Rationale And Design Of Cardiovascular Diseases (CVD)Risk Assessment And Communication By Nurses For Primary And Secondary Preventation Of CVDs In India.

https://doi.org/10.33698/NRF0232-Kavita, J S Thakur ,Rajesh Vijayvergiya ,Sandhya Ghai

Abstract : Background: Rising burden of CVDs is the biggest challenge of 21st century in India and has contributed enormously to the increased burden on health care services including human resources. Innovative approaches are required to implement prevention programmes with limited human resource. One such approach is task shifting of CVD risk assessment and communication to nurses, as nurses are one of the key health care providers in all levels of health care. The present study has been designed to test the innovative approach of risk assessment and communication by nurses for primary and secondary prevention of CVDs in tertiary health care setting. Methods and analysis: The study is quasi experimental in nature with one year follow up to determine the effect of CVD risk assessment and communication by nurses using risk communication package on primary and secondary prevention of CVDs. All the nurses (n=16) working in the selected OPDs of the tertiary health care setting will be trained in CVD risk assessment and communication. A total of 900 patients (400 for primary prevention and 500 for secondary prevention) attending the medicine and allied along with cardiology out patient departments will be enrolled by trained nurses for the study. Primary outcome measures for primary and secondary prevention groups will be the cardiovascular risk modification and medication adherence respectively. Ethics and dissemination : Ethical approval has been obtained from Institute ethics committee. Results will be disseminated via peer reviewed scientific journals and presentation at national and international conferences.

Keywords

Cardiovascular diseases (CVDs), risk assessment by nurses , primary prevention, secondary prevention , task shifting

Correspondence at

Dr. Kavita

Lecturer

National Institute of Nursing Education (NINE) PGIMER, Chandigarh.

Introduction

Worldwide cardiovascular diseases (CVDs) are the major cause of disability and premature death. In 2012 cardiovascular diseases contributed 46.2%(17.5 million) of all non communicable diseases death.1 CVDs accounted for 26% of the total deaths in India(2012)2. Among Cardiovascular diseases, coronary heart disease, are major contributors to the higher death rates in India.3 Coronary artery disease in India occurs at a younger age and affects the more productive section of the society.4

Evidence suggests that cardiovascular diseases are preventable and both primary and secondary prevention measures are important. Primary prevention strategies of risk stratification and communication are for the people who are at high risk but do not have clinically manifest CVD i.e. people with risk factors (e.g. hypertension, diabetes, smoking and increased blood cholesterol). Assessment of individuals with high risk of CVDs assumes a central role in primary prevention. A number of risk prediction equations mainly developed from the cohorts of high income countries are available to assess the absolute risk of cardiovascular event over a specified period of time.5 However in India WHO/ISH risk prediction charts for SEAR D region can be used as no population specific model exists.6

Secondary prevention of CVDs is useful in individuals who are at high cardiovascular risk because they have established cardiovascular disease (patients with history of MI, angina, stroke etc.) or very high levels of individual risk factors. Risk stratification is not necessary for making treatment decisions for these individuals as they belong to the high risk category; all of them need intensive lifestyle interventions and appropriate drug therapy.7, 8

A study from US has demonstrated producing substantially larger mortality reductions than secondary prevention.9 Clark et al in their systematic review and meta analysis found that secondary CVD prevention programs resulted in 17% reduction in all-cause mortality and acute myocardial infarction.10 Various other CVD Prevention Programs like North Karelia project (1972)- Finland, Stanford 3-Community Study (1972-75), Stanford five city project, Minnesota Heart Health Program(MHHP) were undertaken in different regions of the world to demonstrate the importance and effect of preventive measures in the reduction of cardiovascular diseases and its risk factors.11-14 Although there is enough evidence that justifies the need of primary and secondary prevention measures for better health outcomes, the implementation of primary and secondary prevention programmes is a real challenge especially in India because of deficit human resource. Adequate resources especially human resource for health (HRH) are key to the implementation of the prevention programmes but there is huge deficit of HRH in India which is similar to many other countries of the world.15 The density of health workforce in India is less as per the WHO norm of 2.5 health workers/ 1000 population. According to National Sample Survey Organization estimates, the density of allopathic physicians in urban and rural areas was 11.3 and 1.9 respectively per 43% reduction in CHD (Coronary heart ten thousand populations.16 The present disease) mortality between 1980-2000, out of which half is attributable to primary prevention with primary prevention scenario of HRH deficit is detrimental in the implementation of primary and secondary prevention programmes in India.

