Pilot Trial of Network-Based Implementation Strategies to Increase Coalition Adoption and Early Implementation of Evidence-Informed Strategies for Child Health
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 3,300
- 试验地点
- 1
- 主要终点
- Participation and Reach
研究概览
简要总结
Community coalitions bring together residents and organizations to improve child health, but they may need support to identify and put research-supported strategies into practice. This study will examine whether a program called FICAS can be delivered successfully and is useful to coalition members. FICAS uses information about relationships within a coalition to help involve people with relevant perspectives, share evidence, compare possible strategies, make decisions, and adjust support as the coalition's work develops.
Three community coalitions will participate. All three will eventually receive Catalyzing Communities, a program that provides facilitated meetings, collaborative planning, technical assistance, and funding for coalition-led action. One coalition will begin the program later, one will receive Catalyzing Communities alone, and one will receive Catalyzing Communities with FICAS. The study will help determine whether FICAS and the study procedures should be refined and tested in a larger study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- None
盲法说明
Participants, investigators, and intervention personnel cannot be masked because intervention delivery requires active collaboration with participating coalitions. Selected qualitative coding and quantitative analyses may be conducted without condition labels when feasible, but these procedures do not constitute formal masking of an outcomes assessor.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Coalition-level criteria
- •Coalition focuses on child health, childhood obesity prevention, healthy eating, active living, nutrition security, policy, systems, or environmental change, or related community health priorities.
- •Coalition works in or serves a community experiencing socioeconomic disadvantage.
- •Coalition has multisector participation.
- •Coalition has identifiable leadership or backbone capacity to participate in the study.
- •Coalition is willing to participate in study procedures and data collection and accept randomized coalition-level assignment.
- •Coalition has a feasible membership roster or is able to work with the study team to construct one and has an identifiable leadership contact.
- •Coalition can support participant recruitment and scheduling without coercing individual participation.
- •Individual-level criteria
- •Age 18 years or older.
- •Coalition member, leader, staff member, partner, changemaker, committee or core-group participant, named network connection, survey-only participant, invited guest, or other adult with relevant community, organizational, policy, professional, or implementation expertise or connections.
- •Able to provide informed consent.
- •Able to participate in English.
- •For direct committee or core-group participants, able to participate through the internet, telephone, or another study-supported mode.
- •Willing to complete the study activities applicable to the participant's role, which may include meetings, surveys, network assessments, or interviews.
排除标准
- •Coalition-level criteria
- •Coalition is unable to participate in required study activities.
- •Coalition lacks a feasible membership roster or the ability to construct one with study-team assistance, or lacks an identifiable leadership contact.
- •Coalition is unwilling to accept randomized coalition-level assignment.
- •Coalition is participating in a comparable formal coalition intervention that would prevent interpretation of the study findings.
- •Individual-level criteria
- •Younger than 18 years.
- •Unable to provide informed consent.
- •Unable to participate in English.
- •Does not have an eligible coalition, professional, community, organizational, policy, or implementation role, expertise, or connection.
- •For direct committee or core-group participants, unable to participate through an available study-supported mode.
- •Participation would create an unmanaged conflict or undue pressure that cannot be resolved.
研究组 & 干预措施
Delayed Control
During the initial comparison period, this coalition will receive study assessments and retention contacts but no active Catalyzing Communities or FICAS intervention. After the prespecified pre-crossover assessment, the coalition will cross over to Catalyzing Communities only. It will not receive the FICAS augmentation during the registered comparison period.
干预措施: Catalyzing Communities (Behavioral)
Positive Control: Catalyzing Communities
This coalition will receive the Catalyzing Communities base implementation-support platform, including coalition convening, group model building, technical assistance, and seed funding to support coalition-led selection and early implementation of an evidence-informed strategy. It will not receive the FICAS augmentation.
干预措施: Catalyzing Communities (Behavioral)
Augmented Treatment: Catalyzing Communities Plus FICAS
This coalition will receive the Catalyzing Communities base implementation-support platform plus the FICAS multicomponent implementation intervention. FICAS adds data-informed committee selection, opinion leader engagement, structured evidence review, structured decision support, and online network monitoring and adaptation.
干预措施: Catalyzing Communities (Behavioral)
Augmented Treatment: Catalyzing Communities Plus FICAS
This coalition will receive the Catalyzing Communities base implementation-support platform plus the FICAS multicomponent implementation intervention. FICAS adds data-informed committee selection, opinion leader engagement, structured evidence review, structured decision support, and online network monitoring and adaptation.
