Involving Family to Improve Communication in Primary Care

NCT02986958 | Completed Results

• 1 other identifier: R21AG049967
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 3

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)

Conditions

Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

• Ratio of Psychosocial and Socio-emotional Statements Relative to Biomedical Talk and Orientation Statements (Patient-Centered Communication)

  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.

  During enrollment visit, up to 77 minutes

Secondary Outcomes (7)

• Visit Duration

  During enrollment visit, up to 77 minutes

• Patient Verbal Activity

  During enrollment visit, up to 77 minutes

• Companion Verbal Activity

  During enrollment visit, up to 77 minutes

• 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

• Number of Patients Who Agree or Strongly Agree With Being Satisfied With the Primary Care Visit

  During Enrollment visit, up to 77 minutes

Study Arms (2)

Checklist

EXPERIMENTAL

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

Usual Care

PLACEBO COMPARATOR

Care as usual with their primary care provider

Other: Usual care

Interventions

Pre-visit patient-family agenda-setting checklist OTHER

Pre-visit patient-family agenda-setting checklist

Checklist

Usual care OTHER

routine primary care

Usual Care

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• Johns Hopkins Community Physicians: collaborator
• Medstar Health Research Institute: collaborator

Study Sites (3)

Johns Hopkins Community Physicians

Aberdeen, Maryland, 21017, United States

Location

Medstar Center for Successful Aging

Baltimore, Maryland, 21239, United States

Location

Johns Hopkins Community Physicians

Westminster, Maryland, 21157, United States

Location

Related Publications (3)

• 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.

  PMID: 24417565 BACKGROUND

• 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.

  PMID: 27817986 BACKGROUND

• 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.

  PMID: 30022409 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Research Program Manager
• Organization: Johns Hopkins Bloomberg School of Public Health

dechava1@jhu.edu

410-614-7910

Study Officials

• Jennifer L Wolff, PhD

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2016
• First Posted: December 8, 2016
• Study Start: August 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: December 31, 2018
• Results First Posted: October 11, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)