Some of the possible solutions for meeting the challenges of human resources include, training more people, strengthening the public health system, mainstreaming doctors of  AYUSH (Ayurveda, Yoga, Unani, Siddha and Homeopathy), employing task-shifting and strengthening nursing and paramedical cadres.17 Although the substantial scale up of human resource will take many years, task shifting can be one of the interim solution to fill this gap of HRH deficit. Task shifting refers to the transferring clinical tasks from physicians to trained non physician health workers e.g. nurses. Since nurses are qualified and one of the largest workforce in any health care institution, they can be trained in CVD risk assessment and management.

A systematic review by Ogedegbe G et al revealed the applicability of task shifting with proper training and continuous feedback. Authors of this review also recommended that effective task shifting interventions targeted at reducing the global CVD epidemic in LMICs are urgently nurses20 The results of a study in resource- poor area of South Africa on implementation of a nurse-led Non communicable disease (NCD) services based on clinical protocols revealed that the protocols enabled the nurses to control the clinical condition of hypertension, diabetes and asthma.21 However to the best of our knowledge we did not find any study of nurses invovelment in CVD risk assessment and mangment from India. So keeping in mind the rising cardiovascular disease burden and shortage of health workforce, the present study was planned to explore the innovative approach of task shifting of cardiovascular risk assessment and communication by nurses.

Methods and Analysis

Study Design

The present study is a quasi experimental study to determine the effect of CVD risk assessment and communication by nurses using a risk communication package for primary and secondary prevention of CVDs.CVD in the present study refers to needed.18 Another systematic review by coronary artery disease. The study will be Joshi R et al highlighted that task shifting is a successful, cost effective and viable model for managing non communicable diseases.19

Evidence from the Western World have demonstrated that nurses can be successfully trained in CVD risk assessment and management. Result of a randomized controlled trial revealed that the cardiovascular risk significantly reduced after one year of treatment by practicing conducted in the out patient departments(OPDs) of a tertiary care hospital in Chandigarh (North India). Nurses working in the selected OPDs of the hospital will be trained in CVD risk assessment and communication. Risk communication package will be developed to train nurses in cardiovascular risk assessment and communication. These trained nurses will recruit the patients from selected OPDs.Each trained nurse will recruit minimum of 20-25 patients each. Patients from medicine and allied OPDs will be recruited for primary prevention whereas patients for secondary prevention will be recruited from Cardiology OPDs.

Sample size

Study participants include both nurses and patients. All the nurses (approx n=16) working in medicine allied and cardiology of a tertiary health care hospital will be enrolled. A total of 900 patients (400 for primary prevention and 500 for secondary prevention) will be enrolled for the study from the selected OPDs. For the primary prevention of CVDs the required sample size is 400 which is calculated based on the prevalence of hypertension in Chandigarh (50%) and considering 10-15% attrition.22,23 Whereas for the secondary prevention group the sample size calculations will be based on the present medication adherence rate among CHD patients of 50% to the desired 80%.24 Based on this criteria total sample size is 243(approx 250). So the required sample in secondary prevention group is 500, 250 each in intervention and comparison group. All the calculations are done for 80% power and 95% confidence level.

Randomization

Block randomization using computer generated sequence will be done for the random assignment of patients in intervention and comparison arm for the secondary prevention group. Comparison group will receive the usual care. However no randomization will be done for primary prevention group as screening for absolute CVD risk is not routinely done, therefore it is not expected that patients will get any usual care. So because of ethical concerns randomization will only be done in secondary prevention group.

Study population

Study population includes both nurses and patients. Nurses working in selected OPDs will be trained for participation in the study. These trained nurses will assess and communicate cardiovascular risk among patients. Patients attending the medicine and allied OPDs will be eligible for the enrolment in primary prevention group if their Systolic BP> 140 mmHg and/or diastolic BP>90 mmHg or taking medication for hypertension. Patients with the history of any fatal or nonfatal cardiovascular event and critically ill patients will be excluded form the primary prevention group. For the secondary prevention group patients with established CHD e.g. myocardial infarction, angina or CABG( Coronary Artery bypass graft surgery)/PTCA(Percutaneous transluminal coronary angioplasty) attending cardiology OPD will be enrolled and then randomized.Terminally ill patients will be excluded from secondary prevention group.

