Encouraging Patient-Centered Communication in Clinical Video Telehealth Visits

NCT02522494 | Completed Results

• 1 other identifier: SDR 12-282
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 3

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.

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (10)

• HgbA1c

  HgbA1c is regarded as the standard laboratory measurement (blood test) for assessing the control of diabetes over approximately three months preceding the test. HgbA1c is usually checked several times a year in patients with poorly controlled diabetes.

  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.

• Communication Self-efficacy

  Communication Self-Efficacy (pre and post visit) is the degree to which a patient feels able to interact with his/her provider in order to provide information about problems, obtain desired information about diagnosis, treatment and prognosis, and participate in formulating a plan. The Perceived Efficacy in Physician-Patient Interactions scale (PEPPI) is a valid and reliable measure of patients' perceived self-efficacy in interacting with physicians (alpha 0.83). The short form of the PEPPI (PEPPI-5) has 5-items. Score on the PEPPI-5 ranges from 5-25. Higher scores reflect a better perceived self-efficacy in interacting with physicians.

  At the baseline (Pre-CVT visit interview) and post-intervention (interview within one week past CVT visit)

• Consultation Care Measure (CCM)

  Consultation Care Measure (CCM) assesses patient-centered care and patient-centered communication. Patients rate such factors as their providers' (1) communication and partnership, (2) personal relationship, (3) health promotion, (4) positive and clear approach to problem, (5) interest in effect on life on a 21-item scale, each item scores from 1 (strongly disagree) to 5 (strongly agree). Scores can range from 21 to 105. The higher scores mean a better patients' experiences with their provider.

  post-intervention (interview within 1 week after CVT visit)

• Adherence (Self-reported)

  Self-reported adherence is measured using a brief questionnaire - a general measure of adherence to providers' recommendations and includes 5 items and is scored on a 6-level Likert-type scale ranging from "none of the time" to "all of the time". Scores range from 0-100 (after normalizing the standard 6-30 range) with higher numbers reflecting better adherence. Adherence using this measure is assessed with a brief telephone survey 4 weeks following the visit.

  4 weeks after the CVT visit

• Medication Adherence (MPR)

  Medication adherence will be assessed with a medication possession ratio (MPR) for diabetes medications.

  6 months

• Adherence at 1 Year

  Medication adherence will be assessed with a medication possession ratio (MPR) for diabetes medications.

  1 year

• Consultation and Relational Empathy (CARE)

  Consultation and Relational Empathy (CARE) Measure - is a tool for measuring patients' perceptions of relational empathy in the consultation. In this 10-item questionnaire patients rate the statements about their doctor's understanding their concern, showing care, and etc. during the recent CVT visit on a scale from 1 to 5 where 1 is "poor" and 5 is "excellent". Scores can range from 10 to 50. The higher score means a better patient's perception of empathy in consultation.

  Post-intervention (interview within one week past CVT visit)

• Communication Ratings

  The questionnaire assesses patients' ratings of their own participatory communication behavior and patients' ratings of their providers' communication. It is a 15-item scale with 3 sub-scales. Patients' ratings of their (1) providers' informativeness and the extent to which the patient understands that information (information sub-scale) are measured with 5-items; (2) patients' ratings that the provider values and respects them is measured with 5-items; and (3) patients' ratings of their own communication is measured with 5-items. This questionnaire has high internal consistency. The scale is scored from 1 (completely disagree) to 7 (completely agree). The total scores range from 15 to 105. The higher scores indicate a better quality of communication.

  Post-intervention (interview within one week after CVT visit)

• Human Connection Scale

  Human Connection Scale is a 15-item questionnaire that measures the extent to which patient feel a sense of mutual understanding, caring, and trust with their physicians. The scale is a valid and reliable measure of therapeutic alliance between patients and their physicians. The score from 1 to 4 is used where 1 is "not at all" and 4 is "extremely". The scores range from 15 to 60. The higher scores indicate higher therapeutic alliance between patients and physicians.

  At the baseline (Pre-CVT visit interview) and post-intervention (Post-CVT visit interview)

• Resistance to Treatment Questionnaire (RTQ)

  Resistance to Treatment Questionnaire (RTQ) identifies the reasons for resistance to treatment and its intensity among patients with diabetes. 20-item questionnaire consists of four themes (lack of faith or dissatisfaction, emotional reasons, specific problems, factors connected to despair or failure) containing 5 items each; each item is scored from 1 (strongly disagree) to 5 (strongly agree). The scores range from 20 to 100. The higher scores mean more barriers to treatment (a worse outcome).

  4 weeks past CVT visit

Secondary Outcomes (4)

• Trust in Provider Questionnaire

  At the baseline (Pre-CVT visit interview) and post-intervention (interview within one week after CVT visit)

• Patient Satisfaction

  four weeks after CVT visit

• Participatory Decision-Making

  At the baseline (Pre-CVT visit interview) and post-intervention (Post-CVT visit interview)

• Diabetes Self-Efficacy

  At the baseline (Pre-CVT visit interview) and post-intervention (interview within one week after CVT visit)

Study Arms (2)

Intervention

ACTIVE COMPARATOR

Patients randomized to the intervention will view the video

Behavioral: Pamphlet; Behavioral: Video

Pamphlet alone

OTHER

Patients randomized to the pamphlet alone will only receive the pamphlet

Behavioral: Pamphlet

Interventions

Pamphlet BEHAVIORAL

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

Also known as: Speak Up for Telehealth

Intervention; Pamphlet alone

Video BEHAVIORAL

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

Also known as: Speak Up Video for Telehealth

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (3)

Rocky Mountain Regional VA Medical Center, Aurora, CO

Aurora, Colorado, 80045, United States

Location

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

Chicago, Illinois, 60611, United States

Location

Jesse Brown VA Medical Center, Chicago, IL

Chicago, Illinois, 60612, United States

Location

Related Publications (2)

• 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.

  PMID: 34471399 RESULT

• 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.

  PMID: 37213724 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Telemedicine; Videotape Recording

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration; Tape Recording; Audiovisual Aids; Educational Technology; Technology; Technology, Industry, and Agriculture; Television

Results Point of Contact

• Title: Howard S. Gordon, MD
• Organization: Jesse Brown VA Medical Center

howard.gordon2@va.gov

(312) 569-7331

Study Officials

• Howard S. Gordon, MD BS

  Jesse Brown VA Medical Center, Chicago, IL

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2015
• First Posted: August 13, 2015
• Study Start: July 1, 2016
• Primary Completion: December 31, 2019
• Study Completion: March 31, 2020
• Last Updated: August 4, 2022
• Results First Posted: June 1, 2021

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)