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Project OASIS: Optimizing Approaches to Select Implementation Strategies (OASIS)

Primary Purpose

Cirrhosis, Hepatocellular Carcinoma

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
OASIS DA training
Current DA Tool training
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Cirrhosis focused on measuring Implementation science, Implementation strategies, Implementation barriers, Consolidated Framework for Implementation Research, Expert Recommendations for Implementing Change, Precision implementation, Liver cancer, Early detection of cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Veterans: Veterans with two outpatient or one inpatient codes for cirrhosis or its complications who had an encounter in the prior 18 months at a participating VA medical center VA clinicians: Physicians, advance practice providers, nurses, leadership, and staff engaged with selecting and applying implementation strategies to improve care at a participating VA medical center Exclusion Criteria: Veterans post-transplant or with active hepatocellular carcinoma

Sites / Locations

  • VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

OASIS DA

Current DA Tool

Arm Description

Half of the sites will be randomized to receive training on the OASIS decision aid.

Half of the sites will be randomized to receive training on the current decision aid tool.

Outcomes

Primary Outcome Measures

Reach as assessed by hepatocellular carcinoma (HCC) screening rates
Reach of an intervention refers to the absolute number, proportion, and representativeness of individuals who are willing to participate in a given intervention. The reach outcome will be the percentage of active VA patients with a diagnosis of cirrhosis receiving guideline-concordant abdominal imaging every 6 months.
Effectiveness as assessed by patient outcomes
Effectiveness is the impact of an intervention on important individual outcomes. Patient outcomes such as cancers detected and linkage to curative treatment will be used to assess effectiveness.
Adoption as assessed by % improvement in HCC screening performance
Adoption is the absolute number, proportion, and representativeness of settings/people who are willing to initiate a program. The investigators will assess adoption by the percent improvement in screening performance at intervention sites from pre- to post-intervention.
Implementation as assessed by fidelity to HCC screening recommendations
Implementation is the extent to which an intervention is delivered as intended. The investigators will assess implementation by the proportion of patients at an intervention site receiving all hepatocellular carcinoma screening as recommended (correct timing and modality).
Maintenance as assessed by maintenance of other measures
Maintenance is the extent to which a program becomes part of routine organizational practices. The investigators will assess maintenance by sustainment of all above outcomes at 6 months post-intervention.

Secondary Outcome Measures

Acceptability of Intervention Measure (AIM)
Acceptability refers to a given innovation being perceived as agreeable, palatable, or satisfactory by implementation stakeholders. The AIM is a 4-item measure scored on a 5-point Likert scale.
Intervention Appropriateness Measure (IAM)
Appropriateness is the perceived fit of an innovation to address a particular issue or problem. The IAM is a 4-item measure on a 5-point Likert scale.
Feasibility of Intervention Measure (FIM)
Feasibility refers to the extent to which an innovation can be successfully used within a given setting. The FIM is a 4-item measure on a 5-point Likert scale.

Full Information

First Posted
September 21, 2023
Last Updated
September 27, 2023
Sponsor
VA Office of Research and Development
Collaborators
VA Pittsburgh Healthcare System, VA Ann Arbor Healthcare System, VA Palo Alto Health Care System
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1. Study Identification

Unique Protocol Identification Number
NCT06061328
Brief Title
Project OASIS: Optimizing Approaches to Select Implementation Strategies
Acronym
OASIS
Official Title
Project OASIS: Optimizing Approaches to Select Implementation Strategies
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
October 31, 2027 (Anticipated)
Study Completion Date
October 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
Collaborators
VA Pittsburgh Healthcare System, VA Ann Arbor Healthcare System, VA Palo Alto Health Care System

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Barriers that prevent healthcare methods supported by science from being adopted in the real world have led to low-quality, inequitable medical care. Implementation science aims to bridge the evidence-to-practice gap but still lacks simple and convenient methods to identify implementation barriers, systematically track which strategies work to improve care, and provide accessible data and expert recommendations to guide implementation strategy selection for use in research and practice. Project OASIS (Optimizing Approaches to Select Implementation Strategies) will conduct a hybrid type-III, cluster-randomized trial of a new decision aid tool that matches site variables and barriers to successful implementation strategies.
Detailed Description
Implementation science aims to improve the uptake of evidence-based health care practices (EBPs) by defining barriers that prevent their use, offering strategies to overcome these barriers, and developing methods that help clinicians and researchers choose strategies that best address the barriers they encounter. With strategy selection often being inefficient and idiosyncratic, experts have called for methods to make strategy selection scientific, data-driven, and "precise." This "precision implementation" causes a critical need to identify implementation barriers and facilitators quickly and uniformly, track implementation strategy use and effectiveness, and incorporate data and expert knowledge into the process of matching strategies to barriers. Without these improvements, there is a risk of perpetuating implementation failures and health care disparities. Project OASIS (Optimizing Approaches to Select Implementation Strategies) will conduct a cluster-randomized, hybrid type III trial to compare a machine learning derived decision aid (DA) for selecting implementation strategies with a current expert opinion-based tool in 20 VA medical centers. The investigators will apply the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) evaluative framework and assess rates of hepatocellular carcinoma screening (an EBP) for Veterans with cirrhosis at these sites. As this is a facility-level intervention, Veterans with cirrhosis will be cluster randomized to the DA vs. Current Tool arms. The investigators anticipate that Veterans at sites in the DA arm will be significantly more likely to receive screening than Veterans at sites in the Current Tool arm.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cirrhosis, Hepatocellular Carcinoma
Keywords
Implementation science, Implementation strategies, Implementation barriers, Consolidated Framework for Implementation Research, Expert Recommendations for Implementing Change, Precision implementation, Liver cancer, Early detection of cancer