Development of Risk Communication package

Risk communication package will facilitate the nurses in assessing and communicating the 10 year absolute risk of CVDs to the patients for primary and secondary prevention of CVDs. The risk communication package will be developed after thorough literature review and expert consultation. Risk communication will be developed by the investigator and validation will be done by giving it to experts. Various WHO documents will be referred for preparing the package e.g.

  1. Pocket guidelines for assessment and management of Cardiovascular Risk.
  2. Avoiding heart attacks and strokes. Don’t be a victim–Protect yourself.
  3. Global Atlas on Cardiovascular Disease Prevention and Control.
  4. WHO/ISH Training manual for  CVD r i s k   a s s e s s m e n t      a n d management.2009

Risk communication package will include

  1. Flash cards for patient education: A set of 18 to 20 flash cards will be developed to aid nurses in risk communication.

We will take the help of professional artists to make the risk communication package interesting and easily comprehensible. Communication package will be developed in English. Health education material for patient’s communication will be translated into Hindi by language expert. Back translation will also done to establish the validity of translated material. Package will be duly pretested.

Training for Nurses

Nurses participating in the study will be trained in cardiovascular risk assessment

 

  1. Booklet for nurses: Contents of the and communication with the help   of the booklet include:-Introduction to CVDs, assessment and management of CVDs by using WHO/ISH risk prediction charts and guidelines, all the major risk factors of CVD (like tobacco use, physical inactivity, diet, alcohol use),treatment adherence and guidelines for risk communication. It will be developed in English language.
  1. Patient education booklet: It will be developed both in English and Hindi language. It will include information about all the major risk factors of CVDs with appropriate pictures and This booklet will be given to patients after the initial risk communication by nurses.package. Training methodology will include lectures, group work, role plays, case scenarios and interactive sessions. Each lecture will be followed by a practical session and group work. Total duration of training will be 6-8hrs (As recommended in WHO training manual). On site refresher training will also be done as required.
  2. Training will consist of three sessions of two to two and a half hour each . In the first session risk factor and prevention of CVD will be taught to the nurses with the help of lecture cum discussion method. Second session will include lecture on CVD risk assessment by using  WHO/ISH  risk prediction. Following this they will be demonstrated the use of the charts. After the demonstration nurses will be given case scenarios for assessing the risk which will be followed by discussion. Example of case scenario ”What is the 10-year risk of suffering a heart attack in a female non- smoker, non-diabetic, 50 years old, with SBP 160 and no measure of blood cholesterol?”.Each participant will be given scenarios to practice which will help them in developing skill of risk assessment with WHO/ISH risk prediction . Third session will emphasize on risk communication and communication skills. After intitial lecture each participant will be given role plays to act. Example of role play: “Mr X, 50 years man working as a clerk in a office is suffering from hypertension since one year. He is a smoker. On assessment his BP was 160/90 and CVD risk according to WHO/ISH risk prediction chart was 20 to <30%. He asks you ‘Please tell me how can I get rid of smoking?’. How would you communicate the risk and counsel him ?”. Demonstration of communication skills with the help of role plays will help in identification of strengths and weakness of  nurses while communicating so that the necessary modification can be done .

Intervention

For Primary prevention:

Patients aged 40 years and above attending the medicine and allied OPDs will be screened for hypertension by a trained nurse. Patients with hypertension will be enrolled for primary prevention of CVDs . JNC-7 criteria will be used for the diagnosis of hypertension i.e. SBP> 140mmHg or DBP> 90 mmHg or use of antihypertensive drugs. Diabetic status of the enrolled patients will be assessed by random blood sugar using freestyle optium glucometer. Patients will be considered diabetic if they are on treatment for diabetes or their random blood sugar( RBS) of > 200mg/dl. Assessment of the smoking status will be done and nicotine dependence will be assessed by using Fagerstrom test of nicotine dependence.25

Based on the age, gender, systolic blood pressure, diabetic and smoking status, nurses/ or investigator (in case of unavailability of trained nurse) will assess the CVD risk using WHO/ISH risk prediction charts (without cholesterol) of SEAR D region(Patient flow for primary prevention is shown in Fig 1) Risk assessment will be followed by risk communication and advice about lifestyle modification using flash cards from the risk communication package. Patients will also be given the health education booklet. Investigator will evaluate all the risk assessment by nurses to establish reliability.

