Trusted Messenger Intervention

Preliminary Study of a Trusted Messenger Intervention to Promote Vaccine Uptake in Adult Inpatient Psychiatric Hospitals

The objective of this pilot study is to develop and evaluate test a trusted messenger intervention targeting vaccine hesitancy in patients on an inpatient psychiatric hospital setting with both acute and chronic patients.

Study Overview

• Status: Terminated
• Conditions: Vaccine Hesitancy
• Intervention / Treatment: Behavioral: Trusted Messenger

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Hampshire
    • Concord, New Hampshire, United States, 03301
      • New Hampshire Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Able and willing to give verbal informed consent to participate in the study or able to assent with guardian consent
• Expected to remain in the hospital for the duration of the study
• Mental health diagnosis Demographics
• Male, female, or transgender (no exclusion criteria based on gender or sexual orientation)
• Ages 18 or older
• Any race or ethnicity
• English speaking

Exclusion Criteria:

• Cognitive impairment sufficient to interfere with participant's ability to provide assent
• People who are non-English speakers or who have major visual or hearing impairment will be excluded given the need to converse with the Trusted Messenger verbally
• People who have received any of the available forms of the COVID-19 vaccine, or those with a medical exemption for receiving the vaccine.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Trusted Messenger; The trusted messenger patient intervention will involve training a small number of staff "trusted messengers" to engage patients informally and assist with building vaccine confidence in brief one- on-one sessions, supported by trusted messengers weekly consultations with a content expert who can answer specific vaccine related questions that patients have over a 3-week period. Trusted messengers will be full time unit employees, selected with the assistance of the nursing supervisor for having excellent rapport with patients (assessed with the Nurse Coordinator Questionnaire) and for having been vaccinated. Mental health workers or nurses may serve in this role. Both inpatient units involved in this study will be grouped into the same vaccination cohort within the hospital, to provide patients in the intervention and the wait list similar opportunities to be vaccinated.	Behavioral: Trusted Messenger; A nested waitlist design in which patients and staff are nested within two inpatient psychiatric units. New Hampshire Hospital staff will be trained to deliver the trusted messenger intervention up to 24 patients on the first unit while the second unit receives care as usual, during which time in-house vaccinations among patients on both units will be tracked in a registry. After a 3-week study period, up to 24 patients on the second unit will receive the trusted messenger intervention and followed for a period of 3 weeks. The trusted messenger intervention will consist of staff who are trained to engage patients informally and assist building social norms for vaccine uptake supported by weekly and as-needed check-ins with a content expert who can answer specific vaccine related questions over a 3 week period.
No Intervention: Standard Care; After a 3-week study period, up to 24 patients on the second unit will receive the trusted messenger intervention and followed for a period of 3 weeks. The trusted messenger intervention will consist of staff who are trained to engage patients informally and assist building social norms for vaccine uptake supported by weekly and as-needed check-ins with a content expert who can answer specific vaccine related questions over a 3 week period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vaccine acceptance- This will be measured using the COVID Vaccine Hesitancy Questionnaire	The participant is willing to receive the COVID-19 vaccine	Participant is willing to receive the vaccine by the end of week 6 of participation from baseline.

Collaborators and Investigators

• Sponsor: Dartmouth-Hitchcock Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2021
• Primary Completion (Actual): July 14, 2023
• Study Completion (Actual): July 14, 2023

Study Registration Dates

• First Submitted: October 5, 2021
• First Submitted That Met QC Criteria: December 9, 2021
• First Posted (Actual): December 22, 2021

Study Record Updates

• Last Update Posted (Actual): July 17, 2023
• Last Update Submitted That Met QC Criteria: July 14, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 02001055

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