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This hybrid type III trial will compare the effectiveness and implementation of the decision aid (DA) vs. Current Tool to improve liver cancer screening for Veterans with cirrhosis in 20 VA sites, as well as assess how users make decisions based on the source of the recommendation (e.g., expert opinion vs. machine-derived). VA clinicians in both arms will receive a one-time 1-hour webinar training on either the new DA or the Current Tool. Trainers will be available to provide technical assistance after the webinars during the 6-month implementation phase but will not provide additional implementation support. Participants will be encouraged to initiate the recommended strategies within 3 months of training.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
8020 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
OASIS DA
Arm Type
Experimental
Arm Description
Half of the sites will be randomized to receive training on the OASIS decision aid.
Arm Title
Current DA Tool
Arm Type
Active Comparator
Arm Description
Half of the sites will be randomized to receive training on the current decision aid tool.
Intervention Type
Behavioral
Intervention Name(s)
OASIS DA training
Intervention Description
The OASIS decision aid is a novel implementation strategy selection tool developed by a multidisciplinary team of experts using machine learning algorithms and user-centered design approaches.
Intervention Type
Behavioral
Intervention Name(s)
Current DA Tool training
Intervention Description
The CFIR-ERIC Matching Tool is a currently available decision aid tool for selecting implementation strategies that is based on expert opinion.
Primary Outcome Measure Information:
Title
Reach as assessed by hepatocellular carcinoma (HCC) screening rates
Description
Reach of an intervention refers to the absolute number, proportion, and representativeness of individuals who are willing to participate in a given intervention. The reach outcome will be the percentage of active VA patients with a diagnosis of cirrhosis receiving guideline-concordant abdominal imaging every 6 months.
Time Frame
measured quarterly 1 year pre-intervention through 6 months post-intervention
Title
Effectiveness as assessed by patient outcomes
Description
Effectiveness is the impact of an intervention on important individual outcomes. Patient outcomes such as cancers detected and linkage to curative treatment will be used to assess effectiveness.
Time Frame
measured quarterly 1 year pre-intervention through 6 months post-intervention
Title
Adoption as assessed by % improvement in HCC screening performance
Description
Adoption is the absolute number, proportion, and representativeness of settings/people who are willing to initiate a program. The investigators will assess adoption by the percent improvement in screening performance at intervention sites from pre- to post-intervention.
Time Frame
measured quarterly 1 year pre-intervention through 6 months post-intervention
Title
Implementation as assessed by fidelity to HCC screening recommendations
Description
Implementation is the extent to which an intervention is delivered as intended. The investigators will assess implementation by the proportion of patients at an intervention site receiving all hepatocellular carcinoma screening as recommended (correct timing and modality).
Time Frame
measured quarterly 1 year pre-intervention through 6 months post-intervention
Title
Maintenance as assessed by maintenance of other measures
Description
Maintenance is the extent to which a program becomes part of routine organizational practices. The investigators will assess maintenance by sustainment of all above outcomes at 6 months post-intervention.
Time Frame
6 months post-intervention
Secondary Outcome Measure Information:
Title
Acceptability of Intervention Measure (AIM)
Description
Acceptability refers to a given innovation being perceived as agreeable, palatable, or satisfactory by implementation stakeholders. The AIM is a 4-item measure scored on a 5-point Likert scale.
Time Frame
up to 4 weeks, 6 months post-intervention
Title
Intervention Appropriateness Measure (IAM)
Description
Appropriateness is the perceived fit of an innovation to address a particular issue or problem. The IAM is a 4-item measure on a 5-point Likert scale.
Time Frame
up to 4 weeks, 6 months post-intervention
Title
Feasibility of Intervention Measure (FIM)
Description
Feasibility refers to the extent to which an innovation can be successfully used within a given setting. The FIM is a 4-item measure on a 5-point Likert scale.
Time Frame
up to 4 weeks, 6 months post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Veterans: Veterans with two outpatient or one inpatient codes for cirrhosis or its complications who had an encounter in the prior 18 months at a participating VA medical center VA clinicians: Physicians, advance practice providers, nurses, leadership, and staff engaged with selecting and applying implementation strategies to improve care at a participating VA medical center Exclusion Criteria: Veterans post-transplant or with active hepatocellular carcinoma
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shari S Rogal, MD MPH
Phone
(412) 360-2149
Email
shari.rogal@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shari S. Rogal, MD MPH
Organizational Affiliation
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15240
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathleen M Parks
Phone
412-360-2396
Email
Kathleen.Parks@va.gov
First Name & Middle Initial & Last Name & Degree
Shari S. Rogal, MD MPH

12. IPD Sharing Statement

Plan to Share IPD
No

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Project OASIS: Optimizing Approaches to Select Implementation Strategies

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