Trial Outcomes & Findings for Improving Patient-centered Care Using an Inventory (NCT NCT01843803)

Last Updated: 2019-03-13

Results Overview

CARE is a process measure of empathy and holistic care in the context of a therapeutic relationship (medical visit). It has 10 items, each rated from poor to excellent. Example items include: How was the provider at 'making you feel at ease'; letting you tell your story.' Score are added for a maximum of 50, min of 10; higher score reflects greater patient-centeredness.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

276 participants

Primary outcome timeframe

Total time of patient participation 2 to 2.5 hours, including 1 hour prior to provider encounter, encounter (20-40 min) and data collection after encounter (15-30 minutes).

Results posted on

2019-03-13

Participant Flow

Participant milestones

Participant milestones
Measure	Patient Inventory prior to the encounter with his/her provider, the patient completes an inventory that includes information about patient contextual factors (e.g., life circumstances), resources and preferences for care delivery patient inventory: Patients in the intervention arm will complete an inventory of their preferences, resources, and life circumstances that may affect their care. The inventory will be completed on an iPad, and a copy of the results will be given to the patient's provider at the time of their visit.	Attention Control prior to the encounter, the patient will view a brief video containing general health information. attention control: Patients will view a brief healthy living video on an iPad
Overall Study STARTED	137	139
Overall Study COMPLETED	136	136
Overall Study NOT COMPLETED	1	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Patient Inventory prior to the encounter with his/her provider, the patient completes an inventory that includes information about patient contextual factors (e.g., life circumstances), resources and preferences for care delivery patient inventory: Patients in the intervention arm will complete an inventory of their preferences, resources, and life circumstances that may affect their care. The inventory will be completed on an iPad, and a copy of the results will be given to the patient's provider at the time of their visit.	Attention Control prior to the encounter, the patient will view a brief video containing general health information. attention control: Patients will view a brief healthy living video on an iPad
Overall Study not a Veteran, did not see provider	1	3

Baseline Characteristics

Improving Patient-centered Care Using an Inventory

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patient Inventory n=136 Participants prior to the encounter with his/her provider, the patient completes an inventory that includes information about patient contextual factors (e.g., life circumstances), resources and preferences for care delivery patient inventory: Patients in the intervention arm will complete an inventory of their preferences, resources, and life circumstances that may affect their care. The inventory will be completed on an iPad, and a copy of the results will be given to the patient's provider at the time of their visit.	Attention Control n=136 Participants prior to the encounter, the patient will view a brief video containing general health information. attention control: Patients will view a brief healthy living video on an iPad	Total n=272 Participants Total of all reporting groups
Age, Continuous	62.6 years STANDARD_DEVIATION 13.2 • n=5 Participants	62.9 years STANDARD_DEVIATION 11.5 • n=7 Participants	62.75 years STANDARD_DEVIATION 12.3 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants
Sex: Female, Male Male	127 Participants n=5 Participants	126 Participants n=7 Participants	253 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	76 Participants n=5 Participants	64 Participants n=7 Participants	140 Participants n=5 Participants
Race (NIH/OMB) White	47 Participants n=5 Participants	61 Participants n=7 Participants	108 Participants n=5 Participants
Race (NIH/OMB) More than one race	10 Participants n=5 Participants	8 Participants n=7 Participants	18 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Region of Enrollment United States	136 Participants n=5 Participants	136 Participants n=7 Participants	272 Participants n=5 Participants

PRIMARY outcome

Timeframe: Total time of patient participation 2 to 2.5 hours, including 1 hour prior to provider encounter, encounter (20-40 min) and data collection after encounter (15-30 minutes).

