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Table 1 SDM development and acceptability testing process

From: Shared decision-making and planning end-of-life care for patients with end-stage kidney disease: a protocol for developing and testing a complex intervention

Phase/study

Objective

Framework

Method

1/1

To synthesise empirical evidence of patient involvement interventions for patients with ESKD making EoLC decisions in Denmark and internationally

UKMRC

MORECare

JBI

PRISMA-ScR

Literature search through the databases; PubMed, Embase, CINAHL, and Scopus and a Grey literature search.

Inclusion/exclusion of literature using Covidence.

Scoping review of included literature.

Synthesising evidence.

1/2

To explore experiences and needs for involvement in EoLC for patients with ESKD, their relatives, and HPs

UKMRC

MORECare

MIND-IT

Present and carry out semi-structured interviews with patients having ESKD, relatives, and HPs.

Around 12 patients, 12 relatives, and 12 HPs will be interviewed.

1/3

Synthesising the primary and secondary findings from the research and structure a prototype of the SDM intervention

UKMRC

MORECare

MIND-IT

IPDAS

ODSF

IP-SDM Model

Based on the synthesised evidence through phase 1, study 1 and 2, and supported by methods for developing SDM interventions and relevant theory, a prototype of the SDM intervention will be developed and evaluated during workshops involving expert consensus from the steering committee.

2/4

To test if the SDM intervention for planning EoLC is acceptable to patients with ESKD, their relatives and the HPs

UKMRC

MORECare

MIND-IT

IPDAS

A pragmatic, pilot, randomized controlled, non-blinded multicenter superiority trial design will be used to test the SDM intervention in the participating nephrology units.

Different questionnaires will be introduced and carried out to evaluate the patient reported outcomes on the SDM intervention, to evaluate the decision support provided by the HPs, and to evaluate if the intervention leads to better healthcare.

  1. UKMRC the UK Medical Research Council framework for developing complex interventions, MORECare the Methods of Researching End of Life Care statement, JBI Joanna Briggs Institute, PRISMA-ScR Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews Checklist, MIND-IT Making Informed Decisions, Individually and Together, IPDAS the International Patient Decision Aid Standards guideline, ODSF the Ottawa decision support framework, IP-SDM Model the interprofessional shared decision-making model