Table 1 Intervention description

Brief name

Provide the name or a phrase that describes the intervention

A multicomponent complex nurse-delivered intervention informed by the European Society of Cardiology guidelines for a supportive follow-up of persons with heart failure

Why

Describe any rationale, theory, or goal of the elements essential to the intervention

 - The 2016 European Society of Cardiology guidelines [2] recommend a structured multicomponent supportive follow-up in HF including (a) patients’ symptom monitoring and self-care capabilities support; (b) early detection of impending decompensation; (c) optimized medical and device treatment; (d) patient self-care education; (e) psychosocial support for patients and families; (f) facilitated access to care; and (g) multidisciplinary collaboration

 - Small-scale studies conducted to define the problem and determine the needs within our context showed, that

  ○ Physicians and nurses reported important barriers to patient-centred care but felt a strong need to provide it [24]

   ▪ Goal: use a patient-centred approach

  ○ Persons with HF reported a high prevalence of inadequate self-care on virtually all relevant items, while showing important clinical characteristics that would potentially limit their self-care capabilities [25]

   ▪ Goal: considering self-care capabilities alongside patients’ vulnerability characteristics

  ○ Nurse-provided HF patient education rarely addressed individuals’ self-care levels and barriers to self-care as well as nurses reported a lack of appropriate time or role to perform adequate patient self-care education [26]

   ▪ Goal: considering self-care capabilities to make patient self-care education meaningful; considering providing nurse support for, e.g. symptom stability

   ▪ Goal: offering several follow-up visits and on a needs-led basis

 - Central foci /priorities from a range of patients’ self-care capabilities

  ○ Symptom management: in our previous study on this topic, only 10% of patients reported adequate responses when experiencing dyspnoea or peripheral oedema, while 61% reported confidence in their abilities to react appropriately when symptoms occurred (implication: perceived self-efficacy does not reliably reflect patients’ actual symptom management abilities as they arise) [25]

  ○ Medication adherence: medication non-adherence jeopardizes outcomes [2]

  ○ Physical activity: regular aerobic exercise improves functional capacity and symptoms and improves outcomes in persons with HF [2]

 - Combination of counselling, care and treatment [19]:

  ○ Assessment of patients’ self-care capabilities

  ○ Assessment of the patients’ health status, symptom experience, and barriers to self-care

Goal: to provide standardized, tailored self-care education and symptom management support, to support self-care capabilities, to facilitate multidisciplinary collaboration to improve negative outcomes

What materials

Materials: Describe any physical or informational materials used in the intervention, including those provided to participants or used in intervention delivery or in training of intervention providers. Provide information on where the materials can be accessed (e.g. online appendix, URL)

 - Intervention manual

 - French or German version of the “Heart Failure Patient kit” from the Swiss Heart Foundation by a research assistant

 - Web-based self-report tool (see below for description) access via tablet

 - Vscan Extend Dual Wi-Fi portable ultrasound device

 - Stethoscope, blood pressure, thermometer, pulsoximeter, balance

 - Paper-based folder containing the intervention manual; patient-reported outcome measures; key scientific articles related to the intervention components; list of contact information of regional cardio groups, physical activity groups, physiotherapists providing home therapies, home care services, mobile palliative care services

Procedures

Describe each of the procedures, activities, and/or processes used in the intervention, including any enabling or support activities

Before discharge of hospitalization during recruitment into the study:

Provision of the French or German version of the “Heart Failure Patient kit” brochure from the Swiss Heart Foundation (https://www.swissheart.ch); provision of patient self-care education

Intervention during 90-day follow-up:

