Involving Family to Improve Communication in Primary Care (SAMEPage)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02986958|
Recruitment Status : Completed
First Posted : December 8, 2016
Results First Posted : October 11, 2018
Last Update Posted : December 31, 2018
- Study Details
- Tabular View
- Study Results
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|Cognitive Impairment||Other: Pre-visit patient-family agenda-setting checklist Other: Usual care||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||93 participants|
|Intervention Model:||Parallel Assignment|
|Primary Purpose:||Health Services Research|
|Official Title:||Involving Family to Improve Primary Care Visits for Cognitively Impaired Patients|
|Actual Study Start Date :||August 2016|
|Actual Primary Completion Date :||August 2017|
|Actual Study Completion Date :||August 2017|
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
Other: Pre-visit patient-family agenda-setting checklist
Pre-visit patient-family agenda-setting checklist
Placebo Comparator: Usual Care
Care as usual with their primary care provider
Other: Usual care
routine primary care
- Ratio of Psychosocial and Socio-emotional Statements Relative to Biomedical Talk and Orientation Statements (Patient-Centered Communication) [ Time Frame: 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.
- Visit Duration [ Time Frame: During enrollment visit, up to 77 minutes ]Duration of primary care visit in minutes
- Patient Verbal Activity [ Time Frame: 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.
- Companion Verbal Activity [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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."
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||65 Years and older (Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02986958
|United States, Maryland|
|Johns Hopkins Community Physicians|
|Aberdeen, Maryland, United States, 21017|
|Medstar Center for Successful Aging|
|Baltimore, Maryland, United States, 21239|
|Johns Hopkins Community Physicians|
|Westminster, Maryland, United States, 21157|
|Principal Investigator:||Jennifer L Wolff, PhD||Johns Hopkins Bloomberg School of Public Health|
Documents provided by Johns Hopkins Bloomberg School of Public Health:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Johns Hopkins Bloomberg School of Public Health|
|Other Study ID Numbers:||
R21AG049967 ( U.S. NIH Grant/Contract )
|First Posted:||December 8, 2016 Key Record Dates|
|Results First Posted:||October 11, 2018|
|Last Update Posted:||December 31, 2018|
|Last Verified:||December 2018|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|