reflects more social participation.

Outcome measures

Outcome measures
Measure	Intervention (Implementing Patient Priorities Care) n=97 Participants 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. Patient Priorities Care: 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.	Usual Care (Not Implementing PPC) n=88 Participants Patients will receive routine clinical care.
Achievement of Desired Activities	21.9 score on a scale Interval 20.6 to 23.1	21.6 score on a scale Interval 20.2 to 22.9

PRIMARY outcome

Timeframe: from 3 months prior to 12 months following baseline interview

Population: Baseline refers to 90 days before enrollment; follow-up refers to 365 days after enrollment. Baseline measures of nonhealthy days include only encounter 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.

Outcome measures

Outcome measures
Measure	Intervention (Implementing Patient Priorities Care) n=129 Participants 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. Patient Priorities Care: 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.	Usual Care (Not Implementing PPC) n=135 Participants Patients will receive routine clinical care.
Health Care Utilization Defined by Healthcare Contact Days Baseline	0.7 days Interval 0.4 to 1.0	0.7 days Interval 0.4 to 1.0
Health Care Utilization Defined by Healthcare Contact Days Follow up	8.7 days Interval 3.8 to 13.7	13.4 days Interval 6.6 to 20.1

SECONDARY outcome

Timeframe: at 8-9 months follow-up

Population: All results reflect doubly robust imputed models. Variables used in propensity weighting included race, gender, education, and baseline measures of age, living alone, insurance, cognitive status, number of oral prescription medications, number of chronic conditions, heart failure, COPD, baseline PROMIS mental health and physical health, baseline TBQ, baseline CollaboRATE, baseline ACO shared prescribing decision-making quality measure, and Nonhealthy Days in 90 days prior to enrollment.

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?" Scores are dichotomized 100 vs. \<100 with 100 being the percent of participants who reported the top score of all three items.

Outcome measures

Outcome measures
Measure	Intervention (Implementing Patient Priorities Care) n=129 Participants 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. Patient Priorities Care: 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.	Usual Care (Not Implementing PPC) n=135 Participants Patients will receive routine clinical care.
Shared Decision Making and Goal Ascertainment Baseline	46.3 score on a scale Interval 36.5 to 56.5	47.7 score on a scale Interval 37.9 to 57.8
Shared Decision Making and Goal Ascertainment Follow up	58.5 score on a scale Interval 45.6 to 70.3	61.9 score on a scale Interval 50.9 to 71.8

Adverse Events

Intervention (Implementing Patient Priorities Care)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 3 deaths

Usual Care (Not Implementing PPC)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 5 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Mary Tinetti, MD

