Funding for this research was provided by:
Helse Nord RHF (HST1242-15, # HST1243-15)
Received: 12 September 2018
Accepted: 1 August 2019
First Online: 3 October 2019
Ethics approval and consent to participate
: Patients enrolled in the PACT service had to provide an informed oral consent, documented in the Electronic Health Record (EHR), to receive the clinical PACT services. In the case of no consent, the patient would receive usual clinical care. The first patient was enrolled into the PACT service in October 2014.The Regional Ethics committee (REC) (#2014/1707/REK Sør-Øst A), found the intervention itself to be exempt from Ethics review.Even when REC does not review the intervention, REC is by law required to process requests to use routine EHR data for research without consent from patients. Due to high acute morbidity, challenging and overwhelming life situations, and a high proportion of patients with cognitive impairments, the recruitment of PACT patients into the evaluation study was slow. We therefore sought and was granted REC approval for the extraction of patient EHR data, without patient consent, under § 7–26 in the Personal Information Regulation, and the Health-provider Act §26. This approval was provided in October 2015.The privacy ombudsman approved the privacy and information security aspects of the study at the Univ hospital of North Norway (# 0547) in November 2015. Steps taken to ensure privacy protection were: the analytic files were de-identified, i.e. all direct identification variables had been replaced by a pseudonym. Analysis files were saved and analysed on “offline” devices/ computers. Only 3 researchers (GB, JH, TB1) had access to the analysis files. All intermediate and final results were fully anonymized.We report here on secondary outcomes extracted from the EHR: Mortality and health services utilization. The first EHR data were extracted in Jan 2016 after we had obtained necessary formal approvals from REC and the privacy ombudsman.Consent to publish from individual participant data is not applicable to this paper.We continue a consent based collection of Patient reported outcome measures. We enrolled the first patient for PROMs in Nov 2015, which is our primary outcome according to the published protocol. PROMs collection will continued until march 2019. These results will be published later in a separate paper.
: Not applicable
: The authors declare that they have no competing interests.