Clinical trial NCT02522494: Encouraging Patient-Centered Communication in Clinical Video Telehealth Visits
Official title: Encouraging Patient-Centered Communication in Clinical Video Telehealth Visits
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2015-08-13
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Diabetes is common, it is expensive, and it is a chronic condition. Estimates put the prevalence of diabetes at almost 20 percent in VA patients. Poorly controlled diabetes leads to a number of complications including cardiovascular disease, blindness, amputation, and end stage renal disease. Adherence to medication regimens (as well as lifestyle factors such as diet and exercise) is important to achieve diabetes care goals. Adherence to recommended care is related at least in part to effective communication in medical encounters. This project is designed to test a video intervention to improve patients' communication behaviors. Providers will also receive a pamphlet with specific recommendation to improve communication skills. The project will assess the impact of the training programs on communication and outcomes. The study is designed to help make patient care more patient-centered, which is one of the six aims for improvement in the IOM Report, Crossing the Quality Chasm and is a goal of VA transformation efforts.

Detailed description: Background: Clinical video telehealth (CVT) offers the opportunity for more efficient access to high quality primary and specialist care for Veterans. Enthusiasm for CVT is especially high in the VA given geographical separation between many Veterans and their providers at VA Medical Centers. However, because CVT encounters are by nature less personal than in-person visits, communication during CVT visits may be more challenging for both patients and providers resulting in less patient-centered communication. Less personal visits may have less exchange of information, lower satisfaction, less trust, and poorer outcomes. Indeed, research comparing CVT with in-person consultations found that patients in CVT visits were more passive and that CVT interactions were dominated by providers when compared with in-person visits.

This project will leverage prior work from two HSR\&D-funded pilot projects to improve provider - patient communication for Veterans with type 2 diabetes mellitus. In a short-term project, SHP-08-182, the investigators conducted focus groups to elicit and understand patients' barriers to communicating with their providers. This qualitative work was used in a subsequent pilot project, PPO-08-402 to develop an educational video to encourage Veterans to use active participatory communication in their visits to providers. This work was successfully completed and the product is a 10-minute video that, in testing, was found to be acceptable and feasible to show to VA patients immediately preceding their medical encounters.

Objectives: The investigators goal in this project is develop and test a video intervention and to also develop pamphlets for patients and providers to encourage active and positive communication in CVT medical interactions. The investigators goal was developed with and is supported by the project's operational partner the Office of Telehealth Services and is integral to the goal to ensure patient-centered care in new models of care. Patient-centered communication in medical interactions is critical and plays an important, but often overlooked, role in the delivery of health services.

There are two aims. First, the investigators will develop educational interventions to encourage patients and providers to use active communication behaviors during CVT visits. Second, the investigators will conduct a randomized trial of the video and pamphlet (intervention) vs. pamphlet alone (comparison) in a two-arm randomized effectiveness trial. The investigators will evaluate for improvement in visit outcomes including patient and provider measures of patient-centered care and communication, reduction in several common barriers to clinical improvement, and improved medication adherence measures and hemoglobin A1c. In addition, the investigators will assess the mediators and moderators of the relationship of the intervention condition to outcomes.

Methods: The project will have two phases. In the initial phase of the proposed project the investigators will develop the video intervention. Video development will include qualitative interviews with stakeholders and patients regarding CVT barriers and perceived benefits. The investigators will use several existing resources and an expert panel of co-investigators and consultants to bring these elements together and produce the intervention. In phase 2 the investigators will conduct a randomized trial of the intervention, evaluating for improvement in a number of outcomes.

Impacts: The educational tools will be deliverables that could be used prior to CVT visits to improve communication and could serve as a paradigm for developing communication aids for other medical conditions and other clinical settings. The investigators will evaluate whether the educational intervention will help improve communication and will be associated with better visit and intermediate outcomes. Educational tools that encourage more patient-centered communication during CVT encounters may allow more rapid acceptance of CVT, thereby improving access to healthcare and enhancing the operational mission of the project's partner.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of type 2 diabetes mellitus,
* Hemoglobin A1c not controlled,
* Adults,
* Age 18 or older

Exclusion Criteria:

* Dementia,
* Lives in skilled nursing facility,
* Terminal medical condition,
* Drug-induced diabetes,
* Blind or deaf.

Primary outcomes:
measure: HgbA1c
timeFrame: At the baseline (Pre-CVT visit interview) and post-intervention (Post-CVT visit interview). All available values were restricted to one year before Baseline (Pre-Visit Interview) and from 30 days to 6 months past Post-CVT visit Interview.
measure: Communication Self-efficacy
timeFrame: At the baseline (Pre-CVT visit interview) and post-intervention (interview within one week past CVT visit)
measure: Consultation Care Measure (CCM)
timeFrame: post-intervention (interview within 1 week after CVT visit)
measure: Adherence (Self-reported)
timeFrame: 4 weeks after the CVT visit
measure: Medication Adherence (MPR)
timeFrame: 6 months
measure: Adherence at 1 Year
timeFrame: 1 year
measure: Consultation and Relational Empathy (CARE)
timeFrame: Post-intervention (interview within one week past CVT visit)
measure: Communication Ratings
timeFrame: Post-intervention (interview within one week after CVT visit)
measure: Human Connection Scale
timeFrame: At the baseline (Pre-CVT visit interview) and post-intervention (Post-CVT visit interview)
measure: Resistance to Treatment Questionnaire (RTQ)
timeFrame: 4 weeks past CVT visit
Secondary outcomes:
measure: Trust in Provider Questionnaire
timeFrame: At the baseline (Pre-CVT visit interview) and post-intervention (interview within one week after CVT visit)
measure: Patient Satisfaction
timeFrame: four weeks after CVT visit
measure: Participatory Decision-Making
timeFrame: At the baseline (Pre-CVT visit interview) and post-intervention (Post-CVT visit interview)
measure: Diabetes Self-Efficacy
timeFrame: At the baseline (Pre-CVT visit interview) and post-intervention (interview within one week after CVT visit)
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Rocky Mountain Regional VA Medical Center, Aurora, CO
state: Colorado
city: Chicago
country: United States
facility: Jesse Brown VA Medical Center Community-Based Outpatient Clinic Lake Side Divison, Chicago, IL
state: Illinois
city: Chicago
country: United States
facility: Jesse Brown VA Medical Center, Chicago, IL
state: Illinois
Study officials:
affiliation: Jesse Brown VA Medical Center, Chicago, IL
name: Howard S. Gordon, MD BS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gopal RK, Solanki P, Bokhour BG, Skorohod N, Hernandez Lujan DA, Choi W, Gordon HS. Provider, Staff, and Patient Perspectives on medical Visits Using Clinical Video Telehealth: A Foundation for Educational Initiatives to Improve Medical Care in Telehealth. J Nurse Pract. 2021 May;17(5):582-587. doi: 10.1016/j.nurpra.2021.02.020.