Trial Outcomes & Findings for Communication Strategy to PROMOTE HPV Vaccination in Pharmacies: PROMOTE Study (NCT NCT04660331)
NCT ID: NCT04660331
Last Updated: 2024-10-09
Results Overview
The survey was developed by study researchers based upon the Implementation Outcomes Questionnaire (IOQ) (Livet M, et al. 2021.). It was used to capture change of participants' perceptions pre/post training. There are five answers to each survey question and each answer is given a score from 1 to 5, with 1 being strongly disagree and 5 being strongly agree. Higher numerical scores on the 5-point Likert scale indicate greater level of agreement that the intervention was acceptable to support HPV vaccination delivery to children ages 9-17. We calculated the average scale based on numeric scores. For questions that were asked in a reverse fashion, we reversed the score accordingly.
COMPLETED
NA
42 participants
Up to 6 months after baseline survey and communication training
2024-10-09
Participant Flow
Participant milestones
| Measure |
PROMOTE Key Informant Interviews: Parents/Guardians (Aim 1)
Participants in the key informant interview phase (Aim 1) whose goal was to adapt an existing electronic forecasting system and behavioral counseling framework to match barriers and facilitators to HPV vaccination in pharmacies, administered by the Principal Investigator. Participants are parents/guardians of children aged 9-17 in Western Washington.
Key informant interviews were conducted with the participants described above using semi-structured interview techniques and guided by theoretical domain framework.
Interviews were conducted by trained study staff members over the phone and lasted approximately 90 minutes. The interview included demographic survey questions.
|
PROMOTE Key Informant Interviews: Pharmacy Staff (Aim 1)
Participants in the key informant interview phase (Aim 1) whose goal was to adapt an existing electronic forecasting system and behavioral counseling framework to match barriers and facilitators to HPV vaccination in pharmacies, administered by the Principal Investigator. Participants are pharmacy staff in Western Washington.
Key informant interviews were conducted with the participants described above using semi-structured interview techniques and guided by theoretical domain framework.
Interviews were conducted by trained study staff members over the phone and lasted approximately 90 minutes. The interview included demographic survey questions.
|
PROMOTE Intervention (Aim 2)
Participants in the intervention group an adapted multi-modal communication strategy to support HPV vaccination in pharmacies administered by the Principal Investigator. Participants are pharmacy staff in Western Washington.
The intervention consists of a multi-modal strategy that includes adapting an existing electronic "forecasting" system to identify vaccine eligible children who are due for vaccination and communication training for pharmacy staff to effectively recommend HPV vaccination.
The intervention was delivered in one 60-minute session recorded and available online as a continuing education training that covered five modules: 1) educational overview of adolescent vaccination, 2) overview of the communication strategy, 3) process for integrating the strategy into clinical workflow, 4) training on communication strategy, and 5) pharmacy staff practice of the strategy.
|
|---|---|---|---|
|
PROMOTE Key Informant Interviews (Aim 1)
STARTED
|
13
|
11
|
0
|
|
PROMOTE Key Informant Interviews (Aim 1)
COMPLETED
|
13
|
11
|
0
|
|
PROMOTE Key Informant Interviews (Aim 1)
NOT COMPLETED
|
0
|
0
|
0
|
|
PROMOTE Intervention (Aim 2)
STARTED
|
0
|
0
|
18
|
|
PROMOTE Intervention (Aim 2)
COMPLETED
|
0
|
0
|
13
|
|
PROMOTE Intervention (Aim 2)
NOT COMPLETED
|
0
|
0
|
5
|
Reasons for withdrawal
| Measure |
PROMOTE Key Informant Interviews: Parents/Guardians (Aim 1)
Participants in the key informant interview phase (Aim 1) whose goal was to adapt an existing electronic forecasting system and behavioral counseling framework to match barriers and facilitators to HPV vaccination in pharmacies, administered by the Principal Investigator. Participants are parents/guardians of children aged 9-17 in Western Washington.
Key informant interviews were conducted with the participants described above using semi-structured interview techniques and guided by theoretical domain framework.
Interviews were conducted by trained study staff members over the phone and lasted approximately 90 minutes. The interview included demographic survey questions.
|
PROMOTE Key Informant Interviews: Pharmacy Staff (Aim 1)
Participants in the key informant interview phase (Aim 1) whose goal was to adapt an existing electronic forecasting system and behavioral counseling framework to match barriers and facilitators to HPV vaccination in pharmacies, administered by the Principal Investigator. Participants are pharmacy staff in Western Washington.
Key informant interviews were conducted with the participants described above using semi-structured interview techniques and guided by theoretical domain framework.
