Improving Patient-centered Care Using an Inventory
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|ClinicalTrials.gov Identifier: NCT01843803|
Recruitment Status : Completed
First Posted : May 1, 2013
Results First Posted : March 13, 2019
Last Update Posted : March 13, 2019
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||276 participants|
|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|
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
- 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.
- 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.
- % 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.
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT01843803
|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|
|Principal Investigator:||Frances M. Weaver, PhD MA BA||Edward Hines Jr. VA Hospital, Hines, IL|