 1. Nurse-patient direct contact

  a. Assessment of health status, self-care capabilities, and depressive symptomatology via patient self-completion of a series of questions using a web-based self-report tool, specifically developed for this study based on previous work, structured in four parts. To facilitate each instrument’s clinical applicability, we chose the shortest available version of each instrument

   i. One open question to assess a patient’s salient beliefs concerning living with HF (“What do you think of when you think of living with HF?”) ([35], p 6)

   ii. The 22-item Self-Care of Heart Failure Index (SCHFI) (French and German (for Switzerland) versions) to assess self-care capabilities [36]

   iii. The 12-item Kansas City Cardiomyopathy Questionnaire (KCCQ) (French and German versions) to assess disease-specific health status [37], plus a single item from the 23-item KCCQ to measure symptom stability [38]; and

   iv. The two-item Patient Health Questionnaire-2 (PHQ-2) (French and German versions) to assess depressive symptomatology [39]

   v. Nurse assessment of the patient’s main complaint and clinical assessment focusing on health status and fluid overload, including vital signs, pulmonary auscultation, peripheral oedema and the use of the V-scan hand-held ultrasound [40, 41]

   vi. Nurse-patient discussion of the assessments results

    1. Review of the color-coded graphic results (generated of the web-based system according to the scoring and cut-off levels of the respective questionnaires), both on individual items and on each measured dimension (e.g. inadequate self-care maintenance; symptom frequency)

    2. Evaluation of the clinical assessment results

    3. In case of significant health deterioration [42] as judged by the nurse, immediate contact to the study cardiologist for medical evaluation

    4. Nurse-patient exploration of priorities for support needs, according to the algorithm in the intervention manual considering assessment results and related risk for negative outcomes

    5. Nurse provision of related counselling using a person-centred approach [43], teach-back techniques [44] and principles of motivational interviewing

    6. Nurse suggestion of a follow-up procedure, ensuring appropriate care including

     a. Nurse contact and support to take appropriate actions and to make timely checks of the efficacy of the measure taken

     b. Encouragement of patient and family member to contact the nurse for guidance in interpreting symptoms

 2. Write-up of the report on each relevant consultation, within one to seven days following the patient visit

  a. Review of assessment results, report and suggested follow-up procedures and provision of feedback on the results by the study’s Principal Investigator (PSK) to the intervention nurse

 3. Discussion with the cardiologist following the patient visit

  a. Discussion between the intervention nurse and the study’s cardiologist (DG) of the nurse presented patient situation, follow-up procedures and report regarding the patient situation/main complaint, assessment results, interpretation, procedures and follow-up as well as in view of the medical plan and treatment where relevant

 4. Provision of the collaborative written report to the general practitioner, the private cardiologist (if applicable), any home care personnel (if applicable), and the patient; upload to the hospital medical records archive

Who provided

For each category of intervention provider (e.g. psychologist, nursing assistant), describe their expertise, background and any specific training given

 1. Provision of the brochure and patient self-care education during in-hospital phase:

  a. Provision of the brochure: Research assistants (all with a master-degree in nursing science) during recruitment

  b. Provision of patient self-care education: Registered nurses with a bachelor degree or equivalent with or without postgradual education in cardiology care, working in the cardiology clinic or at a medical ward at the hospital

  c. Specific preparation: Refresher on providing patient education principles for persons with HF including the appropriate use of the respective patient education materials (2-h team meeting)

 2. Delivery of the intervention:

  a. Registered nurses with a bachelor or master degree, currently working as a nurse lecturer or scientific collaborator. Main professional clinical experience in internal medicine wards or intensive care unit of a teaching or university hospital. No previous experience in focused examination of the lungs using a hand-held pocket-sized ultrasound. Novice to the multicomponent intervention, but all with postgradual education in motivational interviewing, and experience in providing patient self-care education and conducting clinical assessment

  b. Specific preparation:

   i. Two-day education session on the intervention manual including a) the review and discussion of all intervention components; b) the use of the questionnaires for the evaluation of self-care capabilities, health status, and depressive symptomatology, the interpretation of results, scores as well as review of the algorithm for priority setting and activities; and c) the discussion of the delivery of the intervention using simulated scenarios; education provided by the principal investigator (PSK) who holds a PhD in Nursing Science and has professional experience as advanced nurse practitioner; assisted by a research assistant (JG) who holds a master degree in Nursing Science and has professional experience in palliative home-based care

   ii. One-day education session: refresher on clinical assessment, focus on the cardiovascular system; education provided by a nurse lecturer

   iii. One-day training on the correct use of the hand-held pocket-sized ultrasound device and interpretation of images of a focused lung examination for signs of fluid overload in view of detection of early decompensation; education provided by a physician of the emergency department of the hospital