Interviews were conducted by trained study staff members over the phone and lasted approximately 90 minutes. The interview included demographic survey questions.
|
PROMOTE Intervention (Aim 2)
Participants in the intervention group an adapted multi-modal communication strategy to support HPV vaccination in pharmacies administered by the Principal Investigator. Participants are pharmacy staff in Western Washington.
The intervention consists of a multi-modal strategy that includes adapting an existing electronic "forecasting" system to identify vaccine eligible children who are due for vaccination and communication training for pharmacy staff to effectively recommend HPV vaccination.
The intervention was delivered in one 60-minute session recorded and available online as a continuing education training that covered five modules: 1) educational overview of adolescent vaccination, 2) overview of the communication strategy, 3) process for integrating the strategy into clinical workflow, 4) training on communication strategy, and 5) pharmacy staff practice of the strategy.
|
|---|---|---|---|
|
PROMOTE Intervention (Aim 2)
Lost to Follow-up
|
0
|
0
|
5
|
Baseline Characteristics
This measure was only assessed for participants identifying as pharmacists.
Baseline characteristics by cohort
| Measure |
PROMOTE Aim 1 Interviews: Pharmacy Staff
n=11 Participants
Participants in the key informant interview phase (Aim 1) whose goal was to adapt an existing electronic forecasting system and behavioral counseling framework to match barriers and facilitators to HPV vaccination in pharmacies, administered by the Principal Investigator. Participants are pharmacy staff and in Western Washington.
Key informant interviews were conducted with the participants described above using semi-structured interview techniques and guided by theoretical domain framework.
Interviews were conducted by trained study staff members over the phone and lasted approximately 90 minutes. The interview included demographic survey questions.
|
PROMOTE Aim 1 Interviews: Parents
n=13 Participants
Participants in the key informant interview phase (Aim 1) whose goal was to adapt an existing electronic forecasting system and behavioral counseling framework to match barriers and facilitators to HPV vaccination in pharmacies, administered by the Principal Investigator. Participants are parents/guardians of children aged 9-17 in Western Washington.
Key informant interviews were conducted with the participants described above using semi-structured interview techniques and guided by theoretical domain framework.
Interviews were conducted by trained study staff members over the phone and lasted approximately 90 minutes. The interview included demographic survey questions.
|
PROMOTE Aim 2 Intervention
n=18 Participants
Participants in the intervention group an adapted multi-modal communication strategy to support HPV vaccination in pharmacies administered by the Principal Investigator. Participants are pharmacy staff in Western Washington.
The intervention consists of a multi-modal strategy that includes adapting an existing electronic "forecasting" system to identify vaccine eligible children who are due for vaccination and communication training for pharmacy staff to effectively recommend HPV vaccination.
The intervention was delivered in one 60-minute session recorded and available online as a continuing education training that covered five modules: 1) educational overview of adolescent vaccination, 2) overview of the communication strategy, 3) process for integrating the strategy into clinical workflow, 4) training on communication strategy, and 5) pharmacy staff practice of the strategy.
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
31 years
STANDARD_DEVIATION 8.6 • n=11 Participants
|
44.5 years
STANDARD_DEVIATION 5.1 • n=13 Participants
|
44.17 years
STANDARD_DEVIATION 13.01 • n=18 Participants
|
39.89 years
STANDARD_DEVIATION 7.7 • n=42 Participants
|
|
Sex/Gender, Customized
Sex, Female
|
6 Participants
n=11 Participants
|
13 Participants
n=13 Participants
|
11 Participants
n=18 Participants
|
30 Participants
n=42 Participants
|
|
Sex/Gender, Customized
Sex, Male
|
5 Participants
n=11 Participants
|
0 Participants
n=13 Participants
|
6 Participants
n=18 Participants
|
11 Participants
n=42 Participants
|
|
Sex/Gender, Customized
Sex, Unknown
|
0 Participants
n=11 Participants
|
0 Participants
n=13 Participants
|
1 Participants
n=18 Participants
|
1 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=11 Participants
|
10 Participants
n=13 Participants
|
3 Participants
n=18 Participants
|
13 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=11 Participants
|
3 Participants
n=13 Participants
|
15 Participants
n=18 Participants
|
29 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=11 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=11 Participants
|
0 Participants
n=13 Participants
|
1 Participants
n=18 Participants
|
1 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=11 Participants
