Holistic care program for elderly patients to integrate spiritual needs, social activity, and self-care into disease management in primary care (HoPES3): study protocol for a cluster-randomized trial

Abstract Background Strategies to improve the care of elderly, multimorbid patients frequently focus on implementing evidence-based knowledge by structured assessments and standardization of care. In Germany, disease management programs (DMPs), for example, are run by general practitioners (GPs) for...

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Main Authors: Cornelia Straßner, Eckhard Frick, Gabriele Stotz-Ingenlath, Nicola Buhlinger-Göpfarth, Joachim Szecsenyi, Johannes Krisam, Friederike Schalhorn, Jan Valentini, Regina Stolz, Stefanie Joos
Format: Article
Language:English
Published: BMC 2019-06-01
Series:Trials
Subjects:
Online Access:http://link.springer.com/article/10.1186/s13063-019-3435-z
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author Cornelia Straßner
Eckhard Frick
Gabriele Stotz-Ingenlath
Nicola Buhlinger-Göpfarth
Joachim Szecsenyi
Johannes Krisam
Friederike Schalhorn
Jan Valentini
Regina Stolz
Stefanie Joos
author_facet Cornelia Straßner
Eckhard Frick
Gabriele Stotz-Ingenlath
Nicola Buhlinger-Göpfarth
Joachim Szecsenyi
Johannes Krisam
Friederike Schalhorn
Jan Valentini
Regina Stolz
Stefanie Joos
author_sort Cornelia Straßner
collection DOAJ
description Abstract Background Strategies to improve the care of elderly, multimorbid patients frequently focus on implementing evidence-based knowledge by structured assessments and standardization of care. In Germany, disease management programs (DMPs), for example, are run by general practitioners (GPs) for this purpose. While the importance of such measures is undeniable, there is a risk of ignoring other dimensions of care which are essential, especially for elderly patients: their spiritual needs and personal resources, loneliness and social integration, and self-care (i.e., the ability of patients to do something on their own except taking medications to increase their well-being). The aim of this study is to explore whether combining DMPs with interventions to address these dimensions is feasible and has any impact on relevant outcomes in elderly patients with polypharmacy. Methods An explorative, cluster-randomized controlled trial with general practices as the unit of randomization will be conducted and accompanied by a process evaluation. Patients aged 70 years or older with at least three chronic conditions receiving at least three medications participating in at least one DMP will be included. The control group will receive DMP as usual. In the intervention group, GPs will conduct a spiritual needs assessment during the routinely planned DMP appointments and explore whether the patient has a need for more social contact or self-care. To enable GPs to react to such needs, several aids will be provided by the study: a) training of GPs in spiritual needs assessment and training of medical assistants in patient counseling regarding self-care and social activity; b) access to a summary of regional social offers for seniors; and c) information leaflets on nonpharmacological interventions (e.g., home remedies) to be applied by patients themselves to reduce frequent symptoms in old age. The primary outcome is health-related self-efficacy (using the Self-Efficacy for Managing Chronic Disease 6-Item Scale (SES-6G)). Secondary outcomes are general self-efficacy (using the General Self-Efficacy Scale (GSES)), physical and mental health (using the Short-Form Health Survey (SF-12)), patient activation (using the Patient Activation Measure (PAM)), medication adherence (using the Medication Adherence Report Scale (MARS)), beliefs in medicine (using the Beliefs About Medicines Questionnaire (BMQ)), satisfaction with GP care (using selected items of the European Project on Patient Evaluation of General Practice (EUROPEP)), social contacts (using the 6-item Lubben Social Network Scale (LSNS-6)), and loneliness (using the 11-item De-Jong-Gierveld Loneliness Scale (DJGS-11)). Interviews will be conducted to assess the mechanisms, feasibility, and acceptability of the interventions. Discussion If the interventions prove to be effective and feasible, large-scale implementation should be sought and evaluated by a confirmatory design. Trial registration German Clinical Trials Register (DRKS), DRKS00015696. Registered on 22 January 2019.
