Trial Outcomes & Findings for Well-Child Care Clinical Practice Redesign: A Parent Coach-Led Model of Care (NCT NCT03797898)

Last Updated: 2023-06-26

Results Overview

Using anticipatory guidance items adapted from the Promoting Healthy Development Survey, the investigators will assess whether parents receive the recommended anticipatory guidance topics. scale, 0-100, higher is better

Recruitment status

COMPLETED

Study phase

Target enrollment

937 participants

Primary outcome timeframe

12 months post enrollment

Results posted on

2023-06-26

Participant Flow

Participants were recruited from two multi-site federally qualified health centers (FQHCs) in California and Washington State, with 6 and 4 participating practices each. The first participant was enrolled March 5, 2019 and the last participant was enrolled July 1, 2021. \*\*PLEASE NOTE that there were not multiple phases to the trial. this study was a cluster RCT that did not have multiple phases to the trial.

Of 937 enrolled participants, 914 remained enrolled and were eligible to complete 12-month follow-up. Participants are unique parent/child dyads. The parents were enrolled and each parent had an index child that they provided data on. This was the child for who they were coming to the clinic for a well child visit, and the child had to be 12 months of age or younger.

Unit of analysis: clinics

Participant milestones

Participant milestones
Measure	Intervention Clinics assigned to the intervention arm will use the Parent Coach model for well child care visits, for children ages 0-2. Parents will meet with a Parent Coach during child's routine well visits, and have access to the parent coach between visits for additional follow up and concerns, and have access to a preventive care text messaging services (Healthy Txt). Parent Coach: The Parent Coach intervention uses a health educator who provides anticipatory guidance, psychosocial screening/ referral, and developmental/behavioral surveillance, screening, and guidance at each well-visit. The Parent Coach uses a parent-focused, pre-visit questionnaire to customize the visit to the parents' needs. Every well-visit includes a brief, problem-focused encounter with a clinician for a physical exam and any concerns that require a clinician's attention. Finally, an automated text message service provides for periodic, age-specific messages to reinforce key health messages from Parent Coach-led well-visits.	Control Clinics assigned to control group use usual well child care. They do not have a parent coach as part of the visit.
Overall Study STARTED	452 5	485 5
Overall Study COMPLETED	378 5	407 5
Overall Study NOT COMPLETED	74 0	78 0

Reasons for withdrawal

Reasons for withdrawal
Measure	Intervention Clinics assigned to the intervention arm will use the Parent Coach model for well child care visits, for children ages 0-2. Parents will meet with a Parent Coach during child's routine well visits, and have access to the parent coach between visits for additional follow up and concerns, and have access to a preventive care text messaging services (Healthy Txt). Parent Coach: The Parent Coach intervention uses a health educator who provides anticipatory guidance, psychosocial screening/ referral, and developmental/behavioral surveillance, screening, and guidance at each well-visit. The Parent Coach uses a parent-focused, pre-visit questionnaire to customize the visit to the parents' needs. Every well-visit includes a brief, problem-focused encounter with a clinician for a physical exam and any concerns that require a clinician's attention. Finally, an automated text message service provides for periodic, age-specific messages to reinforce key health messages from Parent Coach-led well-visits.	Control Clinics assigned to control group use usual well child care. They do not have a parent coach as part of the visit.
Overall Study Lost to Follow-up	60	69
Overall Study Withdrawal by Subject	9	7
Overall Study Became ineligible	5	2

Baseline Characteristics

913 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question)

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 12 months post enrollment

Outcome measures

Outcome measures
Measure	Intervention n=375 Participants Parents will meet with a Parent Coach during child's routine well visits, and have access to the parent coach between visits for additional follow up and concerns, and have access to a preventive care text messaging services (Healthy Txt). Parent Coach: The Parent Coach intervention uses a health educator who provides anticipatory guidance, psychosocial screening/ referral, and developmental/behavioral surveillance, screening, and guidance at each well-visit. The Parent Coach uses a parent-focused, pre-visit questionnaire to customize the visit to the parents' needs. Every well-visit includes a brief, problem-focused encounter with a clinician for a physical exam and any concerns that require a clinician's attention. Finally, an automated text message service provides for periodic, age-specific messages to reinforce key health messages from Parent Coach-led well-visits.	Control n=407 Participants usual care well child care
Receipt of Preventive Care Services: Anticipatory Guidance Topics Received by Parent Report at Well Visits	73.9 score on a scale Standard Deviation 23.4	63.3 score on a scale Standard Deviation 27.8

PRIMARY outcome

Timeframe: 12 months post enrollment

Population: all participants completing 12 month survey

any emergency department care visit for the index child in past 12 months (parent report)

Outcome measures

Outcome measures
Measure	Intervention n=376 Participants Parents will meet with a Parent Coach during child's routine well visits, and have access to the parent coach between visits for additional follow up and concerns, and have access to a preventive care text messaging services (Healthy Txt). Parent Coach: The Parent Coach intervention uses a health educator who provides anticipatory guidance, psychosocial screening/ referral, and developmental/behavioral surveillance, screening, and guidance at each well-visit. The Parent Coach uses a parent-focused, pre-visit questionnaire to customize the visit to the parents' needs. Every well-visit includes a brief, problem-focused encounter with a clinician for a physical exam and any concerns that require a clinician's attention. Finally, an automated text message service provides for periodic, age-specific messages to reinforce key health messages from Parent Coach-led well-visits.	Control n=407 Participants usual care well child care
Healthcare Utilization: Emergency Department Utilization	140 Participants	147 Participants

SECONDARY outcome

Timeframe: Data not collected due to COVID Pandemic restrictions on in clinic observations.

