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Phase 3 N=276 Randomized Single-blind Health Services Research

Improving Patient-centered Care Using an Inventory

Primary Care

Enrolled (actual)
276
Serious AEs
0.0%
Results posted
Mar 2019
Primary outcome: Primary: Consultation and Relational Empathy (CARE) Measure — 44.69; 41.99 units on a scale — p=0.029

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
patient inventory (Other); attention control (Other)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
VA Office of Research and Development
Primary completion
Jul 2016

Outcome Measures

OutcomeResultp-value
PRIMARY
Consultation and Relational Empathy (CARE) Measure
44.69; 41.99 0.029 sig
SECONDARY
Consultation Care Measure (CCM)
1.5; 1.4; 1.6; 2.6; 1.6; 1.6
SECONDARY
% of Encounters in Which Provider Probed at Least Once for Contextual Information
.475; .239 .065
SECONDARY
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.
10; 10; 4; 1; 3; 0 <0.05 sig

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.

Eligibility Criteria

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01843803). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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