CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 276 enrolled
Drug / intervention
patient inventory +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01843803
NCT01843803Phase 3Completed

Developing a Patient Inventory to Facilitate Patient-centered Care Delivery

VA Office of Research and Development·interventional·Posted May 1, 2013·Updated Mar 13, 2019

In Brief

A Phase 3 clinical trial evaluating patient inventory and attention control for Primary Care. Completed, enrolled 276 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrimary Care
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMay 1, 2013
Enrollment StartDec 1, 2014
Primary CompletionJul 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 13.2 years ago

Interventions

patient inventoryother

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 controlother

Patients will view a brief healthy living video on an iPad