Utvärdering av en personcentrerad e-Hälsa plattform vid långvarig sjukdom - en
randomiserad kontrollerad studie med exemplen kronisk hjärtsvikt och KOL

Project number : 224881
Created by: Inger Ekman, 2017-03-20
Last revised by: Inger Ekman, 2018-01-07 Verified: 2018-11-25
Project created in: FoU i Västra Götalandsregionen

PublishedPublished

1. Översiktlig projektbeskrivning

Engelsk titel

Evaluation of a person-centred eHealth-platform in long term illness - a randomized controlled trial exemplied by chronic heart failure and chronic obstructive pulmonary disease

Populärvetenskaplig sammanfattning av projektet

I kontrollerade studier har vi visat att personcentrerad vård ger bl a kortare vårdtider, minskad känsla av osäkerhet och ökad tillit till sin egen förmåga. Vi har också visat att ett personcentrerat web- och smartphone-baserat eHälsa stöd i form av en elektronisk hälsodagbok är både användarvänligt och resulterar i hälsoförbättringar. Kronisk hjärtsvikt och kronisk obstruktiv lungsjukdom (KOL) är tillstånd med låg livskvalitet och upprepade slutenvårdstillfällen. Syftet med projektet är att beskriva utveckling av, och utvärdering av personcentrerad vård via en eHälsa-plattform vid långvariga tillstånd såsom kronisk hjärtsvikt och KOL. Frågeställningen är om personcentrerad vård via en eHälsa-plattform kan stärka självtillit och minska sjukhusinläggningar hos personer med kronisk hjärtsvikt och/eller KOL. Att ersätta fysiska möten med stöd av digitalisering och utveckla ett partnerskap över distans är banbrytande och en möjlighet att effektivisera vården. I denna studie med en participatorisk design inkluderas samtliga användare i utvecklingsprocessen vilket ger goda förutsättningar för implementering. Hälso- och sjukvård av lågutbildade och av personer med utländsk bakgrund är sämre i flera avseenden, inte minst vid kroniska sjukdomar såsom kronisk hjärtsvikt och KOL. I våra tidigare studier har vi kunnat visa att personcentrerad vård haft störst effekt i form av reducerad vårdtid och ökad självtillit bland sköra äldre och personer med lägre utbildning och socioekonomiskt status. Forskningsprogrammet har en ”embedded” design bestående av faser som går stegvis men också överlappande och innebär såväl en beskrivande, utforskande del som en randomiserad kontrollerad utvärdering. I studien ska en generisk eHälsa plattform fungera som ett verktyg inte bara för personalen och patienterna utan även för de närstående. Självtillit och återinläggning samt den totala samhälleliga kostnaden mellan kontroll- och interventionsgrupp kommer att utvärderas.

Vetenskaplig sammanfattning av projektet

In controlled studies, we have shown that person-centred care provides among other things, shorter hospital stay, reduced sense of uncertainty and increased self-efficacy. We have also shown that a person-centred web and smartphonebased eHealth support in the form of an electronic health diary is both user friendly and results in health improvement. Chronic heart failure and chronic obstructive pulmonary disease (COPD) are conditions with low quality of life and characterized by rehospitalizations. The project aims to describe the development and evaluation of person-centred care through an eHealth platform for long-term conditions such as chronic heart failure and COPD. The question is whether person-centred care through an eHealth platform can strengthen self-efficacy and reduce hospitalizations in people with chronic heart failure and or COPD? Replacing physical meetings with eHealth and develop a partnership over distance is a brake through opportunity to make care more efficient. In this study we have chosen a participatory design including all the users (patients, relatives and health professionals) in the development process to facilitate implementation. Health care of low-skilled and people with a foreign background are worse in many respects, especially in chronic diseases such as chronic heart failure and COPD. In our previous studies, person-centred care had the greatest impact in terms of reduced hospital stay and increased self-efficacy among the frail elderly and people with lower education and socioeconomic status. The research program has an "embedded" design consisting of phases stepwise but also overlapping and presents both a descriptive, exploratory part as a randomized controlled evaluation. In the study, a generic eHealth platformwill serve as a tool not only for staff and patients, but also for the relatives. Self-efficacy and rehospitalization and total societal costs between the control and intervention groups will be evaluated.

