Implementation of a ColoRectal Cancer Screening Tool in US Primary Care Practices - Usual Quality Improvement (10 Clinics) vs Normalization Process Theory-Participatory Learning in Action (10 Clinics)

Conditions

• Colorectal Carcinoma

Eligibility Criteria

Sex

ALL

Age

45 Years - 75 Years

Healthy Volunteers

Accepted

Interventions

• NPT-PLA — BEHAVIORAL
  NPT-PLA was developed and initially tested in 5 European countries in the EU-funded RESTORE study. PLA "Participatory Learning in Action" is a set of participatory research techniques in which participants use democratic processes to identify key actions needed to achieve a specific goal e.g. implementation of a tested decision making tool such as I2; and prioritize which of these need to be acted upon first and subsequently (in which order). Normalization Process Theory (NPT) is combined with PLA to help implementation teams using PLA to assess organization capacity and readiness to enact the selected action steps vis-a-vis NPT constructs, iteratively. These are coherence "does everyone understand what needs to be done?"; Cognitive participation "Does everyone who needs to act 'buy in' to take action"; collective action "Is everyone who needs to act taking steps to make the change?'; and reflexive monitoring "After the step has been taken, has it had the desired impact on the goal?"
• Usual Quality Improvement — BEHAVIORAL
  Usual quality improvement includes principles of continuous quality improvement, such as Plan-Do-Study-Act cycles, to implement a specific goal. In this study, 'usual QI' methods already in use in 'active comparator' arm will be documented during the baseline assessment of clinical workflows in clinics assigned to that arm; and will be provided with a 'preset protocol' to implement the study shared decision-making tool (I2). Processes that implementation teams in these clinics use to achieve implementation will be documented.

Study Details

Although implementation intentions (I2)-based tools enhance colorectal cancer (CRC) screening uptake, prior studies have not tested their implementation into routine primary care delivery. In this study, investigators will conduct a cluster-randomized trial in 20 US primary care clinics. Specific aims for the project will be: 1) to test whether a Normalization Process Theory-informed Participatory Learning in Action (NPT-PLA intervention) implementation of a proven implementation Intentions-based colorectal cancer screening tool ("I2") improves screening uptake (i.e. screening order and completion) within 6 months of patient enrollment versus usual quality improvement (control) implementation; and 2) to evaluate the facilitators and barriers of each implementation arm using the 2022 expanded Normalization Process Theory (NPT) framework. Multi-disciplinary clinic 'implementation teams' that include clinic staff and patients whose preferred language is Spanish will meet monthly during the first 6 months of clinic participation and aim to integrate into routine primary care the "I2" CRC screening tool, using the NPT-PLA intervention or control approach. The I2 tool addresses the "when," "where" and "how" details of stool sample or colonoscopy screening. The I2 tool will be delivered via an on-line survey or (if patients prefer) by paper form customized for use in English or Spanish. At least 100 patients in each clinic will be enrolled in the first 6 months of clinic participation (2000 in total). All patients eligible for CRC screening will be offered the I2 tool. Their choices will be communicated automatically to clinics for order entry. Primary (Aim 1) outcomes will be CRC screening orders placed (by clinic staff); completion of the I2 tool and CRC screening completion (by patients) over 6 months of patient follow-up. For Aim 2, surveys based on the NPT domains (the "NOMAD") will be used to assess staff comprehension of their role in implementing the I2-based CRC screening tool, its salience, their buy-in, feasibility of altering workflows, and the potential impact of using the tool in their setting. Investigators will conduct summative qualitative focus group discussions in all participating clinics after 6 months of clinic participation. The study will provide important information on barriers and facilitators of embedding NPT-PLA interventions in "real-world" primary care clinical settings.

Key Dates

Start date

Apr 30, 2025

Status verified

Mar 2026

Primary completion

Nov 30, 2028

Completion

Apr 30, 2029

Study Design

Enrollment

2,200 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SCREENING

Arms

• Active Comparator: Usual QI
  I-teams in each Usual QI clinic will be provided a pre-set protocol to implement the I2 tool into routine clinic CRC screening workflow (which they will define via a provided checklist). The protocol instructs the clinic to provide access to I2 zero to two weeks before a clinic visit, review the patient's I2 screening intentions with the patient in the clinic visit, at which time staff will order and schedule CRC screening in the visit. I2 may be completed on-line or via a paper form. I-teams will meet monthly to make progress on their implementation of I2, and complete a report/meet a study staff member monthly (separately) to report on their meetings and progress but will not receive coaching or skill training.
• Experimental: NPT-PLA
  Clinics randomized to NPT-PLA will also define their CRC screening workflow via a checklist and preset I2 implementation protocol but will be trained initially then receive monthly support to facilitate a "Participatory Learning in Action" (PLA) session. NPT-PLA i-teams will identify barriers and supports to I2 implementation, and use Normalization Process Theory (NPT) constructs to guide identification, selection and ordering of action steps to progress implementation e.g. "(before taking the step) does everyone understand the step to be taken, does everyone who needs to act 'buy in', (during implementation of the step) is everyone who needs to act actually taking action to complete the step, (after the step is taken) did taking the step have the intended impact, if not what happened?" . NPT-PLA I-teams can adapt the I2 implementation protocol to fit their context, including when and how patients are presented with I2, to maximize I2 implementation and CRC screening completion.

Primary Outcome Measure

Aim 1: Completion of CRC screening orders [ Time Frame: continuously monitored for 6 months after the patient is invited to complete the I2 tool during each clinic's participation month (0-12) ]

Central Contacts

• Joseph W LeMaster, MD MPH
  573-999-3366
  [email protected]
• Traci Buechner
  715-661-2422
  [email protected]

Locations (1)

Find similar trials in Aurora, CO

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