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Open Access Study protocol

A region-based palliative care intervention trial using the mixed-method approach: Japan OPTIM study

Tatsuya Morita1*, Mitsunori Miyashita2, Akemi Yamagishi3, Nobuya Akizuki4, Yoshiyuki Kizawa5, Yutaka Shirahige6, Miki Akiyama7, Kei Hirai8, Motohiro Matoba9, Masako Yamada10, Taketoshi Matsumoto11, Takuhiro Yamaguchi12 and Kenji Eguchi13

Author Affiliations

1 Department of Palliative and Supportive Care, Palliative Care Team, and Seirei Hospice, Seirei Mikatahara, General Hospital 3453 Mikatahara-cho, Hamamatsu, Shizuoka 433-8558, Japan

2 Department of Adult Nursing/Palliative Care Nursing, School of Health Sciences and Nursing, Graduate, School of Medicine, The University of Tokyo, 7-3-1, Hongo, Bunkyo-ku, Tokyo 113-0033, Japan

3 Department of Adult Nursing/Palliative Care Nursing, School of Health Sciences and Nursing, Graduate, School of Medicine, The University of Tokyo, 7-3-1, Hongo, Bunkyo-ku, Tokyo 113-0033, Japan

4 Psycho-Oncology Division, Research Center for Innovative Oncology, National Cancer Center Hospital East 6-5-1, Kashiwanoha, Kashiwa, Chiba 277-8577, Japan

5 Department of Medical Social Service, Center for Palliative and Supportive Care, Graduate School, University of Tsukuba, 1-1-1 Ten-nohdai, Tsukuba 305-8575, Japan

6 Shirahige Clinic, 1-13-28, Katafuchi, Nagasaki, Nagasaki 850-0003, Japan

7 Faculty of Policy Management, Keio University, 5322 Endo, Fujisawa-shi, Kanagawa 252-8520, Japan

8 Graduate School of Human Sciences; Center for the Study of Communication-Design; Department of Complementary and Alternative Medicine, Graduate School of Medicine, Osaka University, 1-2, Yamadaoka, Suita, Osaka 565-0871, Japan

9 Department of Palliative Medicine and Psycho-Oncology, National Cancer Center, 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan

10 Research Center for Development of Nursing Practice, St. Luke's College of Nursing 3-8-5 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan

11 Division of Respiratory Disease, Head of Regional Support, Kumamoto Takumadai Hospital, 1-14-27 Onoue, Kumamoto-city, Kumamoto 862-0913, Japan

12 Department of Clinical Trial Data Management, Graduate School of Medicine, The University of Tokyo, Hospital, 7-3-1, Hongo, Bunkyo-ku, Tokyo 113-0033, Japan

13 School of Medicine, Tokai University, 143 Shimokasuya, Isehara, Kanagawa 259-1143, Japan

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BMC Palliative Care 2012, 11:2  doi:10.1186/1472-684X-11-2

Published: 11 January 2012

Abstract

Background

Disseminating palliative care is a critical task throughout the world. Several outcome studies explored the effects of regional palliative care programs on a variety of end-points, and some qualitative studies investigated the process of developing community palliative care networks. These studies provide important insights into the potential benefits of regional palliative care programs, but the clinical implications are still limited, because: 1) many interventions included fundamental changes in the structure of the health care system, and, thus, the results would not be applicable for many regions where structural changes are difficult or unfeasible; 2) patient-oriented outcomes were not measured or explored only in a small number of populations, and interpretation of the results from a patient's view is difficult; and 3) no studies adopted a mixed-method approach using both quantitative and qualitative methodologies to interpret the complex phenomenon from multidimensional perspectives.

Methods/designs

This is a mixed-method regional intervention trial, consisting of a pre-post outcome study and qualitative process studies. The primary aim of the pre-post outcome study is to evaluate the change in the number of home deaths, use of specialized palliative care services, patient-reported quality of palliative care, and family-reported quality of palliative care after regional palliative care intervention. The secondary aim is to explore the changes in a variety of outcomes, including patients' quality of life, pain intensity, family care burden, and physicians' and nurses' knowledge, difficulties, and self-perceived practice. Outcome measurements used in this study include the Care Evaluation Scale, Good Death Inventory, Brief pain Inventory, Caregiving Consequence Inventory, Sense of Security Scale, Palliative Care Knowledge test, Palliative Care Difficulties Scale, and Palliative Care Self-reported Practice Scale. Study populations are a nearly representative sample of advanced cancer patients, bereaved family members, physicians, and nurses in the region.

Qualitative process studies consist of 3 studies with each aim: 1) to describe the process in developing regional palliative care in each local context, 2) to understand how and why the regional palliative care program led to changes in the region and to propose a model for shaping regional palliative care, and 3) to systemically collect the barriers of palliative care at a regional level and potential resolutions. The study methodology is a case descriptive study, a grounded theory approach based on interviews, and a content analysis based on systemically collected data, respectively.

Discussion

This study is, to our knowledge, one of the most comprehensive evaluations of a region-based palliative care intervention program. This study has 3 unique aspects: 1) it measures a wide range of outcomes, including quality of care and quality of life measures specifically designed for palliative care populations, whether patients died where they actually preferred, the changes in physicians and nurses at a regional level; 2) adopts qualitative studies along with quantitative evaluations; and 3) the intervention is without a fundamental change in health care systems. A comprehensive understanding of the findings in this study will contribute to a deeper insight into how to develop community palliative care.

Trial Registration

UMIN Clinical Trials Registry (UMIN-CTR), Japan, UMIN000001274.