Outcome measures

Outcome measures
Measure	Patient Inventory n=136 Participants prior to the encounter with his/her provider, the patient completes an inventory that includes information about patient contextual factors (e.g., life circumstances), resources and preferences for care delivery patient inventory: Patients in the intervention arm will complete an inventory of their preferences, resources, and life circumstances that may affect their care. The inventory will be completed on an iPad, and a copy of the results will be given to the patient's provider at the time of their visit.	Attention Control n=136 Participants prior to the encounter, the patient will view a brief video containing general health information. attention control: Patients will view a brief healthy living video on an iPad
Consultation and Relational Empathy (CARE) Measure	44.69 units on a scale Standard Error 1.11	41.99 units on a scale Standard Error 1.14

SECONDARY outcome

Timeframe: immediately following the encounter with the provider, 5-7 minutes to complete

CCM measures the patient's perceptions of patient-centered care during their last visit with their provider. there are 5 subscales in 21 items: communication and partnership, personal relationship, health promotion, positive and clear approach to the problem, interest in effect on life. Items are scores on a 4-point likert scale from 1-very strongly agree to 4=neutral/disagree. The average of the ratings for each subscale is determined, so the score for each subscale ranges from 1.0 to 4.0.

Outcome measures

Outcome measures
Measure	Patient Inventory n=136 Participants prior to the encounter with his/her provider, the patient completes an inventory that includes information about patient contextual factors (e.g., life circumstances), resources and preferences for care delivery patient inventory: Patients in the intervention arm will complete an inventory of their preferences, resources, and life circumstances that may affect their care. The inventory will be completed on an iPad, and a copy of the results will be given to the patient's provider at the time of their visit.	Attention Control n=136 Participants prior to the encounter, the patient will view a brief video containing general health information. attention control: Patients will view a brief healthy living video on an iPad
Consultation Care Measure (CCM) communication & partnership	1.5 units on a scale Standard Error 0.5	1.4 units on a scale Standard Error 0.5
Consultation Care Measure (CCM) personal relationship	1.6 units on a scale Standard Error 0.6	2.6 units on a scale Standard Error 0.7
Consultation Care Measure (CCM) positive and clear approach to problem	1.6 units on a scale Standard Error 0.6	1.6 units on a scale Standard Error 0.7
Consultation Care Measure (CCM) interest in effect on life	1.8 units on a scale Standard Error 0.7	1.7 units on a scale Standard Error 0.7

SECONDARY outcome

Timeframe: based on audio-recordings of the patient-provider encounter, no additional time required by participants

Population: Mixed Effects Logistic Regression Analysis controlling for covariates (demographics, comorbid conditions) on whether or not providers probed at least once for additional information based on whether or not the patient was in the intervention group that used the inventory tool

This methodology assesses patient centered clinical decision making using Content Coding for Contextual Care (4C). 4C evaluates encounters based on whether the provider probes at least once for clinically relevant content and then plans care accordingly.

Outcome measures

Outcome measures
Measure	Patient Inventory n=136 was encounter probed by provider prior to the encounter with his/her provider, the patient completes an inventory that includes information about patient contextual factors (e.g., life circumstances), resources and preferences for care delivery patient inventory: Patients in the intervention arm will complete an inventory of their preferences, resources, and life circumstances that may affect their care. The inventory will be completed on an iPad, and a copy of the results will be given to the patient's provider at the time of their visit.	Attention Control n=136 was encounter probed by provider prior to the encounter, the patient will view a brief video containing general health information. attention control: Patients will view a brief healthy living video on an iPad
% of Encounters in Which Provider Probed at Least Once for Contextual Information	.475 proportion of cases probed Interval -0.029 to 0.979	.239 proportion of cases probed Interval -0.173 to 0.652

SECONDARY outcome

Timeframe: based on audio-recordings of the patient-provider encounter, no additional time required by participants, through study completion

Population: A subset of cases were coded using the IDM tool.

