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

NCT01618097 | Completed

• 1 other identifier: Pro00032794
• Study Type: interventional
• Target: 155
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis

Keywords

Osteoarthritis; Decision Aids; Health Literacy

Outcome Measures

Primary Outcomes (5)

• Change in the Facts about Osteoarthritis section of the Decision Quality Instrument - Knee Osteoarthritis (DQI-KOA; © Massachusetts General Hospital, 2010 46) at Baseline to post.

  Knowledge is a key outcome in this study because it is fundamental to informed decision making process 45. We will use the "Facts about Osteoarthritis" section of the Decision Quality Instrument - Knee Osteoarthritis (DQI-KOA; © Massachusetts General Hospital, 2010 46), which includes 8 items that assess knowledge about the knee OA and its treatment options (behavioral, pharmacological, and surgical). Although this instrument was developed for knee OA, the items are also appropriate for hip OA, and it will be used for both groups.

  Baseline and 1 hour

• Change in Decisional Conflict Scale at Baseline to post.

  We will use the Low Literacy version of this scale, which includes 10 items with 3 response categories (yes, no, unsure), across four subscales: Informed (do patients know the different options, benefits, and risks?), Values Clarity (are patients clear about which benefits and risk matter most to them?), Support (do patients have support and advice to make a choice?), and Uncertainty (are patients clear or sure about what to choose?).

  Baseline and 1 hour

• Change in Decision Self-Efficacy Scale a Baseline to post.

  This is an 11-item scale that measures patients' confidence in completing various tasks related to the decision-making processes, such as getting facts about risks and benefits, asking questions, and expressing concerns. All items are measured on a scale of 0 (not confident at all) to 4 (very confident).

  Baseline and 1 hour

• Change in the Facts about Osteoarthritis section of the Decision Quality Instrument - Knee Osteoarthritis (DQI-KOA; © Massachusetts General Hospital, 2010 46) at 30 days.

  Baseline and 30 days

• Change in Decisional Conflict Scale at 30 days post.

  Baseline and 30 days

Secondary Outcomes (3)

• Measurement of the Acceptability and Usability Scale post viewing of the DAs.

  Up to 1 hour

• Semi-Structured Interviews

  Up to 1 hour

• Time spent viewing different parts of the internet-based DA

  Up to 1 hour

Study Arms (2)

DVD Decision Aid

EXPERIMENTAL

Patient assigned to watch DVD decision aid.

Behavioral: DVD Decision Aid

Internet Based Decision Aid

EXPERIMENTAL

Patient assigned to watch OA specific internet based decision aid.

Behavioral: Internet Based Decision Aid

Interventions

DVD Decision Aid BEHAVIORAL

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

DVD Decision Aid

Internet Based Decision Aid BEHAVIORAL

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

Internet Based Decision Aid

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duke University: lead
• Foundation for Informed Medical Decision Making: collaborator

Study Sites (1)

Duke University

Durham, North Carolina, 27701, United States

Location

Related Publications (1)

• 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.

  RESULT

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Kelli D Allen, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2012
• First Posted: June 13, 2012
• Study Start: January 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: January 1, 2014
• Last Updated: March 5, 2015

Record last verified: 2015-03

Locations

US (1)