IMPLEMENT-IT: Collective implementation in primary and specialised health care – a multimethod study on four different health service domains.

At present, Norwegian health services often offer patient care based on previous or outdated recommendations. Each year more than 600 patients die or suffer severe complications due to harmful or inappropriate care in Norwegian hospitals alone. The main challenge for health care services is their capability and efficiency to implement new and updated knowledge into every-day practice, often through intervention bundles. Through the intervention study Implement-it we will investigate conditions and factors associated with successful adaptation of new knowledge, develop a training and supportive intervention program, and test its impact on implementation and patient outcome. 

Implement-it is a research collaboration between primary health care, hospitals, universities and patient representatives, lead by Helse Bergen and Helse Fonna Health Trusts in Norway. We aim to learn together with and from health care providers across nursing homes, homebased care, medical services in primary health care and hospitals to implement defined patient safety intervention bundles such as the appropriate use of antibiotics, accuracy of medication lists, detection and handling detoriating patients, and/or patient involvement in planning of mental health care. Our aim is to improve knowledge on efficient implementation and improve health services' competence on how to integrate new evidence based practices into everyday clinical practice. By this, we expect to contribute to a faster and wider spread of updated clinical practices and thereby improve the probability of survival, improved prognosis and quality of life. 

Knowledge Needs (KN), Objectives (O) and Research Questions (RQ). Care interventions implemented collectively across care units and organisational levels are often insufficient and limited due to limited compliance, penetration and sustainability. This gives limited returns and lack of high quality health care, and is particularly challenging with interventions jointly across organisational boundaries. We need more knowledge on cooperative implementation. We propose a faster up-take of recommended clinical practices across organisational boundaries. Our research objectives are how to improve implementation of patient safety intervention-bundles across primary and secondary health care settings. We will study successful antibiotic stewardship programs (ASP), and investigate if the implementation of national guidelines for detecting deteriorating patients, medication reconciliation and patient involvement in mental health care may improve by learning from the ASP implementation success.

KN1: Implementing complex interventions effectively. Implementation of interventions across health services such as hospitals, nursing homes, general practice offices and home care require changes involving several organisations, professions and departments. We need to understand why and how to succeed here. 

KN2: Practitioners’ and managers’ implementation knowledge. Health care providers need more theoretical knowledge and practical skills in implementation.

KN3: Implementation science research methods gap. Implementation science started enabling practitioners and managers to copy exactly interventions proven effective elsewhere. However, local adaptations are necessary, with a need to study these, including implementation outcomes, such as acceptability, feasibility and suitability, fidelity and level of uptake of an intervention in particular settings. This is to comprehend why and how patient outcomes improve.

KN4: Learning across medical fields and health services. By studying implementation across different interventions and health services, we can generate knowledge for use across healthcare services.

O: Developing/testing  a program for effective cooperative implementations between patients, health professions and health services, to accomplish cost-effective scale-ups of recommended interventions to improve patient safety, enabling faster dissemination of recommended care in both primary and secondary care and improving outcomes.

RQ1. What are the most important mechanisms and structures for implementation of patient safety intervention-bundles in primary and secondary care settings, as experienced by health care providers?

RQ2. Which combinations of structures and processes are associated with positive implementation outcomes in primary and secondary care settings?

RQ3. Which practical patient-, manager- or clinician activities facilitate the structures and mechanisms associated with positive implementation outcome?

RQ4. What constitutes a program for effective implementation of evidence-based patient safety bundles?

RQ5. To what degree do primary and secondary health services implement a defined patient safety intervention-bundle when following a defined program for implementation, compared to when not following such a program

Phase 1

Literature review in accordance with the PRISMA standard to defined structures andmechanisms found to be associated with implementation success within both primary andsecondary health services, considering antibiotic stewardship programs (ASP, rapid response systems (RRS) and medication reconciliation (MR). 

Focus group interviews with health professionals. Semi structured interview-guide based onresults from the literature review and open questions to reveal new insights. Sample: approx.10 units that have implemented ASPs successfully, supported by 2-3 units with limited success to detect diversity, units being hospitals, general practitioners’ offices, nursing homes and home care. Analyse: Structured content analysis

Surveys: How employees interpret structural and processual factors expected to beimportant for successful implementation: The 27 item validated Implementation ProcessAssessment Tool (IPAT). Sample: 10-15 employees from the same 10 successful units asthe interviews and 10 units with varying degree of success. Analyses: Multi-variatecorrelation analyses on IPAT-scores and degree of implementation outcome.Available information on implementation structures and activities from the national network on antibiotic usage. Sample: Implementation efforts in most Norwegian primary andspecialised health services. Analyses: Multi-variate correlation analyses on structures and activities conducted with implementation outcome.

Phase 2

Development of a middle range theory with context-mechanism-outcome (CMO) propositions basedon results from phase 1. 

Phase 3Gather qualitative and quantitative descriptions of the structures and activities (defined byCMO propositions in phase 2) to enable implementation.

Sample: 4-6 units for each of intervention-bundles (in sum: 16-24 units). Hospitals, GPs offices,nursing home and home care will be represented. Also, we may consider inclusion of unitsintending to implement the new combination of the WHO Surgical Safety checklist andSurgical Patient Safety System, recently found to be even more effective than the WHOChecklist alone. Qualitative focus group interview with employees will be conducted pre andpost intervention. IPAT-survey (see description in phase 1) at baseline, after 6 months and after 12 months.Sample: 10-15 employees at the 16-24 units (intervention-arm) and at 8-10 unitsimplementing the bundles without receiving defined support (control-arm). Analyses: multivariateregression analyses to investigate the suggested propositions (hypotheses). Implementation outcomes will be measured by a developed fidelity-score (defining thedegree of compliance to the intervention-bundle) and by penetration (number of patientsreceiving the recommended intervention of those eligible). Sample: Data from each of the16-24 intervention-units and the 8-10 control-units. It will be supported by data from thenational improvement and research register for these intervention-bundles. Analyses:Triangulation of comparisons by pre-post within unit (process), between intervention andcontrol units within same intervention bundle (structure), and between units representingsame type of health service (context) to investigate the propositions suggested in phase 2.Patient- or population outcomes will be measured by existing indicators for each of theintervention-bundle, such as reported adverse events and others that are developed at anational level. For patient-involvement in mental health care, patient referred to specialisedmental health care will be invited to a patient survey on their experiences with theinvolvement in the planning and referral process