Evaluation of DVD and Internet Decision Aids for Hip and Knee Osteoarthritis: Focus on Health Literacy

NCT ID: NCT01618097

Last Updated: 2015-03-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 155 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2014-01-31

Brief Summary

The purpose of this study is to advance the evidence base regarding methods for facilitating informed decisions among patients with knee and hip osteoarthritis by comparing DVD and online formats of decision aids for these conditions. The project will assess how these different formats impact key outcomes including: patient knowledge about treatment options, decisional conflict, preparation for decision making, decision self-efficacy, stage of decision making, and acceptability and usability of the decision aids.

Detailed Description

Osteoarthritis (OA) is one of the most common chronic conditions and a leading cause of pain and disability. Many patients with OA know very little about treatment options and are not well equipped to make informed decisions regarding these treatments. Further, there are racial and gender disparities in perceptions of the risks and benefits of total joint replacement, which also highlights the need to improve facilitation of informed treatment choices in these patients. Decision aids have great potential to improve patient satisfaction, safety, and outcomes for patients with OA, but there is no evidence base regarding best formats for delivering this information. This project will compare patient decision-making outcomes immediately following viewing of DVD and web-based versions of the Health Dialog DAs for hip and knee OA, as well as three days and one month later. Patients with symptomatic knee and hip OA (n=200) will be enrolled from a primary care and orthopedic clinics. Participants will be randomized, with stratification according to health literacy level, to view the DVD or web-based DA. Outcomes will include: Knowledge about OA and Treatments, Decisional Conflict, Preparation for Decision-Making, Decision Self-Efficacy, Stage of Decision Making, Acceptability and Usability of the DA, and home use of the DA. This project will make a novel contribution with direct clinical applicability, providing information regarding best methods for disseminating tools to enhance informed decision-making among patients with hip and knee OA, with particular attention to patients with low literacy.

Conditions

Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

DVD Decision Aid

Patient assigned to watch DVD decision aid.

Group Type: EXPERIMENTAL

DVD Decision Aid

Intervention Type: BEHAVIORAL

Patients will receive the DVD decision aid to view, and follow up 3 days and 30 days post visit.

Internet Based Decision Aid

Patient assigned to watch OA specific internet based decision aid.

Group Type: EXPERIMENTAL

Internet Based Decision Aid

Intervention Type: BEHAVIORAL

Patients will receive the OA specific internet based decision aid to view, and follow up 3 days and 30 days post visit

Interventions

DVD Decision Aid

Patients will receive the DVD decision aid to view, and follow up 3 days and 30 days post visit.

Intervention Type: BEHAVIORAL

Internet Based Decision Aid

Patients will receive the OA specific internet based decision aid to view, and follow up 3 days and 30 days post visit

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Clinician diagnosis of knee/hip OA, based on radiographic evidence in Duke medical records.
• Moderate or worse current joint symptoms, assessed at telephone screening using standard items.

Exclusion Criteria

• Diagnosis of rheumatoid arthritis, fibromyalgia, or other systemic rheumatic disease.
• Active diagnosis of psychosis or dementia, or other cognitive impairment.
• Severe hearing or visual impairment that would prohibit effective use of the DAs.
• Planning, scheduled for or on a wait list for joint replacement surgery.
• Had a prior hip or knee joint replacement surgery.
• Inability to read English, since the DAs are in English.
• Current participation in another OA interventional study.

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

Sponsors

Foundation for Informed Medical Decision Making

OTHER

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kelli D Allen, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University

Durham, North Carolina, United States

Countries

United States

References

Allen, K.D., Sanders, L. Olsen, M., Bowlby, L., Katz, J.N., Mather, R.C., Powers, B., Sperber, N., Voils, C.I., Williams, J.W. Effectiveness of Internet and DVD Decision Aids for Patients with Hip and Knee Osteoarthritis. April 2014 World Congress on Osteoarthritis. Paris, France.

Reference Type: RESULT

Other Identifiers

Pro00032794

Identifier Type: -

Identifier Source: org_study_id