Typ av projekt

Forskningsprojekt

MeSH-termer för att beskriva typ av studier

checked Randomiserad klinisk prövning (Randomized Controlled Trial)


(Only selected options are displayed. Click here to display all options)

MeSH-termer för att beskriva ämnesområdet

information Added MeSH terms
Heart Failure
A heterogeneous condition in which the heart is unable to pump out sufficient blood to meet the metabolic need of the body. Heart failure can be caused by structural defects, functional abnormalities (VENTRICULAR DYSFUNCTION), or a sudden overload beyond its capacity. Chronic heart failure is more common than acute heart failure which results from sudden insult to cardiac function, such as MYOCARDIAL INFARCTION.
Pulmonary Disease, Chronic Obstructive
A disease of chronic diffuse irreversible airflow obstruction. Subcategories of COPD include CHRONIC BRONCHITIS and PULMONARY EMPHYSEMA.

Projektets delaktighet i utbildning

checked Avhandling


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2. Projektorganisation och finansiering

Arbetsplatser involverade i projektet

information Added workplaces
Regioner - Västra Götalandsregionen - Närhälsan - Vårdcentraler - Område V3 - Närhälsan Backa vårdcentral (Göteborg) workplace verified by Västra Götalandsregionen on 2018-02-27
Regioner - Västra Götalandsregionen - Närhälsan - Vårdcentraler - Område V3 - Närhälsan Biskopsgården vårdcentral (Göteborg) workplace verified by Västra Götalandsregionen on 2018-02-27
Regioner - Västra Götalandsregionen - Närhälsan - Vårdcentraler - Område V3 - Närhälsan Bjurslätt vårdcentral (Göteborg) workplace verified by Västra Götalandsregionen on 2018-02-27
Regioner - Västra Götalandsregionen - Närhälsan - Vårdcentraler - Område V3 - Närhälsan Brämaregården vårdcentral (Göteborg) workplace verified by Västra Götalandsregionen on 2018-02-27
Regioner - Västra Götalandsregionen - Närhälsan - Vårdcentraler - Område V3 - Närhälsan Eriksberg vårdcentral (Göteborg) workplace verified by Västra Götalandsregionen on 2018-02-27
Regioner - Västra Götalandsregionen workplace verified by Västra Götalandsregionen on 2018-02-27
Regioner - Västra Götalandsregionen - Närhälsan - Vårdcentraler - Område V3 - Närhälsan Kärra vårdcentral (Göteborg) workplace verified by Västra Götalandsregionen on 2018-02-27
Regioner - Västra Götalandsregionen - Närhälsan - Vårdcentraler - Område V3 - Närhälsan Torslanda vårdcentral workplace verified by Västra Götalandsregionen on 2018-02-27
Regioner - Västra Götalandsregionen - Närhälsan - Vårdcentraler - Område V3 - Närhälsan Tuve vårdcentral (Göteborg) workplace verified by Västra Götalandsregionen on 2018-02-27
Regioner - Västra Götalandsregionen - Närhälsan - Vårdcentraler - Område V3 - Närhälsan Öckerö vårdcentral workplace verified by Västra Götalandsregionen on 2018-02-27

Coworker

Andreas Fors
Leg.Sjuksköterska, Sektion reproduktiv och perinatal hälsa, vårdpedagogik och radiografi, Närhälsan FoU-centrum Göteborg och Södra Bohuslän
Lilas Ali
Forskare, Institutionen för vårdvetenskap och hälsa, Psykiatri Affektiva
Hanna Gyllensten
Leg apotekare, Institutionen för klinisk neurovetenskap, Institutionen för vårdvetenskap och hälsa
Anders Ullman
Överläkare/sektionschef, Geriatrik, Lungmedicin och Allergologi
Michael Fu
Professor, Överläkare, Universitetssjukhusöverläkare, MD, PhD, FESC, Avdelningen för molekylär och klinisk medicin, Medicin, Geriatrik och Akutmottagning Östra
Karl Swedberg
Överläkare, Institutionen för medicin, Cardiovascular Science, Medicin, Geriatrik och Akutmottagning Östra
Elin Blanck
Doktorand, psykiatrisjuksköterska, Neurologi, psykiatri och habilitering, Institutionen för vårdvetenskap och hälsa

