A lowered threshold to partnerships: a mixed methods process evaluation of participants' experiences of a person-centred eHealth intervention.

BACKGROUND: In order to understand pathways of complex interventions, the Medical Research Council has suggested that process evaluations should be conducted alongside randomised controlled trials (RCTs). This paper presents a mixed methods process evaluation of a complex, person-centred eHealth intervention for persons on sick leave with common mental disorders. AIM: The aim of the study was to explore participants' experiences of a person-centred eHealth intervention and illuminate meaningful activities and processes. METHODS: Participants were recruited from the intervention arm of an RCT (n = 102). Questionnaires on perceived meaningfulness of the overall intervention and intervention activities were sent to participants on two occasions, after 3 and 6 months, and semi-structured interviews were conducted with a purposeful sample of 15 participants in the intervention group. Questionnaire data were analysed using descriptive statistics, and interview data were analysed using qualitative content analysis. The quantitative and qualitative data strands were integrated at interpretation. RESULTS: At both follow-ups, a majority of participants reported that the intervention was fully or partly meaningful and that the most meaningful activity was the phone calls with health care professionals working in the intervention. In the qualitative analysis, three categories describing participants' experiences of the intervention were formed: Acknowledgment in a disconcerting situation, Finding ways forward and Unmet expectations. A synthesis of quantitative and qualitative findings resulted in the overarching theme of meaningfulness as constituted by a lowered threshold to partnerships: support within reach, when needed. CONCLUSION: Experiences of meaningfulness of the intervention were constituted by a lowered threshold to forming care partnerships, in which support was within reach, when needed. If the content of the intervention was not in accordance with individuals' needs or expectations, access alone did not suffice to constitute meaningfulness. TRIAL REGISTRATION: ClinicalTrials.gov; NCT03404583; 19/01/2018.

Effects of a Person-Centered eHealth Intervention for Patients on Sick Leave Due to Common Mental Disorders (PROMISE Study): Open Randomized Controlled Trial.

BACKGROUND: Sick leave due to common mental disorders (CMDs) is a public health problem in several countries, including Sweden. Given that symptom relief does not necessarily correspond to return to work, health care interventions focusing on factors that have proven important to influence the return to work process, such as self-efficacy, are warranted. Self-efficacy is also a central concept in person-centered care. OBJECTIVE: The aim of this study is to evaluate the effects of a person-centered eHealth intervention for patients on sick leave due to CMDs. METHODS: A randomized controlled trial of 209 patients allocated to either a control group (107/209, 51.2%) or an intervention group (102/209, 48.8%) was conducted. The control group received usual care, whereas the intervention group received usual care with the addition of a person-centered eHealth intervention. The intervention was built on person-centered care principles and consisted of telephone support and a web-based platform. The primary outcome was a composite score of changes in general self-efficacy (GSE) and level of sick leave at the 6-month follow-up. An intention-to-treat analysis included all participants, and a per-protocol analysis consisted of those using both the telephone support and the web-based platform. RESULTS: At the 3-month follow-up, in the intention-to-treat analysis, more patients in the intervention group improved on the composite score than those in the control group (20/102, 19.6%, vs 10/107, 9.3%; odds ratio [OR] 2.37, 95% CI 1.05-5.34; P=.04). At the 6-month follow-up, the difference was no longer significant between the groups (31/100, 31%, vs 25/107, 23.4%; OR 1.47, 95% CI 0.80-2.73; P=.22). In the per-protocol analysis, a significant difference was observed between the intervention and control groups at the 3-month follow-up (18/85, 21.2%, vs 10/107, 9.3%; OR 2.6, 95% CI 1.13-6.00; P=.02) but not at 6 months (30/84, 35.7%, vs 25/107, 23.4%; OR 1.8, 95% CI 0.97-3.43; P=.06). Changes in GSE drove the effects in the composite score, but the intervention did not affect the level of sick leave. CONCLUSIONS: A person-centered eHealth intervention for patients on sick leave due to CMDs improved GSE but did not affect the level of sick leave. TRIAL REGISTRATION: ClinicalTrials.gov NCT03404583; https://clinicaltrials.gov/ct2/show/NCT03404583.

The interactive work of narrative elicitation in person-centred care: Analysis of phone conversations between health care professionals and patients with common mental disorders.

INTRODUCTION: Narratives play a central part in person-centred care (PCC) as a communicative means of attending to patients' experiences. The present study sets out to explore what activities are performed and what challenges participants face in the interactive process of narrative elicitation, carried through in patient-professional communication in a remote intervention based on PCC. METHODS: Data were gathered from a randomized controlled trial (RCT) in a Swedish city where health care professionals (HCPs) conducted remote PCC for patients on sick leave due to common mental disorders. A sample of eleven audio-recorded phone conversations between HCPs and patients enroled in the RCT were collected and subjected to conversation analysis. RESULTS: Three interactive patterns in narrative elicitation were identified: Completed narrative sequences driven by the patient, question-driven narrative sequences guided by the HCP, and narrative sequences driven as a collaborative project between the patient and the HCP. In the question-driven narrative sequences, communication was problematic for both participants and they did not accomplish a narrative. In the other two patterns, narratives were accomplished but through various collaborative processes. CONCLUSION: This study provides insight into what challenges narrative elicitation may bring in the context of a remote PCC intervention and what interactive work patients and HCP need to engage in. Importantly, it also highlights tensions in the ethics of PCC and its operationalization, if the pursuit of a narrative is not properly balanced against the respect for patients' integrity and personal preferences. Our findings also show that narrative elicitation may represent an interactive process in PCC in which illness narratives are jointly produced, negotiated and transformed. PATIENT OR PUBLIC CONTRIBUTION: Stakeholders, including patient representatives, were involved in the design of the main study (the RCT). They have been involved in discussions on research questions and dissemination throughout the study period. They have not been involved in conducting the present study.

Person-centred eHealth intervention for patients on sick leave due to common mental disorders: study protocol of a randomised controlled trial and process evaluation (PROMISE).

INTRODUCTION: The number of people dealing with common mental disorders (CMDs) is a major concern in many countries, including Sweden. Sickness absence resulting from CMDs is often long-lasting and advancing return to work is a complex process impacted by several factors, among which self-efficacy appears to be an important personal resource. Person-centred care (PCC) has previously shown positive effects on self-efficacy however this needs to be further investigated in relation to patients with CMDs and in an eHealth context. METHODS AND ANALYSIS: This study is an open randomised controlled trial comparing a control group receiving standard care with an intervention group receiving standard care plus PCC by telephone and a digital platform. The primary outcome measure is a composite score of changes in sick leave and self-efficacy. Participants will include 220 primary care patients on sick leave due to CMDs and data will mainly be collected through questionnaires at baseline and 3, 6, 12 and 24 months from the inclusion date. Inclusion is ongoing and expected to be completed during the fall of 2020. A process and health economic evaluation will also be conducted. ETHICS AND DISSEMINATION: This study was approved by the Regional Ethical Review Board in Gothenburg, Sweden. Results will be published in peer-reviewed scientific journals and presented at national and international scientific conferences. This project is part of a broader research programme conducted at the Gothenburg Centre for Person-Centred Care (GPCC), where extensive work is undertaken to disseminate knowledge on and implementation of PCC. TRIAL REGISTRATION NUMBER: NCT03404583.