Involving Family to Improve Communication in Primary Care (SAMEPage)

• ClinicalTrials.gov Identifier: NCT02986958
• Recruitment Status: Completed
• First Posted: December 8, 2016
• Results First Posted: October 11, 2018
• Last Update Posted: December 31, 2018
• Sponsor: Johns Hopkins Bloomberg School of Public Health
• Collaborators: Johns Hopkins Community Physicians; Medstar Health Research Institute
• Information provided by (Responsible Party): Johns Hopkins Bloomberg School of Public Health

Tracking Information

• First Submitted Date: December 6, 2016
• First Posted Date: December 8, 2016
• Results First Submitted Date: August 8, 2018
• Results First Posted Date: October 11, 2018
• Last Update Posted Date: December 31, 2018
• Actual Study Start Date: August 2016
• Actual Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 12, 2018)

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.

Original Primary Outcome Measures (submitted: December 6, 2016)

Patient-centered communication [ Time Frame: Enrollment visit ]

Summary measure from coded audiotaped communication during primary care visits

Current Secondary Outcome Measures (submitted: November 14, 2018)

• 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."

Original Secondary Outcome Measures (submitted: December 6, 2016)

• Visit duration [ Time Frame: Enrollment visit ]
  Duration of primary care visit
• Patient and companion verbal activity [ Time Frame: Enrollment visit ]
  Proportion of primary care visit statements contributed by patient and companion (versus primary care provider)
• Subjective rating of visit communication [ Time Frame: Enrollment visit ]
  Patient, companion, primary care provider perspectives of visit communication and role of companion during visit
• Discussion of patient memory [ Time Frame: Enrollment visit ]
  Patient, companion, physician discussion of patient's memory and cognition (yes/no)

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Involving Family to Improve Communication in Primary Care
• Official Title: Involving Family to Improve Primary Care Visits for Cognitively Impaired Patients
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Investigator); Primary Purpose: Health Services Research
• Condition: Cognitive Impairment

Intervention

• Other: Pre-visit patient-family agenda-setting checklist
  Pre-visit patient-family agenda-setting checklist
• Other: Usual care
  routine primary care

Study Arms

• Experimental: 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
  Intervention: Other: Pre-visit patient-family agenda-setting checklist
• Placebo Comparator: Usual Care
  Care as usual with their primary care provider
  Intervention: Other: Usual care

Publications *

• Wolff JL, Roter DL, Barron J, Boyd CM, Leff B, Finucane TE, Gallo JJ, Rabins PV, Roth DL, Gitlin LN. A tool to strengthen the older patient-companion partnership in primary care: results from a pilot study. J Am Geriatr Soc. 2014 Feb;62(2):312-9. doi: 10.1111/jgs.12639. Epub 2014 Jan 13.
• Wolff JL, Guan Y, Boyd CM, Vick J, Amjad H, Roth DL, Gitlin LN, Roter DL. Examining the context and helpfulness of family companion contributions to older adults' primary care visits. Patient Educ Couns. 2017 Mar;100(3):487-494. doi: 10.1016/j.pec.2016.10.022. Epub 2016 Oct 25.
• Wolff JL, Roter DL, Boyd CM, Roth DL, Echavarria DM, Aufill J, Vick JB, Gitlin LN. Patient-Family Agenda Setting for Primary Care Patients with Cognitive Impairment: the SAME Page Trial. J Gen Intern Med. 2018 Sep;33(9):1478-1486. doi: 10.1007/s11606-018-4563-y. Epub 2018 Jul 18.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 13, 2018): 93
• Original Estimated Enrollment (submitted: December 6, 2016): 100
• Actual Study Completion Date: August 2017
• Actual Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 65 Years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02986958
• Other Study ID Numbers: R21AG049967( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Johns Hopkins Bloomberg School of Public Health
• Original Responsible Party: Same as current
• Current Study Sponsor: Johns Hopkins Bloomberg School of Public Health
• Original Study Sponsor: Same as current

Collaborators

• Johns Hopkins Community Physicians
• Medstar Health Research Institute

Investigators

• Principal Investigator: Jennifer L Wolff, PhD; Johns Hopkins Bloomberg School of Public Health

• PRS Account: Johns Hopkins Bloomberg School of Public Health
• Verification Date: December 2018