Population: Data were not collected due to COVID 19 pandemic restrictions on in clinic observations

time spent in parent-provider visit during the well child care visit. these data were not collected for trial participants at baseline. At follow-up, we did not collect data due to pandemic restrictions in doing observations.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months post enrollment

Population: all participants completing 12 month survey

Using items adapted from the Promoting Healthy Development Survey, the investigators will assess whether parents received psychosocial assessment on all 7 items

Outcome measures

Outcome measures
Measure	Intervention n=378 Participants Parents will meet with a Parent Coach during child's routine well visits, and have access to the parent coach between visits for additional follow up and concerns, and have access to a preventive care text messaging services (Healthy Txt). Parent Coach: The Parent Coach intervention uses a health educator who provides anticipatory guidance, psychosocial screening/ referral, and developmental/behavioral surveillance, screening, and guidance at each well-visit. The Parent Coach uses a parent-focused, pre-visit questionnaire to customize the visit to the parents' needs. Every well-visit includes a brief, problem-focused encounter with a clinician for a physical exam and any concerns that require a clinician's attention. Finally, an automated text message service provides for periodic, age-specific messages to reinforce key health messages from Parent Coach-led well-visits.	Control n=407 Participants usual care well child care
Receipt of Preventive Care Services: Psychosocial Screening Received by Parent Report at Well Visits	253 Participants	203 Participants

SECONDARY outcome

Timeframe: 12 months post enrollment

Population: Number analyzed differs from overall because of missing data (participant did not respond to item in question)

Using items adapted from the Promoting Healthy Development Survey, the investigators will assess whether parents receive the recommended developmental screening and were asked if they had their developmental concerns addressed.

Outcome measures

Outcome measures
Measure	Intervention n=378 Participants Parents will meet with a Parent Coach during child's routine well visits, and have access to the parent coach between visits for additional follow up and concerns, and have access to a preventive care text messaging services (Healthy Txt). Parent Coach: The Parent Coach intervention uses a health educator who provides anticipatory guidance, psychosocial screening/ referral, and developmental/behavioral surveillance, screening, and guidance at each well-visit. The Parent Coach uses a parent-focused, pre-visit questionnaire to customize the visit to the parents' needs. Every well-visit includes a brief, problem-focused encounter with a clinician for a physical exam and any concerns that require a clinician's attention. Finally, an automated text message service provides for periodic, age-specific messages to reinforce key health messages from Parent Coach-led well-visits.	Control n=407 Participants usual care well child care
Receipt of Preventive Care Services: Developmental Concerns Addressed and Screening Received by Parent Report at Well Visits. Behavioral Concerns Elicited & Addressed	305 Participants	292 Participants
Receipt of Preventive Care Services: Developmental Concerns Addressed and Screening Received by Parent Report at Well Visits. Developmental Screening	310 Participants	332 Participants

SECONDARY outcome

Timeframe: 12 months post enrollment

Population: all participants completing 12 month survey

any hospitalizations for index child in past 12 months by parent report

Outcome measures

Outcome measures
Measure	Intervention n=376 Participants Parents will meet with a Parent Coach during child's routine well visits, and have access to the parent coach between visits for additional follow up and concerns, and have access to a preventive care text messaging services (Healthy Txt). Parent Coach: The Parent Coach intervention uses a health educator who provides anticipatory guidance, psychosocial screening/ referral, and developmental/behavioral surveillance, screening, and guidance at each well-visit. The Parent Coach uses a parent-focused, pre-visit questionnaire to customize the visit to the parents' needs. Every well-visit includes a brief, problem-focused encounter with a clinician for a physical exam and any concerns that require a clinician's attention. Finally, an automated text message service provides for periodic, age-specific messages to reinforce key health messages from Parent Coach-led well-visits.	Control n=406 Participants usual care well child care
Healthcare Utilization: Hospitalizations	12 Participants	9 Participants

SECONDARY outcome

Timeframe: 12 months post enrollment

Population: all enrolled participants who remained eligible, and consented to chart review by the 12-month post intervention assessment

up to date on well child care by clinic electronic medical record review at 12 months post enrollment

