Help guide our efforts to modernize
Send us your comments by March 14, 2020. Menu

Improving Patient-centered Care Using an Inventory

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01843803
Recruitment Status : Completed
First Posted : May 1, 2013
Results First Posted : March 13, 2019
Last Update Posted : March 13, 2019
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:

This study will use a multi-phase mixed-methods approach to develop and test a patient inventory to facilitate patient-centered care delivery. In Phase I the investigators will identify which factors should be considered for inclusion in the patient inventory. This will involve qualitative data collection with providers and patients using interviews and focus groups, respectively; and developing a question repository. The interviews and focus groups will take place at the six study sites: Hines VA Hospital and two Community Based Outpatient Clinics(CBOCs) in LaSalle, Illinois (IL) and Kankakee, IL; Jesse Brown VA Medical Center; and two CBOCs in Crown Point, IN; and Chicago Heights, IL. The question repository will involve a research assistant (RA) performing a literature review to gather items related to areas of patient context.

Phase II will develop and test an item inventory using a Delphi panel - a panel of stakeholders including Veteran representatives, VA providers, researchers and representatives from the investigators' operations partners. The panel of at least 14 respondents will develop a questionnaire through three rounds of email exchanges ranking the list of items to be included in the patient inventory. Once the patient inventory is finalized, it will be integrated into an iPad application for patient use.

In Phase III the investigators will test the patient inventory in a randomized trial.

The investigators will conduct a randomized trial of the patient inventory to a control condition (e.g., healthy living video) to assess whether use of the inventory results in care that is more patient-centered and decisions that are more collaborative. Eligible participants will be identified and recruited from the Patient Aligned Care Team (PACT) clinics at Hines and Jess Brown VA facilities. Patients will be randomly assigned to either complete the patient inventory on the iPad or watch a health video on the iPad. Patients in the Intervention group will give a copy of the summary of the inventory to their provider. Both groups will be asked to carry a concealed tape recorder during their visit. Following the visit, patients in both groups will complete a set of questionnaires about the encounter including the CARE and CCM. The recordings will be analyzed by the team using a coding system developed in a previous Health Services Research and Development (HSR&D) study to see if the use of the patient inventory facilitated patient-centered care during the encounter. A second coding scheme, the Informed Decision Making (IDM) will also be applied to examine collaborative decision making.

Condition or disease Intervention/treatment Phase
Primary Care Other: patient inventory Other: attention control Phase 2 Phase 3

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 276 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Health Services Research
Official Title: Developing a Patient Inventory to Facilitate Patient-centered Care Delivery
Study Start Date : December 2014
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: patient inventory tool
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. This information is presented to the provider to facilitate care delivery.
Other: 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.

Active Comparator: attention control
prior to the encounter, the patient will view a brief video containing general health information.
Other: attention control
Patients will view a brief healthy living video on an iPad

Primary Outcome Measures :
  1. Consultation and Relational Empathy (CARE) Measure [ Time Frame: 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). ]
    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.

Secondary Outcome Measures :
  1. Consultation Care Measure (CCM) [ Time Frame: 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.

  2. % of Encounters in Which Provider Probed at Least Once for Contextual Information [ Time Frame: based on audio-recordings of the patient-provider encounter, no additional time required by participants ]
    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.

  3. 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. [ Time Frame: based on audio-recordings of the patient-provider encounter, no additional time required by participants, through study completion ]
    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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

Phase I:

  • VA patients who have had some experience with care receipt through technology (e.g., home telehealth, CVT, secure messaging with providers).
  • A second group will be conducted with patients who have not had experience receiving care through technology.
  • There are no other specific inclusion criteria and the investigators plan to recruit both male and female Veterans, as well as minorities.

Phase II:

  • Veterans who receive care from VA and are comfortable using the Internet.
  • There are no other specific inclusion criteria and the investigators plan to recruit both male and female Veterans, as well as minorities.

Phase III:

  • Veterans who receive care from Hines VA or Jesse Brown VA in a primary care/PACT clinic.
  • No subjects will be excluded based on gender, race, or ethnicity. Eligibility criteria include:

    • (1) adult, age 18 or over
    • (2) assigned primary care provider in PACT clinic
    • (3) no history of dementia
    • (4) no blindness (unable to view iPad app).
  • Only patients of participating providers will be eligible for the study, to ensure both patient and provider consent to audio-recordings and study procedures.
  • There are no other specific inclusion criteria and the investigators plan to recruit both male and female Veterans, as well as minorities.

Exclusion Criteria:

  • A history of dementia
  • Blindness

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01843803

Layout table for location information
United States, Illinois
Jesse Brown VA Medical Center, Chicago, IL
Chicago, Illinois, United States, 60612
Edward Hines Jr. VA Hospital, Hines, IL
Hines, Illinois, United States, 60141-5000
Sponsors and Collaborators
VA Office of Research and Development
Layout table for investigator information
Principal Investigator: Frances M. Weaver, PhD MA BA Edward Hines Jr. VA Hospital, Hines, IL

Publications of Results:
Layout table for additonal information
Responsible Party: VA Office of Research and Development Identifier: NCT01843803    
Other Study ID Numbers: SDR 12-280
First Posted: May 1, 2013    Key Record Dates
Results First Posted: March 13, 2019
Last Update Posted: March 13, 2019
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by VA Office of Research and Development:
patient centered care
collaborative decision making
cost impact