Feasibility and Economic Evaluation of a Teleconsultation Care Pathway for Older Patients With Noncommunicable Diseases at an Academic Primary Care Clinic in Kuala Lumpur, Malaysia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Change from Baseline in Patient Satisfaction at 6 Months
研究概览
简要总结
The purpose of this study is to evaluate a newly developed virtual care program for older adults with chronic diseases (hypertension, diabetes and lipid disorders) whether it is feasible and economical to implement in the Malaysian primary healthcare settings. We hypothesize that the use of this virtual care program (TeleCOOP-NCD©) will be more cost-effective (lower total costs per benefits gained) compared to the usual onsite care at the clinic for older adults who have stable chronic diseases. We also hypothesize that there is no significant difference in control of clinical parameters compared to usual care. Researchers will compare the primary outcomes such as patient satisfaction, health-related quality of life, provider cost and patient cost between the intervention and control group. Researchers will also check participant recruitment rate, participant retention rate and clinical parameters (including blood pressure, hemoglobin A1c, fasting blood glucose, fasting serum lipids) as secondary outcomes. Eligible participants will receive either virtual care program (intervention) or usual care (regular in-person visits) at a primary care clinic, called the Klinik Primer of Hospital Canselor Tuanku Muhriz (KP-HCTM), in Bandar Seri Permaisuri, Kuala Lumpur, Malaysia. Researchers will do outcome assessments at baseline, 3 months and 6 months respectively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with the age of 60 years and above;
- •Patients who are literate in either Malay or English language;
- •Patients who are not frail or mildly frail (with the scores of 0-8 in the Pictorial Fit-Frail Scale assessment);
- •Patients who are receiving treatment for hypertension, diabetes and/or dyslipidemia (any of the three NCDs); and
- •Patients who have internet access and know how to operate a smartphone/device or are able to receive assistance for its use from their family members or caregivers.
排除标准
- •Patients who are completely transferred out from the Klinik Primer or Hospital Canselor Tuanku Muhriz (HCTM);
- •Patients who are newly referred to the clinic and attending their first visit;
- •Patients who visit the clinic for teaching sessions or non-doctor consultations (allied health, procedures, or prescription refill).
研究组 & 干预措施
TeleCOOP-NCD
干预措施: Teleconsultation care pathway for older adults with NCDs (TeleCOOP-NCD©) (Other)
Conventional care
All participants in this conventional care arm will receive the care at the clinic as usual. They will not receive the intervention (teleconsultation by using the TeleCOOP-NCD© care pathway).
结局指标
主要结局
Change from Baseline in Patient Satisfaction at 6 Months
时间窗: Baseline and 6 months
The original English version of the Patient Satisfaction Questionnaire Short Form (PSQ-18) or the validated Malay version (Ganasegeran K et al., 2014) will be used. The PSQ-18 includes 18 items covering 7 domains: general satisfaction (2 items), technical quality (4 items), interpersonal manners (2 items), communication (2 items), financial aspects (2 items), time spent with the doctor (2 items), and accessibility and convenience (4 items). All Items are scored on a 5-point Likert scale (minimum 1 and maximum 5). 9 items are to be reverse-scored. After that, overall satisfaction score will be calculated by averaging the scores from all items and the change from baseline in patient satisfaction at 6 months will be reported for each arm. The higher score means greater overall patient satisfaction.
Change from Baseline in Health-related Quality of Life (HRQoL) at 6 Months
时间窗: Baseline and 6 months
The EQ-5D-5L questionnaire is a validated tool to measure the HRQoL. It includes two parts: the descriptive part with five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and the visual analogue scale (EQ-VAS). Each dimension has a 5-point Likert scale (1= no problems; 5= extreme problems). These responses are combined into a single multi-attribute utility index score for each participant. Then it will be converted to the respective EQ-5D index values of individual participants by using the EQ-5D-5L value set for the Malaysian Population (minimum possible utility score= -0.442 and maximum score = 1.0; higher index values representing a better health state). The EQ-VAS allows patients to rate their overall health on the day of the assessment, with the minimum score being 0 (the worst imaginable health) and the maximum score being 100 (the best imaginable health). Higher EQ-VAS scores represent better HRQoL.
Difference in the Provider Cost between the TeleCOOP-NCD Arm and Conventional Care Arm
时间窗: From enrollment to the end of 6-month follow-up visit
The step-down costing method will be used to calculate the capital costs (for buildings and required clinic equipment which cost more than or equal to Ringgit Malaysia - RM 500) and the activity-based costing method will be used to calculate the recurrent cost incurred to operate the study site (including the costs for administration, maintenance, utilities, staff emolument and consumables). The provider cost for each arm is assessed by combing the capital costs and recurrent costs. From that, the difference in the provider cost between the two arms will be computed.
Difference in the Patient Cost between the TeleCOOP-NCD Arm and the Conventional Care Arm
时间窗: From the enrollment to the end of 6-month follow-up visit
The direct and indirect costs related to the clinic visit will be assessed by using the cost diary for clinic visit expenditure (filled by the participants/ their caregivers) and activity-based costing method. The patient cost will be computed by combing the direct and indirect costs related to the clinic visit from the patients' perspective.
次要结局
- Incremental Cost-Effectiveness Ratio (ICER) of TeleCOOP-NCD versus Conventional Care(From the enrollment to the end of 6-month follow-up visit)
- Participant Recruitment Rate(From the start of study recruitment to the anticipated completion of enrollment (estimated at 12 months))
- Participant Retention Rate(From enrollment to the end of 6-month follow-up visit)
- Change from Baseline in Systolic Blood Pressure (SBP) at 3 Months and 6 Months(Baseline, 3 months and 6 months)
- Change from Baseline in Diastolic Blood Pressure (DBP) at 3 Months and 6 Months(Baseline, 3 months and 6 months follow-up visits)
- Change from Baseline in Hemoglobin A1c (HbA1c) at 6 Months(Baseline and 6 months)
- Change from Baseline in Fasting Blood Glucose (FBS) Levels at 3 Months and 6 Months(Baseline, 3 months and 6 months)
- Change from Baseline in Total Cholesterol Levels at 6 Months(Baseline and 6 months)
- Change from Baseline in Low-density Lipoprotein Cholesterol (LDL-C) Levels at 6 Months(Baseline and 6 months)