Trusted Messenger Intervention

Sponsor

Dartmouth-Hitchcock Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT05167422

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Vaccine Hesitancy	Behavioral: Trusted Messenger	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Intervention Model Description:

Nested quasi-experimentalNested quasi-experimental

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

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

Actual Study Start Date :

Sep 14, 2021

Anticipated Primary Completion Date :

Mar 15, 2022

Anticipated Study Completion Date :

Mar 15, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	New Hampshire Hospital	Concord	New Hampshire	United States	03301

Sponsors and Collaborators

Dartmouth-Hitchcock Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jeffrey C. Fetter, MD Chief Medical Officer, Dartmouth-Hitchcock Medical Center

ClinicalTrials.gov Identifier:

NCT05167422

Other Study ID Numbers:

02001055

First Posted:

Dec 22, 2021

Last Update Posted:

Dec 22, 2021

Last Verified:

Dec 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Dec 22, 2021