IDM includes 7 elements of a complete decision: discussion of patient's role in decision making, clinic issue or nature of the decision, alternatives, pros and cons, uncertainties, patient understanding, and patient preference. A score between 0-7 is assigned based audio-recording. A higher score is expected for a more complex decision (decisions are categorized as basic, intermediate or complex). For basic decisions (e.g. refilling a medication) a score of 2-3 would indicate a good IDM event, an intermediate decision (e.g., prescribing use of new equipment) should result in a score of 5-6; and a complex decision (e.g. lifestyle counseling) would receive a score of 7 if all the elements of the IDM were noted. We will look at the distribution of the decisions by group to determine whether the decision complexity differs by whether or not patients complete the inventory. Also, we will look at the average IDM score by decision complexity and study group.

Outcome measures

Outcome measures
Measure	Patient Inventory n=46 Participants prior to the encounter with his/her provider, the patient completes an inventory that includes information about patient contextual factors (e.g., life circumstances), resources and preferences for care delivery patient inventory: Patients in the intervention arm will complete an inventory of their preferences, resources, and life circumstances that may affect their care. The inventory will be completed on an iPad, and a copy of the results will be given to the patient's provider at the time of their visit.	Attention Control n=53 Participants prior to the encounter, the patient will view a brief video containing general health information. attention control: Patients will view a brief healthy living video on an iPad
All Participants Assessed by Informed Decision Making (IDM). The IDM Tool Measures the Extent to Which Decision Making Involving Patient and Provider by Analyzing Recordings of Encounters Between Providers and Patients. Patient role in decision making	10 Participants	10 Participants
All Participants Assessed by Informed Decision Making (IDM). The IDM Tool Measures the Extent to Which Decision Making Involving Patient and Provider by Analyzing Recordings of Encounters Between Providers and Patients. discussion of clinical decision	4 Participants	1 Participants
All Participants Assessed by Informed Decision Making (IDM). The IDM Tool Measures the Extent to Which Decision Making Involving Patient and Provider by Analyzing Recordings of Encounters Between Providers and Patients. discussion of alternatives	3 Participants	0 Participants
All Participants Assessed by Informed Decision Making (IDM). The IDM Tool Measures the Extent to Which Decision Making Involving Patient and Provider by Analyzing Recordings of Encounters Between Providers and Patients. discussion of pros and cons	8 Participants	7 Participants
All Participants Assessed by Informed Decision Making (IDM). The IDM Tool Measures the Extent to Which Decision Making Involving Patient and Provider by Analyzing Recordings of Encounters Between Providers and Patients. discussion of uncertainities	2 Participants	1 Participants
All Participants Assessed by Informed Decision Making (IDM). The IDM Tool Measures the Extent to Which Decision Making Involving Patient and Provider by Analyzing Recordings of Encounters Between Providers and Patients. assessment of patient understanding	10 Participants	17 Participants
All Participants Assessed by Informed Decision Making (IDM). The IDM Tool Measures the Extent to Which Decision Making Involving Patient and Provider by Analyzing Recordings of Encounters Between Providers and Patients. exploration of patient preferences	41 Participants	47 Participants

Adverse Events

Patient Inventory

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Attention Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Patient Inventory n=136 participants at risk prior to the encounter with his/her provider, the patient completes an inventory that includes information about patient contextual factors (e.g., life circumstances), resources and preferences for care delivery patient inventory: Patients in the intervention arm will complete an inventory of their preferences, resources, and life circumstances that may affect their care. The inventory will be completed on an iPad, and a copy of the results will be given to the patient's provider at the time of their visit.	Attention Control n=136 participants at risk prior to the encounter, the patient will view a brief video containing general health information. attention control: Patients will view a brief healthy living video on an iPad
Social circumstances breach of confidentiality	0.00% 0/136 • 18 months Adverse event is loss of patient confidential information from audio recordings	0.00% 0/136 • 18 months Adverse event is loss of patient confidential information from audio recordings

Other adverse events

Adverse event data not reported

Additional Information

Frances M Weaver

Department of Veterans Affairs

Phone: 708-202-5866

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place