Preventive Health Services (PREV HEALTH SERV)
Conditions
Keywords
Communication, Immunization
Brief summary
The overall goal of this project is to determine whether a novel and innovative provider communication strategy is effective in improving vaccine acceptance among vaccine-hesitant parents (VHPs) and visit experience among VHPs and their health care providers.
Detailed description
The primary goal of this covariate constrained, cluster randomized controlled trial is to evaluate the effectiveness of an innovative provider communication strategy (PIVOT-MI) intervention in improving provider-parent vaccine discussions and increasing vaccine acceptance. Providers at intervention clinics will be trained to use the PIVOT-MI strategy in which a presumptive format is used to initiate the childhood vaccine recommendation with all parents, followed by use of motivational interviewing (MI) with parents who voice resistance to that recommendation. Providers at control clinics will deliver care as usual. Specific aims are to evaluate the impact of PIVOT-MI, relative to control, on (1) child's immunization status; (2) parent-rated visit experience with their child's provider; and (3) change in provider experience of the vaccine discussion with vaccine-hesitant parents.
Interventions
Providers in participating intervention clinics will be trained in the PIVOT-MI strategy in which a presumptive format is used to initiate the childhood vaccine recommendation with all parents followed by use of motivational interviewing (MI) with parents who voice resistance to that recommendation. Parent participants will receive PIVOT-MI.
Providers at participating control clinics will deliver care as usual. Parent participants will receive standard care.
Sponsors
Study design
Masking description
Data Analysis study team members and parent participants will be masked to study assignment.
Eligibility
Inclusion criteria
* Parents: must be English or Spanish speaking, ≥18 years old, have an infant ≤18 months old, have legal guardianship of the infant, and is receiving pediatric care at an enrolled clinic * Providers: All providers at participating study practices will be eligible to participate.
Exclusion criteria
* Parents: not English or Spanish speaking, under 18 years old, have an infant older than 18 months, not the legal guardian of the infant, and/or having a child who is not receiving pediatric care at an enrolled clinic. * Providers: Providers who are not at participating study practices.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Child Immunization Status at 19 Months, 0 Days of Age Characterized as Percent Days Under-immunized (DUI) | Child's immunization status at 19 months of age | Immunization status was obtained from WA or CO state immunization registry or directly from participating practices. At enrollment, parent/infant dyads completed the Parental Attitudes about Childhood Vaccines short version (PACV-SF), a validated survey scored from 0 to 4. A score of 2 or more represented parent/infant dyad with negative vaccine attitudes. Among parent/infant dyads with negative vaccine attitudes, the child's immunization status at 19 months was calculated based on recommended ages and intervals between doses provided by ACIP for summing late days for each dose of the 8 routine vaccines recommended by 19 months (HepB, rotavirus, DTaP, Hib, pneumococcal conjugate, inactivated polio virus, MMR, and varicella). There was a max of 23 recommended doses for the 8 vaccines - doses varied depending on brand. Total max DUI was a sum of total possible days late for each dose through 19mo(2830 days).Percent DUI was calculated by dividing child's DUI by the total maximum DUI. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-Visit Parental Satisfaction Survey Scored on a 7-point Likert Scale | approximately 6 months post birth | To assess parental satisfaction with their clinician during a health supervision visit, we asked all vaccine hesitant parents (identified by a Parental Attitudes about Childhood Vaccines-Short Form (PAC-V SF) score of 2 or more) in both both intervention and control arms if they would complete an additional 15-question survey over the phone within 24-48 hours after the completion of a health supervision visit for their child around 6 months of age. Due to COVID-19 restrictions, we had to extend the time frame to within 1 week after a health supervision visit at 2, 4, or 6 months of age. Ratings were on a 7-point Likert scale - Very Poor (1), Poor (2), Fair (3), Good (4), Very Good (5), Excellent (6), Outstanding (7). Overall experience with a rating of Good (4) or higher was considered to be a satisfactory visit. |