How

Describe the modes of delivery (e.g. face-to-face or by some other mechanism, such as internet or telephone) of the intervention and whether it was provided individually or in a group

 - Face-to-face contact with a patient, accompanied or not by a family member

 - Telephone contacts via phone calls to the patient

Where

Describe the type(s) of location(s) where the intervention occurred, including any necessary infrastructure or relevant features

 - Clinic visits at the cardiology department of the hospital, in a separate room

 - Home visits at a patient’s home

When and how much

Describe the number of times the intervention was delivered and over what period of time including the number of sessions, their schedule, and their duration, intensity or dose

During a period of 3 months, follow-up included 2.14 (mean, ± 0.97) visits per patient lasting a total of 166.96 min (mean, ± 72.55); and 3.1 (mean, ± 1.7) additional telephone contacts

 0. Visit pre-intervention delivery before hospital discharge during recruitment period

 1. First intervention delivery realized between day 7 and 15 after hospital discharge

  a. Schedule of a 1-h visit

  b. Normally scheduled at the cardiology outpatient; at the patient’s request, visit/s occurred at the patient’s home (e.g. for restricted mobility reasons)

   i. In cases of assessment of severe health problems that required immediate treatment (e.g. rapid worsening of dyspnoea), the nurse contacted to study cardiologist for medical evaluation

 2. Further intervention delivery visits were scheduled on a needs-led basis during a period of 3 months (e.g. if further patient education was necessary, or in cases of unstable symptoms of worsening heart failure)

 3. Additional telephone contacts were realized in case of following up activities taken against unstable symptoms

  a. At telephone contacts, in cases of severe health problems that required immediate treatment (e.g. rapid worsening of dyspnoea), patients were encouraged and, if necessary, assisted to contact their general practitioners and/or the emergency services

Tailoring

If the intervention was planned to be personalized, titrated or adapted, then describe what, why, when, and how

 - Consistent procedures and use of a person-centred approach [43] and motivational interviewing principles [30]

 - Personalized priority setting based on an individual’s assessment results of health status [37, 38, 42] and self-care capabilities [36]; and self-care support priorities on symptom stability [2], medication adherence [2], and physical activities [2] (see algorithms in the intervention manual). Provision of several follow-ups in the patient’s preferred setting, with tailoring of the intervention to fit individual situations, based on:

 - Objective and subjective information obtained via patient assessment

 - Each nurse’s clinical judgement and expertise concerning each patient’s situation and needs

 - Related follow-up priorities

Modifications

If the intervention was modified during the course of the study, describe the changes (what, why, when, and how)

None

How well

How well. Planned: If intervention adherence or fidelity was assessed, describe how and by whom, and if any strategies were used to maintain or improve fidelity, describe them

Assessment of intervention fidelity

 - Nurse report via completion of a 7-item paper-based checklist at the end of each relevant consultation

Maintaining intervention fidelity

 - Review of the nurse documentation regarding each patient situation, main complaint, assessment results, intervention priorities, report of each consultation by the study PI; nurse-study PI discussion in case of disagreements

 - Nurse group discussions on patient situations and intervention priorities with the PI and a research assistant (JG)

 - Two group discussions with two HF nurse experts external to the core group

Actual

Actual. If intervention adherence or fidelity was assessed, describe the extent to which the intervention was delivered as planned

Proportion of yes responses to the intervention components:

 (a) patient involvement in symptom monitoring and support for self-care capabilities;

 (b) facilitation of early decompensation detection;

 (c) optimized medical and device treatment following ESC guidelines;

 (d) psychosocial support for patient and family;

 (e) patient education;

 (f) easy access to care; and

 (g) facilitation of multidisciplinary collaboration.