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spelling doaj.art-bb956cee16cc49b093a8596eac053c512022-12-21T18:00:27ZengBMCTrials1745-62152019-06-0120111110.1186/s13063-019-3435-zHolistic care program for elderly patients to integrate spiritual needs, social activity, and self-care into disease management in primary care (HoPES3): study protocol for a cluster-randomized trialCornelia Straßner0Eckhard Frick1Gabriele Stotz-Ingenlath2Nicola Buhlinger-Göpfarth3Joachim Szecsenyi4Johannes Krisam5Friederike Schalhorn6Jan Valentini7Regina Stolz8Stefanie Joos9Department of General Practice and Health Services Research, University Hospital HeidelbergDepartment of Psychosomatic Medicine and Psychotherapy, Research Center Spiritual Care, Technical University of MunichDepartment of Psychosomatic Medicine and Psychotherapy, Research Center Spiritual Care, Technical University of MunichDepartment of General Practice and Health Services Research, University Hospital HeidelbergDepartment of General Practice and Health Services Research, University Hospital HeidelbergDepartment for Medical Biometry, Institute for Medical Biometry and Informatics, University Hospital HeidelbergInstitute of General Practice and Interprofessional Care, University Hospital TübingenInstitute of General Practice and Interprofessional Care, University Hospital TübingenInstitute of General Practice and Interprofessional Care, University Hospital TübingenInstitute of General Practice and Interprofessional Care, University Hospital TübingenAbstract Background Strategies to improve the care of elderly, multimorbid patients frequently focus on implementing evidence-based knowledge by structured assessments and standardization of care. In Germany, disease management programs (DMPs), for example, are run by general practitioners (GPs) for this purpose. While the importance of such measures is undeniable, there is a risk of ignoring other dimensions of care which are essential, especially for elderly patients: their spiritual needs and personal resources, loneliness and social integration, and self-care (i.e., the ability of patients to do something on their own except taking medications to increase their well-being). The aim of this study is to explore whether combining DMPs with interventions to address these dimensions is feasible and has any impact on relevant outcomes in elderly patients with polypharmacy. Methods An explorative, cluster-randomized controlled trial with general practices as the unit of randomization will be conducted and accompanied by a process evaluation. Patients aged 70 years or older with at least three chronic conditions receiving at least three medications participating in at least one DMP will be included. The control group will receive DMP as usual. In the intervention group, GPs will conduct a spiritual needs assessment during the routinely planned DMP appointments and explore whether the patient has a need for more social contact or self-care. To enable GPs to react to such needs, several aids will be provided by the study: a) training of GPs in spiritual needs assessment and training of medical assistants in patient counseling regarding self-care and social activity; b) access to a summary of regional social offers for seniors; and c) information leaflets on nonpharmacological interventions (e.g., home remedies) to be applied by patients themselves to reduce frequent symptoms in old age. The primary outcome is health-related self-efficacy (using the Self-Efficacy for Managing Chronic Disease 6-Item Scale (SES-6G)). Secondary outcomes are general self-efficacy (using the General Self-Efficacy Scale (GSES)), physical and mental health (using the Short-Form Health Survey (SF-12)), patient activation (using the Patient Activation Measure (PAM)), medication adherence (using the Medication Adherence Report Scale (MARS)), beliefs in medicine (using the Beliefs About Medicines Questionnaire (BMQ)), satisfaction with GP care (using selected items of the European Project on Patient Evaluation of General Practice (EUROPEP)), social contacts (using the 6-item Lubben Social Network Scale (LSNS-6)), and loneliness (using the 11-item De-Jong-Gierveld Loneliness Scale (DJGS-11)). Interviews will be conducted to assess the mechanisms, feasibility, and acceptability of the interventions. Discussion If the interventions prove to be effective and feasible, large-scale implementation should be sought and evaluated by a confirmatory design. Trial registration German Clinical Trials Register (DRKS), DRKS00015696. Registered on 22 January 2019.http://link.springer.com/article/10.1186/s13063-019-3435-zSpiritual carePrimary careLonelinessMedicationOld ageHome remedies
spellingShingle Cornelia Straßner
Eckhard Frick
Gabriele Stotz-Ingenlath
Nicola Buhlinger-Göpfarth
Joachim Szecsenyi
Johannes Krisam
Friederike Schalhorn
Jan Valentini
Regina Stolz
Stefanie Joos
Holistic care program for elderly patients to integrate spiritual needs, social activity, and self-care into disease management in primary care (HoPES3): study protocol for a cluster-randomized trial
Trials
Spiritual care
Primary care
Loneliness
Medication
Old age
Home remedies
title Holistic care program for elderly patients to integrate spiritual needs, social activity, and self-care into disease management in primary care (HoPES3): study protocol for a cluster-randomized trial
title_full Holistic care program for elderly patients to integrate spiritual needs, social activity, and self-care into disease management in primary care (HoPES3): study protocol for a cluster-randomized trial
title_fullStr Holistic care program for elderly patients to integrate spiritual needs, social activity, and self-care into disease management in primary care (HoPES3): study protocol for a cluster-randomized trial
title_full_unstemmed Holistic care program for elderly patients to integrate spiritual needs, social activity, and self-care into disease management in primary care (HoPES3): study protocol for a cluster-randomized trial
title_short Holistic care program for elderly patients to integrate spiritual needs, social activity, and self-care into disease management in primary care (HoPES3): study protocol for a cluster-randomized trial
title_sort holistic care program for elderly patients to integrate spiritual needs social activity and self care into disease management in primary care hopes3 study protocol for a cluster randomized trial
topic Spiritual care
Primary care
Loneliness
Medication
Old age
Home remedies
url http://link.springer.com/article/10.1186/s13063-019-3435-z
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