| Change in Clinician Self-Efficacy With Parent/Infant Dyads With Negative Vaccine Attitudes - Pre-vs Post-Surveys | At Baseline and Post-Intervention (up to 2 years after baseline) | To assess changes in clinicians' perceived self-efficacy when discussing vaccines with parents/infant dyads with negative vaccine attitudes, a survey was administered to all participating clinicians at baseline and at study completion asking about vaccine recommendation behaviors and how they perceived their impact on parental decision making regarding vaccines. Self-efficacy was assessed with a 3-part question scored on a Likert Scale - Strongly Disagree, Somewhat Disagree, Somewhat Agree, Strongly Agree. Changes in perceived self-efficacy over time was assessed by comparing the number of clinicians who answered Strongly Agree or Somewhat Agree to the statement When parents wish to delay or refuse childhood vaccines for their child, there is not much I can say to change their minds at baseline and at post-study. Note that fewer clinicians completed the post-study survey due to such factors as retirement and staff turnover. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PIVOT With MI Clinics in which the Presumptively Initiating Vaccines and Optimizing Talk with Motivational Interviewing (PIVOT-MI) communication strategy has been implemented. | 9,905 |
| Control Care delivered as usual. | 7,541 |
| Total | 17,446 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 74 | 32 |
| Overall Study | Staff turnover at enrolled clinics | 32 | 23 |
Baseline characteristics
| Characteristic | PIVOT With MI | Control | Total |
|---|---|---|---|
| Age, Categorical Parent/Infant Dyads <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Parent/Infant Dyads >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Parent/Infant Dyads Between 18 and 65 years | 4889 Participants | 3728 Participants | 8617 Participants |
| Ethnicity (NIH/OMB) Clinicians Hispanic or Latino | 3 Participants | 5 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Clinicians Not Hispanic or Latino | 123 Participants | 79 Participants | 202 Participants |
| Ethnicity (NIH/OMB) Clinicians Unknown or Not Reported | 1 Participants | 1 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Parent/Infant Dyads Hispanic or Latino | 551 Participants | 460 Participants | 1011 Participants |
| Ethnicity (NIH/OMB) Parent/Infant Dyads Not Hispanic or Latino | 4,162 Participants | 3158 Participants | 7320 Participants |
| Ethnicity (NIH/OMB) Parent/Infant Dyads Unknown or Not Reported | 176 Participants | 110 Participants | 286 Participants |
| Race (NIH/OMB) Clinicians American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Clinicians Asian | 13 Participants | 8 Participants | 21 Participants |
| Race (NIH/OMB) Clinicians Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Clinicians More than one race | 6 Participants | 2 Participants | 8 Participants |
| Race (NIH/OMB) Clinicians Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Clinicians Unknown or Not Reported | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Clinicians White | 106 Participants | 74 Participants | 180 Participants |
| Race (NIH/OMB) Parent/Infant Dyads American Indian or Alaska Native | 62 Participants | 28 Participants | 90 Participants |
| Race (NIH/OMB) Parent/Infant Dyads Asian | 228 Participants | 358 Participants | 586 Participants |
| Race (NIH/OMB) Parent/Infant Dyads Black or African American | 85 Participants | 63 Participants | 148 Participants |
| Race (NIH/OMB) Parent/Infant Dyads More than one race | 188 Participants | 142 Participants | 330 Participants |
| Race (NIH/OMB) Parent/Infant Dyads Native Hawaiian or Other Pacific Islander | 14 Participants | 19 Participants | 33 Participants |
| Race (NIH/OMB) Parent/Infant Dyads Unknown or Not Reported | 315 Participants | 187 Participants | 502 Participants |
| Race (NIH/OMB) Parent/Infant Dyads White | 3997 Participants | 2931 Participants | 6928 Participants |
| Region of Enrollment United States | 9905 participants | 7541 participants | 17446 participants |
| Sex/Gender, Customized Clinicians Female | 88 Participants | 61 Participants | 149 Participants |
| Sex/Gender, Customized Clinicians Male | 39 Participants | 24 Participants | 63 Participants |
| Sex/Gender, Customized Clinicians Unknown | 0 Participants | 0 Participants | 0 Participants |
| Sex/Gender, Customized Parent/Infant Dyads Female | 4138 Participants | 3200 Participants | 7338 Participants |
| Sex/Gender, Customized Parent/Infant Dyads Male | 567 Participants | 425 Participants | 992 Participants |
| Sex/Gender, Customized Parent/Infant Dyads Unknown | 184 Participants | 103 Participants | 287 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 5,016 | 0 / 3,813 |
| other Total, other adverse events | 0 / 5,016 | 0 / 3,813 |
| serious Total, serious adverse events | 0 / 5,016 | 0 / 3,813 |
Outcome results
Child Immunization Status at 19 Months, 0 Days of Age Characterized as Percent Days Under-immunized (DUI)
Immunization status was obtained from WA or CO state immunization registry or directly from participating practices. At enrollment, parent/infant dyads completed the Parental Attitudes about Childhood Vaccines short version (PACV-SF), a validated survey scored from 0 to 4. A score of 2 or more represented parent/infant dyad with negative vaccine attitudes. Among parent/infant dyads with negative vaccine attitudes, the child's immunization status at 19 months was calculated based on recommended ages and intervals between doses provided by ACIP for summing late days for each dose of the 8 routine vaccines recommended by 19 months (HepB, rotavirus, DTaP, Hib, pneumococcal conjugate, inactivated polio virus, MMR, and varicella). There was a max of 23 recommended doses for the 8 vaccines - doses varied depending on brand. Total max DUI was a sum of total possible days late for each dose through 19mo(2830 days).Percent DUI was calculated by dividing child's DUI by the total maximum DUI.