Study investigator will evaluate the communication skills of nurses with help of Gap Kalamazoo communication skill assessment form (GKCSAF).26 Nearly one fourth of all risk communication by nurses will also be evaluated by external rater in addition to investigator. GKCSAF is a five point likert scale which evaluates the nine sub domains of communication to generate a domain specific as well as total score. The nine sub domains include building relationship ,opening the discussion, gathering information, understanding patient and family perspective, sharing information, reaching agreement, providing closure, demonstrating empathy and communicating accurate information. After the initial risk assessment and communication there will be four patient follow ups, first three at 1st ,3rd and 6th months telephonically to reinforce risk reduction and last face to face follow up at one year to assess the modification of risk.

For Secondary Prevention

Patients attending the cardiology OPDs will be enrolled for secondary prevention of CVDs by trained nurses. Consenting patients with established CVD(coronary artery diseases ) attending cardiology OPD will be enrolled. CVD risk assessment/risk stratification will not be done in these patients as they are already at high cardiovascular risk. Patients will be randomly assigned to the intervention and comparison group by using a computer generated block randomization sequence.After enrolment medication adherence of the patients will be assessed using Morisky Medication Adherence Scale (MMAS) in both the groups (Patient flow for secondary prevention in shown in fig 2) .Validated Hindi version of the tool will be used in the study.27

Risk communication and advices about lifestyle modification will be done by trained nurses or investigator (in case of unavailability of trained nurse) only in the inter vention group. Initial r isk communication will be followed by four follow ups , first three at 1,3,6 months telephonically to reinforce medication adherence and lifestyle modification Comparison group will receive the usual care. All the patients in comparison group will be recruited by the investigator. The last follow up at one year will be done face to face in both the groups to assess the medication adherence with the help of MMAS.

Study outcomes

Primary outcome of the study is the risk modification and medication adherence at one year follow up for primary and secondary prevention of CVDs.respectively. Risk modification will be  assessed according to the shift in the CVD risk category using WHO/ISH risk prediction charts at one year follow up. Mc Nemar test will be used to assess significance of the change in the risk category. Change in the individual risk factors e.g. systolic and diastolic blood pressure, random blood sugar and smoking status will also be assessed. Overall mean change in risk factors from baseline to one year follow up will be calculated to determine the effect of the intervention. Medication adherence with MMAS-8 will be assessed at one year follow up in both the intervention and comparison group. Mean change form baseline will be calucated. Unpaired t- test will be used to test the significance of difference in both the groups.

Reliability of risk assessment by nurses will be calculated by kappa statistic. Risk score generated by nurses will be compared with investigator score to establish inter rater reliability. To assess the inter rater reliability of risk communication between investigator and external rater, intraclass correlation coefficient will be used. Overall reliability as well as reliability for each communication domains of GKCSAF will be calculated. The score on GKCSAF ranges from 9-45, the score of 27 and above is considered to be good. Mean communication scores of the nurses will be calculated to assess their communication skills.

Statistical considerations

Statistical analysis will be done using both descriptive and inferential statistics. SPSS version 19 will be used for data analysis. Mean, SD and percentages will be used to summarize the  baseline characteristics. t-test and chi square tests will be used to assess the effect of intervention on risk modification and treatment adherence. Kappa statistic and intraclass correlation will be used to assess the reliability of risk assessment and risk communication by nurses. All testing will be done at 0.05 level of significance.

Ethics and dissemination

Formal ethical approval has been obtained from the Institute Ethics committee of Postgraduate Institute of Medical Education and Research, Chandigarh. Written informed consent will be taken from all the participants. The findings of the study will be disseminated via peer reviewed scientific journals and presentations at national and international conferences.

Conclusion

The study will evaluate the innovative approach of CVD risk assessment and management by nurses for primary and secondary prevention CVDs in India. The findings of this study will help policymakers and institute authorities to decide on the policy of task shifting of CVD risk assessment and management unto nurses so that all the nurses in the institute can be trained and the task can be incorporated in their job profile.

