이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

Post Operative Survey Through a Bi-Directional Secure Mobile Messaging System (mCare)

Defense and Veterans Pain Rating Scale (DVPRS)and Post Operative Survey Through a Bi-Directional Secure Mobile Messaging System - A Randomized Feasibility Study (mCare)

  • Purpose The general purpose of this project is to assess the utility of the mCare application and MHCE (Mobile Healthcare Environment) system - a secure, mobile, smartphone app based platform - for same day surgery postoperative follow up of patients receiving peripheral nerve blocks.
  • Research Design Randomized open-label study, comparing the satisfaction of the two groups with the method of follow up, which is either over the phone or via a mCare application. A separate group made up of nurses and physicians will have the opportunity to take a short anonymous survey to rank their opinion on the use of the smartphone application for patient feedback.

연구 개요

상태

완전한

정황

상세 설명

The primary objective of the study is to evaluate the feasibility of the implementation of the mCare system for postoperative follow-up and querying of patients receiving peripheral nerve blocks during their perioperative care. The investigators intend to perform a randomized pilot study comparing mCare with the current standard of care. Participants will be randomized into 2 groups: a) standard of care groups and b) mCare group. In the standard of care group, the participants will be followed-up via a phone call by an Acute Pain Service (APS) nurse, according to current standards. During the past year there have been 375 calls made, 64 of which have not been answered (17%). In the mCare group participants will be followed-up via mCare application. 48 hours after discharge an APS nurse is going to call the participants in group a) and the mCare system will notify participants in group b) to answer follow-up questions about their pain and peripheral nerve block. If necessary (based on the follow-up algorithm), participants in either group will be contacted (via phone call or the app, depending on group assignment) 7 days after their surgery to assess resolution of the peripheral nerve block. At the end of follow-up, on postoperative day 8, each patient will be asked to complete the satisfaction and convenience surveys. 10 days after their surgery participants in the mCare group will complete the System Usability Survey (SUS).At the end of the study, APS nurses and medical providers will be asked to complete the satisfaction and convenience surveys, and follow-up response data will be summarized and analyzed. Our research question is whether the use of the mCare system would result in improved patient compliance, satisfaction, and convenience on both the patient and the provider side, while being at least as safe as the standard of care.

Research question 1: Does the use of mCare app improve postoperative follow-up response rate of patients receiving perioperative peripheral nerve blocks who are discharged the same day?

Research question 2: Does satisfaction, convenience and ease of use differ between the mCare system and current standards a) in the patient population and b) among health care providers?

The pain assessment tool adapted for the mCare app will be the Defense and Veterans Pain Rating Scale(DVPRS),which is a 6 item questionnaire for assessing current pain, average and worst pain over the last 24 hours, and physical and emotional function. The DVPRS has been validated at Walter Reed National Military Medical Center (WRNMMC), but the administration has been paper based during rounds by the Acute Pain Service.

The current standard for follow up with patients who receive regional anesthesia for same day surgery is that the APS nurse contacts them 48 hours after the procedure and asks about their pain, qualities and duration of the nerve block, and their satisfaction with the service. If the patient's answers make it necessary (e.g. the block doesn't wear off, the numbness still persists) then the APS nurse calls them again one week after the surgery. If the numbness still persists at that point, then the APS nurse escalates their case by informing the regional anesthesia provider who decides further steps.

In this study, the investigators intend to substitute the phone call by the APS nurse with the use of the mCare app. Our research question is whether the app is at least as safe as the standard of care, and at least as easy to use and convenient as the phone call.

연구 유형

중재적

등록 (실제)

50

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • Maryland
      • Bethesda, Maryland, 미국, 20889
        • Walter Reed National Military Medical Center

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

연구 대상 성별

모두

설명

Inclusion Criteria:

  • Male and female military health care beneficiaries age 18 and 89 years old
  • Receive peripheral nerve block affecting their limb(s)
  • Same day surgery
  • Owns a personal cell phone with the following features:
  • A 320 x 240 screen display resolution or greater
  • ii. Text messaging capabilities
  • iii. Data service capabilities
  • iv. Service provided by either: AT&T, AllTel, Sprint, T-Mobile, or Verizon
  • Ability to use their personal cell phone
  • Ability to read and respond to a message in English as the app is only in English.
  • Receives reliable cell phone service in their home.
  • DEERS eligibility

Exclusion Criteria:

  • Under age 18 and over 89 years old
  • Non-English speaking-App will only be in English as this is an app developed just for this study.
  • Active participation in other research studies involving mobile devices
  • Inability to interact with a touch screen mobile device
  • Receive Exparel(which is a pain medication drug they can receive during surgery since these patients will be called 48 hour post discharge)

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 건강 서비스 연구
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
다른: Group A - Standard of Care
Participants will be followed-up via phone call by Acute Pain Research Nurse
실험적: Group B - mCare group
Participants will be followed-up via mCare mobile app

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Clinical Burden of Contact Method
기간: 10 days
This will be measured by comparing the proportion of patients who completed clinical measures at initial contact attempt and any contact attempt. The initial contact method is a phone call for the SOC group, and an initial text reminder for mCare group. Patients who do not respond to the initial contact attempt are subsequently re-contacted, which is a clinical burden.
10 days

2차 결과 측정

결과 측정
측정값 설명
기간
Participant-Reported Contact-Method Evaluations
기간: 10 days
A contact-method satisfaction survey asked participants the degree to which they were satisfied with their contact method (phone or mCare app) (1=not satisfied at all, 5=completely satisfied), whether they would like to use their respective contact method for follow-up after a future surgery (yes/no), and the degree to which the contact method was convenient (1=not convenient at all, 5=very convenient). An 8-item system usability survey was completed by mCare participants. Participants rated the degree to which they agreed with statements of app usability on a 5-point scale (1=strongly disagree, 5=strongly agree).
10 days
Nurse Satisfaction and Preferences
기간: 10 days
A 5-item nurse satisfaction survey assessed nurse satisfaction and preferences for each contact method. This included which method they gave more accurate information, was easier to understand and use, was more convenient, was safer, and preferred for post-surgical follow-up for regional anesthesia. Response options included: phone call, mCare, and both methods equally.
10 days

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: COL (ret) Chester C Buckenmaier, MD, Defense and Veterans Center for Integrative Pain Management

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2016년 6월 16일

기본 완료 (실제)

2018년 6월 15일

연구 완료 (실제)

2018년 8월 30일

연구 등록 날짜

최초 제출

2017년 11월 28일

QC 기준을 충족하는 최초 제출

2018년 2월 6일

처음 게시됨 (실제)

2018년 2월 13일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2018년 9월 19일

QC 기준을 충족하는 마지막 업데이트 제출

2018년 9월 18일

마지막으로 확인됨

2018년 9월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • 500249

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

통증에 대한 임상 시험

Phone Call에 대한 임상 시험

구독하다