|
1 Participants
n=13 Participants
|
4 Participants
n=18 Participants
|
11 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=11 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=11 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=11 Participants
|
9 Participants
n=13 Participants
|
13 Participants
n=18 Participants
|
27 Participants
n=42 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=11 Participants
|
3 Participants
n=13 Participants
|
0 Participants
n=18 Participants
|
3 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=11 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=42 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=11 Participants
|
13 participants
n=13 Participants
|
18 participants
n=18 Participants
|
42 participants
n=42 Participants
|
|
Role
Pharmacist
|
0 Participants
n=11 Participants
|
0 Participants
n=13 Participants
|
10 Participants
n=18 Participants
|
10 Participants
n=42 Participants
|
|
Role
Pharmacy technician
|
4 Participants
n=11 Participants
|
0 Participants
n=13 Participants
|
5 Participants
n=18 Participants
|
9 Participants
n=42 Participants
|
|
Role
Pharmacy assistant
|
0 Participants
n=11 Participants
|
0 Participants
n=13 Participants
|
2 Participants
n=18 Participants
|
2 Participants
n=42 Participants
|
|
Role
pharmacy director
|
0 Participants
n=11 Participants
|
0 Participants
n=13 Participants
|
1 Participants
n=18 Participants
|
1 Participants
n=42 Participants
|
|
Role
pharmacist-in-charge
|
3 Participants
n=11 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=18 Participants
|
3 Participants
n=42 Participants
|
|
Role
Staff pharmacist
|
4 Participants
n=11 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=18 Participants
|
4 Participants
n=42 Participants
|
|
Role
Parents
|
0 Participants
n=11 Participants
|
13 Participants
n=13 Participants
|
0 Participants
n=18 Participants
|
13 Participants
n=42 Participants
|
|
Years in practice (pharmacist only)
|
7.4 years
STANDARD_DEVIATION 7 • n=7 Participants • This measure was only assessed for participants identifying as pharmacists.
|
—
|
19.22 years
STANDARD_DEVIATION 17.13 • n=18 Participants • This measure was only assessed for participants identifying as pharmacists.
|
13.31 years
STANDARD_DEVIATION 8.36 • n=25 Participants • This measure was only assessed for participants identifying as pharmacists.
|
|
Years working in pharmacy (other personnel)
|
—
|
—
|
11.88 years
STANDARD_DEVIATION 6.83 • n=18 Participants • This measure of was only assessed for Aim 2 participants.
|
11.88 years
STANDARD_DEVIATION 6.83 • n=18 Participants • This measure of was only assessed for Aim 2 participants.
|
PRIMARY outcome
Timeframe: Up to 6 months after baseline survey and communication trainingPopulation: This outcome measure was only assessed for Aim 2 participants. Only Aim 2 participants who completed all required Aim 2 protocol activities were assessed for this measure.
The survey was developed by study researchers based upon the Implementation Outcomes Questionnaire (IOQ) (Livet M, et al. 2021.). It was used to capture change of participants' perceptions pre/post training. There are five answers to each survey question and each answer is given a score from 1 to 5, with 1 being strongly disagree and 5 being strongly agree. Higher numerical scores on the 5-point Likert scale indicate greater level of agreement that the intervention was acceptable to support HPV vaccination delivery to children ages 9-17. We calculated the average scale based on numeric scores. For questions that were asked in a reverse fashion, we reversed the score accordingly.
Outcome measures
| Measure |
PROMOTE Intervention (Aim 2)
n=13 Participants
Participants in the intervention group an adapted multi-modal communication strategy to support HPV vaccination in pharmacies administered by the Principal Investigator. Participants are pharmacy staff in Western Washington.
The intervention consists of a multi-modal strategy that includes adapting an existing electronic "forecasting" system to identify vaccine eligible children who are due for vaccination and communication training for pharmacy staff to effectively recommend HPV vaccination.
The intervention was delivered in one 60-minute session recorded and available online as a continuing education training that covered five modules: 1) educational overview of adolescent vaccination, 2) overview of the communication strategy, 3) process for integrating the strategy into clinical workflow, 4) training on communication strategy, and 5) pharmacy staff practice of the strategy.
|
|---|---|
|
Acceptability of Providing HPV Vaccination to Children and of the Proposed Communication Strategy to Support HPV Vaccination
|
4.1 units on a scale
Standard Deviation 0.664
|
PRIMARY outcome
Timeframe: Up to 6 months after baseline survey and communication trainingPopulation: This outcome measure was only assessed for Aim 2 participants. Only Aim 2 participants who completed all required Aim 2 protocol activities were assessed for this measure.
