Effectiveness of a Health Systems Strengthening Intervention to Improve Detection, Treatment, and Control of Multiple Long-Term Conditions in Primary Health Care Facilities in the Western Cape and KwaZulu Natal, South Africa
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,837
- 试验地点
- 32
- 主要终点
- Composite outcome: Diagnosis and treatment initiation for a new condition, intensification or change of treatment for a condition treated at enrolment, or improved control for a condition not optimally controlled at enrolment.
研究概览
简要总结
The goal of this study is to determine the effect of the ENHANCE intervention in improving clinical outcomes and evaluating the effects of the intervention on implementation processes and outcomes. The specific questions it aims to answer are:
- To test and estimate the effect of the intervention in people with MLTCs attending
PHCs on:
i. Detection of, and initiation of treatment for, additional chronic conditions ii. Treatment intensification and changes in medication iii. Control of chronic conditions iv. patient reported health-related quality of life and functioning v. health care utilisation and adherence vi. costs of health care 2. To use the RE-AIM framework to assess implementation processes and outcomes through measurements of reach, adoption, implementation, and maintenance. 3. To understand implementation processes and outcomes within the wider context of primary healthcare, provide explanations for the observed effects of the clinical findings and identify recommendations for wider implementation of the ENHANCE intervention.
The participants in the control group will receive usual care at their primary health care facility, which includes the use of the Practical Approach to Care Kit (PACK) or Adult Primary Care (APC) clinical decision support tool. Participants in the intervention group will receive care for their multiple chronic condition by a clinician trained to use the ENHANCE clinical decision support tool (intervention tool), and receive two CHW visits in their home to provide treatment literacy and adherence support.
详细描述
Control facilities Participants in control facilities will continue to receive usual care. Primary health care of long-term conditions is delivered free-at-point-of-care in public sector primary care facilities which includes the management of HIV, NCDs and mental health problems, according to South Africa's Ideal Clinic and Integrated Clinical Services Management model. This care model, which has combined the long-term care of HIV together with NCDs within each facility, has greatly enabled the feasibility of further interventions specifically addressing MLTCs and includes the Adult Primary Care (APC) or PACK clinical guidance. Patients attending these chronic services usually attend the same clinic regularly, 3 to 6-monthly for periodic monitoring of their chronic conditions. Chronic medication is collected monthly either at the facility (through fast-track queues), or through decentralised chronic medication dispensing systems which provide for collection from a range of sites including community venues (e.g. halls), wellness or adherence clubs, trailers, retail pharmacies (in KZN) or e-Lockers.
Intervention clinics
Participants in intervention clinics will continue with usual care as described for control clinics but in addition will receive the ENHANCE health systems intervention comprising tools and implementation strategies that have been co-developed with stakeholders through an iterative process, drawing on:
i. Evidence on the commonest MLTC combinations ii. Scoping reviews conducted on effectiveness of MLTCS interventions and systems barriers and enablers of person-centred care for MLTCs in LMICs iii. Provincial and district learning collaborative workshops with stakeholders from KZN and Western Cape.
iv. Clinical working groups with clinicians and health workers, a Guidance Oversight Board v. Input from our ENHANCE advocacy academy of 16 people living with MLTCs in the Western Cape and KZN
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 40 years or older
- •Receiving care for at least two of the following conditions, with at least one of the first five listed conditions being uncontrolled or patients indicated as struggling with the management of their condition:
- •i. HIV (Self-reported current treatment). ii. hypertension (Self-reported current treatment. iii. diabetes (Self-reported current treatment). iv. asthma (Self-reported current treatment). vi. depression (Self-reported current treatment). vii. previous myocardial infarction (self-reported). viii. previous stroke (self-reported history).
排除标准
- •Participants planning to relocate from either uMgungundlovu, KwaZulu-Natal, and Cape Metro in Western Cape, or changing their facilities during the period of the study.
- •Participants who are unable to give informed consent due to loss of capacity.
- •Participants self-reporting pregnancy
- •Participants who cannot communicate in English, isiXhosa, isiZulu, or Afrikaans.
- •Participants who are not willing to receive care for chronic conditions in their homes.
研究组 & 干预措施
Intervention
- Treatment literacy in chronic condition waiting rooms/pick-up points (posters, health promotion talks)
- 1-2 longer consultations with ENHANCE guide trained clinician
- Treatment literacy event - a contact between a CHW and a person with MLTC in their home (hopefully with carer), at 2 weeks and 4 weeks, using Health Diary
- Referrals to additional adherence counselling if necessary
干预措施: ENHANCE intervention (health systems) (Other)
Control
Usual care at primary health care clinic, which includes consultation with a clinician using the PACK/APC guide. No additional support is usually provided for care of MLTCs.
结局指标
主要结局
Composite outcome: Diagnosis and treatment initiation for a new condition, intensification or change of treatment for a condition treated at enrolment, or improved control for a condition not optimally controlled at enrolment.
时间窗: 12 months
Number of participants who meet any of the following criteria during follow-up: 1. . Diagnosis and initiation of treatment during follow-up of one or more additional chronic conditions, 2. . Intensification or change of treatment during follow-up for at least one of the chronic conditions present and treated at enrolment, or, 3. . Improved control of at least one condition that was not optimally controlled at baseline, defined as follows: HIV - viral suppression (viral load \<50 copies/mL); hypertension - systolic blood pressure\<140 mmHg and diastolic blood pressure less than 90mmHg; diabetes - HbA1c \<8%, asthma - Asthma Control Test score ≥16, depression - Patient Health Questionnaire 8 (PHQ-8) \<10
次要结局
- Diagnosis and initiation of treatment during follow-up of one or more additional chronic conditions(12 months)
- Intensification or change of treatment during follow-up for at least one of the chronic conditions present and treated at enrolment(12 months)
- Patient Health Questionnaire-8 (PHQ-8) score(12 months)
- Social Support(12 months)
- Healthcare utilisation - Number of clinic visits(12 months)
- Healthcare utilisation - Number of hospital outpatient visits(12 months)
- Healthcare utilisation - hospital admissions(12 months)
- Healthcare utilisation - hospital admission days(12 months)
- Health care costs(12 months)
- Patient experience with treatment and self-management(12 months)
- Improved control of at least one condition that was not optimally controlled at baseline(12 months)
- World Health Organisation Disability Assessment Schedule 2.0 score(12 months)
- Health-related quality of life EuroQol 5-Dimension 5-Level score(12 months)
- Health-related quality of life visual analogue scale score(12 months)
- Patient Assessment of Chronic Illness Care(12 months)
研究者
Inge Petersen
Director, Centre for Rural Health
University of KwaZulu