3. Processen och projektets redovisning

Publikationer från detta projekt

Detaljerad projektbeskrivning

Background

Partly funded by the Swedish Research Council, the University of Gothenburg and Centre for Person-centred Care have developed and tested a novel approach to care, the Gothenburg Person Centred Care (gPCC) approach, which has been shown to facilitate the transition to a more patient-inclusive approach to care. The gPCC approach (gPCC) has been evaluated in several contexts and conditions, and shown to result in several positive effects. 1-6 For

instance, it shortens hospital stay, improves self-efficacy, reduces health care costs and maintains functional performance 7-9. Previous trials have all been performed in hospitals and primary care. A recently concluded pre-study made the first step to explore the feasibility of extending gPCC to patients’ homes, “gPCC at distance”. The study has shown that

worsening events were significantly reduced by 20% in patients with CHF and COPD following delivery of care over the phone (unpublished data; n= 240; randomized into two groups). On top of this, the gPCC group reported decreased anxiety levels and increased self-efficacy. Where the previous study focused on preventing rehospitalization of previously admitted patients, this project proposal takes gPCC one step further and aims at preventing hospitalization of patients with a chronic condition:

gPCC at Home·

To facilitate gPCC at Home, we developed - in collaboration with patients, relatives and health professionals - a web based application to provide patients with a means for better communication with health professionals and a way to keep track of their health plan. For the development and validation of the application we chose to focus on patients with COPD and/or CHF recruited from primary care.

Patients, relatives and health professionals who have initially tested the application have reported the application as user friendly, technically stable and leading to increased co-creation of care.

Aims of the project

• To investigate the preventive effects of gPCC at Home on self-efficacy, symptom distress/anxiety and hospitalisation of chronically ill patients, using the care of patients with COPD and/or CHF as an example.

• To evaluate the efficacy of a customised web based gPCC application supporting patients with chronic illnesses to manage their condition from their own homes.

• To perform a societal cost-utility analysis of gPCC at Home in comparison with the traditional approach to health care.

We hypothesise that gPCC at Home will increase self-efficacy and reduce symptom burden, and consequently the need for hospitalisation of people with chronic conditions, reducing the cost of health care.

Theoretical frame of reference

This project takes the point of departure from the theoretical framework by Amartya Sen and Paul Ricoeur 10,11,12 where the assumption is that human beings are capable and aware of their human responsibility for their life and health. If these human capabilities, such as will, imagination and abstract reasoning are used systematically, also in the health care of patients with long term illness, such practise may translate into the mobilisation of resources and

strengthening of self-respect and self-efficacy. On the other hand, it demands responsibility, awareness and skills from health professionals to balance patients´ needs, vulnerability and capabilities. Co-creation of care between the patients, their family and carers, and health professionals is the core component of person centred care.

Method

Study design

The study is a randomized, open, parallel group intervention study.

Patient selection:

• Inclusion criteria: Men and women listed at a public primary care centre in Gothenburg and registered with a diagnosis of COPD and/or CHF.

• Exclusion criteria: Not willing to participate, severe impairment that prevents the patient from using the tool; no registered address, any severe disease with an expected survival 6); ongoing documented diagnosis of alcohol or drug abuse; other disease that can interfere with follow-up (e.g. severe depression, other severe mental illness); participating in another conflicting randomized intervention study.

Implementation steps of the gPCC approach

Patients with COPD and/or CHF and cared for in primary care will be randomized to usual care (control) or gPCC at Home (intervention), after receiving oral and written information about the study and after they have given written

consent to participate.

Power

To achieve 80% power based on an alfa-error of 0.05 for an increase of the proportion of improved patients from 20% to 40%, the number of participants in each group (comparison and intervention) needs to comprise 91 patients.

We need to include 110 patients in each group to have some margin for withdrawals. Thus a minimum of 220 patients has to be randomized.

Usual care group:

Patients randomized to usual care will be managed by regular evidence-based treatment and care as outlined in

treatment guidelines and followed at their local primary care centre.

Intervention group:

Patients randomized to the intervention group will be called by dedicated RNs. Based on the patient narrative, the patient´s goals, resources and needs will be identified. The patient (sometimes together with relatives) and the RN will formulate a person-centred health plan. This plan is part of and will be up-loaded to the gPCC at Home platform, which also contains individual notes and information about CHF and COPD. The plan will be the point of

departure for the forthcoming dialogue at distance via gPCC at Home that the patient and the RN will have during the study period (six months).

Patients will be inspired to make notes on “a good day” or “a bad day” respectively to thoroughly consider how to reach the goals in their health plan, containing three parts;

1. “My goal is to feel or be able to do”.

2. “To be able to reach my goal I will.”

