Trusted Messenger Intervention

NCT05167422 | Terminated DMC

• 1 other identifier: 02001055
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Vaccine Hesitancy

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Trusted Messenger

EXPERIMENTAL

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

Standard Care

NO INTERVENTION

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.

Interventions

Trusted Messenger BEHAVIORAL

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.

Trusted Messenger

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Ages 18 or older
• Any race or ethnicity
• English speaking
• 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.

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead

Study Sites (1)

New Hampshire Hospital

Concord, New Hampshire, 03301, United States

Location

MeSH Terms

Conditions

Vaccination Hesitancy

Condition Hierarchy (Ancestors)

Vaccination Refusal; Treatment Refusal; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD Chief Medical Officer

Model Details: Nested quasi-experimental

Study Record Dates

• First Submitted: October 5, 2021
• First Posted: December 22, 2021
• Study Start: September 14, 2021
• Primary Completion: July 14, 2023
• Study Completion: July 14, 2023
• Last Updated: July 17, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)