References

  1. World Health Organization .Global status report on Non communicable Genava; WHO: 2014.
  2. World Health Organization . NCD country profiles; India:
  3. Patel V, Chatterji S, Chisholm D, Ebrahim S, Gopalakrishna G, Mathers C et Chronic diseases and injuries in India. Lancet 2011;377:4,13–28.
  4. Iyengara SS, Gupta R, Ravi S, Thangam S, Alexander T, Manjunath CN et al. Premature coronary artery disease in India: coronary artery disease in the young (CADY) Indian Heart J .  2              0              1              6              : http://dx.doi.org/10.1016/j.ihj.2016.09.009
  5. Matheny M, McPheeters ML, Glasser A, Mercaldo N, Weaver RB Jerome RN et Systamtic review of CVD assessment tools. Agency for healthcare research & quality.US. 2011
  6. World Health Organization. Prevention of Cardiovascular Disease: Pocket guidelines for assessment and management of cardiovascular risk.Genava;WHO:2007.
  7. Hobbs FDR. Cardiovascular Disease: Different Strategies for primary and secondary Heart 2004; 90:1217-1223.
  8. World Health Organization. Prevention of Cardiovascular Disease: Guidelines for assessment and management of cardiovascular risk. Genava; WHO:2007.
  9. Young F, Capewell S,Ford ES,Critchley Coronary mortality declines in the U.S. between 1980 and 2000- quantifying the contributions from primary and secondary prevention. Am J Prev Med. 2010;39(3):228-234.
  10. Clark AM, Hartling L, Vandermeer B, McAlister Metaanalysis: secondary prevention programs for patients with coronary artery disease. Ann Intern Med. 2005;143(9):659-672.
  11. Puska The North Karelia Project:30 years successfully preventing chronic diseases Diabetic Voice. 2008;53: Special issue.
  12. Farquhar Stanford community trials. Accessed from internet on 7-4-2013.
  13. Winkleby MA, Taylor CB, Jatulis D , Fortmann The long term effects of a cardiovascular disease prevention trial: The Stanford five city project. American Journal of Public Health. 1996:86(12): 1773-1779.
  14. Lando HA, Pechacek TF, Pirie PL, Murray DM, Mittlelmark MB, Lichtenstein E, et al. Changes in adult cigarette smoking in the Minnesota heart health American Journal of Public Health. 1995:85(2): 201-208.
  15. Terry B, Bisanzo M , McNamara M,Dreifuss B, Chamberlain S, Nelson SWet al. Task shifting: Meeting the human resources needs for acute and emergency care inAfrica, African Journal of Emergency Medicine (2012)
  16. Rao M, Rao KD, Kumar AKS, Chatterjee M, Sundararaman India: Towards Universal Health Coverage 5, Human resources for health in India. Lancet 2011; 377: 587–98
  17. High Level Expert Group Report on Universal Health Coverage for Human Resources for Health.
  18. Ogedegbe G, Gyamfi J, Rhue JP, Surkis A, Rosenthal DM, Airhihenbuwa C Task shifting interventions for cardiovascular risk reduction in low income and middle income countries: a systematic review of randomised controlled trials. BMJ Open;4:e 005983.doi:10.1136/bmjopen- 2014-005983.
  19. Joshi R, Alim M, Kengne AP, Jan S, Maulik PK, Peiris D Task shifting for non communicable disease management in low and middle income countries- a systematic review. PLoS ONE 9(8): e103754.doi10.1371/journal.pone.0103754.
  1. Tiessen AH, Smit AJ, Broer J, Groenier KH, Meer Randomized controlled trial on cardiovascular risk management by practice nurses supported by self monitoring in primary care. BMC Family Practice 2012, 13:90
  2. Coleman R, Gill IG, Wilkinson Noncommunicable disease management inresource-poor settings: a primary care modelfrom rural South Africa.Bull. of the World Health Organization, 1998, 76 (6): 633- 640.
  3. Lateef S .Cardiovascular diseases on rise in The pioneer report. 17 February 2012 21:37
  4. Thakur Emerging Epidemic of Non Communicable Diseases-An Urgent Need for Control Initiative(Editorial).Indian Journal Community Medicine.2005; 30( 4):103.
  5. Thakur JS, Jaswal N, Bhatnagar N, Vijayvergia R, Kaur M. A pilot study to assess medication adherence rate among patients on follow up treatment of Acute Coronary Syndrome.2012, Unpublished
  6. Heatherton F Kozlowski LT & Fagerström K O.The Fagerström test for nicotine dependence: A revision oJof uthrneaFloagf AerdsdtricötmionTso1le9r9a1n;c8e6:Q1u1e1s9t-io-‐n1n1a2ir7e..British
  7. Calhoun AW Rider EA, Meyer EC, Lamiani G, Truog Assessment of Communication Skills and Self- Appraisal in theSimulated Environment: Feasibility of Multirater Feedback withGap Analysis.Simul Healthcare ;2009(4):22–9.
  8. Morisky DE, Ang A, Krousel-Wood M, Ward H. Predictive Validity of a Medication Adherence Measure for Hypertension Control. Journal of Clinical Hypertension 2008; 10(5):348-354.