Increasing Social Connection Through Crisis Caring Contacts: A Pragmatic Trial

The main purpose is to learn if sending messages from the VA (called "Caring Contacts") reduces loneliness and improves mental health. The investigators want to understand if these messages are effective in Veterans aged 60 and above who have missed appointments at the VA even though they have health problems. Participants will receive up to 10 postcards mailed in envelopes from a fellow Veteran (Peer Specialist) from their local VA, and will be asked to fill out four surveys. The investigators are recruiting 920 Veterans aged 50 years and older who have felt isolated and have missed appointments at the VA to join this study.

Study Overview

• Status: Recruiting
• Conditions: Loneliness
• Intervention / Treatment: Behavioral: Crisis Caring Contacts post cards; Behavioral: Control post cards

Detailed Description

Lack of social connection is a common and powerful predictor of suicidal ideation, suicide attempts, functional decline, and death, even after adjustment for sociodemographic and clinical variables. Loneliness, specifically, is associated with a 26% increased likelihood of all-cause mortality. The urgency of addressing these problems is only amplified by the COVID-19 pandemic, which for some time may further increase loneliness, suicide, and other causes of mortality. Due to their risk for loneliness and negative health outcomes, a group of particular concern is older adults and patients with medical or psychiatric comorbidity who have poor treatment engagement.

Caring Contacts is an intervention that can address loneliness and treatment disengagement. It involves periodically sending brief messages to at-risk individuals with nondemanding expressions of care and concern. It is one of just two non-pharmacologic interventions to have evidence in randomized controlled trials (RCTs) for reducing rates of suicide. However, Caring Contacts has only been evaluated in a relatively narrowly indicated population of patients with acute psychiatric issues.

Major gaps in the understanding of Caring Contacts include whether it reduces loneliness, whether it can diminish causes of mortality besides suicide, and whether it is effective older Veterans and patients with treatment disengagement. The overarching objective of this project is to evaluate "Crisis Caring Contacts" (CCC), an adaptation of Caring Contacts tailored to Veterans at risk for lack of social connection and lapses in treatment amidst the COVID-19 pandemic and its aftermath.

Primary aims for this study are: 1) Among older Veterans with poor treatment engagement, evaluate the effectiveness of Crisis Caring Contacts in decreasing loneliness, compared to enhanced usual care; 2) Evaluate the effect of Crisis Caring Contacts on other important outcomes, including treatment engagement and suicidal ideation; 3) Explore potential moderators of treatment response to Crisis Caring Contacts; and 4) Explore the effect of Crisis Caring Contacts on all-cause mortality, suicide attempts, and drug overdoses.

Impact: This project will advance scientific understanding of key gaps related to the mechanisms and outcomes of Caring Contacts, while also evaluating a timely, pragmatic, low-cost, and scalable intervention for Veterans affected by lack of social connection and treatment engagement.

• Study Type: Interventional
• Enrollment (Estimated): 920
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aaron A Call; Phone Number: (503) 220-8262; Email: Aaron.Call@va.gov
• Study Contact Backup: Name: Alan R Teo, MD MS; Phone Number: 52461 (503) 220-8262; Email: Alan.Teo@va.gov

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48105-2303
      • Recruiting
      • VA Ann Arbor Healthcare System, Ann Arbor, MI
      • Contact: Paul N Pfeiffer, MD MS; Phone Number: 734-769-1000; Email: Paul.Pfeiffer@va.gov
      • Sub-Investigator: Paul N Pfeiffer, MD MS
  • Oregon
    • Portland, Oregon, United States, 97207-2964
      • Recruiting
      • VA Portland Health Care System, Portland, OR
      • Contact: Alan R Teo, MD MS; Phone Number: 52461 (503) 220-8262; Email: Alan.Teo@va.gov
      • Contact: Aaron A Call; Phone Number: 503-220-8262; Email: Aaron.Call@va.gov
      • Principal Investigator: Alan R. Teo, MD MS
  • Washington
    • Seattle, Washington, United States, 98108-1532
      • Recruiting
      • VA Puget Sound Health Care System Seattle Division, Seattle, WA
      • Contact: Mark Reger, PhD; Phone Number: 253-583-3295; Email: Mark.Reger@va.gov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• age 50 years and above
• have at least four VA appointments in the prior 6-18 months in primary care or mental health
• have at least two comorbidities contained in the Elixhauser Index
• a) zero completed appointments in the past 6 months and zero appointments scheduled, or b) in the 90th percentile or higher in terms of no-shows or appointments canceled by patient in the prior 12 months

Exclusion Criteria:

• no valid mailing address
• no valid phone number
• inclusion in an existing Caring Contacts program
• diagnosis of neurocognitive disorder or other significant cognitive impairment indicative of inadequate decision-making capacity

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; Participants in the treatment arm will receive the intervention post cards	Behavioral: Crisis Caring Contacts post cards; A series of post cards with Crisis Caring Contacts content sent over 10 months
Sham Comparator: Control; Participants in the control arm will receive the control post cards	Behavioral: Control post cards; A series of post cards intended to control for attention received but not including elements thought to be "active ingredients" in the intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
UCLA Loneliness Scale, Version 3	This scale has a score range from 20 -80, with higher scores representing greater degrees of loneliness.	12-month follow-up
Count of mental health or primary care visits over 12 months	Treatment engagement will be assessed by counting VA outpatient visits to mental health or primary care during the 12 months after randomization. Visits will be required to be linked to a chronic psychiatric or medical diagnosis, and occur at one of the study sites to count. More visits will represent greater treatment engagement.	The 12-month period from the date of randomization to 12-month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PROMIS Short Form v2.0 ? Emotional Support 4a	This scale has a range from 4 - 20, with higher scores representing greater perceived emotional support.	12-month follow-up
Trust in Public Healthcare System, Institutional Trust Subscale (adapted for VA)	Adapted to assess trust in the VA specifically, this scale has a score range from 3 - 15, with higher scores representing more trust.	12-month follow-up
Depressive Symptom Index Suicidality Subscale (DSI-SS)	This scale has a score range from 0 - 12, with higher scores representing greater degrees of suicidality.	12-month follow-up
Suicide Ideation Scale (SIS)	This scale has a score range from 10 - 50, with higher scores representing greater degrees of suicidality.	12-month follow-up

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Alan R. Teo, MD MS, VA Portland Health Care System, Portland, OR

Publications and helpful links

General Publications

• Das A, Padala KP, Crawford CG, Teo A, Mendez DM, Phillips OA, Wright BC, House S, Padala PR. A systematic review of loneliness and social isolation scales used in epidemics and pandemics. Psychiatry Res. 2021 Dec;306:114217. doi: 10.1016/j.psychres.2021.114217. Epub 2021 Oct 8.

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2023
• Primary Completion (Estimated): September 30, 2025
• Study Completion (Estimated): September 30, 2025

Study Registration Dates

• First Submitted: July 12, 2022
• First Submitted That Met QC Criteria: July 29, 2022
• First Posted (Actual): August 2, 2022

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 25, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: SDR 21-087; 1I01HX003428-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No