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Telephone-Based Decision Support for Rural Patients

NCT01217333 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2012-10-18

No results posted yet for this study

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

Interventions

BEHAVIORAL

In-person CP

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.

BEHAVIORAL

Tele-CP

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.

Sponsors & Collaborators

Principal Investigators

  • Jeff Belkora, Ph.D. · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2010-12-31
Completion
2011-06-30

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01217333 on ClinicalTrials.gov