Telephone-Based Decision Support for Rural Patients

NCT01217333 | Completed

• 1 other identifier: CBCRP 12BB-3900
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 2

Brief Summary

The investigators community based resource center has implemented visit preparation by prompting patients to write down their questions. This is a proven approach to increasing the number of questions and concerns that patients voice during their visits with doctors. The resource center's usual practice is to provide their visit preparation intervention, called Consultation Planning, through in-person counseling sessions. This study asks whether telephone delivery of Consultation Planning would be almost as effective in terms of increasing patient's decision self-efficacy, or confidence in their ability to navigate decisions effectively with their physicians. The study also asks about the cost-effectiveness of telephone delivery compared to in-person delivery. The investigators are answering these questions through a randomized, controlled, non-inferiority trial with two arms: in-person versus telephone delivery of Consultation Planning. The investigators are measuring self-reported psychological outcomes such as decision self-efficacy (primary outcome), preparation for decision making, anxiety, and distress, along with economic outcomes such as health resource utilization and willingness to pay. The investigators hypothesize that Tele-CP can be delivered at a lower patient and resource center cost than in-person CP, and that it will be as effective in terms of impact on a patient's decisional self-efficacy.

Conditions

Breast Cancer

Keywords

Telephones; Community-Based Participatory Research; Participation, Patient; Rural health services

Outcome Measures

Primary Outcomes (2)

• Decisional Self-Efficacy (DSE)

  -1 hour (1 hour prior to intervention)

• Decisional Self-Efficacy (DSE)

  5 min after intervention

Secondary Outcomes (17)

• CRCMC Client Intake Form

  Immediately upon consent

• STAI Form Y-1 (Anxiety)

  -1 hour (1 hour prior to intervention)

• Decisional Conflict Scale (DCS)

  -1 hour (1 hour prior to intervention)

• Critical Incident Survey

  5 min (5 minutes after intervention)

• Patient Intervention Costs

  5 min (5 minutes after intervention)

Study Arms (2)

In-person

ACTIVE COMPARATOR

Participants in this arm have been randomized to receive Consultation Planning in-person

Behavioral: In-person CP

Telephone

ACTIVE COMPARATOR

Participants in this arm have been randomized to receive Consultation Planning by telephone.

Behavioral: Tele-CP

Interventions

In-person CP BEHAVIORAL

CP is a structured interview in which a lay health worker prompts a patient to articulate questions and concerns about decision issues in preparation for a treatment discussion with a provider. The Consultation Planner (CPer) then completes and prints out a word-processed template, paraphrasing and summarizing the patient's questions and concerns. The patient takes away the printed Consultation Plan to serve as a visual aid and agenda during the meeting with the doctor. CPers are trained to avoid providing medical advice or information. Arrangements will be made for participants who do not have transportation to the CRCMC.

Also known as: SCOPED Model, Question listing

In-person

Tele-CP BEHAVIORAL

Participants in the Tele-CP arm will receive CP by telephone. Arrangements will be made for participants who do not have access to a telephone.

Also known as: SCOPED Model, Question listing

Telephone

Eligibility Criteria

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

You may qualify if:

• Females age 18 or older
• Diagnosis of Ductal Carcinoma in Situ (DCIS) or local recurrence of DCIS
• New (stage 1, 2, 3, 4) invasive breast cancer or recurrence
• Upcoming appointment to see a surgeon or oncologist to discuss treatment options
• Surgeons or oncologists whom the patient is consulting
• Able to speak, read, and understand English or Spanish

You may not qualify if:

• Females less than 18 years of age
• Males with breast cancer
• Females with breast cancer who are also pregnant (pregnancy changes the breast cancer treatment)
• Clients who are determined to have "diminished mental capacity" according to the standards of the CRCMC Policy on Mental Competence

Sponsors & Collaborators

• University of California, San Francisco: lead
• California Breast Cancer Research Program: collaborator

Study Sites (2)

Cancer Resource Centers of Mendocino County

Mendocino, California, 95460, United States

Location

Cancer Resource Centers of Mendocino County

Ukiah, California, 95482, United States

Location

Related Publications (1)

• Belkora J, Stupar L, O'Donnell S, Loucks A, Moore D, Jupiter C, Johnson N, Wilson L. Decision support by telephone: randomized controlled trial in a rural community setting. Patient Educ Couns. 2012 Oct;89(1):134-42. doi: 10.1016/j.pec.2012.06.009. Epub 2012 Jul 7.

  PMID: 22776761 RESULT

MeSH Terms

Conditions

Breast Neoplasms; Patient Participation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Jeff Belkora, Ph.D.

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Surgery and Health Policy Director, Decision Services

Study Record Dates

• First Submitted: September 28, 2010
• First Posted: October 8, 2010
• Study Start: October 1, 2007
• Primary Completion: December 1, 2010
• Study Completion: June 1, 2011
• Last Updated: October 18, 2012

Record last verified: 2012-10

Locations

US (2)