Encouraging Patient-Centered Communication in Clinical Video Telehealth Visits

NCT ID: NCT02522494

Last Updated: 2022-08-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-01
• Study Completion Date: 2020-03-31

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.

Conditions

Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

Intervention

Patients randomized to the intervention will view the video

Group Type: ACTIVE_COMPARATOR

Pamphlet

Intervention Type: BEHAVIORAL

An educational intervention delivered prior to patients' visits with primary care physicians.

Video

Intervention Type: BEHAVIORAL

An educational intervention delivered prior to patients' visits with primary care providers.

Pamphlet alone

Patients randomized to the pamphlet alone will only receive the pamphlet

Group Type: OTHER

Pamphlet

Intervention Type: BEHAVIORAL

An educational intervention delivered prior to patients' visits with primary care physicians.

Interventions

Pamphlet

An educational intervention delivered prior to patients' visits with primary care physicians.

Intervention Type: BEHAVIORAL

Video

An educational intervention delivered prior to patients' visits with primary care providers.

Intervention Type: BEHAVIORAL

Other Intervention Names

Speak Up for Telehealth; Speak Up Video for Telehealth

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Howard S. Gordon, MD BS

Role: PRINCIPAL_INVESTIGATOR

Jesse Brown VA Medical Center, Chicago, IL

Locations

Rocky Mountain Regional VA Medical Center, Aurora, CO

Aurora, Colorado, United States

Jesse Brown VA Medical Center Community-Based Outpatient Clinic Lake Side Divison, Chicago, IL

Chicago, Illinois, United States

Jesse Brown VA Medical Center, Chicago, IL

Chicago, Illinois, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 34471399 (View on PubMed)

Gordon HS, Pugach O, Solanki P, Gopal RK. A brief pre-visit educational video improved patient engagement after telehealth visits; results from a randomized controlled trial. PEC Innov. 2022 Sep 5;1:100080. doi: 10.1016/j.pecinn.2022.100080. eCollection 2022 Dec.

Reference Type: DERIVED

PMID: 37213724 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

SDR 12-282

Identifier Type: -

Identifier Source: org_study_id