Outcome measures

Outcome measures
Measure	Intervention n=419 Participants Parents will meet with a Parent Coach during child's routine well visits, and have access to the parent coach between visits for additional follow up and concerns, and have access to a preventive care text messaging services (Healthy Txt). Parent Coach: The Parent Coach intervention uses a health educator who provides anticipatory guidance, psychosocial screening/ referral, and developmental/behavioral surveillance, screening, and guidance at each well-visit. The Parent Coach uses a parent-focused, pre-visit questionnaire to customize the visit to the parents' needs. Every well-visit includes a brief, problem-focused encounter with a clinician for a physical exam and any concerns that require a clinician's attention. Finally, an automated text message service provides for periodic, age-specific messages to reinforce key health messages from Parent Coach-led well-visits.	Control n=465 Participants usual care well child care
Healthcare Utilization: Well Child Care Visits Up to Date	309 Participants	295 Participants

SECONDARY outcome

Timeframe: 12 months post enrollment

Population: all participants completing 12 month survey

parent reported helpfulness of care, using items adapted from Promoting Healthy Development Survey scale is 0-100, higher is better

Outcome measures

Outcome measures
Measure	Intervention n=378 Participants Parents will meet with a Parent Coach during child's routine well visits, and have access to the parent coach between visits for additional follow up and concerns, and have access to a preventive care text messaging services (Healthy Txt). Parent Coach: The Parent Coach intervention uses a health educator who provides anticipatory guidance, psychosocial screening/ referral, and developmental/behavioral surveillance, screening, and guidance at each well-visit. The Parent Coach uses a parent-focused, pre-visit questionnaire to customize the visit to the parents' needs. Every well-visit includes a brief, problem-focused encounter with a clinician for a physical exam and any concerns that require a clinician's attention. Finally, an automated text message service provides for periodic, age-specific messages to reinforce key health messages from Parent Coach-led well-visits.	Control n=407 Participants usual care well child care
Experiences of Care: Helpfulness of Care Assessment by Parent Report	77.8 score on a scale Standard Deviation 25.2	69.8 score on a scale Standard Deviation 30.7

SECONDARY outcome

Timeframe: 12 months post enrollment

Population: all participants completing 12 month survey

receipt of family centeredness of care using items adapted from National Survey of Children's Health scale 0-100, higher is better

Outcome measures

Outcome measures
Measure	Intervention n=378 Participants Parents will meet with a Parent Coach during child's routine well visits, and have access to the parent coach between visits for additional follow up and concerns, and have access to a preventive care text messaging services (Healthy Txt). Parent Coach: The Parent Coach intervention uses a health educator who provides anticipatory guidance, psychosocial screening/ referral, and developmental/behavioral surveillance, screening, and guidance at each well-visit. The Parent Coach uses a parent-focused, pre-visit questionnaire to customize the visit to the parents' needs. Every well-visit includes a brief, problem-focused encounter with a clinician for a physical exam and any concerns that require a clinician's attention. Finally, an automated text message service provides for periodic, age-specific messages to reinforce key health messages from Parent Coach-led well-visits.	Control n=407 Participants usual care well child care
Experiences of Care: Family Centeredness of Care- Whether it Was Received by Parent Report	89.0 score on a scale Standard Deviation 22.5	85.5 score on a scale Standard Deviation 27.1

Adverse Events

Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 1 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Intervention n=452 participants at risk Parents will meet with a Parent Coach during child's routine well visits, and have access to the parent coach between visits for additional follow up and concerns, and have access to a preventive care text messaging services (Healthy Txt). Parent Coach: The Parent Coach intervention uses a health educator who provides anticipatory guidance, psychosocial screening/ referral, and developmental/behavioral surveillance, screening, and guidance at each well-visit. The Parent Coach uses a parent-focused, pre-visit questionnaire to customize the visit to the parents' needs. Every well-visit includes a brief, problem-focused encounter with a clinician for a physical exam and any concerns that require a clinician's attention. Finally, an automated text message service provides for periodic, age-specific messages to reinforce key health messages from Parent Coach-led well-visits.	Control n=485 participants at risk usual care well child care
General disorders death	0.00% 0/452 • 12 months As there were no risk of harm to participant dyads, we did not conduct a systematic approach to collecting data on harms. However, if in the course of the 12-month data collection, we gained information on participant harm to either the parent or child of the dyad, we report those as "adverse events". The only such information we received was on one parent of the parent/child dyads enrolled, and this event (parent death) is reported both in the serious adverse event and in all cause mortality.	0.21% 1/485 • Number of events 1 • 12 months As there were no risk of harm to participant dyads, we did not conduct a systematic approach to collecting data on harms. However, if in the course of the 12-month data collection, we gained information on participant harm to either the parent or child of the dyad, we report those as "adverse events". The only such information we received was on one parent of the parent/child dyads enrolled, and this event (parent death) is reported both in the serious adverse event and in all cause mortality.

Other adverse events

Adverse event data not reported

Additional Information

Tumaini R. Coker, MD, MBA

Seattle Children's

Phone: 206-884-0559

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place