Trusted Messenger Intervention

Vaccine Hesitancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05167422
• Other study ID #: 02001055
• Status: Terminated
• Phase: N/A
• Start date: September 14, 2021
• Est. completion date: July 14, 2023

Study information

• Verified date: July 2023
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: July 14, 2023
• Est. primary completion date: July 14, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Vaccine Hesitancy

Intervention

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.

Locations

Country	Name	City	State
United States	New Hampshire Hospital	Concord	New Hampshire

Sponsors (1)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.