3.”Support I need to reach my goal”.

gPCC at Home is designed to fit the patient record online (www.1177.se) and to inspire usage as the patient can also keep a health diary (through text and video logs), view trend graphs concerning their health and communicate with e.g. relatives and health professionals by sending text or voice messages or by calling. The platform is interactive and is based on the patient´s self-reported symptoms and daily condition. Thereby the patient is made aware of both promoting and risk factors to maintain health, which results in relevant and achievable goal setting.

In the communication between the RN and patient during the study period, the health plan is regularly evaluated and any needs of reformulating the goals may be discussed. The overall goal is to help patients identify and use their own capabilities/resources such as strong will, social relations etc. and formulate goals that help them increase their selfefficacy

and cope with their condition in daily life. The RN presents the gPCC at Home web based support for communication (I-pad, smartphone) and they agree on how they will be in contact thereafter. The RN invites the patient and activates their account where he/she can login

via an individual user name and formulate, comment and evaluate the agreed health plan developed from the initial phone conversation. Access to the diary will be password protected. Different forms of symptom-ratings and comments can also be made. The RN can see the patient´s account and make comments. The patient can add or delete staff or private persons that have access to the account. The patient can also limit access to the account. This

form of access makes it simple to connect the gPCC at Home health plan to the health account for each patient (patient record through internet (www.1177.se)). By this approach patients are “self-implementing” the gPCC at Home approach into the existing medical system.

Data collection

Follow-up questionnaires on self-efficacy, health–related quality of life, shortness of breath, anxiety and depression will be sent out to all patients in both groups after 3,6,12, and 24 months.

The health-economic evaluation will use data from the following resources:

• data from the regional patient register VEGA (Region Västra Götaland),

• social care from the city of Gothenburg,

• lost productivity for the patient, from sickness absence registered in the MiDAS database (Social insurance agency) and self-report in patient questionnaires (since the first 14 days of each sick-leave are not covered by official statistics),

• lost productivity for next of kin as well as other costs to the individual and/or family and friends related to the treatment collected from patient questionnaires and diaries.

• time used by the RNs in communication with patients and relatives

Endpoints

The primary efficacy endpoint is a composite score of changes in general self-efficacy 13 based on the General Self- Efficacy Scale (GSE), hospitalization and death. The rationale for such an endpoint is the value of combining patient experience and clinical outcomes

A patient is classified as improved, deteriorated or unchanged accordin to the following criteria::

A patient is classified as deteriorated if

• at 6 months, self-efficacy has decreased by > 5 units (the minimal change of clinical significance) or has been admitted to hospital for unscheduled reasons or the patient has died.

A patient is classified as improved if

• self-efficacy has increased by > 5 units and has not been hospitalized.

Those who have neither deteriorated nor improved are considered unchanged.

The secondary efficacy endpoints are:

• Health care utilization measured as the number of re-admissions and unscheduled outpatient visits due to unplanned visits to hospital and/or primary care centre due to symptoms of COPD,

• Incremental cost-utility ratios,

• EuroQol Group´s five-dimension health state questionnaire (EQ-5D) 14,15,

• General Self- Efficacy scale (GSE-scale) 13,

• Shortness of breath in heart failure (SOB-HF) 16,

• COPD Assessment Test (CAT) 17,

• Hospital anxiety and depression scale (HADS) 18.

Health-economic evaluation of the intervention study

The primary objective of the health-economic analyses is to estimate the difference in total societal costs between the two approaches in relation to the difference in quality-adjusted life-years gained (incremental cost-utility ratios) for the “average” patient, and analyse its dependence on personal characteristics. The estimation includes two steps: a) to quantify all resource use and quality of life related to illness and treatment in physical terms and b) to valuate uses of resources in monetary terms and calculate a utility measure between minus and plus one from the quality-of-life instrument.

There are a number of issues involved in valuing healthcare in monetary terms, related to the basic economic theoretical concept of “opportunity cost” true societal valuations and marginal costs. We will follow state of the art and make alternative estimates of costs and present the results as sensitivity analyses which will be a test of the robustness of results. Health related quality of life measured by EQ-5D is collected repeatedly in the patient questionnaires. As a sensitivity analysis, we will use both a general population value set from UK , as there is no such value set validated for Sweden and a Swedish patient population set for the translation of EQ-5D results to utilities. Difference in costs and difference in utilities will be compared (assuming that there will be no difference in length of life between the two groups) and cost-utility ratios will be estimated. The dependence of personal characteristics,

e.g., education and income (collected from the LISA database at Statistics Sweden and though patient questionnaires), will be tested using multivariate statistical analyses. Furthermore, the distribution of costs will be analysed by major stake-holders, i.e. county council/region, municipality, market sectors (productivity loss) and

individual/family/friends, respectively, to facilitate also more limited approaches to economic evaluation.

