Involving Family to Improve Communication in Primary Care
- Conditions
- Cognitive Impairment
- Interventions
- Other: Usual careOther: Pre-visit patient-family agenda-setting checklist
- Registration Number
- NCT02986958
- Lead Sponsor
- Johns Hopkins Bloomberg School of Public Health
- Brief 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)
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 93
- Older adults: 65 years or older, established patient of participating primary care provider, regularly attend medical visits with one or more family member or unpaid friend "companion(s)", agree to allow companion to be contacted and participate in the study, authorize disclosure of Protected Health Information (PHI) in their electronic health record, able to provide informed consent or have a legally authorized representative
- Companion: family member (spouse, adult child, parent, adult sibling) or unpaid friend who accompanies older adult participant to medical visits.
- Primary care provider: practicing physician, nurse practitioner or physician assistant at a participating primary care practice.
- Older adults: younger than 65 years, no evidence of cognitive impairment, do not attend medical visits with family member or unpaid friend.
- Companion: paid non-family member who accompanies patient to visits
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Usual Care Usual care Care as usual with their primary care provider Checklist Pre-visit patient-family agenda-setting checklist One-page paper-pencil agenda setting checklist involving two activities for older primary care patients and their family companion. The purpose of the checklist is to 1. clarify the role of the family companion during the visit, and 2. to discuss patient health issues to discuss with the primary care provider
- Primary Outcome Measures
Name Time Method Ratio of Psychosocial and Socio-emotional Statements Relative to Biomedical Talk and Orientation Statements (Patient-Centered Communication) During enrollment visit, up to 77 minutes Patient-centered communication is reflected as a ratio of psychosocial and socio-emotional statements relative to biomedical talk and orientation statements from coded audio-taped communication during primary care visits. Higher values indicate more patient-centered communication.
- Secondary Outcome Measures
Name Time Method Patient Verbal Activity During enrollment visit, up to 77 minutes Patient verbal activity is the proportion of visit statements contributed by the patient in relation to overall visit statements, including statements by the companion and primary care provider.
Visit Duration During enrollment visit, up to 77 minutes Duration of primary care visit in minutes
Companion Verbal Activity During enrollment visit, up to 77 minutes Companion verbal activity is the proportion of visit statements contributed by the companion in relation to overall visit statements, including statements by the patient and primary care provider.
Number of Participants for Whom There Was Any Discussion of the Patient's Memory and/or Cognition During the Primary Care Visit During enrollment visit, up to 77 minutes The number of participants for whom there was any discussion of the patient's memory and/or cognition during the audio-recorded primary care visit.
Number of Patients Who Agree or Strongly Agree With Being Satisfied With the Primary Care Visit During Enrollment visit, up to 77 minutes The number of patients who endorsed "Agree" or "Strongly Agree" to the statement: "Overall, I was satisfied with today's visit."
Number of Companions Who Agree or Strongly Agree With Being Satisfied With the Primary Care Visit During Enrollment visit, up to 77 minutes The number of companions who endorsed "Agree" or "Strongly Agree" to the statement: "Overall, I was satisfied with today's visit."
Number of Primary Care Providers Who Agree or Strongly Agree With Being Satisfied With the Primary Care Visit During Enrollment visit, up to 77 minutes The number of primary care providers who endorsed "Agree" or "Strongly Agree" to the statement: "Overall, I was satisfied with today's visit."
Trial Locations
- Locations (2)
Johns Hopkins Community Physicians
🇺🇸Westminster, Maryland, United States
Medstar Center for Successful Aging
🇺🇸Baltimore, Maryland, United States