Improving Patient-centered Care Using an Inventory

NCT01843803 | Completed Phase 2 Results DMC

• 1 other identifier: SDR 12-280
• Study Type: interventional
• Target: 276
• Locations: 1 country
• Sites: 2

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.

Conditions

Primary Care

Keywords

patient centered care; collaborative decision making; cost impact

Outcome Measures

Primary Outcomes (1)

• Consultation and Relational Empathy (CARE) Measure

  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.

  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).

Secondary Outcomes (3)

• Consultation Care Measure (CCM)

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

• % of Encounters in Which Provider Probed at Least Once for Contextual Information

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

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

Study Arms (2)

patient inventory tool

EXPERIMENTAL

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

attention control

ACTIVE COMPARATOR

prior to the encounter, the patient will view a brief video containing general health information.

Other: attention control

Interventions

patient inventory OTHER

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.

patient inventory tool

attention control OTHER

Patients will view a brief healthy living video on an iPad

attention control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Phase II:
• Veterans who receive care from VA and are comfortable using the Internet.
• 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.

You may not qualify if:

• A history of dementia
• Blindness

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (2)

Jesse Brown VA Medical Center, Chicago, IL

Chicago, Illinois, 60612, United States

Location

Edward Hines Jr. VA Hospital, Hines, IL

Hines, Illinois, 60141-5000, United States

Location

Related Publications (1)

• Binns-Calvey AE, Malhiot A, Kostovich CT, LaVela SL, Stroupe K, Gerber BS, Burkhart L, Weiner SJ, Weaver FM. Validating Domains of Patient Contextual Factors Essential to Preventing Contextual Errors: A Qualitative Study Conducted at Chicago Area Veterans Health Administration Sites. Acad Med. 2017 Sep;92(9):1287-1293. doi: 10.1097/ACM.0000000000001659.

  PMID: 28353498 RESULT

Results Point of Contact

• Title: Frances M Weaver
• Organization: Department of Veterans Affairs

frances.weaver@va.gov

708-202-5866

Study Officials

• Frances M. Weaver, PhD MA BA

  Edward Hines Jr. VA Hospital, Hines, IL

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2013
• First Posted: May 1, 2013
• Study Start: December 1, 2014
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: March 13, 2019
• Results First Posted: March 13, 2019

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)