Department of Medicine, Yale School of Medicine

Phone: 203-688-5238

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Intervention (Implementing Patient Priorities Care) n=129 Participants Patient Priorities Care (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 (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. 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.	Usual Care (Not Implementing PPC) n=135 Participants Patients will receive routine clinical care. No study intervention was provided before or during their scheduled visit.	Total n=264 Participants Total of all reporting groups
Age, Continuous	75.5 years STANDARD_DEVIATION 6.4 • n=125 Participants • Total is not 264 because of missing data.	75.4 years STANDARD_DEVIATION 6.1 • n=134 Participants • Total is not 264 because of missing data.	75.5 years STANDARD_DEVIATION 6.3 • n=259 Participants • Total is not 264 because of missing data.
Sex: Female, Male Female	54 Participants n=127 Participants • there were missing data in the outcomes.	66 Participants n=135 Participants • there were missing data in the outcomes.	120 Participants n=262 Participants • there were missing data in the outcomes.
Sex: Female, Male Male	73 Participants n=127 Participants • there were missing data in the outcomes.	69 Participants n=135 Participants • there were missing data in the outcomes.	142 Participants n=262 Participants • there were missing data in the outcomes.
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=128 Participants • One participant did not answer.	0 Participants n=135 Participants • One participant did not answer.	1 Participants n=263 Participants • One participant did not answer.
Race (NIH/OMB) Asian	2 Participants n=128 Participants • One participant did not answer.	2 Participants n=135 Participants • One participant did not answer.	4 Participants n=263 Participants • One participant did not answer.
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=128 Participants • One participant did not answer.	0 Participants n=135 Participants • One participant did not answer.	0 Participants n=263 Participants • One participant did not answer.
Race (NIH/OMB) Black or African American	10 Participants n=128 Participants • One participant did not answer.	1 Participants n=135 Participants • One participant did not answer.	11 Participants n=263 Participants • One participant did not answer.
Race (NIH/OMB) White	110 Participants n=128 Participants • One participant did not answer.	129 Participants n=135 Participants • One participant did not answer.	239 Participants n=263 Participants • One participant did not answer.
Race (NIH/OMB) More than one race	0 Participants n=128 Participants • One participant did not answer.	0 Participants n=135 Participants • One participant did not answer.	0 Participants n=263 Participants • One participant did not answer.
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=128 Participants • One participant did not answer.	3 Participants n=135 Participants • One participant did not answer.	8 Participants n=263 Participants • One participant did not answer.
Education high school or less	25 Participants n=124 Participants • Not all respondents answered all questions. Raw numbers are reported.	46 Participants n=132 Participants • Not all respondents answered all questions. Raw numbers are reported.	71 Participants n=256 Participants • Not all respondents answered all questions. Raw numbers are reported.
Medicare Advantage	59 Participants n=126 Participants • Not all respondents answered all questions. Raw numbers are reported.	63 Participants n=135 Participants • Not all respondents answered all questions. Raw numbers are reported.	122 Participants n=261 Participants • Not all respondents answered all questions. Raw numbers are reported.
Lives alone	54 Participants n=125 Participants • Not all respondents answered all questions. Raw numbers are reported.	40 Participants n=132 Participants • Not all respondents answered all questions. Raw numbers are reported.	94 Participants n=257 Participants • Not all respondents answered all questions. Raw numbers are reported.
5-Word recall score	3.4 words STANDARD_DEVIATION 1.4 • n=118 Participants • Score ranges between 0 to 5. Higher score represents better cognition. Some participants declined to perform this task.	3.7 words STANDARD_DEVIATION 1.4 • n=131 Participants • Score ranges between 0 to 5. Higher score represents better cognition. Some participants declined to perform this task.	3.6 words STANDARD_DEVIATION 1.4 • n=249 Participants • Score ranges between 0 to 5. Higher score represents better cognition. Some participants declined to perform this task.
PROMIS physical health	14.8 units on a scale STANDARD_DEVIATION 2.9 • n=119 Participants • Not all respondents answered all questions. Raw numbers are reported.	14.3 units on a scale STANDARD_DEVIATION 2.7 • n=131 Participants • Not all respondents answered all questions. Raw numbers are reported.	14.6 units on a scale STANDARD_DEVIATION 2.8 • n=250 Participants • Not all respondents answered all questions. Raw numbers are reported.
PROMIS mental health	14.3 units on a scale STANDARD_DEVIATION 2.9 • n=119 Participants • Not all respondents answered all questions. Raw numbers are reported.	13.9 units on a scale STANDARD_DEVIATION 2.8 • n=131 Participants • Not all respondents answered all questions. Raw numbers are reported.	14.1 units on a scale STANDARD_DEVIATION 2.8 • n=250 Participants • Not all respondents answered all questions. Raw numbers are reported.
The Treatment Burden Questionnaire (TBQ) score	12.2 units on a scale STANDARD_DEVIATION 12.6 • n=121 Participants • Not all respondents answered all questions. Raw numbers are reported.	10.3 units on a scale STANDARD_DEVIATION 10.7 • n=128 Participants • Not all respondents answered all questions. Raw numbers are reported.	11.2 units on a scale STANDARD_DEVIATION 11.7 • n=249 Participants • Not all respondents answered all questions. Raw numbers are reported.
CollaboRATE top score	48 Participants n=111 Participants • Not all respondents answered all questions. Raw numbers are reported.	60 Participants n=127 Participants • Not all respondents answered all questions. Raw numbers are reported.	108 Participants n=238 Participants • Not all respondents answered all questions. Raw numbers are reported.
Number of chronic conditions, mean (+/- SD)	6.0 condition(s) STANDARD_DEVIATION 2.3 • n=129 Participants • The number reported here is based on EHR data.	6.1 condition(s) STANDARD_DEVIATION 2.1 • n=135 Participants • The number reported here is based on EHR data.	6.1 condition(s) STANDARD_DEVIATION 2.2 • n=264 Participants • The number reported here is based on EHR data.
Heart failure	17 Participants n=129 Participants • The number reported here is based on EHR data.	19 Participants n=135 Participants • The number reported here is based on EHR data.	36 Participants n=264 Participants • The number reported here is based on EHR data.
COPD	36 Participants n=129 Participants • The number reported here is based on EHR data.	29 Participants n=135 Participants • The number reported here is based on EHR data.	65 Participants n=264 Participants • The number reported here is based on EHR data.
Number or oral prescription medications for chronic conditions, mean (+/- SD)	8.5 medication(s) STANDARD_DEVIATION 3.9 • n=129 Participants • The number reported here is based on EHR data.	8.0 medication(s) STANDARD_DEVIATION 3.0 • n=135 Participants • The number reported here is based on EHR data.	8.2 medication(s) STANDARD_DEVIATION 3.5 • n=264 Participants • The number reported here is based on EHR data.