References

1. Feldthusen C, Dean E, Forsblad-d'Elia H, et al. Effects of Person-Centered Physical Therapy on Fatigue-Related Variables in Persons With Rheumatoid Arthritis: A Randomized Controlled Trial. Archives of physical medicine and rehabilitation 2016;97(1):26-36.

2. Fors A, Ekman I, Taft C, et al. Person-centred care after acute coronary syndrome, from hospital to primary care - A randomised controlled trial. Int J Cardiol 2015;187:693-99.

3. Larsson A, Palstam A, Lofgren M, et al. Resistance exercise improves muscle strength, health status and pain intensity in fibromyalgia-a randomized controlled trial. Arth res & ther 2015;17:161.

4. Brännström M, Boman K. Effects of person‐centred and integrated chronic heart failure and palliative home care. PREFER: a randomized controlled study. European journal of heart failure 2014;16(10):1142-51.

5. Ekman I, Wolf A, Olsson L-E, et al. Effects of person-centred care in patients with chronic heart failure: the PCC-HF study. European heart journal 2012;33(9):1112-19.

6. Olsson LE, Karlsson J, Ekman I. The integrated care pathway reduced the number of hospital days by half: A prospective comparative study of patients with acute hip fracture. Journal of orthopaedic surgery and research 2006;1(3)

7. Hansson E, Ekman I, Swedberg K, et al. Person-centred care for patients with chronic heart failure - a cost-utility analysis. Eur J Cardiovasc Nurs 2016;15(4):276-84.

8. Olsson L-E, Karlsson J, Berg U, et al. Person-centred care compared with standardized care for patients undergoing total hip arthroplasty—a quasi-experimental study. Journal of orthopaedic surgery and research 2014;9(1)

9. Olsson LE, Hansson E, Ekman I, et al. A cost-effectiveness study of a patient-centred integrated care pathway. J Adv Nurs 2009;65(8):1626-35.

10. Ekman I, Swedberg K, Taft C, et al. Person-centered care—Ready for prime time. European journal of cardiovascular nursing 2011;10(4):248-51.

11. Ricoeur P. Oneself as another. University of Chicago Press, 1992.

12. Sen A. Capability and Well-being. In: Nussbaum M, Sen A, eds. The Quality of Life. Oxford: Clarendon Press 1993:30-53.

13. Schwarzer R, Jerusalem M. Generalized Self-Efficacy scale. In: Weinman J, Wright S, & Johnston M, eds.Measures in health psychology: A user’s portfolio Causal and control beliefs. Windsor, England.: NFER-NELSON 1995:35-37.

14. Brooks R. EuroQol: the current state of play. Health policy (Amsterdam, Netherlands)

1996;37(1):53-72.

15. EuroQol--a new facility for the measurement of health-related quality of life. Health policy (Amsterdam, Netherlands) 1990;16(3):199-208.EM 

16. Ekman I, Granger B, Swedberg K, et al. Measuring shortness of breath in heart failure (SOB-HF): development and validation of a new dyspnoea assessment tool. Eur J Heart Fail

2011;13(8):838-45.

17. Jones PW, Brusselle G, Dal Negro RW, et al. Properties of the COPD assessment test in a crosssectional European study. The European respiratory journal 2011;38(1):29-35.

18. Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta psychiatrica

Scandinavica 1983;67(6):361-70.

19. Sahlen KG, Boman K, Brannstrom M. A cost-effectiveness study of person-centered integrated heart failure and palliative home care: Based on a randomized controlled trial. Palliative medicine 2016;30(3):296-302.

20. Wolf A, Fors A, Ulin K, Thorn J, Swedberg K, Ekman I. An eHealth Diary and Symptom-Tracking Tool Combined With Person-Centered Care for Improving Self-Efficacy After a Diagnosis of Acute Coronary Syndrome: A Substudy of a Randomized Controlled Trial. J Med Internet Res. 2016;18(2):e40.


Utvärdering av en personcentrerad e-Hälsa plattform vid långvarig sjukdom - en
randomiserad kontrollerad studie med exemplen kronisk hjärtsvikt och KOL, from FoU i Västra Götalandsregionen
http://www.researchweb.org/is/html/vgr/project/224881