The survey was developed by study researchers based upon the Implementation Outcomes Questionnaire (IOQ) (Livet M, et al. 2021.). It was used to capture change of participants' perceptions pre/post training. There are five answers to each survey question and each answer is given a score from 1 to 5, with 1 being strongly disagree and 5 being strongly agree. Higher numerical scores on the 5-point scale indicate greater level of agreement that the intervention was appropriate to support HPV vaccination delivery to children ages 9-17. We calculated the average scale based on numeric scores. For questions that were asked in a reverse fashion, we reversed the score accordingly.
Outcome measures
| Measure |
PROMOTE Intervention (Aim 2)
n=13 Participants
Participants in the intervention group an adapted multi-modal communication strategy to support HPV vaccination in pharmacies administered by the Principal Investigator. Participants are pharmacy staff in Western Washington.
The intervention consists of a multi-modal strategy that includes adapting an existing electronic "forecasting" system to identify vaccine eligible children who are due for vaccination and communication training for pharmacy staff to effectively recommend HPV vaccination.
The intervention was delivered in one 60-minute session recorded and available online as a continuing education training that covered five modules: 1) educational overview of adolescent vaccination, 2) overview of the communication strategy, 3) process for integrating the strategy into clinical workflow, 4) training on communication strategy, and 5) pharmacy staff practice of the strategy.
|
|---|---|
|
Appropriateness of Providing HPV Vaccination to Children and of the Proposed Communication Strategy to Support HPV Vaccination
|
4.0 units on a scale
Standard Deviation 0.502
|
PRIMARY outcome
Timeframe: Up to 6 months after baseline survey and communication trainingThe survey was developed by study researchers based upon the Implementation Outcomes Questionnaire (IOQ) (Livet M, et al. 2021.). It was used to capture change of participants' perceptions pre/post training. There are five answers to each survey question and each answer is given a score from 1 to 5, with 1 being strongly disagree and 5 being strongly agree. Higher numerical scores on the 5-point scale indicate greater level of agreement that the intervention was feasible to support HPV vaccination delivery to children ages 9-17. We calculated the average scale based on numeric scores. For questions that were asked in a reverse fashion, we reversed the score accordingly.
Outcome measures
| Measure |
PROMOTE Intervention (Aim 2)
n=13 Participants
Participants in the intervention group an adapted multi-modal communication strategy to support HPV vaccination in pharmacies administered by the Principal Investigator. Participants are pharmacy staff in Western Washington.
The intervention consists of a multi-modal strategy that includes adapting an existing electronic "forecasting" system to identify vaccine eligible children who are due for vaccination and communication training for pharmacy staff to effectively recommend HPV vaccination.
The intervention was delivered in one 60-minute session recorded and available online as a continuing education training that covered five modules: 1) educational overview of adolescent vaccination, 2) overview of the communication strategy, 3) process for integrating the strategy into clinical workflow, 4) training on communication strategy, and 5) pharmacy staff practice of the strategy.
|
|---|---|
|
Feasibility of Providing HPV Vaccination to Children and of the Proposed Communication Strategy to Support HPV Vaccination
|
4.1 units on a scale
Standard Deviation 0.529
|
PRIMARY outcome
Timeframe: Baseline (pre-intervention) and up to 6 months following receipt of one 60-minute training session (post-intervention)Population: This outcome measure was only assessed for Aim 2 participants. Only Aim 2 participants who completed all required Aim 2 protocol activities were assessed for this measure.
The survey was developed by study researchers and included validated measures from a 31-item medication therapy management (MTM) efficacy scale (Martin B, et al. 2010) and a statewide survey of healthcare providers (McRee AL, et.al. 2014). It was used to capture change of participants' perceptions pre/post training. For this outcome there were five answers to each survey question reflecting how confident the respondent is in performing tasks related to providing HPV vaccinations to children, and each answer is given a score from 1 to 5, with 1 being not at all confident/strongly disagree and 5 being completely confident/strongly agree. Higher numerical scores on the 5-point scale reflect higher levels of self-efficacy or confidence in personal ability to complete vaccination process actions. We calculated the average scale based on numeric scores.
Outcome measures
| Measure |
PROMOTE Intervention (Aim 2)
n=13 Participants
Participants in the intervention group an adapted multi-modal communication strategy to support HPV vaccination in pharmacies administered by the Principal Investigator. Participants are pharmacy staff in Western Washington.
The intervention consists of a multi-modal strategy that includes adapting an existing electronic "forecasting" system to identify vaccine eligible children who are due for vaccination and communication training for pharmacy staff to effectively recommend HPV vaccination.
