Clinical Trials Directory

Trials / Completed

CompletedNCT02522286

Creating a Zone of Openness to Increase Patient-Centered Care

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
300 (actual)
Sponsor
Palo Alto Medical Foundation · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

Summary

This study implements a simple evidence-based patient activation intervention - "Ask 3 Questions"- augmented by a novel theory-based intervention - "Open Communication" - aimed at activating patients and healthcare providers. The goal of this project is to increase patient and physician's preparedness for more having more questions, expressing differing opinions, and working collaboratively in making medical decisions that are both informed and responsive to patients' needs and preferences.

Detailed description

Conduct a pilot randomized controlled trial (RCT) to compare two interventions, "Ask 3 Questions," "Open Communication," a combination of both "Ask 3 Questions" and "Open Communication," to a usual care control condition. These data will inform a potential future large scale evaluation of the interventions in clinical practice. Consistent with a patient-centered approach, outcome measures are selected in collaboration with a group of patient stakeholders and will include measures of patient satisfaction. The study aims to collect 75 post-visit surveys and 10 appointment audio-recordings from patients at each of 4 participating sites (a total of 300 post-visit surveys and 40 audio-recordings).

Conditions

Interventions

TypeNameDescription
BEHAVIORALAsk 3 QuestionsParticipants were asked to bring an "Ask 3" questions flyer into their appointment to use if they needed to make a choice about their health care during their appointment. These 3 questions have been shown to help patients make more informed decisions about their healthcare.
BEHAVIORALOpen CommunicationOpen Communication includes a combination of interventions. 1) Participants used a Visit Companion Booklet to write out issues they would like to discuss with their physician during their appointment before showing up. They were also asked to write out any next steps decided on during their appointment and to repeat back to their doctor what they wrote before leaving. 2\) Patients watched a short, informational cartoon video to better understand the Visit Companion Booklet. 3\) Participating physicians received a training through the use of a Standardized Patient Instructor as a means of providing convenient, individualized training on communication techniques. Dyads (physicians and their medical assistants) were trained on how to incorporate the Visit Companion Booklet into workflow.

Timeline

Start date
2014-06-01
Primary completion
2015-04-01
Completion
2015-05-01
First posted
2015-08-13
Last updated
2018-07-20
Results posted
2018-07-20

Source: ClinicalTrials.gov record NCT02522286. Inclusion in this directory is not an endorsement.