Human Factors Intervention to Reduce Risk in Primary Care of the Elderly (SAFE-C)
A Human Factors Intervention to Reduce Risk in Primary Care of the Elderly
Human factors engineering literature makes clear that appropriate, well-designed and well-timed information improves decision making and can reduce mental workload. Data from a previous study showed that appropriate, well-designed and well-timed information is not present in many primary care encounters with elderly patients. This puts primary care physicians at risk of higher mental workload and poor decision making which can affect the quality and safety of care delivered to patients. Elderly patients are at particular risk because they are more likely to have more comorbidities, medications, and cognitive impairments.
Dr. Karsh and his research team will test an intervention to improve the performance of primary care physicians and, thus the safety of primary care of the elderly. The investigators will use a randomized experiment, with random assignment at the level of patient, to test and evaluate the intervention. The evaluation will involve 4 primary care clinics, with 4 primary care physicians per clinic. The investigators will collect data from 768 patient visits pre-intervention and 1536 patient visits during the intervention. Intervention patients will be randomly assigned to the intervention or care as usual.
The Intervention has two components:
Pre-visit care coordination:
- 5-7 days prior to a study patient's appointment with his/her doctor, the doctor's nurse/MA will call the study patient and collect pertinent clinical information about the patient using a data collection form the investigators call a Patient Overview Document or POD.
- The nurse/MA will ensure that any lab results, consultant reports, ER reports, imaging studies, etc., that will be needed by the physician are available to the doctor.
Team Meeting:
On the day of the patient's appointment and prior to the beginning of the clinic session, the nurse/MA will meet briefly with the doctor to jointly review the POD.
Hypotheses:
H1. Primary Care Physician (PCP): The intervention will increase situation awareness, reduce PCP mental workload, reduce PCP perceived likelihood of error, and improve PCP visit satisfaction. PCP efficiency, as measured by encounter problem density during a visit, will also improve.
H2. Patient: The intervention will improve patients' perceptions of their visits on a variety of AHRQ CAHPS measures, such as physician knowledge of patient history.
H3. Patient: The intervention will not impact the number or types of problems addressed during the visit.
H4. Clinic: The intervention will not affect visit RVUs
調査の概要
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Wisconsin
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Madison、Wisconsin、アメリカ、53705
- University of Wisconsin, Madison
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Must be greater than or equal to 65 years of age
- Must be patients of participating physicians
Exclusion Criteria:
- Cannot speak English
- Cannot hear well enough to respond to questions via the telephone or do not have a caregiver who can respond to questions on their behalf
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:ヘルスサービス研究
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的:intervention
Received the intervention: previsit planning phone call with filled out patient overview document & clinician huddle
|
The Intervention has two components:
On the day of the patient's appointment, prior to the beginning of the clinic session, the nurse/MA and doctor will jointly review the POD. |
|
介入なし:observation
Received usual care
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number and types of problems discussed during visit
時間枠:04/12
|
There are no outcome measures for individual patients. We will review the dictated clinic note for each study patient visit in order to
We will compare the number of problems and the kind of problems found in the intervention patient group with the number and kind of problems found in the care-as-usual group. |
04/12
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Resource utilization
時間枠:04/12
|
There are no outcome measures for individual patients.
We will look at the resource utilization (RVUs) during care-as-usual visits compared to resource utilization during intervention visits.
To assess resource utilization, we will collect E&M/CPT codes for each study visit and calculate the RVUs.
A study patient is seen only once.
|
04/12
|
協力者と研究者
捜査官
- 主任研究者:Ben-Tzion Karsh, PhD、University of Wisconsin, Madison
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。