The intervention was delivered in one 60-minute session recorded and available online as a continuing education training that covered five modules: 1) educational overview of adolescent vaccination, 2) overview of the communication strategy, 3) process for integrating the strategy into clinical workflow, 4) training on communication strategy, and 5) pharmacy staff practice of the strategy.
|
|---|---|
|
Self-efficacy of Providing HPV Vaccination
vaccine administration tasks (pre)
|
4.2 units on a scale
Standard Deviation 0.893
|
|
Self-efficacy of Providing HPV Vaccination
vaccine administration tasks (post)
|
4.3 units on a scale
Standard Deviation 0.798
|
|
Self-efficacy of Providing HPV Vaccination
personal interactions (pre)
|
2.8 units on a scale
Standard Deviation 0.830
|
|
Self-efficacy of Providing HPV Vaccination
personal interactions (post)
|
3.4 units on a scale
Standard Deviation 0.919
|
|
Self-efficacy of Providing HPV Vaccination
goal setting (pre)
|
2.7 units on a scale
Standard Deviation 0.983
|
|
Self-efficacy of Providing HPV Vaccination
goal setting (post)
|
3.5 units on a scale
Standard Deviation 1.107
|
|
Self-efficacy of Providing HPV Vaccination
HPV vaccine hesitancy (pre)
|
2.6 units on a scale
Standard Deviation 0.941
|
|
Self-efficacy of Providing HPV Vaccination
HPV vaccine hesitancy (post)
|
3.3 units on a scale
Standard Deviation 1.045
|
PRIMARY outcome
Timeframe: Baseline (pre-intervention) and up to 6 months following receipt of one 60-minute training session (post-intervention)Population: vaccine administration data for pharmacists who were participating in the study, pre and post-intervention. This outcome measure was only assessed for Aim 2 participants. Only Aim 2 participants who completed all required Aim 2 protocol activities were assessed for this measure.
Will conduct audits of the pharmacy electronic records to assess adoption of HPV vaccination, measured as the total sum (count) of HPV vaccinations administered by all eligible Aim 2 pharmacists.
Outcome measures
| Measure |
PROMOTE Intervention (Aim 2)
n=13 Participants
Participants in the intervention group an adapted multi-modal communication strategy to support HPV vaccination in pharmacies administered by the Principal Investigator. Participants are pharmacy staff in Western Washington.
The intervention consists of a multi-modal strategy that includes adapting an existing electronic "forecasting" system to identify vaccine eligible children who are due for vaccination and communication training for pharmacy staff to effectively recommend HPV vaccination.
The intervention was delivered in one 60-minute session recorded and available online as a continuing education training that covered five modules: 1) educational overview of adolescent vaccination, 2) overview of the communication strategy, 3) process for integrating the strategy into clinical workflow, 4) training on communication strategy, and 5) pharmacy staff practice of the strategy.
|
|---|---|
|
Adoption of HPV Vaccination
pre-intervention
|
2 sum of vaccine doses administered
|
|
Adoption of HPV Vaccination
post-intervention
|
20 sum of vaccine doses administered
|
PRIMARY outcome
Timeframe: Baseline (pre-intervention) and up to 6 months following receipt of one 60-minute training session (post-intervention)Population: vaccines administered by pharmacists participating in the study, pre- and post-intervention. This outcome measure was only assessed for Aim 2 participants. Only Aim 2 participants who completed all required Aim 2 protocol activities were assessed for this measure.
Will conduct audits of the pharmacy electronic records to assess adoption of other adolescent vaccination, measured as the total sum (count) of adolescent vaccinations administered by all eligible Aim 2 pharmacists.
Outcome measures
| Measure |
PROMOTE Intervention (Aim 2)
n=13 Participants
Participants in the intervention group an adapted multi-modal communication strategy to support HPV vaccination in pharmacies administered by the Principal Investigator. Participants are pharmacy staff in Western Washington.
The intervention consists of a multi-modal strategy that includes adapting an existing electronic "forecasting" system to identify vaccine eligible children who are due for vaccination and communication training for pharmacy staff to effectively recommend HPV vaccination.
The intervention was delivered in one 60-minute session recorded and available online as a continuing education training that covered five modules: 1) educational overview of adolescent vaccination, 2) overview of the communication strategy, 3) process for integrating the strategy into clinical workflow, 4) training on communication strategy, and 5) pharmacy staff practice of the strategy.
|
|---|---|
|
Adoption of Other Adolescent Vaccines
pre-intervention
|
75 sum of vaccine doses administered
|
|
Adoption of Other Adolescent Vaccines
post-intervention
|
145 sum of vaccine doses administered
|
Adverse Events
PROMOTE Intervention
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place