干预措施: FICAS Implementation Intervention (Behavioral)
结局指标
主要结局
Participation and Reach
时间窗: From the beginning of participant recruitment through the primary assessment window, up to 12 months after intervention initiation
The number of eligible coalition members who provide informed consent and complete at least one study data-collection activity will be divided by the total number of eligible coalition members invited to participate and multiplied by 100. Scores range from 0% to 100%. Higher percentages indicate greater study reach.
Percentage of Enrolled Participants Retained Through the Primary Endpoint
时间窗: Baseline through intervention month 12
The number of participants in the baseline cohort who complete the final scheduled primary assessment will be divided by the number enrolled in the baseline cohort and multiplied by 100. Scores range from 0% to 100%. Higher percentages indicate greater retention.
Mean Acceptability of Intervention Measure Score for FICAS
时间窗: Intervention months 6, 9, and 12
Acceptability of FICAS will be measured using the four-item Acceptability of Intervention Measure. Each item is scored from 1, completely disagree, to 5, completely agree. Item scores will be averaged to produce a mean score ranging from 1 to 5. Higher scores indicate greater perceived acceptability. Mean scores will be reported separately at each assessment.
Mean Intervention Appropriateness Measure Score for FICAS
时间窗: Intervention months 6, 9, and 12
Perceived appropriateness of FICAS will be measured using the four-item Intervention Appropriateness Measure. Each item is scored from 1, completely disagree, to 5, completely agree. Item scores will be averaged to produce a mean score ranging from 1 to 5. Higher scores indicate greater perceived appropriateness. Mean scores will be reported separately at each assessment.
Mean Feasibility of Intervention Measure Score for FICAS
时间窗: Intervention months 6, 9, and 12
Perceived feasibility of FICAS will be measured using the four-item Feasibility of Intervention Measure. Each item is scored from 1, completely disagree, to 5, completely agree. Item scores will be averaged to produce a mean score ranging from 1 to 5. Higher scores indicate greater perceived feasibility. Mean scores will be reported separately at each assessment.
次要结局
- Percentage of Selected-Strategy Adoption Milestones Completed(Intervention months 9 and 12)
- Normalized Early Implementation Readiness and Action-Initiation Score(Intervention months 9 and 12)
- Coalition Child-Health Discussion Network Density(Pre-intervention baseline and monthly through intervention month 12)
- Percentage of Child-Health Discussion Ties Connecting Different Sectors(Pre-intervention baseline and monthly through intervention month 12)
- Percentage of Prespecified Strategic Representation Categories Represented(Pre-intervention baseline and intervention months 6, 9, and 12)
- Mean Coalition-Wave Dyadic Trust Score(Pre-intervention baseline and monthly through intervention month 12)
- Mean Number of Child-Health Discussion Ties per Participant(Pre-intervention baseline and monthly through intervention month 12)
- Mean Perceived Relative Advantage Score for the Selected Evidence-Informed Strategy(Intervention months 6, 9, and 12, after a candidate or selected strategy has been identified)
- Mean Perceived Compatibility Score for the Selected Evidence-Informed Strategy(Intervention months 6, 9, and 12, after a candidate or selected strategy has been identified)
- Mean Perceived Ease-of-Use Score for the Selected Evidence-Informed Strategy(Intervention months 6, 9, and 12, after a candidate or selected strategy has been identified)
- Mean Perceived Result-Demonstrability Score for the Selected Evidence-Informed Strategy(Intervention months 6, 9, and 12, after a candidate or selected strategy has been identified)
- Mean Perceived Trialability Score for the Selected Evidence-Informed Strategy(Intervention months 6, 9, and 12, after a candidate or selected strategy has been identified)
- Mean Evidence-Input Domain Score on the Structured Interview for Evidence Use(Intervention months 6, 9, and 12)
- Mean Evidence-Appraisal Process Domain Score on the Structured Interview for Evidence Use(Intervention months 6, 9, and 12)
- Mean Evidence-Application Output Domain Score on the Structured Interview for Evidence Use(Intervention months 6, 9, and 12)
- Percentage of Structured Evidence-Review Milestones Completed(Intervention months 6 and 12)
研究者
Travis R Moore
Assistant Professor
University of Pittsburgh