Involving Family to Improve Communication in Primary Care

Status Completed

Clinical Trial Summary

This study evaluates an agenda-setting checklist for patients with cognitive impairment and their family companions that is completed in the waiting room in advance of a primary care visit. The study team will conduct a two-group randomized trial to examine feasibility of the protocol and to compare medical communication (from visit audiotapes) during visits of patient-companion dyads who complete the checklist (n=50) with patient-companion dyads who receive usual care (n=50)

Clinical Trial Description

The study team has established proof of concept for a paper-pencil checklist to be used by older patients and their companions in the waiting room prior to medical visits. The checklist is designed to elicit and align patient and companion perspectives regarding patient health issues to discuss with the doctor, and to stimulate discussion about the companion's role in the visit. The premise for the checklist is that companions are typically motivated to support patients during medical visits, but that they often lack knowledge of the patient's health concerns and preferences for communication assistance.

The study team will conduct a two group pilot randomized trial of up to 100 (50 per group) patients ages 65+ with cognitive impairment and their unpaid companion to test the effects of the refined checklist for medical communication. Each patient-companion dyad will be randomized to the intervention (to receive the checklist) or to a control protocol. The study will evaluate the feasibility of delivering the study protocol to patients with cognitive impairment and their companions in primary care, and to generate preliminary evidence regarding the effect of the checklist on medical communication. For these reasons, the control group protocol will comprise usual care which is in this case existing clinical practice. Patients (when feasible), companions, and doctors in both intervention and control groups will complete in-person post-visit surveys immediately after the visit. Patients (when feasible) and companions will separately complete follow-up surveys by telephone two weeks after the doctor visit conducted by a research staff member. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02986958
Study type	Interventional
Source	Johns Hopkins Bloomberg School of Public Health
Contact
Status	Completed
Phase	N/A
Start date	August 2016
Completion date	August 2017

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Involving Family to Improve Communication in Primary Care — SAMEPage

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms