Involving Family to Improve Communication in Primary Care — SAMEPage  

Cognitive Impairment Clinical Trial

Official title: Involving Family to Improve Primary Care Visits for Cognitively Impaired Patients

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. ;

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment

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