Time frame: Child's immunization status at 19 months of age
Population: Infants of parents/caregivers who had negative vaccine attitudes (Parental Attitudes about Childhood Vaccines short form (PACV-SF) score of 2 or higher)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PIVOT With MI: Parent/Caregiver and Infant Dyad | Child Immunization Status at 19 Months, 0 Days of Age Characterized as Percent Days Under-immunized (DUI) | 32 percentage of days under-immunized | Standard Deviation 38 |
| Control: Parent/Caregiver and Infant Dyad | Child Immunization Status at 19 Months, 0 Days of Age Characterized as Percent Days Under-immunized (DUI) | 24 percentage of days under-immunized | Standard Deviation 32 |
Change in Clinician Self-Efficacy With Parent/Infant Dyads With Negative Vaccine Attitudes - Pre-vs Post-Surveys
To assess changes in clinicians' perceived self-efficacy when discussing vaccines with parents/infant dyads with negative vaccine attitudes, a survey was administered to all participating clinicians at baseline and at study completion asking about vaccine recommendation behaviors and how they perceived their impact on parental decision making regarding vaccines. Self-efficacy was assessed with a 3-part question scored on a Likert Scale - Strongly Disagree, Somewhat Disagree, Somewhat Agree, Strongly Agree. Changes in perceived self-efficacy over time was assessed by comparing the number of clinicians who answered Strongly Agree or Somewhat Agree to the statement When parents wish to delay or refuse childhood vaccines for their child, there is not much I can say to change their minds at baseline and at post-study. Note that fewer clinicians completed the post-study survey due to such factors as retirement and staff turnover.
Time frame: At Baseline and Post-Intervention (up to 2 years after baseline)
Population: Clinicians enrolled across n=24 clinics (n=12 intervention clinics; n=12 control clinics)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PIVOT With MI: Parent/Caregiver and Infant Dyad | Change in Clinician Self-Efficacy With Parent/Infant Dyads With Negative Vaccine Attitudes - Pre-vs Post-Surveys | Baseline Survey Results | 54 Participants |
| PIVOT With MI: Parent/Caregiver and Infant Dyad | Change in Clinician Self-Efficacy With Parent/Infant Dyads With Negative Vaccine Attitudes - Pre-vs Post-Surveys | Post-Study Survey Results | 23 Participants |
| Control: Parent/Caregiver and Infant Dyad | Change in Clinician Self-Efficacy With Parent/Infant Dyads With Negative Vaccine Attitudes - Pre-vs Post-Surveys | Baseline Survey Results | 39 Participants |
| Control: Parent/Caregiver and Infant Dyad | Change in Clinician Self-Efficacy With Parent/Infant Dyads With Negative Vaccine Attitudes - Pre-vs Post-Surveys | Post-Study Survey Results | 20 Participants |
Post-Visit Parental Satisfaction Survey Scored on a 7-point Likert Scale
To assess parental satisfaction with their clinician during a health supervision visit, we asked all vaccine hesitant parents (identified by a Parental Attitudes about Childhood Vaccines-Short Form (PAC-V SF) score of 2 or more) in both both intervention and control arms if they would complete an additional 15-question survey over the phone within 24-48 hours after the completion of a health supervision visit for their child around 6 months of age. Due to COVID-19 restrictions, we had to extend the time frame to within 1 week after a health supervision visit at 2, 4, or 6 months of age. Ratings were on a 7-point Likert scale - Very Poor (1), Poor (2), Fair (3), Good (4), Very Good (5), Excellent (6), Outstanding (7). Overall experience with a rating of Good (4) or higher was considered to be a satisfactory visit.
Time frame: approximately 6 months post birth
Population: A subset of parent/infant dyads in both intervention and control clinics who were identified as vaccine hesitant (score of 2 or more on the Parental Attitudes about Childhood Vaccines short form (PACV-SF)) and who completed the post-healthcare visit satisfaction survey.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PIVOT With MI: Parent/Caregiver and Infant Dyad | Post-Visit Parental Satisfaction Survey Scored on a 7-point Likert Scale | 96 % of participants scoring 4 or higher |
| Control: Parent/Caregiver and Infant Dyad | Post-Visit Parental Satisfaction Survey Scored on a 7-point Likert Scale | 96 % of participants scoring 4 or higher |