Clinical trial NCT03975530: Piloting a Precision Approach to Home Visiting
Official title: Piloting a Precision Approach to Home Visiting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parenting
Mother-Child Relations
Child Development
Keywords: Home visiting interventions
American Indian
Community based participatory research
Pregnancy
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: Inter-Tribal Council of Michigan, Inc.
First posted: 2019-06-05
Enrollment: 66
Sex: FEMALE
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The proposed study will be a randomized pilot study. Family Spirit home-visiting sites from the Inter-Tribal Council of Michigan (ITC of MI) will be selected based on comparability and randomized to provide either standard Family Spirit or precision Family Spirit to their clients. Sites in both groups will use an electronic platform to support implementation. The investigators will select four sites and randomize two of them to standard Family Spirit and two to precision Family Spirit. Sites will be matched based on annual volume of clients served and geographic similarity (i.e. urban vs. rural). All participating sites will be trained in the electronic implementation support platform. The two sites randomized to provide the precision approach will receive additional training on how to provide it.

In each site, all new clients who are prenatal or up to 2-months postpartum will be offered participation in the study. The study will then follow them until 12 months postpartum and measure outcomes during this time (see measurement table below). Qualitative interviews with precision participants will be done at 6 and 12 months postpartum. Focus group discussions with home visitors will also be completed during regular study team meetings. Analysis of study instruments (basic psychometrics based on baseline and end line data) and preliminary differences between the sites on Aim 3 and 4 outcomes will be done in December 2019 assuming the investigators have achieved their estimated sample size with enough retention for 6-months post enrollment. Dissemination of results will be done upon completion of the analysis.

Detailed description: Home visiting programs provide critical support to families and young children to promote healthy development and reduce health disparities. Decades of research has yielded a robust evidence base supporting their effectiveness and impact on maternal and child outcomes. In 2010, the importance of these interventions was recognized nationally with the authorization of $1.5 billion to fund Maternal, Infant, and Early Childhood Home Visiting (MIECHV) across states and tribes. MIECHV was most recently reauthorized and funded for five years in early 2018. There are now 21 evidence-based early childhood home visiting models nationwide, all of which have evidence from multiple randomized controlled trials, favorable impacts on primary and secondary outcomes, and sustained impacts of the intervention over time.

Despite robust evidence of early childhood home-visiting effectiveness, replication and scale-up beyond the context of research has been challenging. Improving program retention, enhancing program content to address families' unique and often complex needs, and increasing fidelity have been identified as priority areas for further research. While building the evidence base for home-visiting programs, researchers necessarily took a "one-size-fits-all" approach - designing programs that are often lengthy (2-3 years long) and include standard lesson sequencing and dosing delivered in the same way to all participants. However, mothers and children do not all need the same program content or dosages. A one-size-fits-all approach fails to address maternal-child need and has led to differential outcomes across studies and populations, indicating that the promise of home-visiting to improve health has yet to be fully realized.

The need for home-visiting programs that can address maternal-child diverse and emergent needs and improve client reach and retention, while maintaining fidelity to the active ingredients of evidence-based home-visiting programs, is at the forefront of research and practice-based dialogue in the US. Recent qualitative research on high- and low-retention sites within the Nurse Family Partnership network showed that nurses in high retention sites were more collaborative with families and adapted the program to align more with families' needs compared to nurses in low retention sites. Based on these findings, Ingoldsby and colleagues used principals of motivational interviewing to provide nurses with more explicit control over the visit schedule and content to families. When they compared retention rates for nurses trained in motivational interviewing to rates for nurses trained in the standard approach, they found retention rates were significantly better when nurses had more flexibility in service delivery.

For the past several years, the Johns Hopkins Center for American Indian Health (CAIH) at Johns Hopkins University has partnered with the Annie E. Casey Foundation for formative work to develop a precision public health approach to the Family Spirit home-visiting program. Leveraging CAIH's existing evidence-based home-visiting program, Family Spirit, the goal of this project was to enhance the Family Spirit model to aid home visitors in tailoring content to meet families' specific needs and continuously monitor clients' emergent issues or improvements so that home-visiting education remains responsive, relevant, and feasible. This precision approach and corresponding implementation support have been developed. The current study will be a pilot study of the precision approach compared to the standard of care. In the standard of care, families receive regular home visits, delivered in the same sequence for up to 39 months. In the precision approach, there is a core set of lessons that every mother will get, but then additional lessons will be added based on maternal or child need. For example, if a mother is a first-time mom, they will get additional baby care lessons that are included in the standard Family Spirit curriculum but may not be relevant for moms with previous children.

Eligibility criteria: Inclusion Criteria:

* Prenatal or postpartum females who have a baby no older than 2 months old
* At least 14 years of age at time of conception
* Receiving Family Spirit services through ITC of MI

Exclusion Criteria:

* \< 13 years old at time of conception of index pregnancy
* Index child is older than 2 months of age
* Inability to participate in full intervention or evaluation

Primary outcomes:
measure: Acceptability of the home-visiting program from the perspective of mothers enrolled
timeFrame: Baseline, 2-months postpartum, 6-months postpartum, 12-months postpartum
measure: Retention in the home-visiting programs
timeFrame: 2-months postpartum, 6-months postpartum, 12-months postpartum
measure: Participant satisfaction
timeFrame: 6-months postpartum, 12-months postpartum
measure: Adherence
timeFrame: Study enrollment through study completion, an average of 1 year
measure: Home visitor-participant relationship
timeFrame: 2-months postpartum, 6-months postpartum, 12-months postpartum
Secondary outcomes:
Other outcomes:
Locations:
city: Sault Sainte-Marie
country: United States
facility: Inter-Tribal Council of Michigan (ITC of MI)
state: Michigan
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Emily Haroz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ingalls A, Rebman P, Martin L, Kushman E, Leonard A, Cisler A, Gschwind I, Brayak A, Amsler AM, Haroz EE. Towards precision home visiting: results at six months postpartum from a randomized pilot implementation trial to assess the feasibility of a precision approach to Family Spirit. BMC Pregnancy Childbirth. 2022 Sep 23;22(1):725. doi: 10.1186/s12884-022-05057-4.
citation: Ingalls A, Barlow A, Kushman E, Leonard A, Martin L, Team PFSS, West AL, Neault N, Haroz EE. Precision Family Spirit: a pilot randomized implementation trial of a precision home visiting approach with families in Michigan-trial rationale and study protocol. Pilot Feasibility Stud. 2021 Jan 6;7(1):8. doi: 10.1186/s40814-020-00753-4.